Friday, February 25, 2005

Patent Settlement Aids University of Rochester

from the Rochester Democrat and Chronicle:

Merck & Co. and GlaxoSmithKline announced that they have settled their disputes over patents in connection with vaccines that could prevent cervical cancer. This should speed up the development of the vaccines that will protect against human papillomavirus, an infection that causes most cervical cancer.

Research done a decade ago by three UR scientists plays a key role in the vaccine technology.

While no financial details were disclosed, Marjorie Hunter, director of the UR medical center's Office of Technology Transfer, said royalty payments to the university would be "substantial."

Wednesday, February 23, 2005

The CBS people asked to resign in Rather-gate didn't resign

Back around January 10, 2005, in the context of the "60 Minutes Wednesday" report about Bush's National Guard Service, CBS fired producer Mary Mapes and asked three others to resign. Apparently, the three have not yet resigned, so, as of the moment, there is only one casualty of Rather-gate. In the matter of Jan-Hendrik Schon, there was only one casualty, Schon. In the matter of false statements in law reviews, there have been zero casualties.

From the Observer:

As it stands, the report’s conclusions about the news gathering—and particularly about the follow-up—are still under attack. As of Tuesday evening [Feb. 22, 2005], the three CBS staffers asked to resign as a result of the investigation continued to refuse to do so, with former 60 Minutes Wednesday executive producer Josh Howard demanding CBS correct the record about his own responsibility.

But also on Tuesday, Salon reported on a 2,600-word letter that Mr. Burkett had written to CBS, in which the former National Guardsman seemed to agree with the panel: He blamed CBS for failing to properly vet the documents, which he said he had offered only on the condition that he not have to explain their chain of custody.

"CBS, through its employees, had to make a critical decision as to whether they were willing to take that risk," he wrote. "There were no expressed or implied warranties about the documents. Yet I believed them to be authentic."

Few producers inside CBS News seemed interested in the veracity of the memos, focusing instead on their colleagues who had taken the blame. But few felt that the report had led to justice—and that its injustice began with its failure to resolve the mystery.

The Observer also discussed future possibilities about uncovering the source of the documents:

Other avenues of cracking the case, outside the network’s own investigation, don’t appear very promising at the moment. If the documents are fakes, they are apparently illegal—it is against the law in Texas to forge a government document, according to Chapter 32.21 of the Texas Penal Code. The chapter on forgery makes it clear that forging a government record, state or federal, is a felony.

But Mr. Burkett has never been pursued by authorities, who could feasibly force him to answer questions under oath about where he got the memos supposedly drafted by former Texas Air National Guard Lt. Col. Jerry Killian, who was President Bush’s commanding officer in the early 1970’s.

On Oct. 5, 2004, 51 members of Congress called for an investigation into the suspected forgery. A spokesperson for Texas Representative Lamar Smith said that Mr. Smith’s efforts to drum up support for an investigation had not yielded results. "We are not aware of any legal action on this," he said.

Kathy Colvin, a spokesperson for the U.S. attorney’s office in Dallas, said she was "not aware of any charges that have been filed."

Another twist in Rambus/Hynix case?

from techworld

The district court (D Northern Ca]in the infringement case scheduled for trial April 11, 2005 has ordered Hynix to produce a document allegedly revealing details of a secret DRAM manufacturers' cartel that Rambus claims was called "the JRA Group".

The court also ordered that Rambus be provided details of a joint defense agreement apparently entered into in August 2000 by several semi-conductor manufacturers, including three DRAM makers: Hynix; Micron; and Infineon.

Hynix has asserted that these documents are privileged and need not be produced under a joint-defense agreement. The documents apparently include communications between Hynix and its competitors regarding Rambus and its patents.

John Danforth, a senior VP and general counsel at Rambus, said: "While we cannot know the contents of the documents withheld on the basis of a claim of 'joint defense', they seem to show a high degree of co-operation among defendants relating to Rambus and its patents. The dates of these documents may also be significant. They predate the design of new DRAM products using Rambus technology and fall in a time period when, according to the recent guilty pleas of one DRAM company and four of its executives, there existed a criminal conspiracy among certain DRAM companies to eliminate
competition."

***from Bloomberg -->
On the flip side, a lawyer for Infineon Technologies AG , concerning a different proceeding in Virgina, asserted Rambus Inc. destroyed documents knowing that competitors would need them to defend against the company's patent infringement lawsuits. Rambus, which doesn't make the chips it designs, claims its patents cover aspects of all chips made in the $26 billion memory- chip market. The company is seeking royalties from Infineon and other companies who refused to sign agreements to license its patents for dynamic random access memory, or DRAM. DRAM, the most common type of computer memory, loses its content when the power is turned off. DRAM chips are used in computers, digital cameras, mobile phones and other products.
Rambus sued Infineon for patent infringement in August 2000. Infineon counter-sued claiming Rambus should lose its patent rights because of its fraudulent participation in the Joint Electronic Device Engineering Council [JEDEC], a memory-chip standards committee.


***
Of the patent/antitrust boundary, in September 2004, Infineon pleaded guilty to fixing memory prices and agreed to pay a $160 million fine, the US Department of Justice (DoJ) has announced. The fine is the third largest in the history of the DoJ's anti-trust division.

The DoJ charged Infineon with violating the Sherman Anti-trust Act by conspiring with unnamed DRAM manufacturers between July 1999 and June 2002 to fix prices on DRAM sold to computer and server vendors.

Tuesday, February 22, 2005

Partnership held liable for inequitable conduct of partner

In Evident v. Dwight and Church, we see the aftermath of a poorly-thought out patent litigation. The patent was declared unenforceable for withholding references and attorneys fees were gained by the defendant.

The CAFC cites Cybor, 138 F3d 1448, and Stevens, 822 F2d 1047, among others. The case delves into the responsibility of one partner for the acts of other partners, citing Malanga, 146 A2d 105 (NJ 1958).

Compare this case to Nelson v. Adams.

Remnants of another patent dispute involving academia

The CAFC posted a nonprecedential decision on a case that (at one time) involved an academic patent dispute involving among others Florida State University concerning US 5,780,653.

Another science setback in IPT: rf inductance heating analogized to microwave ovens

The article in the Feb. 2005 issue of Intellectual Property Today by Michael M. Carlson ("An approach to effective opening statements in patent cases") also has an interesting discussion of rf (radiofrequency) heating wherein rf heating is analogized to microwave heating.

At page 11, the author explains how his client "patiently explained that a microwave sends out RF waves at exactly the right frequency to vibrate water molecules. When the water molecules vibrate, they get hot, and, in turn, the food, which contains water molecules heats up.

The RF heating on a semiconductor reactor works the same way, except that the RF waves are tuned to vibrate graphite molecules in the pedestal, which gets hot, and in turn, heats the wafer sitting on the pedestal."


Actually, rf induction heating uses an AC current in a coil (not "tuned" to "vibrate" graphite "molecules") to generate a magnetic field which generates eddy currents in the electronic conductor material (susceptor, here graphite).

RF induction heating does not work for non-electronic conductors (eg, most foods) and microwave heating does not work well when an electronic conductor is placed within the microwave, as some people have learned.

Of the comment about "vibrate," microwave heating of materials is produced by the microwave electromagnetic field causing the molecules of the water to rotate back and forth and the
resulting friction between molecules produces heating through out the material.

Of the relevant frequency, microwave ovens used in the home generate between 500 watts and one thousand watts of microwave power at a frequency of about 2400 megahertz (MHz or 2400 million cycles per second), corresponding to a wavelength of 12.5 cm (4.9 inches)in air. This frequency of a domestic microwave oven (=2.45GHz) is not selected so that it is at the maximum absorbency for water (which is something like 10GHz). This high frequency explains why it is not good to place metals in a microwave. If a metallic conductor is placed in a microwave cavity, most of the microwave energy is reflected with relatively little energy penetrating beyond a few microns into the surface. However, colossal surface voltages may still be induced, and these are responsible for the dramatic electrical discharges that can be observed when a metal is placed in a microwave oven.

In contrast to microwave ovens, rf induction operates at a much lower frequency: low frequencies of 5 to 30kHz are effective for thicker materials requiring deep heat penetration, while higher frequencies of 100 to 400kHz are effective for smaller parts or shallow penetration.

Although many simplifications may be necessary to introduce technical material to a judge (or a jury), a lawyer has to be careful in oversimplifying, lest his opponent jump on an obvious error and harp on the error to attack the lawyer's credibility. Here, the (false) tennis ball analogy, as well as the microwave analogy, could have been attacked by a skilled opponent.

An earlier issue of IPT pointed to the adverse consequences when an expert witness erroneously referred to 35 USC 112 as discussing one of ordinary skill in the art. Although the difference between the artisan of 112 and the one of ordinary skill may be ephemeral, the credibility of the expert was destroyed.


***Basics of induction heating***

The basic components of an induction heating system are an AC power supply, induction coil, and workpiece (material to be heated or treated). The power supply sends alternating current through the coil, generating a magnetic field. When the workpiece is placed in the coil, the magnetic field induces eddy currents in the workpiece, generating precise amounts of clean, localized heat without any physical contact between the coil and the workpiece.

The induced current flow within the part is most intense on the surface, and decays rapidly below the surface. So the outside will heat more quickly than the inside; 80% of the heat produced in the part is produced in the outer "skin". This is described as the "skin depth" of the part. The skin depth decreases when resistivity decreases, permeability increases or frequency increases.

***Practical example

Of an asserted analogy between microwave heating and rf heating, from US 4,439,267:

FIG. 1 schematically shows a system with which the instant methods may be practiced and includes reactor 10 in which the crystals are grown, with susceptor 11 therein. The reactor is surrounded in part by coil 12 fed by radio-frequency generator 13. The walls of reactor 10 are made of a material (such as glass or quartz) transparent to the output energy of 13, and susceptor 11 is made of a material such as carbon (graphite) which will absorb the output energy of 13 and which is non-reactive with the materials to be placed on or in it.

The substrate is placed on a susceptor pedestal made of carbon for example, and heated by R.F. induction.

Novartis: king of the generics?

from Reuters:

Novartis AG became the world's biggest generic [copy-cat] drug maker by agreeing to buy unlisted German firm Hexal and U.S. company Eon Labs in a cash deal worth a total of more than $8 billion.

Novartis will buy all of Hexal and 67.7 percent of Eon Labs from Germany's Struengmann family for 5.65 billion euros ($7.4 billion), it said on Monday, giving it a leading position in the major markets for generic versions of off-patent drugs.

Monday, February 21, 2005

More on return to taxpayer from California's Prop. 71 on stem cells

An article in IP Law & Business suggests that research from California's Proposition 71 may not lead to royalties in the near term AND points to the absence of language as to how royalty agreements would be structured.

from IP Law & Business, Feb. 15, 2005:

When the backers of California's stem-cell initiative were seeking
voter support last year, they not only promised cures for dread diseases, but also licensing revenue for the state.

A statement posted on the initiative proponents
CuresforCalifornia.com Web site says that "California will benefit for decades from patents and royalties that result from the research."

But most biotech IP lawyers say it is foolhardy and wildly optimistic to predict that royalty revenue will come to California in the uncertain area of stem cell-derived therapies. "No one has figured out how to commercialize this technology and generate substantial revenues," says Donald Ware, a biotech
litigation partner in Boston's Foley Hoag. "People have looked at cell therapies . . . but no industry has taken off."

Proposition 71 established the California Institute for Regenerative
Medicine, which will distribute $300 million in grants per year over
the next decade for in-state stem-cell research. Scientists will work with human embryonic stem cells-those miracle cells that can become any kind of tissue in the body-seeking therapies for such conditions as spinal-cord injury, Parkinson's disease, and diabetes.

Under the name Cures for California, a coalition of movie stars,
universities, venture capitalists, disease-advocacy groups, medical
associations, and biotech companies waged a $30 million campaign for
Proposition 71, which passed with a 59 percent voter approval in November. In their campaign materials proponents touted a report from the Los Angeles-based Analysis Group Inc. that predicted stem-cell research will yield California "royalty revenues
of from $537 million to $1.1 billion."

Nicholas Seay is cautious about the prospect of California getting any of its money back from licensing revenue, at least any time soon. Seay, a partner in Milwaukee's Quarles & Brady who prosecuted the University of Wisconsin's stem-cell patents, has been looking at the economics of this new science for
much of the last decade. "I have a hard time imagining [payback from
licensing revenue] in the time frame envisioned," he says.

In any case, the initiative's vague language gives no clues as to
how any licensing deals will be structured. "It doesn't tell us one hell of a lot," complains Brian Cunningham, former general counsel of Genentech, Inc., and a biotech partner at Palo Alto's Cooley Godward.

Gerald Dodson suggests that his colleagues' concerns may be
overstated. Dodson, a partner in the Palo Alto office of San Francisco's Morrison & Foerster, has spent much of the last decade representing the University of California in high-profile biotech patent battles. [Dodson also represented the University of Rochester in its ill-fated litigation over COX-2 inhibitors.]

In December 2004, Dodson was asked to speak at a meeting about Prop 71 hosted by the National Academies at the University of California at Irvine. "I said money can be made from this and come back to the state," Dodson says.
"I told them this doesn't have to be a situation in which the taxpayers get fleeced."

Dodson insists that any vagueness in Prop 71 relating to IP
licensing is not a problem. "If you had a working group of IP lawyers, I don't think it would have been better. They'd start writing details into it and one would have tried to outdo the other," he says.

**
There is a useful article on biotech patent licenses by Marc S. Friedman and Barry J. Marenberg in the February 2005 issue of Intellectual Property Today. [pages 32-34]

C&E News discusses the Yale/Fenn dispute

The dispute between John Fenn and Yale University involves issues of contract law (the relationship of Fenn and Yale) as well as federal law, the Bayh-Dole Act, governing the relationship between the non-profit (here, Yale University) and the federal funding agency (here, NIH).

It is possible for an individual professor to take assignment in a patent deriving from federal funding. In Madey v. Duke University, Madey himself took assignment of a patent derived from work at Stanford University. Part of the issue in the Fenn/Yale matter seems to concern Fenn's representation to Yale of the value of the patent. The C&E News article [below] does bring out the fact that the patent at issue in the Fenn/Yale matter was NOT the first electrospray MS patent filed with Fenn as an inventor, but does not really analyze the significance of that [see also my earlier post on IPBiz.blogspot on the Fenn/Yale matter which discusses the other patents]. Given that the Yale University office of technology transfer should have been somewhat "sensitized" to the (potential) value of electrospray MS patents, one does wonder what was going on here.

Separately, one notes that the money at issue in the case is to go from Fenn to Yale. The federal government does not get a return on royalties gained from commercialized inventions funded with federal taxpayer dollars. Recall how this aspect played out in the California stem cell initiative.

Stu Borman of C&E News on the Fenn/Yale litigation in Chemical and Engineering News (C&E News), Volume 83, Number 8 p. 11 (Feb. 21, 2005):

Yale University has won a patent dispute with a former faculty member, chemistry professor John B. Fenn, 87, now of Virginia Commonwealth University, Richmond. In a court decision dated Feb. 8, Yale was awarded damages of more than $1 million and was assigned ownership of one of the basic patents on electrospray ionization mass spectrometry.
While at Yale in the late 1980s, Fenn developed ESI-MS for the analysis of large molecules, such as proteins. That work won him a share of the 2002 Nobel Prize in Chemistry. Unbeknownst to Yale administrators, Fenn applied for a patent, and it was approved in 1992, with Fenn as assignee.

Fenn licensed it to Analytica of Branford, Conn., which he cofounded. Analytica then sublicensed rights to instrument makers. When Yale found out about the patent, it claimed rights to it and asked Fenn to reassign it to the university, but Fenn refused.

Fenn sued Yale, the university filed a counterclaim, and the U.S. District Court in Hartford decided the case in Yale's favor in a preliminary decision in 2003. The court found that Fenn "misrepresented the importance and commercial viability of the invention, ... actively discouraged Yale from preparing and filing a patent application," and wrongfully filed one himself without notifying Yale and the National Institutes of Health, which helped fund the work.

In this month's final decision, the court ordered that Fenn pay Yale damages--$545,000 in misdirected royalties and penalties and about $500,000 in attorney fees--and that the patent be transferred to Yale. Fenn "is guilty of civil theft," it concluded.

Timothy J. Oyer of Wolf, Greenfield & Sacks, Boston, an intellectual property attorney with a doctorate in inorganic chemistry, comments that "the percentage of net patent royalties flowing to inventors under Yale's current policy is quite generous when compared with other universities, and certainly when compared with industry. If Dr. Fenn indeed induced Yale not to file a patent application on the invention by intentionally downplaying its significance, he made an improper and highly atypical decision as a professor."

"We are pleased by the court's vindication of the Yale patent policy," says Thomas Conroy, Yale deputy director of public affairs. "Yale has the greatest respect for Dr. Fenn as a scientist. We made repeated attempts to mediate with Dr. Fenn."

"I filed for a patent because Yale didn't," after the university decided there was insufficient commercial interest, Fenn tells C&EN. "Then Yale found out it was worth a substantial amount of money and said I stole it." Two earlier electrospray patents were assigned to Yale and were even more valuable, he notes. Fenn denies the theft charge and says he intends to appeal.

Sunday, February 20, 2005

Setback to physical chemistry in Int. Prop. Today?

The district court in the Osram case set back basic concepts in chemistry more than 150 years by using atomic number, rather than atomic weight, to perform stoichiometric calculations.

In the Feb. 2005 issue of Intellectual Property Today, we have an interesting issue as to physical chemistry. In an article entitled "An Approach to Effective Opening Statements in Patent Cases" (p. 10 of the Feb. issue), we have the statement:

"If I place a number of tennis balls in a bag a bag, they have an amorphous organization; ...
If I pour the balls out of the bag and into the bottom of a banker's box, they start to line up in rows and columns. Each ball is surrounded by four other balls."

Well, this is one "chemistry" experiment that lawyers can do. Grab some uniform spheres (eg, tennis balls; marbles; malted milk balls) and place them in a level tray (eg, top of the bankers box).

You will quickly notice that they line up such that they have six nearest neighbors, and that's only in "two" dimensions. If you go to more than one layer, you will see that you have a basic choice in stacking epitaxy, ABABAB...(hexagonal closest packing (hcp)) or ABCABC...(cubic closest packing (fcc, alias ccp)) [there are more stacking choices of lower symmetry]

So, the idea that each tennis ball (or marble or bowling all) is surrounded by four nearest neighbors is simply wrong. As a different point, the idea that tennis balls filling a bag are amorphous (because there is no particular relationship between the location of any one tennis ball and that of another) is also incorrect. Because balls (or atoms) occupy volume, the probability that a second ball is a given distance away from the center of the first ball is not constant. First, the second ball cannot approach the first ball within the radius of the first ball (incompressible ball assumed). Second, there is a high probability (in a filled bag) that the second ball will be found outside of one radius but within two radii of the first ball. As a scientific matter, liquids do give peaks in x-ray diffraction.

***As to the atomic number matter -->

In the Sept. 2001 issue of IPT, John Rogitz commented on Durel v. Osram, 59 USPQ2d 1238 (CAFC 2001), and implicitly was suggesting that 3 to 5 [weight] % hydrogen might be a "minor amount." Because hydrogen has an atomic weight of about 1 gram/mole, a low weight percentage of hydrogen can be a relatively high atomic percentage. Separately, as noted previously in IPT ("The End of the Millennium: Legally Correct but Scientifically Incorrect, or Vice Versa?," pp. 20-21, Jan. 2000), the district court in Durel [52 USPQ2d 1418, 1429 (D. Az.)] had incorrectly used atomic number, rather than atomic weight, to calculate formula weights. The text of the claim element "minor amounts of other elements" is one which introduced ambiguity, the harm of which is seen in the scientifically inaccurate way in which atomic numbers were used in the litigation and in the reported district court decision.



**
Of basic stacking of balls, one can visit
http://www.bbc.co.uk/dna/h2g2/A2466092

Friday, February 18, 2005

Advice as to provisional applications

Some individual inventors ask about the option of filing a provisional application. If that option is taken, the disclosure must support relevant claims.

from Intellectual Property Today, September 2002:

The case of NEW RAILHEAD MANUFACTURING, L.L.C. v. VERMEER MANUFACTURING COMPANY, 2002 U.S. App. LEXIS 15287 (CAFC), should serve as a wake-up call to those who sought to reduce costs of patent application by filing abbreviated provisional applications. To be effective as a priority document, the specification of the provisional must "contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms," 35 U.S.C. § 112 P 1, to enable an ordinarily skilled artisan to practice the invention CLAIMED in the non-provisional application. Unconventional provisionals, such as photocopies of journal articles or sales brochures, are unlikely to get the job done. Placing an article on sale, in the belief that such activity is protected by the filing of such a provisional, can lead to the inventor-created invalidation of the patent based on the later filed non-provisional. The NEW RAILHEAD case cited the Supreme Court FESTO decision (122 S. Ct. 1831, 1840 (2002)), and an underlying issue of both cases is how to deal with the inability of many inventive entities (including corporations, both large and small) to muster resources for drafting of patent applications sufficient to withstand later legal scrutiny. The problem is not so much a failure of language as it is an inability to allocate optimal funds to adequately describe inventions which later prove economically viable. Separately, the article "Festo Schmesto" [IPT, pp. 6-10, Aug. 2002] is one of at least three articles on Festo including the word Schmesto in the title, and one of many to indicate that we are still on uncertain terrain as to the doctrine of equivalents.

Canadian government considers ban on export of patented drugs

The Canadian government is considering a total ban on all exports of patented drugs as a way to preserve the country's lower prices for medicine, Health Minister Ujjal Dosanjh said on Feb. 18, 2005.

Medtronic loses to Guidant as to validity, infringement in D. Del.

Medtronic Inc. reported Feb. 18, 2005 that a federal jury in D. Del. found that rival Guidant Corp.'s so-called Lau patent is valid and that some Medtronic stents, including the S7 and Driver stents, infringe upon certain Guidant patents.

A ruling by the judge on an asserted defense of inequitable conduct is currently outstanding. If Medtronic prevailed on this assertion, the patent could be found unenforceable, even though valid.

Computer Associates to make patents available [?]

-->
Computer Associates [CA] plans to submit a portion of its patent portfolio to open-source developers, following moves by other technology companies delving into open source.

The Islandia, N.Y., company also intends to use its patents to defend against legal action directed at open-source products, according to a company representative. The timing of the patent donation and the terms governing use are still being worked out, the representative said.

(...)
CA CEO, John Swainson : "Open Source is a tool. As a commercial software company, I look at this as one of the tools that I have available to help establish a standard. So I can build products on it, above it, below it, beside it. But it's just a tool, and it's not always the right tool."
<--

Thursday, February 17, 2005

Buzz on Altair Nanotechnologies

The stock of Altair Nanotechnologies increased 140% from last Wednesday to this Monday, supposedly based on a breakthrough in rechargeable lithium batteries.

Electrospray mass spectrometry of John Fenn; Bayh-Dole dispute

Nobel Laureate (chemistry 2002) John Fenn lost a law suit to Yale University, concerning who had rights in US 5,130,538 on electrospray ionization mass spectrometry. Fenn argued that he himself had rights under the Bayh-Dole Act.

from Susie Poppick of the Yale Daily News (Feb. 14, 2005):

A Nobel Laureate and former Yale professor must pay the University more than $1 million for stealing, licensing and unjustly profiting from his own prize-winning invention, a federal judge ruled Thursday.

Though John Fenn GRD '40 argued that he had rights to his discovery under the Bayh-Dole Act, a federal patent law, U.S. District Judge Christopher Droney determined that Fenn knew Yale rightfully owned his invention -- a method of mass spectrometry for analyzing large biological molecules -- under the University's official patenting policy.

"Dr. Fenn only obtained the patent through fraud, civil theft, and breach of fiduciary duty; he may not profit from his own wrongdoing," Droney wrote in the decision. "A patent is property which, when wrongfully obtained, may be reassigned to its rightful owner."

Droney ordered that Fenn, 87, pay Yale for penalties, royalties and legal bills and hand over the rights to his patented invention, which earned him a share of the 2002 Nobel Prize in chemistry.

The judge's decision stated that Fenn misled the University about the value of his invention, while he secretly obtained a patent in 1992 and sold licensing rights to Analytica, a company he jointly owned.

"Clearly, Dr. Fenn's motives included an intentional desire to 'show up' and embarrass Yale by depriving the institution of a valuable patent, but also included a desire to keep permanently the patent and the profits it generated," Droney wrote.

Yale's patenting policy states that the University collects a portion of faculty royalties to fund further research. But Yale does not claim any ownership of inventions unrelated to an employee's designated activities or made without use of University facilities.

All University inventions must be reported to the Office of Cooperative Research, whether or not Yale will claim joint ownership. OCR Managing Director Jonathan Soderstrom said patenting policies like Yale's are common in academia.

Fenn said he never intended to deceive the University and is considering an appeal, but he would not comment further on the case, as his attorneys are still examining the implications of the court decision.

"My side of story is a good one, which has not been heard very much in this case," Fenn said. "That will be clear when more of the facts come out."

Fenn said he completed development of electrospray ionization after Yale's retirement policies forced him to forfeit laboratory space and graduate assistants when he turned 70.

The legal conflict began when Fenn and his Analytica business partner, graduate student Craig Whitehouse, entered litigation over patenting rights. Fenn sued Yale in 1996, after the University struck a licensing deal with Analytica without his involvement. Yale then filed counterclaims, seeking assignment of the patent and damages for charges ranging from breach of contract and fiduciary duty to theft.

Fenn said he believes Yale's division of royalties is unfair. Under current policy, the first $100,000 of net royalties is split 50-50 between the inventor and University, with 40 percent of the second $100,000 and 30 percent of anything above $200,000 going to the inventor.

Fenn's patent, No. 5,130,538, has already earned more than $5 million in royalties and will not expire for six years.




Some patents with Fenn as inventor:

US 4,531,056 issued July 23, 1985 filed April 20, 1983

Cited by 63 US patents as of Feb. 17, 2005.

Inventors: Labowsky; Michael J. (Wayne, NJ); Fenn; John B. (Branford, CT); Yamashita; Masamichi (Tokyo, JP)

An electrospray ion source for a mass spectrometer capable of generating ions from samples dissolved in a solution comprises a capillary tube through which the said solution is pumped into a first chamber maintained substantially at atmospheric pressure and in which an inert gas is flowing in a direction counter to the flow of the solution, and a small orifice in the end wall of the chamber opposite to and aligned with the capillary. A high potential difference is applied between the capillary and the end wall so that the solution is electrosprayed into the chamber and ions characteristic of the sample are formed. These ions are desolvated to a controllable extent by the inert gas, which may also be heated to improve the efficiency of the process and increase the maximum permissible flow rate of solution. The ions so formed pass through the small orifice into a second chamber maintained at a reduced pressure, and into a mass spectrometer. Alternatively an additional pressure reduction stage can be included, so that the ions pass into a third chamber maintained at a still lower pressure in which the mass spectrometer is situated through a conventional nozzle and skimmer arrangement. The ion source is particularly effective for the production of unfragmented and unsolvated ions from thermally unstable or involatile samples, and may be used as a liquid chromatograph--mass spectrometer interface.

First claim:

1. In a method of generating ions for mass spectral analysis from a sample dissolved in a solution by electrospray ionization the improvement comprising:

(a) causing said solution to flow through a capillary tube or jet;

(b) maintaining a high electrical potential difference between said capillary tube or jet and a first conductive wall spaced from and disposed facing the outlet of said capillary tube or jet thereby causing said solution to be electrosprayed from said outlet;

(c) maintaining the ambient pressure between said outlet and said wall at substantially atmospheric pressure;

(d) providing between said wall and said outlet a flow of inert gas substantially counter to the flow from said outlet;

(e) providing an orifice in said wall in alignment with the axis of said capillary tube or jet at the outlet thereof; and

(f) maintaining the pressure on the side of said wall remote from said outlet at a reduced pressure whereby gas containing ions from said solution characteristic of said sample flows through said orifice.

US 4,542,293 issued Sept. 17, 1985 filed April 20, 1983

****

US 5,130,538 issued July 14, 1992 filed Oct. 10, 1991

This is a file wrapper continuation application of application Ser. No. 07/683,105, filed Apr. 10, 1991, which is a file wrapper continuation application of Ser. No. 07/354,393 filed May 19, 1989, both now abandoned.

***
US 5,306,412 issued April 26, 1994
assigned to Analytica of Branford, Inc. (Branford, CT)

***US 5,581,080 issued Dec. 3, 1996 filed September 21, 1994

RIGHTS STATEMENT

The U.S. Government has a paid-up license to this invention and the right in limited circumstances to require the patent owner to license others on reasonable terms as provided for by the terms of Grant No. 2R01 GM31660-04A1 awarded by the National Institutes of Health.

The present application is a divisional of application No. 07/911,405, filed Jul. 10, 1992, now abandoned, which is a divisional of application No. 07/773,776, filed Oct. 10, 1991 (Pat. No. 5,130,538), which is a continuation of application No. 07/683,105 filed Apr. 10, 1991 (abandoned), which is a continuation of application No. 07/354,393, filed May 19, 1989 (abandoned).

Wednesday, February 16, 2005

HP Linux VP Fink: "Software patents are a fact of life"

Paula Rooney of CRN states that Hewlett-Packard Vice President of Linux Martin Fink chided those in the open-source industry who dismiss the potential threat of patent lawsuits or the value of patents.

Fink is quoted: "Software patents are a fact of life, and to refute them is a little bit naive. We need to be more pragmatic."

Fink is also quoted: "It's what you do with the patent that matters, not whether you have a patent." From a company that lost its CEO for lack of innovation and production, that sounds reasonable.

In the article, we have the following questionable text:

Unlike a copyright, which allows others to make copies or prepare derivative works of intellectual property, a patent is an exclusive right to exclude others from taking, using, modifying or selling someone's work, said Lawrence Rosen, an attorney for RosenLaw & Einschlag.

Well, yes, there is a "fair use" defense in copyright, but it is NOT a blanket right to make copies or prepare derivative works. Of patent, what happened to make, use, sell, and offer for sale?

Rooney also wrote:

Over the next five years, the open-source services market will reach $14 billion, and customers will increasingly need integration, deployment and consulting services, according to Fink. "It's the next step—to build value while reducing overall cost," he said. "We finally have an approach that allows businesses and Linux to thrive in the business world."

Tuesday, February 15, 2005

Newman/Rifkin effort succeeds; patent application rejected

An opponent of patents on living things, Stuart Newman had no intention of making the entities disclosed in his patent application. His goal was to set a legal precedent that would keep others from profiting from any similar ‘‘inventions.’’

PTO officials said it was not so difficult to make the call this time because Newman’s technique could easily have created something that was much more person than not. But newer methods are allowing scientists to fine-tune those percentages, putting the patent office in an awkward position of being the federal arbiter of what is human.

Newman said: ‘‘The whole privatization of the biological world has to be looked at, so we don’t suddenly all find ourselves in the position of saying, ‘How did we get here? Everything is owned.’’’

The application, filed by Newman and Jeremy Rifkin, in 1997, described a technique for combining human embryo cells with cells from the embryo of a monkey, ape or other animal to create a blend of the two —— a “chimera”.

These issues also arose in the discussion of recent Australian work by Richard A. Jefferson, of CAMBIA [Centre for the Application of Molecular Biology to International Agriculture]in agricultural biotech.

Of the Jefferson work, the Australian reported on October 5, 2004 :

Researchers are "increasingly frustrated by a growing forest of
patents around innovations in the biological sciences", according to a Nature
report and editorial featured in its latest issue. "There is discontent that innovations from publicly funded scientists are being sold to private companies and locked up in exclusive licensing," the prestigious science journal says.
[See Nature, Vol 431, pg 491 and 494 September 30, 2004]

"Concern is mounting that poorer nations are being further
disenfranchised by richer countries' ownership and control of enabling technologies. "Even purely academic scientists are not immune from the effect of licensing obstacles on new techniques."

Already on the slate are agricultural and animal-breeding tools,
genetic resources, medical treatments and environmental remedies. The initial
BIOS portfolio will include a new method, developed by CAMBIA, for
transferring genes into plants using modified bacterial species. Professor Jefferson says this technique will sidestep patents held by biotech firm Monsanto. CAMBIA's
approach to open source has also been recognised by Computer Sciences Corp in
its new report, Open Source: Open for Business.

"CAMBIA's goal is to help local communities solve their agricultural
and environmental problems by unblocking the intellectual property logjam
that has stymied the full potential of modern genetics," CSC says.

"Open source is central to CAMBIA's mission: the open access toolkit
has been likened to Linux."

Meanwhile, Nature notes, the success of BIOS depends on active
participation by scientists willing to share information and contribute research
tools, as well as financial support from private and public backers.

Ariba to pay EPlus $37 million to settle patent case

Ariba Inc., a maker of software that helps businesses manage costs, agreed Feb. 14, 2005 to pay $37 million to settle a patent-infringement lawsuit in D N Va by competitor EPlus Inc. Ariba and EPlus also agreed to cross-license their patents.

Phillip G. Norton, chief executive of the winning party EPlus noted the settlement "is in the best interest of EPlus and our customers as it eliminates the uncertainty of the trial and inevitable appeals process which can take several years,"

Patent in MALDI area

NanoHorizons, Inc., stated on Feb. 15, 2005 that it has received a patent covering the company's deposited thin-film system for high-throughput small-molecule mass spectrometry. QuickMass-enhanced targets enable MALDI mass spectrometers to be used for accurate and convenient small molecule analysis using matrix-less and thin-layer matrix test techniques.

MALDI stands for Matrix Assisted Laser Desorption & Ionization.

It is used in mass spectrometry technique to facilitate large molecule analysis, operating effectively in the 1,000 to 180,000 amu range. Prior to the advent of QuickMass, small molecule analysis could not be reliably performed using these laser-desorption-based mass spectrometers. Instead, small molecules could only be analyzed using slower and costlier Liquid Chromatography/Ion Electrospray analysis.

QuickMass-enhanced targets utilize NanoHorizons' patented nanoscale non-porous germanium layer to desorb the laser energy of the MALDI instrument, avoiding the use of a matrix and thereby allowing the acquisition of a clear spectrum below 1,000 amu. Using QuickMass+MALDI creates an 80% improvement in the time it takes researchers to get results. This translates into significant time and cost reductions for pharmaceutical development, ADME (Administration, Distribution, Metabolism, and Excretion) testing, biomarker, proteomics, bio/chemical hazard, environmental testing and numerous other applications.

In the buckminsterfullerene (buckyball) saga, the C60 entities were generated by laser ablation of graphite, and analyzed in a TOF mass spectrometer. Ion trap mass spectrometers are also useful for analyzing high mass entities.

Another patent in hydrogen area

Quantum Fuel Systems Technologies Worldwide, Inc. announced on Feb. 15, 2005 that it received a United States patent for portable and transportable hydrogen refueling systems. Quantum's patent covers portable and transportable hydrogen refueling systems that incorporate self-contained hydrogen producing subsystems or accept low pressure hydrogen from external sources, and are capable of compressing and dispensing at either 5,000- or 10,000-psi (35 or 70 MPa). Transportable hydrogen refueling stations are envisaged to play a major role in developing a hydrogen refueling infrastructure, for both commercial and military
applications.

Jury deliberation begins in Zoloft "defense" murder trial

On February 14, 2005, jurors in Charleston, SC began deliberation in the murder trial of a 15-year-old boy who claims the antidepressant Zoloft drove him to kill his grandparents three years ago.

Zoloft is the most widely prescribed antidepressant in the United States with 32.7 million prescriptions written in 2003. In October 2004, the Food and Drug Administration [FDA] ordered Zoloft and other antidepressants to carry "black box" warnings — the government's strongest warning short of a ban — about an increased risk of suicidal behavior in children.

One recalls Pfizer recently won a litigation against Teva over a patent concerning Zoloft (sertraline hydrochloride). Therein, there was an issue of what it takes to file a declaratory judgment [DJ] action in the context of the Hatch-Waxman Act.

The US 4,356,518 patent on the composition of matter expires June 30, 2006, and the 5,248,699 patent on a polymorph expires in 2010. Pfizer lists both patents in the FDA's Orange Book (formally titled Approved Drug Products With Therapeutic Equivalence Evaluations).

In an earlier Hatch-Waxman case, Pfizer sued Ivax for patent infringement but Ivax and Pfizer settled the patent litigation between them over Zoloft in 2002, agreeing that Ivax would receive a license to the '699 patent and could begin marketing generic setraline hydrochloride by June 30, 2006.

Thursday, February 10, 2005

Bicycle patents

Although some legal commentators of today complain of games played to alter claims to cover competitors' products, this practice has been around for a while.

from Robert Mionske in VeloNews:

While the reissue of Mackenzie's 1862 patent wound its way through the patent office, Smith and Witty sued each other over the Mackenzie and Lallement patents. Instead of fighting it out, they settled out of court and combined forces, using Witty's resources to jointly enforce royalties. They demanded retroactive payments of $10 to $20 per unit from both importers and manufacturers. The velocipede craze was rapidly dying by this time, and the royalty demand persuaded many firms to pull out of the business. Exactly how much money they made is unclear. Witty claims he earned over $25,000 in December 1869 alone, and Lallement biographer David Herlihy believes he turned down a $75,000 offer at the peak of the fad. After Smith died in 1874 his wife sold off the Mackenzie patents to her husband's former lawyer, Charles Durgin, who in turn sold them in the spring of 1876 to the Montpelier Manufacturing Company, a Vermont maker of baby carriages, sleds, hobby-horses and other toys.

With the American velocipede industry dead after 1869, all four patents lay idle and ignored. However, as Americans began to show some interest in the high-wheeled bicycle after the 1876 Philadelphia world's fair, their owners started to pull them out of safes and file drawers and give them a second look. In July, 1877 the Montpelier firm reissued Mackenzie's 1864 patent, changing its claims language in a way similar to that earlier done by Smith to Mackenzie's 1862 patent.

In September, Calvin Witty sold the Lallement patent to the Boston firm of Richardson & McKee. The partnership of Henry M. Richardson and George McKee manufactured children's carriages and baby buggies. In 1876 and 1877 they were joined by a relative of George McKee named Joseph McKee. It was probably a part-time arrangement, as Joseph was a partner in a New York firm, McKee & Harrington, a manufacturer of carriages and carts. It is possible that Colonel Pope was acquainted with the Boston firm, as Albert A. Pope and Company, the colonel's shoefindings firm, shared the same address as Richardson & McKee, 6 Merrimac, for several months in 1875. In any event, Pope took out a license from Richardson & McKee when he had the Weed Sewing Machine Co. of Hartford make his first 50 high-wheelers in early 1878.

Pope's application galvanized Richardson & McKee. They immediately sought a reissue of the Lallement patent that dramatically expanded the scope of its claims language. Three days after the Lallement reissue was approved, Richardson & McKee bought three velocipede patents from Harvey Reynolds, including the crucial March 1865 patent with opposable cranks.

In January, 1878 Richardson & McKee and Montpelier entered into an indenture agreement effectively pooling the rights to the eight patents they held, including the Lallement, Mackenzie and Reynolds documents. Together, the two firms now controlled the basic rights to the bicycle, and Pope was in a bind. By early 1879, Richardson & McKee were squeezing him for royalty demands totaling $27.50 per bicycle. Pope turned to Charles Eadward Pratt to sort out the mess.

Born in Vassalborough, Maine, in 1845, the son of a Quaker minister, Pratt graduated from Haverford College in Pennsylvania in 1870. By April 1878 he was working for Pope, writing David Brandon about French bicycle patents prior to 1866. Brandon replied, "We presume that your object is to find a previous patent in order to upset Lallement's U. S. Patent." Brandon was correct, but the information he could locate was of little assistance, and unable to break the patent pool, Pope instead opened his checkbook.

In March 1879 Richardson & McKee sold half of their rights - a quarter of the total - in the eight pooled patents to the Pope Manufacturing Company. Although the agreement was dated March 19, the full text of the agreement that Pope was required to submit to the patent office was not sent until April 21, suggesting that the parties were tweaking the exact language of the document for a month after entering into their initial agreement. The next day, April 22, the directors of the Montpelier firm agreed to sell all rights in their one-half interest in the eight patents. Interestingly, Montpelier did not sell to the Pope Manufacturing Company, but to Charles Pope, the colonel's father, who subsequently conveyed his interest to the firm.

Although the Pope company's 1907 official history, with Albert talking Richardson & McKee into a deal, then racing through the night by express train from Boston to Vermont to cinch the Montpelier sale, makes for good reading, the patent office ledgers suggest that in reality Albert carefully crafted an agreement with the Boston firm, while Charles spent several days, possibly weeks, in Vermont negotiating with Montpelier. Once the Boston agreement was finalized, Albert wired his father in Vermont, who closed the other half of the deal. Six days later, Richardson & McKee capitulated and sold their remaining interests to Pope.

Interview with patent attorney. Invention companies.

From an interview with patent attorney Joseph Maraia in The Beacon:

Q: How did you get interested in inventions, patents and patent law?

A: I first became interested in patents and patent law as an undergraduate student at Worcester Polytechnic Institute. My father was seeking to patent a game he developed and hired an invention company to help him with the process. I read all their literature and became increasingly fascinated with patents and the patent process. Sadly, despite paying more than $5,000, my father did not get a patent to protect his invention because the invention company never retained a patent attorney.

Q: What's interesting or important about patent files and the patent system that may not be well known or obvious to the public? Are the files full of great ideas just waiting for a sponsor?

A: patent is essentially a monopoly granted by the government for a limited time in order to induce individuals to freely disclose their inventions for the benefit of the general public. In order to preserve and protect the public benefit, the law provides that free use may be made of any invention covered by an expired patent. Many patents fail for various reasons, these patents may be exploited by the public; however they are part of the public domain and are not further protectable in their current form. Therefore, if one exploits an expired patent, without further improving upon the invention, another may come along and exploit it as well.

[Note: a patent does not confer monopoly rights. A patent is a right to exclude others; it is not a right to make, use, or sell.]

BBC, New York Times on open source practices in biotechnology

In a paper in the journal Nature, out on Feb. 10, Dr. Richard Jefferson of Australia offers a method of transferring foreign genes into plants that may be outside the scope of patent claims employing Agrobacterium tumifaciens. The properties of Agrobacterium tumifaciens allow scientists to engineer any desired genes into the bacterial DNA and then insert them into plant genomes.

Some of the policy issues surrounding this development are not unrelated to policy issues in the case Merck v. Integra, now pending before the US Supreme Court.

from Paul Rincon of the BBC (Feb. 10, 2005):

In a paper published in the British journal Nature, Dr Richard Jefferson of Cambia in Canberra, Australia and his colleagues describe how they engineered benign bacteria capable of transferring genes into plants.

By introducing "disarmed" plasmids together with a helper molecule into bacteria, they were able to transfer genes into tobacco, rice and Arabidopsis plants.

The open-source method is not bound by the patent system. So scientists are free to use the technique without commercial restrictions, but must share any improvements they make to this scientific "toolkit".

"It isn't about making it cost-free or busting patents. It's about harnessing the latent creativity of a very large number of people who are out of the loop right now," said Dr Jefferson, a descendent of Thomas Jefferson, the third president of the US and also the country's first patent commissioner.

"I see this as unfinished family business," he told the BBC News website.

The team hopes this approach to managing intellectual property could jumpstart research into agricultural biotechnology in developing countries, addressing issues of hunger and poverty.

Markus Payer, a spokesperson for Syngenta, said the company would look carefully at the research but that it had no current business implications for the company.

"There are already other technologies around [for researchers to use]. This is not the first and only alternative to Agrobacterium," said Mr Payer.

"We are contributing investment to agriculture and opening scientific findings for public and academic use."

Dr Jefferson said initiatives like his own would benefit the marketplace, encouraging more competition and innovation. He cited IBM as a company that had made money out of the open-source model in software.

Praising the work, Dr Jeff Dangl, a plant scientist at the University of North Carolina in Chapel Hill, US, said the science was "very tight".

"This group's most important contribution...may well be to open up facile transformation of legumes, and other important crops for which Agrobacterium or expensive tissue culture-based methods are either inefficient or simply not possible," he commented.

Dr Wendy Harwood of the John Innes Centre in Norwich, UK, said the work "may open up more efficient ways of carrying out gene transfer".

The team behind the Nature paper has also launched a collaborative research platform on the internet called BioForge, which will allow scientists to develop new technology within a protected "commons".








from Andrew Pollack of the New York Times (Feb. 10, 2005):

In a paper, being published today in the journal Nature, Australian researchers said that they had modified three types of bacteria so they could be used for transferring desirable genes into plants and that they had inserted genes into three plants - rice, tobacco and Arabidopsis, a weed often used in lab experiments.

The new technology-sharing initiative, called the Biological Innovation for Open Society, or BIOS, is the brainchild of Richard A. Jefferson, chief executive of Cambia, a nonprofit Australian research institute. Both Cambia and BIOS are supported by the Rockefeller Foundation.

The people behind the initiative say that patents covering the basic tools for genetically engineering plants - which are controlled by companies like Monsanto, Syngenta and Bayer CropScience - have impeded the use of biotechnology in developing countries and also in smaller-acreage crops, like vegetables, in the United States.

The issue has become a larger one in recent years as agricultural research has increasingly shifted from a public-sector activity involving governments and universities to a private-sector one led by companies.

Gary Toenniessen, director of food security at the Rockefeller Foundation in New York, said Dr. Jefferson "has come up with two technologies that basically engineer around two of the tools that the companies really have control of and that are a major constraint to applying biotechnology to crop improvement."

Spokesmen for Monsanto and for Syngenta, a European company, said they welcomed public innovation and had made contributions of data and technology to help improve crops in developing countries.

But Dr. Toenniessen said there was often red tape involved and the process did not always work. He said, for instance, that specialists in some Asian countries want to grow varieties of insect-resistant rice developed at American universities. But that cannot be done yet, he said, because the universities were granted rights by the patent holders to use the technology only for research, not for commercial purposes.

The main technique now used to splice non-native genes into plants relies on Agrobacterium tumefaciens, a soil-dwelling microbe that in its natural form causes crown gall disease by inserting its own genes into plant cells. Biotechnologists remove some of the disease-causing genes from the bacterium and insert the genes they want added to the plant, such as those providing resistance to insects or herbicides. That technique is covered by various companies' patents.

Dr. Jefferson and other researchers at Cambia have modified other types of bacteria so they can also ferry genes into plants. They did this by transferring the necessary DNA from the Agrobacterium into the other bacteria through a natural mechanism that microbes use to exchange genes.

Whether this technique, called TransBacter, would withstand a patent challenge is still unclear, although Dr. Jefferson, who has compiled a database of life-science patents, says he is confident that it would.

There are limits to the usefulness of the new technique, because it is not yet highly efficient, and measures beyond gene transfer are required in making biotechnology crops. But one of those measures, a marker system so scientists can tell which plant cells take up the foreign genes, is also being made available by BIOS.

Dr. Jefferson said that if scientists worldwide get behind a collective research effort, the new genetic engineering technique would be quickly improved and new tools developed, just as programmers everywhere are constantly sending fixes and upgrades to Linux and other open-source software programs.

He said that while he wanted to provide competition for Monsanto and other companies just as open-source software did with Microsoft, he hoped that some companies might use the technology. The more corporate participation, the more likely is corporate sponsorship of his foundation.

Dr. Jefferson said that while users of the gene-splicing technology would be required to put any improvements they made into the common pool, companies and universities would be allowed to patent any products they made using the technology, like a genetically modified crop.

BIOS is one of several efforts aimed at more open biotechnology development. Software used for biological analysis has been developed using open-source methods, and certain databases, including the one containing the human genetic code, are freely available. Scientists at the Massachusetts Institute of Technology have been trying to create a catalog of biological components that others could use to impart novel functions into cells. But BIOS seems to be the first instance of applying the model to a laboratory technique.

There are factors that could make it more difficult for the open-source approach to catch on in biology than in software. Writing software usually requires just a computer and a desk, while biological research requires advanced equipment and can be much more expensive.

Patents also seem more important in spurring innovation in biotechnology than in software, said Arti Rai, a professor of law at Duke University. For that reason, Professor Rai said, it was probably wise of Dr. Jefferson to allow crops developed using the tools from BIOS to be patented.

"It's a creative way of thinking how to maintain a commons in the biological research space," she said.



Kemin prevails over Pigmentos Vegetales del Centro S. A. de C. V. (PIVEG)

from npicenter.com:

An order, filed Tuesday, Feb. 8, 2005, by Judge James E. Gritzner in the U.S. District Court for the Southern District of Iowa, held that the two contested patents [U.S. Patents 5,382,714 (‘714) and 5,648,564 (‘564)] are both valid and enforceable. The ruling also confirmed the jury’s findings that PIVEG infringed the ‘564 patent and upheld the associated monetary damage award to Kemin.

Pharma strategies of line extension and flanking

from PRnewswire:

More than $80 billion in blockbuster drugs will face patent expiration and generic competition by 2008.

One source of hope for pharmaceutical companies lies in the release of extension products. If a company can introduce an extension, such as an extended release version for the drug, six months or a year before an existing drug’s patent expires, it has a chance to shift patients to the new, patent- protected drug. If this strategy is successful, the company can retain market share even after generic copies of the original drug reach market. Without a line extension, companies risk losing 80% or greater market share to less expensive generics.

Another source of hope is flanking. Flanking generics involves brand-name drug companies signing licensing agreements with their generic competitors in order to establish a manufacturer-distributor relationship. According to a new industry report from pharmaceutical business intelligence firm Cutting Edge Information
( http://www.pharmagenerics.com/ ), this strategy enables branded companies to capture a share of the generic market -- via royalty payments from generics distributors -- after their drugs’ patents expire[!], and allows them to keep manufacturing facilities running at capacity.

Cutting Edge Information’s report, "Combating Generics: Pharmaceutical Brand Defense," combines qualitative research with quantitative surveys, as well as over 70 metrics to ensure your company will move ahead of the competition.

Wednesday, February 09, 2005

"Lawrence Lessig" character on West Wing Feb. 9

"Lawrence Lessig" (not self-portrayed) appeared on West Wing on Feb. 9. The President (Martin Sheen) asks "The Future of Ideas Lessig"?

Barr beats Ferring BV and Aventis Pharmaceuticals Inc. in antidiuretic case

from Forbes:

A decision in the SDNY clears the way for the Food and Drug Administration to approve Barr's pending application to market a generic version of DDAVP (desmopressin acetate). Barr said it is the first to file an abbreviated new drug application for the doses and has 180 days of exclusivity on the products.


Barr filed an ANDA in July 2002, and was sued Dec. 13, 2002 [?] by Ferring and Aventis. Ferring manufactures DDAVP for Aventis, which markets the product in the United States. Barr filed for summary judgment in April 2004.

DDAVP tablets had annual sales of $177 million last year. They are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus - a disorder of the pituitary gland characterized by intense thirst and by the excretion of large amounts of urine - and for the management of the temporary excessive urination and thirst following head trauma or surgery in the pituitary region. They are also indicated for the management of primary nocturnal enuresis, or bed-wetting.




Fiorina out at Hewlett-Packard

from Rachel Konrad of AP:

Carly Fiorina's nearly six-year reign at Hewlett-Packard Co. ended Wednesday as the company's board forced her out as chief executive, disappointed by her efforts to make the technology giant whose strongest business is printers more nimble and innovative. HP shares surged 7 percent.

Board members said they fired Fiorina, one of corporate America's highest ranking female executives, because she failed to execute a planned strategy of slashing costs and boosting revenue as quickly as directors had hoped.

***

One recalls the conflict over the Compaq acquisition. One of the lead dissenters was HP director Walter Hewlett, the son of one of HP's late co-founders, who argued that HP was overpaying and couldn't afford to risk the difficulties of combining the two companies.

Note this change occurs after the Wall Street Journal had announced an HP "milestone" in computing technology concerning nanotechnology. Some Wall Street analysts have been suggesting that shareholders might be better off if the company were split into two or more pieces because the relatively dowdy printer business was sucking up resources and shifting focus from higher-profit opportunities in consulting services and areas of emerging technology.



Study on fuel cell patents

Thomson Scientific Ltd prepared a study of fuel cell patent documents obtained from Derwent World Patents Index. The search revealed 11,000 documents on fuel cells in the time 1999-2003 in a search over 40 patent issuing authorities.

Applications went from 870 in 1999 to about 4,000 in 2003. Matsushita and Mitsubishi were big players. Toshiba has been active in direct methanol fuel cells (DMFC).

In 2003, half of the major assignees were major car manufacturers.

Toward the end, the report delved into the area of carbon nanotubes as hydrogen storage vehicles. The report places the discovery as the late 1980's, although this might be questioned. Iijima's work at NEC came later, but work on filamentary carbon, such as by R. T. K. ("Terry") Baker goes back to the 1970's, and Boudouard carbon goes back to the 19th century.

In terms of geography, over 1999-2003, fuel cell patent applications are most likely to originate from Japan, with Germany next, followed by the EU.

In terms of 2003 alone, the US is number 2.

I could not help noting something in the conclusion. "Thirty years ago the need to develop fuel cell technologies as an alternative to plentiful coal and oil supplies simply did not exist."

One wonders where author Ed White was thirty years ago, circa 1974-1975. Obviously, not waiting in line for gasoline during the oil embargo shortages. In the 1970's there was a lot of research on batteries and fuel cells (recall Ford's work on sodium beta alumina, and review a 1970's edition of the textbook by John O'M. Bockris; Bockris was first to coin the very term "hydrogen economy" back in the 1970's: "Boiled down to its minimalist description, the 'Hydrogen Economy' means that hydrogen would be used to transport energy from renewables (at solar or nuclear sources) over large distances; and to store it (for supply to cities) in large amounts." ).

Also in the 1970's, Exxon worked on the Exxon Donor Solvent (EDS)process to convert coal into liquid fuels. Lots of companies were looking at oil shale in Colorado and elsewhere.

[A few remarks about energy density might be in order, but that can wait for another day.]

Some background from Gene Mallove (now deceased):

But just what is a fuel cell, which is said to be the corner-stone of the hydrogen economy? First, realize that fuel cells come in several different types, only a few of which have been touted for use in the proposed conventional 'hydrogen economy.' In purest form, one can think of a fuel cell as a reverse electrolysis cell. So instead of, for example, water being decomposed into hydrogen and oxygen (separately at two different electrodes) by the passage of electricity between the electrodes, in a fuel cell hydrogen may flow through and from an anode catalyst material (such as platinum), then through an intervening material substrate that allows the ionized hydrogen to move toward the cathode, where it is recombined with oxygen, producing water. The electron removed from the hydrogen at the anode then flows through the external power load of the fuel cell back to the cathode side, where it participates in the formation of the water by-product.


The basic fuel cell principle was actually discovered in 1839 in England by a research physicist friend of Michael Faraday, John Grove. But though the principle of the fuel cell has been known for a long time, there was apparently not a great technological need for electricity-producing fuel cells (called 'gas batteries' originally) for over a century after their discovery. Chemical storage batteries or primary cells worked just fine for most applications.

A two-page color advertising spread by General Motors in a recent New York Times (March 16, 2004, pp. C12-13) shows two little girls in a colorful plastic toy car tootling along a path through green grass with an expansive blue sky. The message written large in the heavens: "WHO'S DRIVING THE HYDROGEN ECONOMY?" More hype in the ad: "The hydrogen economy isn't a pipe dream. And it isn't the buzz du jour on the front page of the business section. The hydrogen economy is the endgame of a multi-faceted strategy GM set in motion years ago, with steps that are real, progressive, and well-underway ...We're making sure children today are in cleaner cars tomorrow. And in the driver's seat of the hydrogen economy."

So, what, if anything, is wrong with hydrogen fuel cells? First of all, as we have seen, they do not represent a new source of energy, but that is precisely how they are often billed in some publications that hype them. Jeremy Rifkin blurts out at one point in his book, crossing the line from insidious deception to outright falsehood: "For the first time in human history, we have within our grasp a ubiquitous form of energy, what proponents call the 'forever fuel.'"(p. 217) Hydrogen is not a 'ubiquitous form of energy' - it is merely a carrier of energy, once it is obtained at the cost of other energy input from some other source. Today, for example, the least expensive way to make hydrogen is by steam reformation of natural gas (methane). Electrolysis produces a more purified form of hydrogen, but this requires a source of electric power-solar, nuclear, chemical, etc.

Peter Hoffman notes: "Hydrogen is not an energy 'source,' a mistake still made fairly often by otherwise sophisticated, well-informed people. That is, it is not primary energy (like natural gas or crude oil), existing freely in nature. It is an energy carrier-a secondary form of energy that has to be manufactured (like electricity, which doesn't exist freely in usable form either)."

Dr. Joseph J. Romm writes: "commercially viable and environmentally beneficial hydrogen vehicles are in the post-2035 future." [long after patents from applications filed in 2005 will have expired].


Tuesday, February 08, 2005

Matsushita and Hitachi unite in PDP area

On or about Feb. 7, 2005, Matsushita and Hitachi joined forces in the plasma display panel (PDP) business.

The alliance consolidates Japan’s industry in PDP — large-screen televisions which offer state-of-the-art resolution — by uniting Japan’s top player in the sector Matsushita, maker of the Panasonic brand, with number-two Hitachi.

But Matsushita and Hitachi have slipped to third and fourth respectively in worldwide sales of plasma displays beneath global number-one Samsung and second-ranked LG Electronics, both from South Korea.

This looks more and more like an inter-country battle.

A lot of the players are in New Jersey: a lot of benefits in consumer electronics growth accrued to North Jersey - where some of the largest consumer electronics companies have headquarters or major operations, including Sony, Panasonic, Sharp, LG, Samsung, JVC, Toshiba and Maxell.

In Ridgefield Park, NJ, Samsung is planning to occupy more floors at its headquarters building. Last year, too, the company opened its first Samsung Experience interactive showroom - which features products in technology demonstrations and does not sell products - at the Shops at Columbus Circle in New York's Time Warner Center.


Oral argument in AWH v. Phillips

Yes, oral argument in AWH v. Phillips was today, Feb. 8, 2005. So many issues presented, and so little time to discuss them.

Manana...

Festo fog

From Mark R. Hull, Festo: A Fog Between the Bars, 37 Akron L. Rev. 339 (2004):

The Supreme Court's rejection of the Federal Circuit's complete bar rule has been viewed by many as a triumph for the patent system. n131 Some commentators have, however, taken a far less enthusiastic view of the Supreme Court's new rebuttable presumption rule. n132 Of concern is that the Court's approach appears to be a new, never before used creation n133 for which the Court provides scant guidance on its proper application. n134 As a result, a substantial number of unanswered [p. 365] questions make it difficult to understand Festo's true impact. n135

(...)
the Federal Circuit could echo Bernard Witkin's famous quote, "on a clear day, you can foresee forever," by taking a broad view of foreseeability. n142 A broad view could result in patentees' inability to claim any equivalents, or, at most, only equivalents in a rapidly developing field. n143

(...)
The amicus curiae brief from the Institute of Electrical and Electronics Engineers has been suggested as the source for the Court's [*368] use of foreseeability. n144 The brief, however, proposed a "foreseeable bar' that focused on the foreseeability of the effect of an amendment, which differs somewhat from the foreseeable equivalent test specified in Festo. n145 A discussion of foreseeability that is closer to the Festo test can be found in two recent Federal Circuit opinions. n146

Some of the footnotes:

n131. See Lawrence B. Ebert, Supreme Court Festo; Equivalents Still
Limited, Intell. Prop. Today, July, 2002, at 10. (indicating that the popular press believe the Supreme Court's Festo decision to be a victory for inventors over copyists); See e.g. Ron Cahill, Festo Restores Right Economic Incentives, U.S. Supreme Court Affirms Worth of Existing Patent, Companies, 168 N.J.L.J. 1225
(2002) (stating that the Supreme Court decision "restored the right
economic incentives," and will encourage competitions to invest in creating innovative advances in technology rather than making insubstantial changes to patented technology in order to avoid infringement); Jennifer Miller, Festo: Blessing to
Patent Holders or Thorn in Their Sides?, 2002 Duke L. & Tech. Rev. 17, 18 (2002) ...

n133. See Lawrence B. Ebert, It's a Strange, Strange World, Intell.
Prop. Today, October 2002, at 46 (indicating that the tests enunciated by the Court bear no citation to previous legal authority and appear to have never been used). See also supra note 115 (indicating that the source of the rebuttable
presumption was the amicus curiae brief from the United States); Brief for the United States as Amicus Curiae Supporting Vacatur and Remand, Festo Corporation v. Shoketsu Kinzoku Kogyo Kabushiki Co., 2001 WL 1025650 (2001) (No. 00-1543)

n134. See Ebert, supra note 133 (stating that the Supreme Court
provided no footnotes as to the origins of the three situations it articulated); Lawrence B. Ebert, Litera Scripta Manet?, Intell. Prop. Today, August 2002, at n.2

****
An issue now is that the tangential prong of Festo begins to resemble the old Hughes-I flexible bar. Just remember: no extrinsic evidence for the tangential prong, so say something (short) about why you're amending.




Diamond planets?

Some planets in our galaxy could harbor an unexpected treasure: a thick layer of diamonds hiding under the surface, astronomers reported on Feb. 7, 2005. No diamond planet exists in our solar system, but some planets orbiting other stars in the Milky Way might have enough carbon to produce a diamond layer, Princeton University astronomer Marc Kuchner said in a telephone news conference.

In gas with extra carbon or too little oxygen, carbon compounds like carbides and graphite could form instead of silicates, Kuchner said at a conference on extrasolar planets in Aspen, Colorado.

[and maybe buckyballs and fullerenes, too?]


Bruce Sunstein on patents: get out the sword

From an interview with Bruce Sunstein at SearchEnterpriseLinux.com:

How important are patents?

Sunstein: Patents are all about leverage in business. If a patent is really well crafted, and if the company's technology is good enough, a patent can give disproportionate leverage to a company and its business. A well-crafted patent can make a big difference.


How are IP conflicts most often resolved?

Sunstein: You give each one a sword and let them battle to the death. Well, most cases are not litigated absolutely; they're settled by doing a license deal that everybody finds okay.

[Ask the Wright Brothers and Integra about how their licensing went.]

On patent insurance:

Do companies need to purchase IP insurance?

Sunstein: There are a couple of different kinds, and none of it is particularly cheap. One kind will allow you to defend against claims of patent infringement. Patent insurance is a funny beast. You can actually get patent insurance working in the other direction. You can buy insurance for that instance when you might be asserting a patent downstream. Typically you can get insurance like this by interacting through the company with a patent lawyer or two and an insurance company that knows about it. But companies that know about this are few and far between. And even when they do know about it, it tends to be relatively expensive stuff.




New Jersey censures talk show host

More Jerseyana than IP but of interest.

On Monday, Jan. 24, 2005, New Jersey talk show host Craig Carton of 101.5 ridiculed women "who claim they suffer from this post-partum depression" and got into a tiff with (among others) acting Governor Codey. On Monday, Feb. 7, 2005, a committee in the New Jersey legislature voted 5-0 (two Republicans abstained) to censure the talk show host.

from JEFF PILLETS at northjersey.com:

A panel of state lawmakers voted reluctantly Monday to "censure" Craig Carton, the irreverent radio talk show host whose barbs at New Jersey's first lady nearly brought him to blows with acting Governor Codey.

Members of the Assembly Telecommunications and Utilities Committee took pains to argue that their 5-0 vote was a personal slap at the New Jersey 101.5 host - not a jab at media freedom and the First Amendment.

"To censure is a bit strong, to censor is intolerable. ... No one believes in freedom of speech of more than I do,'' said Assemblyman Jeff Van Drew, a D-Cape May County.

He then voted for the measure because he said he was "deeply disturbed" by Carton's on-air comments regarding Mary Jo Codey's bouts with mental illness.

Two Republicans, Assemblymen Kirk Conover and David Wolfe, abstained. Both said they wanted to vote "no" but refrained out of respect to the resolution's sponsor and committee chairman, Assemblyman Wilfredo Caraballo, D-Essex.

"When you use the auspices of the government to call for the censuring of a private individual, it's wrong,'' Conover said.

But Caraballo said Carton had "crossed the line" when he poked fun at Mary Jo Codey's illness. Caraballo said he was especially upset by Carton's on-air threats to work against Codey's election if he ran for governor.

"We have a right to say we won't be bullied by someone's raw assertion of power,'' Caraballo said.

After the vote, Carton said New Jersey's elected officials should turn their attention to more serious matters - like the property tax crisis and the state's multibillion-dollar budget shortfall.

Carton said his remarks have been reported out of context and that he was not making fun of mental illness. The radio host also pledged that, despite the committee's censure, he would continue to aggressively offer his views.

"I get paid to give my opinions. If I can't air my opinions without having the governor come in here with four state troopers by his side and try to bully me into silence - then something is very wrong," Carton said.

Carton, co-host of the popular ''Jersey Guys,'' said during a show last month that the governor should legalize marijuana for medical uses, ''so women can relax and have a joint instead of putting their babies in a microwave.''

Mary Jo Codey has talked openly about recurrent bouts with mental illness and postpartum depression that included violent feelings toward her two sons - who are now 16 and 20 - when they were newborn. She confessed that she had even been tempted to place one child in a microwave.

''Women who claim they suffer from this postpartum depression,'' Carton said on the air, ''must be crazy in the first place.''

Codey confronted Carton about the comments at the Mercer County station before a taping of "Ask the Governor," a weekly call-in program. The two had a brief shouting match and Codey challenged Carton to fight it out.

Nothing came of the challenge. But Codey's action was cheered by many, including his wife, who said she was "pleased as punch."

Andy Santoro, the station's vice president and general manager, suggested Monday that Codey staged the entire confrontation in a shrewd move to boost his appeal to the public.

He pointed out that the governor's office moved quickly to publicize the incident, even going so far as to make transcripts of Carton's on-air comments available to reporters the next morning.

Santoro added that Codey's office negotiated with the station on possible ways for the governor and the radio host to reconcile. He said Codey's office approached the station with several ideas, including an exhibition boxing match between Codey and Carton to benefit mental health charities.

He said plans for the exhibition fight fell through because the governor's office demanded an apology first.

Kelley Heck, the governor's spokeswoman, said suggestions that Codey had staged the confrontation and negotiated with the radio station are "completely false and outrageous.'' She declined to make further comment, saying that Codey has moved on.

Monday, February 07, 2005

Nanotechnology and the law

From an article by Sonia E. Miller in the Feb. 1, 2005 issue [page 5] of the New York Law Journal:

Qustion to Mihail C. Roco, Ph.D., the architect behind the National
Nanotechnology Initiative [NNI]: What would you advise the legal community regarding the advance of nanotechnology?

A: We are in the 'Age of innovation.' Society is changing not only through nanotechnology, but in connection with converging technologies integrated at the nanoscale, impacting policies about investments, laws, and education. The legal system is important to guard personal freedom of decision and the right of each
individual to have access to the best information in a society expected to become more complex because of the rapid advance of these technologies.

[Yes, but what was your advice?]

Question to James R. Von Ehr II, the founder and chairman of Zyvex
Corporation: The federal government funds studies on the societal implications of nanotechnology. The U.S. Patent and Trademark Office recently created Category 977 specifically for nanotechnology. What, in your belief, are some anticipated legal implications of nanotechnology?

A: Patents concern me greatly, particularly in nanotubes. There are so many patents being issued. I fear that we are setting ourselves up for many years of IP lawsuits. This will have a chilling effect on innovation.

[Not really a dominant patent in nanotubes, and no composition of matter patent on buckyballs.]

Question to Douglas W. Jamison of New York-based Harris & Harris Group, Inc.: What makes nanotechnology different from previous innovations?

A: It makes it difficult to start a lab in a garage. There is a lot of capital investment at the research level. Nanotechnology is very rigorous science protected by rigorous patents. It is about new compositions of matter that have different material characteristics because of their size. It will redefine how we think about governing future industries. The courts and legal system need to be educated to understand this difficult and complex science.

Question to Manish Mehta, Ph.D., the director of collaboration programs at the National Center for Manufacturing Sciences [NCMS]: What top challenges face the nanomanufacturing industry today?

A: The top industry concerns are: public perception that
nanotechnology products are far from commercialization; insufficient investment capital; intellectual property issues impeding commercialization progress; process scalability; high cost of processing; and that the societal benefits of nanotechnology are not yet recognized. The implications of nanoscale products
need to be recognized because liability could extend back to the
manufacturing process.


***
Keep in mind that, while it has been said that uncertainty over patents impeded commercialization of the buckyball (C60), the US composition of matter patent vanished into an interference black hole. Lack of commerical opportunites were the big problem. The Wall Street Journal wrote "Whatever happened to the buckyball?" and no satisfactory answer has ever been provided.



***UPDATE on Oct. 8, 2006 ***

A google search on "whatever happened..." did NOT return this IPBiz post.

It did however return

Recent Developments - Bucky Balls
"Whatever Happened to the Buckyball?", May 4th, 1998. THE WALL STREET JOURNAL, SCIENCE SECTION , May 4th, 1998 ran a provocative article called: "Whatever Happened to the Buckyball?" by SUSAN WARREN, Staff Reporter.

from the URL:

http://www.absoluterocknet.com/complete_list_of_mineral_and_crystal_names/Bucky-Balls.asp

Query: remember those articles in Intellectual Property Today?

Friday, February 04, 2005

Bayer, Monsanto and Max Planck Society cut deal

According to Reuters on February 4, 2005:

Monsanto Co., Bayer CropScience and the Max Planck Society on Feb. 4 said they have resolved a long-standing patent dispute by agreeing to cross-license each other for a type of technology that allows scientists to transfer DNA into plant cells. Monsanto, a leader in the development of genetically modified plants, uses the process to make cotton plants resistant to pests, while Bayer has been using the technology to make herbicide-resistant canola and cotton seed products.

We have discussed elsewhere some issues with the success of Bt-cotton in India.

In February 2004, Monsanto announced a similar settlement with Swiss agrochemicals maker Syngenta. The two agreed to swap licenses relating to transgenic broad leaf crops to end a patent-interference case with the U.S. Patent and Trademark Office.

The various settlements remind one of the settlement between Fairchild and Texas Instruments over the integrated circuit (IC).


HP, EMC in arbitration in case involving Bridgewater, NJ company

According to Infoworld :
EMC initially sued StorageApps in October 2000 claiming that the Bridgewater, New Jersey, company had infringed three of EMC's software patents relating to the creation of identical copies, or mirrors, of system files. Two of the patents cover a remote mirroring technique used in EMC's Symmetrix Remote Data Facility, EMC said. The other covers a mirroring technique used in the company's TimeFinder software. In July 2001 HP acquired StorageApps and the lawsuit. An Oct. 4, 2004, court injunction prohibits HP from selling technology that uses the patents, including versions of HP's StorageApps SV3000 and CASA (Continuous Access Storage Appliance) devices. The binding arbitration will determine what damages are to be awarded EMC, but not necessarily cover whether or not HP will be able to resume selling the products in question, the EMC spokeswoman said. "The injunction is permanent," she said. "At this point this damages phase is purely financial."

A Bloomberg report in the Boston Globe stated:

HP and EMC Corp. agreed to let an arbitrator decide how much Hewlett-Packard should pay for infringing on three EMC patents related to computer data storage. A federal jury in Worcester found HP liable for infringement in May 2004, and a trial to set damages was scheduled for Feb. 16. The two sides instead agreed to ''private, binding arbitration," court documents said. The dispute centers on HP's OpenView Continuous Access Storage Appliance, which the company obtained when it bought closely held StorageApps Inc. in 2001. US District Judge Nathaniel M. Gorton on Jan. 27 granted the companies' request to refer the damages issue to arbitration. Hopkinton-based EMC sued StorageApps in 2000, claiming the software used EMC's patented technology that makes mirror copies of data on systems.

Barr files suit on Allegra-D challenging FDA policy

Also on Hatch-Waxman, from Reuters:

Barr Pharmaceuticals Inc said on February 4, 2005 it sued the U.S. Food and Drug Administration, seeking exclusive rights to sell a generic version of Aventis' Allegra-D allergy drug.

Barr said its lawsuit challenges the FDA's policy of awarding generic exclusivity on a patent-by-patent basis, rather than solely to the first company to file a patent challenge.

Barr filed suit in the U.S. District Court for the District of Columbia. Barr won tentative approval to market generic Allegra-D in July.

The active compound in Allegra is fexofenadine.

Hatch-Waxman paragraph IV issues

Yali Friedman at about.com has a discussion of Hatch-Waxman issues. He states:

-->Generic manufacturers not satisfied waiting until patents expire have the option of trying to prove that an existing patent is invalid. The company that successfully challenges a patent is allowed six months before other generic firms are allowed to compete. A new strategy is to seek settlements from patent holding companies in lieu of patent prosecution. <--

Under paragraph IV, the ANDA filer can certify to invalidity or noninfringement. In one of the old omeprazole cases, noninfringement was the only issue. On multiple patents, the ANDA filer may state that he is waiting the composition of matter patent out, and assert invalidity of a more specific polymorph patent.

The "new" strategy of the first generic company cutting a deal with the proprietary company has been under scrutiny by the FTC (recall the Cardizem case, for example). Also, in the omemprazole case, the various generics cut deals, because the winner did not have sufficient production capacity.

Friedman also wrote:

By 2006, almost 200 patents covering $36 billion in US pharmaceutical sales will expire. When a pharmaceutical patent expires, manufacturers can lose a majority of their market share overnight.

With traditional pharmaceuticals, a generic company files an abbreviated new drug application (ANDA) with the FDA. This approval process takes 2-5 years, and one of the requirements is that the generic pharmaceutical be bioequivalent to the brand-name original. The current definition of bioequivalent is that the generic and brand-name pharmaceuticals must have the same amount of active ingredient in a patients blood over a period of time. While this arrangement is satisfactory for many traditional pharmaceuticals, biological compounds are not as easy to quantify. Biologically produced compounds are subject to minor modifications that are not always easily detected in traditional screens. Subtle differences in pH, ionic strength or temperature of the conditions used to produce a biological pharmaceutical can result in inactive products or products with unwanted activities. Both the FDA and Health Canada are working on additional regulations for generic forms of biological pharmaceuticals.

Thursday, February 03, 2005

CAFC rules against ISCO in superconductor case

In the nonprecedential ISCO v. Conductus and Superconductor Technologies Inc. [STI], the CAFC entered the realm of superconductors.

The CAFC mentioned that this case illustrates the difficulty in reversing a jury's finding of fact, citing to Hayes, 982 F2d 1527, 1532 (CAFC 1992).

Here, there was an issue as to whether or not an ARPA report was prior art, and who bore the burden of proof. The court cited Union Carbide, 724 F2d 1567 (CAFC 1984), for the proposition that the appellant must show the RESULT, not the reasoning, was erroneous. The CAFC also got into issues of nunc pro tunc conception.

The CAFC also got into the issue of motivation in an obviousness rejection, citing to ProMold, 73 F3d 1568.

Wednesday, February 02, 2005

Chicago Brand v. Mitutoyo on res judicata

In the non-precedential Chicago Brand v. Mitutoyo, the CAFC took on issues of res judicata (claim preclusion).

The topic was not unique to patent law, and the law of the regional circuit (here, Ninth Circuit) was applied. (Beech, 990 F.2d 1237 (CAFC 1993)). Elements for res judicata were as presented in Tahoe-Sierra, 322 F.3d 1064 (CA9 2003).

There was a side issue of Rule 11 sanctions.

IEX v Blue Pumpkin: another district court claim construction shot down

In the non-precedential IEX v. Blue Pumpkin Sotware, the CAFC shot down another district court claim construction. [2005 U.S. App. LEXIS 1628; CAFC opinion by Judge Clevenger]

The CAFC emphasized that the claims define the invention, citing to the old Supreme Court case Altoona Publix, 294 US 477, 487 (1935) and emphasized that claim terms are generally given their accustomed meaning, citing to the more recent CAFC case Innova/Pure Water, 381 F3d 1111 (CAFC 2004)[which also has text showing that claims define the invention]. The idea that the claims, rather than the specification, define the invention is relevant to arguments in patent reform proposed by Quillen and Webster, which arguments rely on a specification-centric view of the invention in arguing that continuing applications reflect repeated attempts to obtain the same invention.

Note that the CAFC also got into the "patentee as lexicographer" issue [recall Merck v. Teva and Judge Rader), citing Day v. Reeves, 260 F3d 1343 (CAFC 2001). The CAFC also noted that patent scope is not limited to preferred embodiments, citing Cordis, 339 F3d 1352.


From Blue Pumpkin:

Because "it is the claims of the patent which define the invention,"
Altoona Publix Theatres v. Am. Tri-Ergon Corp., 294 U.S. 477, 487, 79 L. Ed. 1005, 55 S. Ct. 455, 1935 Dec. Comm'r Pat. 785 (1935), in construing the claims we look first and foremost to the claim language, see Rexnord, 274 F.3d at 1341. While the terms of the patent claims are generally accorded their ordinary and accustomed meaning to one of ordinary skill in the relevant art, see Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004), we must also examine the remaining intrinsic evidence-- the rest of the specification and the prosecution history--" to determine whether the patentee has set forth an explicit definition of a term contrary to its ordinary meaning, has disclaimed subject matter, or has otherwise limited the scope of the claims," Day Int'l, Inc. v. Reeves Bros., Inc., 260 F.3d 1343, 1348 (Fed. Cir. 2001). With these claim construction principles in mind, we begin with the district court's treatment of "skill group."



Additionally, this is another case wherein the district court did not fully articulate its reasons for holding a certain way.

The CAFC stated in conclusion:

In conclusion, the district court erred in relying on incorrect claim constructions in granting Blue Pumpkin's motion for summary judgment, though the extent to which it did so is not entirely clear from the Magistrate Judge's recommendation or the district court's memorandum adopting that recommendation. The district court also did not fully articulate its reasons for rejecting IEX's expert evidence, particularly that from Mr. McAlexander. Accordingly, we vacate the district court's grant of summary judgment in favor of Blue Pumpkin and remand for further consideration in light of the claim constructions set forth in this opinion. We also reinstate and remand Blue Pumpkin's invalidity, unenforceability and attorney's fees claims.

Recall the words of the Third Circuit in Caprio v. Bell Atlantic, 2004 U.S. App. LEXIS 14101,

In fact, notwithstanding the foregoing statement, the court did not indicate, following the appellees' renewal of their motion for summary judgment, exactly what standard of review it was using, though it had considered this point preliminarily in its May 31, 2002 opinion. Moreover, it never said at any time that CORE "did not abuse its discretion in denying Caprio's appeals . . . ." Indeed, as appellees acknowledge, the court did not render any opinion when it granted summary judgment. Rather, it simply entered orders granting appellees' motion, denying Caprio's motion, and granting a judgment in favor of the appellees, following which Caprio appealed.

(...)

The fact is that we are not certain whether the district court granted summary judgment for appellees through the application of Firestone with or without our refinement of that case in Pinto. Moreover, whatever standard the court followed, we do not know the reasoning that led it to grant the appellees' motion for summary judgment. Thus, we will vacate the orders of the district court entered on April 1, 2003, and remand the case to that court for further proceedings. In those proceedings the court may revisit its substantive decision granting appellees summary judgment if it concludes that it would be appropriate to do so.
We regret that the consequence of our disposition is to put the parties to additional expense which they fairly may attribute to the district court's failure to conform to our directions in Vadino. Accordingly, in order that the procedural oversight here not be replicated, we point out that in future cases in which district courts overlook the procedure we set forth in Vadino the parties should not hesitate to bring that case to the court's attention.
We make this suggestion even though we can understand why parties might be wary of advising a district court of its oversight, and we do not require that they do so. Yet we note that our suggestion is consistent with requirements in other situations that parties bring procedural requirements to a court's attention if it should overlook them. Thus, Federal Rule of Civil Procedure 24(c) provides that when the constitutionality of any act of Congress or statute of a State affecting the public interest is drawn in question in an action in which the United States or the State or any agency, officer, or employee thereof is not a party, the court shall notify the Attorney General of the United States or the State's attorney general, depending upon the statute implicated, as provided by 28 U.S.C. § 2403, so that he or she may intervene on the question of constitutionality. It further provides that the party challenging the constitutionality of the legislation "should call the attention of the court to its consequential duty." Similarly, under some case law when a party following trial moves for judgment as a matter of law and, in the alternative, moves for a new trial, it should notify the court of the need for it to make a contingent ruling on the motion for a new trial if it grants the judgment as a matter of law but does not rule on the motion for a new trial. See Lowenstein v. Pepsi-Cola Bottling Co. of Pennsauken, 536 F.2d 9, 12 n.8 (3d Cir. 1976); Arenson v. Southern Univ. Law Ctr., 43 F.3d 194, 196 (5th Cir. 1995). Indeed, if the party does not notify the court of this procedural requirement it may lose the possibility of obtaining a new trial if the judgment as a matter of law in its favor is reversed. See Lowenstein, 536 F.2d at 12 n.8.
In closing we point out that we have not overlooked our authority to retain jurisdiction as we did in Forbes after we remanded that case to the district court to specify the material facts in issue which precluded the court from granting the defendants' motion for summary judgment in a 42 U.S.C. § 1983 action on the basis of qualified immunity. Forbes, 313 F.3d at 151. If we retained jurisdiction, we then could determine the matter without a new appeal being filed following the remand, perhaps after additional briefing. We have determined, however, not to retain jurisdiction because we have authorized the court to revisit its decision on the merits and thus it is conceivable that the court's outcome on remand could be different from that which it reached previously. Moreover, it is possible that the disappointed party, after considering the court's explanation for its determination, may not wish to pursue the matter further. n2