Judge Newman dissents in attorney sanction case, Tesco

From the Tesco case:


The Attorneys argue that there remains an Article III case or controversy because the statements made in the district court’s opinion constitute a sanction against the Attorneys, and the subsequent reputational harm to the Attorneys is a sufficient injury-in-fact to justify our jurisdiction. The Attorneys further claim that the district court erred, as a procedural matter, in issuing a sanctions order under its inherent authority without providing the Attorneys notice and an opportunity to be heard. The Attorneys believed that the result of the hearings held in early 2014 would be, at worst, a trial on NOV’s exceptional case motion, and they claim to have been taken by surprise by the sanctions order. On the merits of the sanctions order, the Attorneys argue that the district court erred in finding bad faith because Ballard relied on Karr’s statements during trial when Ballard made the representations to the court about the brochure, and Karr was equivocal during his deposition testimony about what he told Luman. According to the Attorneys, the deposition evidence of Karr and Orcherton was an insufficient basis upon which to premise an exercise of the court’s inherent authority. They contend, moreover, that this is especially true because the court chose to dismiss the case with prejudice.



Footnote 6 states:


At oral argument, the Attorneys contended that, even though they admit they knew during trial that the statements made to the district court turned out to be incorrect, they had no affirmative duty to correct the misimpression to the court under the Texas Disciplinary Rules of Professional Conduct. Oral Argument at 41:50– 42:15, Tesco Corp. v. Nat’l Oilwell Varco, L.P., No. 151041, available at http://oralarguments.cafc.uscourts.gov/ default.aspx?fl=2015-1041.mp3



IPBiz notes attorneys should pay attention to RPC 3.3(a) about candor to the tribunal.

Of the issues, the CAFC noted:


This appeal presents two questions that must be resolved in order for us to have jurisdiction over the dispute: (1) can the sanctions order that was explicitly issued against Tesco be considered a formal reprimand against the Attorneys so as to provide them with standing to pursue this appeal; and (2) what is the effect of the settlement by all parties on the redressability of the Attorneys’ request for relief?



The attorneys lost. Judge Newman dissented:



These sanctioned attorneys ask for the opportunity to provide privileged records that they say will clear their name, stating that these records were proffered to the district court judge, who declined to receive them. These sanctioned attorneys are surely entitled to an appeal (or remand to the district court, as alternatively requested). Precedent in all of the other circuits would so allow, and fundamentals of due process so require. From my colleagues’ contrary ruling, I respectfully dissent


AND


The majority argues that this dissent “fails to recognize” the “fine factual distinctions” upon which sanctions are based. Maj. Op. at 12 n.7. On this ground, the majority justifies ignoring the vast body of precedent in which sanctioned attorneys have had the right and opportunity to defend their reputations. To the contrary, precedent demands that fine facts be found. My concern is that the district court repeatedly refused to receive the Appellants’ proffered evidence, although that evidence could affect the factual weight and perhaps even change the conclusion. The appellate obligation is to assure an adequate and fair factual foundation to which the law is applied. I dissent for precisely this reason: the incompleteness of the record renders the sanction possibly unfair. All of the precedents that I cite are founded on the position that when the trial judge issues a reprimand, it is incumbent on the appellate tribunal to assure that the processes of law are fully recognized.



AND



The district court invoked its inherent power to punish what it saw as bad faith and willful misconduct. Such power is available “only if clear and convincing evidence supports the court’s finding of bad faith or willful abuse of the judicial process.” In re Moore, 739 F.3d 724, 729–30 (5th Cir. 2014). The issue is not whether the district court has such inherent disciplinary power, but whether these sanctioned attorneys are entitled to appeal and to bring forth privileged documents to defend themselves. My colleagues hold we do not have jurisdiction to consider this issue.


AND



Common to all circuits is the requirement that sanctionable behavior must be established by clear and convincing evidence on the record as a whole. There cannot be clear and convincing evidence without an opportunity to present contrary evidence. Although my colleagues state that the Appellants had adequate opportunity to “recant their statements to the court,” it was not until three years after these attorneys’ conversations, that the witnesses were deposed.

An exercise in foreseeability: Morgan Robertson "predicts" Titanic sinking in 1898

After KSR, there is much discussion of foreseeability in the obviousness analysis.

An interesting, and eerie, example of foreseeability is found in the novella by Morgan Robertson titled: Futility.


The ship in the 1898 novella was named the "Titan," and was within 25 meters of the length of the Titanic. The largest ship of its day, the Titan was deemed unsinkable. But it hit an iceberg in the northern Atlantic, and sunk.

As noted in Time magazine (and elsewhere):


After the sinking of the Titanic, Robertson gained great acclaim for being a clairvoyant, a title he denied.

“No,” he would reply. “I know what I’m writing about, that’s all.”




One of ordinary skill in the art, or of extraordinary skill?

link to Time story: http://newsfeed.time.com/2012/04/14/author-predicts-titanic-sinking-14-years-earlier/

St. Jude's win over Atlas IP vacated by CAFC

The win of ST. JUDE MEDICAL, of summary judgment of non-infringment in Southern District of Florida was vacated by the CAFC.

The CAFC noted its differences with the interpretation of the district court:


In Atlas v. Medtronic, we today hold that the starting
time and duration of the cycle and of remote-transmission
intervals within each cycle must be communicated by the
hub to the remotes before the time at which remotes may
begin transmitting. Here we hold, in agreement with
Atlas, that the claim language at issue does not require
that the cycle’s starting time and duration be communicated
to the remotes even earlier, i.e., before the communication
cycle begins. The district court’s contrary
conclusion, adopting St. Jude’s argument, rests at bottom
on the notion that, unless that information is sent before
the start of the cycle, the remotes would not be awake to
receive the hub-sent information about the cycle. J.A. 8
(“the remotes must know when to power up for the beginning
of the next communication cycle, or they would be
unable to receive the information frame” with the schedule
for the cycle). But the patent does not support that
premise or, therefore, the district court’s construction.

Nothing in the claim language requires that the hub
transmit information to the remotes about the starting
time of the communication cycle before the start of the
communication cycle. The claims recite that the hub
establishes repeating communication cycles and then
transmits information to the remotes to establish the
communication cycle and its intervals. ’734 patent, col.
48, lines 7–17 (claim 11); id., col. 49, lines 44–54 (claim
14). The claims also state that the remotes power off
their transmitters and receivers for times outside the
relevant interval. Id., col. 48, lines 22–25 (claim 11); id.,
col. 49, lines 59–62 (claim 14). Nowhere do the claims
indicate that the starting time of the communication cycle
is communicated in advance of that cycle.

Similarly, the claims do not require that the duration
of the communication cycle be sent in advance of the
communication cycle, and nothing in the intrinsic record
dictates that result. Other claim language positively
suggests, if it does not necessitate, that information about
the duration may be sent during the communication cycle.
Clause [g] of claim 14 itself recites that “the hub transmit[
s] a frame containing information describing the
length of the communication cycle prior to the end of the
communication cycle whose length is established.” Id.,
col. 49, lines 65–68 (emphasis added).1 Claim 33, which
also contains the transmitting clause [c], states that “the
hub transmit[s] a frame containing information to establish
a first interval in the communication cycle during
which the information establishing the communication
cycle . . . is transmitted.” Id., col. 53, lines 49–53.



The bottom line is "vacated and remanded"


We conclude that the district court erred in construing
the “transmitting” limitation to require that the starting
time and duration of a communication cycle be sent in
advance of the communication cycle. Because there is no
ruling about infringement under any other claim construction,
we vacate the summary judgment of noninfringement
and remand for further proceedings.




Note also: St. Jude Medical Inc., St. Jude Medical S.C. Inc. and Pacesetter Inc. v. Atlas IP LLC, IPR2014-00916.


***In the Florida action, St. Jude is a patent infringment defendant.

Elsewhere, it has been a plaintiff, for example against the University of Pennsylvania. From the Philadelphia Inquirer in January 2014:


Penn's T-cell therapy and its development deal are at the heart of the lawsuit that Juno Therapeutics has joined.

Juno, based in Seattle, is a partnership of Sloan-Kettering, Fred Hutchinson Cancer Research Center, and Seattle Children's Research Institute. Last month, Juno signed a licensing agreement to commercialize T-cell technology patented by St. Jude Children's Research Hospital in Memphis, according to legal papers.

The technology involves a "chimeric antigen receptor," or CAR - a synthetic genetic structure that programs the patient's T cells to target and attack cancer.

St. Jude is suing Penn, accusing the university of breaching an agreement to share St. Jude's CAR and infringing on St. Jude's patent.

On Dec. 18, a federal judge granted Juno permission to intervene in the lawsuit, which seeks financial compensation and an end to the patent infringement.

"The license agreement between Juno and St. Jude explicitly provides that Juno will 'control, pursue, and defend' the present case between St. Jude and Penn," attorneys for Juno wrote in legal papers.

Mytheos Holt trashes Joe Nocera in the American Spectator over patent reform

**One sees from the title of the Holt post Dear Conservative Patent Reform Skeptics: Stop Backing the New York Times that one is dealing with a "guilt by association" piece rather than a substantive analysis of patent reform issues.

The Holt piece begins:


The number of Leftist interests and household names lining up to oppose patent reform continues to mount. Now, on top of trial lawyers, university administrators, and the architects of Obamacare, patent reform can add the New York Times op-ed page to their ranks.

And not just any op-ed page writer, oh no. No, this particular anti-reform rant comes courtesy of Joe Nocera, the man who has called Tea Partiers “terrorists” and accused Republicans of wanting to poison peoples’ food (despite never having met them until adulthood). Although, as at least one enthusiastic pro-troll blog blared, Nocera has won the Gerald Loeb Award, an award that has gone to the likes of Paul Krugman in 2011, and a veritable who’s who of Leftist polemicists along with him. Hey, I guess some prize is better than no prize. Just ask President Obama about the Nobel Peace Prize.



WARF gets trashed too:



Nocera could have saved himself the process of writing this entire embarrassing op-ed if he’d simply consulted Business Insider, which labels the UWM-affiliated entity he’s referring to — the Wisconsin Alumni Research Foundation (WARF) — as one of the eight worst patent trolls in the market. Our gasping English professor is going to have to sit down.


And Mark Lemley, the professor who thinks Gary Boone invented the integrated circuit,
is praised:


No less an entity than Stanford Law School Professor Mark Lemley asks the question “Are Universities Patent Trolls?” in a journal article, and concludes that yes, sometimes, they are. I suppose Lemley doesn’t attend enough Manhattan press junkets to realize the error of his ways.



And, no, Lemley never retracted his foolish comment about Boone, or, separately, his incorrect assertions about the inventors of the transistor, based upon, you guessed it,
a non-existent article in the New York Times [see 8 JMRIPL 80 (2008)]

Getting back to "Dear Conservative," Dana Rohrabacher (R-Ca) is a conservative who opposes the present Goodlatte Innovation Act for "conservative" based reasons. How will Holt attack his credentials?


**Separately, within a Washington Examiner op-ed, one finds the text:


Littered across the Internet are various analyses that about 95 percent of pending lawsuits end in trial, and settlement prior to trial is in the low 90 percent range. Few — often cited as less than 1 percent of disputes — are ever settled by the court. To take one state as an example, in Florida only 0.2 percent of civil disputes even make it to trial. So to claim that only 1 percent of patent disputes end up in court is to say they are fairly common or maybe even more common in court resolution.



link: http://www.washingtonexaminer.com/debunking-myths-about-patent-trolls/article/2575017

One might question a comparison of all civil suits in Florida to patent suits.
Maybe, "loser pays" is an item which bothers opponents of patent reform.

Lowell Woods obtains 1,085th patent; breaks Edison record.

A communication received by LBE notes


Lowell Wood just broke Thomas Edison's patent record!

We are proud to share that long time Hertz Director and Senior Interviewer Lowell Wood just surpassed Thomas Edison's patent record.



The release notes that Lowell now has 1,085 patents.

V.K Gupta on TDKL database: "If we give access, these multinationals will steal everything.”

Nicola Twilley has an interesting post at the New Yorker titled: Who Owns the Patent on Nutmeg?.

Apart from the predictive quote of V.K. Gupta, which may have great relevance to issues in patent reform, there are some
anecdotes about the indigenous knowledge issue.

For example, there are significant quotations of Professor Chris Sprigman [UofC Law, 1993] , now at NYU:


Back in July, the Indian media triumphantly reported a news item that escaped the attention of many of their American and European counterparts—the country’s successful challenge of two European Union patents awarded to Colgate-Palmolive. The multinational had claimed intellectual-property rights on a nutmeg-based mouthwash and an herbal toothpaste. These products worked—that much was undisputed. Indeed, their usefulness in promoting dental health had been known in Indian culture for several thousand years. (In the case of the toothpaste, the Colgate chemists’ only substantive modification was to make the recipe less abrasive.) And there lay the problem: patents, as Christopher Sprigman, a professor at New York University School of Law, told me, “are only supposed to be granted on inventions that are novel and nonobvious. It’s not supposed to go to the ninth guy who invents the wheel.” The formulas that Colgate-Palmolive had claimed as its own inventions were clearly no such thing, and the Indian government promptly—and, ultimately, successfully—contested them.




The neem patent controversy is briefly mentioned:


According to the T.K.D.L.’s creator, V. K. Gupta, the final straw for him and his colleagues was a patent that the United States granted, in 1995, to two researchers at the University of Mississippi Medical Center for the oral and topical application of turmeric to treat ulcers and surgical wounds. “The use of turmeric for healing wounds is known to every Indian,” Gupta said. “It is also in several of our ancient texts.” And yet the battle to overturn this and other patents—on a particular strain of basmati rice, on the use of neem oil as a pesticide—dragged on for the better part of a decade, with each case costing, Gupta estimated, between three million and five million dollars in legal fees.



IPBiz has been covering these controversies for some time. For example, from 2006


Thailand will submit information on mangosteen to the United States Patent and Trademark Office (USPTO) to try to stop an American food company from taking out patents based on the popular fruit. US-based Nature's Sunshine Products, a producer of herbal and food supplements, applied for patents for drinks made from mangosteen extracts on Oct 27, 2004. According to Kanissorn Navanugraha, the director-general of the Intellectual Property Department, extracting mangosteen for beverages was part of Thai traditional wisdom. "I will submit to the US authorities that Thais have been using traditional knowledge to derive extracts from mangosteen for a long time," he said.

This reminds one of the controversies surrounding the neem plant. One also thinks of the use of a book by "beat generation" poet Ginsburg as prior art in a certain plant patent case.



And in 2010, from
"Discovery" already known?

And, in 1999, from Intellectual Property Today


Interestingly, in rejecting Plant Patent 5,751 on Nov. 4, the PTO may have gone to a low-tech, but unconventional, source: the 1971 book "The Yage Letters" by beat-generation writers Allen Ginsberg and William Burroughs which described their experiences under the influence of the plant (the ayahuasca). FROM: LBE, Commercialization of Information: Science Journals as Infomercials? IPT (Dec 99)

Valeant stock takes a beating after drug price increases

Not unrelated to the controversy related to Turning Pharma, Valeant was under scrutiny in a post
on Reuters Drugmaker Valeant raises detailed defense but doubts remain

Text on Wikipedia summarizes the recent problems:



Much of the criticism relates to price increases Valeant has made to drugs it acquired the rights to through mergers and acquisitions.[66] For instance, following the company's acquisition of Salix Pharmaceuticals in 2015, it raised the price of one Salix drug, the diabetes pill Glumetza, about 800 percent.[66] The price of Valeant's stocks sank following the scathing New York Times article about Valeant's business model which enriches investors by overpricing life-saving drugs. Regulators are investigating the controversial model.[15]

The article described how,[66]


"Valeant is known for buying companies and laying off their employees to achieve savings, while accumulating a debt of about $30 billion. It spends an amount equivalent to only 3 percent of its sales on research and development, which it views as risky and inefficient compared with buying existing drugs. Traditional big drug companies spend 15 to 20 percent of sales on research and development. Valeant also pays extremely low taxes because it is officially based in Canada, although Mr. Pearson operates from New Jersey."

— New York Times 4 October 2015

On October 5, 2015 Valeant closed sharply dropping $26.52 to $213.10 CAD.[4] Demetris Afxentiou argued in an article published in The Motley Fool that a "single tweet from Democratic presidential candidate Hillary Clinton" sparked a sell-off of Valeant stocks.[67] Clinton's September 21st, 2015 tweet, aimed at price gouging in specialty drugs, posted on social media, "Price gouging like this in the specialty drug market is outrageous. Tomorrow I’ll lay out a plan to take it on."[68] Neither Clinton's Tweet, nor the New York Times article[16] linked in her Tweet focused on Valeant. They referred to Turing Pharmaceuticals' Daraprim, a 62-year-old drug whose price increased from $13.50 each to $750. However "Valeant’s heart drugs Nitropress and Isuprel increased in price by over 210% and 520% each the day that Valeant acquired the rights to sell them."[67] A few after Clinton's tweet, Valeant lost nearly 20%, "a significant portion of its value




link to Wikipedia: https://en.wikipedia.org/wiki/Valeant_Pharmaceuticals

Now, if a politician sold short on a pharma stock, and then criticized the pharma the next day, is that any different from
the Kyle Bass IPR strategy?

CBS Sunday Morning on October 25, 2015

Of note in the news portion, Osgood
referenced the event at the University of
Oklahoma, rather than Oklahoma State
University.

An inserted factoid was that pumpkins come in white,
blue, and green.

Almanac was on TWA, and the first
transcontinetsl flight on Oct. 25, 1930.

Faith Salie had an opinion piece critical of
Donald Trump, noting that people cheer his insults.
And that Trump is consumed with appearance of women.
Salie said Trump speaks like a third grader and his language
makes him the ugly American. One notes Trump has big
leads in New Hampshire and South Carolina.

The moment of nature was of vultures in Roaring River
State Park in Cassville, Missouri.

Link: http://www.cbsnews.com/videos/nature-vultures/

The concept of “efficient infringing”

In a piece in the NYT titled The Patent Troll Smokescreen , Joe Nocera mentions the concept of “efficient infringing.”



As it happens, thanks to the 2011 America Invents Act and those rulings, big companies can now largely ignore legitimate patent holders.

Of course, they don’t call it stealing. But according to Robert Taylor, a patent lawyer who has represented the National Venture Capital Association, a new phrase has emerged in Silicon Valley: “efficient infringing.” That’s the relatively new practice of using a technology that infringes on someone’s patent, while ignoring the patent holder entirely. And when the patent holder discovers the infringement and seeks recompense, the infringer responds by challenging the patent’s validity.

Should a lawsuit ensue, the infringer, often a big tech company, has top-notch patent lawyers at the ready.



Of some interest in the Nocera piece:


What got me thinking about this was, in fact, a recent lawsuit between Apple and WARF over a University of Wisconsin innovation that Apple uses to help speed the processing time of several versions of the iPhone and iPad. Apple not only couldn’t be bothered to license the patent; it wouldn’t even let WARF in the door to negotiate. Instead, Apple sent the foundation a link to a page on the Apple website, which says that the company can lay claim to any unsolicited idea. So WARF sued. What choice did it have?




Of course, when one presents an "unsolicited" idea to any third party, one had better be sure that patent protection is in place.
Then, the third party cannot "lay claim" to the idea.

**Elsewhere, Forbes discusses Kyle Bass and the short sell/IPR strategy in an article


Are Short-Sellers Really Making Money Off New Patent-Review Law? Not Yet.





Bass’s traders would have to have had nerves of steel to make money on Acorda, however, covering their short as it made a one-day downward spike on Sept. 29. Since then Acorda has rallied above $36, erasing nearly all the gains from shorting the stock in the belief the IPR challenges would drive it down. It won two challenges in August, and then on Thursday it reported earnings and revenue that beat forecasts.

Hayman’s other early targets have either failed or generated returns for reasons other than IPR challenges. Celgene is up since Hayman filed IPR challenges against in April and May. Jazz is down 30% since August, but analysts attribute that mostly to concerns about the Clinton proposal and Jazz’s reliance on a single drug, Xyrem, for narcolepsy. Shire is down significantly, but mainly since the Food and Drug Administration rejected its dry-eye drug lifitegrast. The stock has actually risen 6% since Hayman scored its first victory before the Patent Trial and Review Board on Oct. 8, winning review of Shire’s patents covering Lialda, a colitis drug. Biogen is also down since Hayman filed its first challenge in April, but most of the decline came after the company’s top researcher resigned and an analyst downgraded the stock in July. The PTAB rejected Hayman’s challenges in September.


link: http://www.forbes.com/sites/danielfisher/2015/10/24/are-short-sellers-really-making-money-off-new-patent-review-law-not-yet/

One notes Bass's problems have been denials of petitions to institute an IPR, and he apparently has been re-filing updated petitions. There has been NO substantive ruling on a granted IPR filed by Bass.

Anti-patent polemic in the American Spectator by Mytheos Holt exploded

Talk about bad timing! The anti-patent rant by Mytheos Holt titled THE HIGH PRICE OF OUR MEDICAL PATENT SYSTEM focuses on the recent price high for the drug Daraprim (which drug is not on patent and which price hike had nothing to do with the patent system) and which price hike has been rendered nugatory by actions of the pharma company Imprimis, which is planning to sell a variant for $99 for a 100-count bottle.

See USA Today post Drug company attempts $1 alternative to Daraprim

The American Spectator should be ashamed.

Statements such as


Worse, as the Left’s rapid railing about Daraprim shows, that patent system is a boon to the supporters of socialized medicine, because it gives them an ever-increasing cost of care to rail against with zero opposition from Big Pharma so long as they leave the patent system intact

(...)

Yet because of the perverse incentives created by a patent system that grants ten years of exclusive rights to price gouge drugs on the flimsiest pretexts, that is exactly what American taxpayers are subsidizing, particularly with the money they spend on Obamacare-approved insurance plans.

(...)

But it doesn’t have to be that way, and if patent reform can get past the obstacles created by anticapitalist big business, it won’t




have nothing to do with Turing's price hike on Daraprim, which would not have been remedied by any currently proposed patent reform.

Additionally, Holt mentions only the opposition to patent reform by pharma, but neglects to mention "why" universities and small inventors also oppose reforms such as the Goodlatte bill.

***Details of the issues with Daraprim are included in an article in Law360:


Daraprim was first approved by the FDA on Jan. 23, 1953.[3] Through a chain of title that included GlaxoSmithKline PLC, Amedra Pharmaceuticals LLC and Impax Laboratories Inc., Turing acquired the rights of Daraprim in August 2015. Daraprim is a reference listed drug in the FDA’s Orange Book[4] and no generic version of the drug is currently available.[5]

One reason no generic may be available is the small number of patients who take Daraprim. The U.S. market for Daraprim is estimated to be about 2,000 patients. The relatively small number of patients, coupled with a modest price of $17.50 per pill for the brand product (which a generic would likely lower), do not create a significant financial incentive for a generic market entry.

Another potential reason why a generic is not currently available is the presence of a restricted distribution program.[6] According to press coverage, Turing, the sole U.S. supplier of Daraprim, acquired exclusive rights from Impax Laboratories in August 2015. Prior to the acquisition, Impax subsidiary Amedra Pharmaceuticals LLC, the then-manufacturer of Daraprim, implemented a restricted distribution program.[7] Restricted distribution programs are often put in place when required by the FDA as part of a risk evaluation and mitigation strategy ("REMS"). REMS help to mitigate a drug’s risk profile by various means, including controlling drug access to ensure that only educated physicians prescribe the drug to patients that actually need it.

Amedra’s restricted distribution program does not appear to be associated with an approved REMS, and therefore it appears to have been a self-implemented restricted distribution.[8] While restricted distribution can make drugs safer, restricted distribution programs in some circumstances could also make it tougher for generics to enter the market. In order to receive FDA approval, a generic manufacturer must show that its drug is bioequivalent to the marketed drug.

Restricted distribution programs potentially could make it more difficult to get sufficient quantities of the marketed drug to perform these bioequivalence studies. Thus, as a result of the restricted distribution program, a generic competitor — seeing the opportunity to make profits by entering the marketplace after Turing’s price hike — might have a harder time developing the required data package to support approval. Restricted distribution programs in the context of REMS have been evaluated under the antitrust laws,[9] and restricted distribution absent a REMS likewise potentially could raise antitrust issues.



Link: http://www.law360.com/articles/709116/a-look-at-the-legality-behind-daraprim-s-price-spike

One notes that there is no mention of a patent blocking generics from providing a bioequivalent form of Daraprim.

One note that Forbes wrote:


But unless you’ve been offline or away from the news for the last month, you’ll know that’s exactly what happened when Turing Pharmaceuticals’ CEO Martin Shkreli announced a price increase for Daraprim, a patented formulation of the antiprotozoal drug, pyrimethamine.

link:

The CAFC on contract law in Integrated Technology v. Rudolph

From Integrated Technology v. Rudolph :




Rudolph argues that, if we affirm the exceptionality
finding, Rudolph should not be held to the stipulation it
drafted prior to the first appeal regarding the amount of
attorneys’ fees. We agree. We review contract interpretation
de novo and the district court’s ultimate decision for
abuse of discretion. Doe I v. Wal-Mart Stores, Inc., 572
F.3d 677, 681 (9th Cir. 2009) (“Contract interpretation is
a question of law that we review de novo.”); Bywaters v.
United States, 670 F.3d 1221, 1228 (Fed. Cir. 2012) (“[I]n
determining the amount of reasonable attorneys’ fees to
award under federal fee-shifting statutes, the district
court is afforded considerable discretion.”).
We interpret the stipulation’s text to be binding only
when Rudolph is liable for fees for the entire case. The
stipulation states that “Rudolph will not contest the
reasonableness of ITC’s request for fees in the amount of
$3,252,228.50.” J.A. 18396.1. This language assumes
that the district court has already held Rudolph liable for
fees encompassing the entire case—the stipulation relates
only to “ITC’s request for fees.” Id. Even when a party is
liable for fees covering the entire case, the losing party
may still contest the reasonableness of the prevailing
party’s fee request. The stipulation refers only to this
issue: “the reasonableness of the dollar amount.” Id.
Moreover, Rudolph explicitly reserves the right “to contest
or appeal ITC’s entitlement to attorneys’ fees on appeal or
otherwise as may be appropriate . . . .” Id. In other
words, Rudolph remains able to contest the extent of its
liability for fees.

(...)

The context in which the stipulation was entered supports
our textual interpretation. The district court had
just resolved the judgment as a matter of law motions
heavily in favor of ITC—the court upheld the jury’s infringement
and willfulness verdict, it trebled damages, it
held the case exceptional, and it entered a broad injunction.
In that climate, Rudolph agreed not to contest the
amount of ITC’s requested fees.
Now, however, the case’s posture has substantially
changed. Indeed, ITC won only a fraction of its original
claims. In this case, ITC asserted two patents against
both Rudolph’s pre- and post-redesign products. It also
accused Rudolph of willful infringement, and it sought
treble damages and an injunction. After the initial district
court proceedings had concluded, ITC won a complete
victory on one of the two asserted patents. However, on
appeal, we reversed the infringement finding as to the
redesigned products, which vacated the willfulness finding,
vacated the injunction, vacated the trebled damages,
and vacated the exceptionality determination. After the
appeal, ITC won only a portion of its original case—
simple infringement of one patent on only the preredesign
products.
Furthermore, the district court provided no explanation
in holding Rudolph to the stipulation. The court
merely stated that “[t]he parties previously stipulated to
the amount of fees,” without resolving Rudolph’s argument
that the stipulation was no longer binding. J.A. 72.
As the court provides no reasoning, it is difficult to defer
to the district court’s view of the case.
Federal Circuit law requires that the amount of the
fee award “bear some relation to the extent of the misconduct.”
Special Devices, Inc. v. OEA, Inc., 269 F.3d 1340,
1344 (Fed. Cir. 2001)

The "ice cream patent wars" of the 1920's: insights into software patents, or not?

Charles Duan (director of the Patent Reform Project at Public Knowledge ) has a post at Slate titled Ice Cream Patent Headache: What the history of Eskimo Pies tells us about software patents today.

This is a story with an agenda, as can be gathered by reading merely the title. The more typical "patent story" for this purpose is the patent of George Selden, used against automaker Henry Ford.


**From LBE's article in Intellectual Property Today in June 2001 titled "Looking Backward"


The beginning of the decision reads: “The subject is most important; the interests involved, of great magnitude; the record phenomenally long; and the questions presented, complex.” The decision continued: “During this long time the [...] art made marked advances along different lines, and when, in [...], the patent was granted, it disclosed nothing new. Others had then made the patentee’s discovery and had reduced it to practice in ignorance of what he had done. While he withheld his patent, the public learned from independent inventors all that it could teach. For the monopoly granted by his patent he had nothing to offer in return. The public gained absolutely nothing from his invention, whatever it was. Fromthe point of view of public interest it were even better that the patent had never been granted.”

The patent in question is not to a business method, nor even to such a thing as BT’s claim to a hyperlink. It is not a patent to Lemelson. The patent in question is US 549,160 issued in 1895 to a Rochester lawyer named George B. Selden and the decision in question is Columbia Motor Car Co. v. C. A. Duerr, 184 F. 893 (CA 2 1911), which found, among other things, that Henry Ford’s cars did not fall within the scope of the patent, mainly because Ford’s cars employed an engine different from that disclosed in the ‘160 patent.



See for example: http://ipbiz.blogspot.com/2009/03/selden-patent-as-discussed-in-ipt-in.html

** The Duan story of October 2015 is about Christian Nelson and Russell Stover, but the last sentences of the article states:


The Eskimo Pie ended up being sold stickless. The mass marketing of a chocolate-coated ice cream bar on a stick would require a new visionary who would see beyond the Eskimo Pie, a man named Harry Burt, who would go on to found the Good Humor company.



IPBiz covered a part of the Harry Burt story in a post in June 2014 titled
Popsicle patent wars of yesteryear.

One item that Duan did not get into was the patents of Burt, which were evolving about the same time as Nelson's patent.

The first claim of the Nelson patent, US 1,404,539 [ filed Dec. 23, 1921; granted January 24, 1922 ] related simply to coated ice cream (actually merely a normally liquid material frozen to a solid state) and did not relate to a stick:

1. A confection comprising a core of normally 1iquid material frozen to a substantially solid state and sealed within an edible,
sustaining and form-retaining casing adapted to-maintain the confection in its original form durin handling.

[One notes that the claim would encompass coated ice cream with or without a stick.]

Burt's US 1,470,524 was filed Jan 30, 1922 (less than one week after Nelson's patent issued!).

PatentPlaques suggests that Harry Burt had invented a chocolate coated ice cream in the year 1920.


In 1920, a candy maker in Youngstown, Ohio created a recipe for coating ice cream with chocolate. Harry Burt’s smooth chocolate coated ice cream treats were delicious. The first taste tester was his daughter Ruth who loved the flavor but hated the mess. Earlier, Burt had invented a lollipop on a stick known as a Jolly Boy Sucker. Taking the advice of his son, Harry Jr., Burt froze the same stick into his ice cream, creating handles for the treats. Burt named his new ice cream invention the Good Humor Bar. The name came from the belief that a person’s humor or temperament came from their sense of taste.

On January 30, 1922, Burt applied for patents on the process and manufacturing of the frozen treat as well as for the treat itself. The United States Patent Office was reluctant to grant the patents because of the product’s similarities to Eskimo Pies. It took a trip to Washington, D.C. with a five-gallon bucket of Good Humor bar samples before his patent would be approved. Ultimately, Burt received US Patent 1,470,524 for the Process of Making Frozen Confections on October 9, 1923. He did not receive a patent for the confection itself.




Although it is true HARRY Burt did not get a patent on the confection, CORA Burt did get such a patent (1718997 ), with first claim:

A frozen confectionery product including a frozen body portion formed of an edible substance which is fiuid at normal temperatures and congeals by refrigeration, and a stick member partially embedded in the body portion and attached thereto by congelation, the projecting end of the stick member forming a handle.

The application was filed on January 30, 1922, but the patent did not issue until July 2, 1929. [Harry Burt died in 1926.] As noted in the 2014 IPBiz post, the significant claims of US '524 and US '997 would later be invalidated, as were the claims of Nelson's patent.

Patent litigation did not bankrupt Burt. PatentPlaques notes:


Eventually, he dropped the suit against the Citrus Products Company because he realized they refused to settle in order to see if his patent would hold up in court. Burt and Popsicle reached an agreement out of court. Popsicle paid a licensing fee to Burt and was permitted to manufacture frozen treats from ice and sherbert. Burt kept the exclusive rights to produce the frozen suckers from ice cream and other dairy products.



Returning to the Duan article, one notes the story was discussed in 1998 in an article by Maurita Baldock, which included:


On January 24, 1922, the United States granted patent number 1,404,539 for the Eskimo Pie. Nelson's patent applied to any type of frozen material covered with candy. Nelson also had the name "Eskimo Pie" trademarked. Initially, even the word "Pie" in a brand name frozen treat was covered by this trademark. The breadth of the patent was detrimental to Eskimo Pie because of growing legal costs associated with its defense.

Russell Stover sold his share of the company in 1922. Because of the cost of litigation, high salaried salesmen, and difficulties in collecting royalties, the company was sold in 1924. Eskimo Pie became a subsidiary of United States Foil Company, the supplier of the Eskimo Pie wrapper. Headed by R.S. Reynolds, Sr., the company later became known as Reynolds Metals Company.

In 1925, dry ice was invented. Nelson was eager to find a way to make buying Eskimo Pie as easy as buying another snack from a vendor. Nelson began to market thermal jugs with dry ice supplied with Eskimo Pies to vendors without access to a freezer. This increased visibility and distribution and made Eskimo Pie an "impulse" item.

The patent litigation continued until October 3, 1929, when the U.S. Circuit Court of Appeals upheld the decision of the lower courts declared that the 1922 patent was invalid, due to "lack of invention." Eskimo Pie resembled an earlier product that also called for ice cream with cocoa butter dipped in chocolate. The judge declared that Nelson had merely changed the shape for an existing product. Even his trademark on the work "pie" was invalidated, as the judge said the word had a wide variety of use.


link: http://amhistory.si.edu/archives/d8553.htm
from the Archives Center, National Museum of American History

**As to a conclusion, although the "ice cream patent wars" are interesting, the more telling story of a patent, not based on a working embodiment, which threatened other innovators, is that of George Selden.

Curiously, although the ice cream patents were invalidated, Selden's patent was not.

The dissent of Judge Newman in In re Morsa: the majority decision was precedent defying

Judge Newman's dissent


I write to attempt to stabilize the law of “anticipation,”
for the court confuses the laws of anticipation and
obviousness, and the role of enablement as applied to
prior art references.

“Anticipation” in patent law means that the claimed
subject matter is not new; that is, that it was already
known. To “anticipate” in patent law requires that a
single reference contains all of the elements and limitations
of the claim at issue, explicitly or inherently. If the
single reference is not enabled with respect to the subject
matter under examination, “anticipation” cannot be
found; it is not permissible to go outside the single reference
in order to find “anticipation,” unlike the protocols by
which references are combined to show “obviousness.”

These simple rules have provided the foundation for
examination of patentability; they have been explored and
refined and applied without challenge to their foundation.
This distinction between sections 102 and 103 of the
Patent Act should not now be blurred. This court should
not ratify the shortcut the PTO Board took here. From
this and other errors and imprecision, I respectfully
dissent.



PTAB's statement incomprehensible?


The Board’s statement that Mr. Morsa waived the issue
of anticipation before the Board is not comprehensible,
for Mr. Morsa’s appeal brief to the Board states:
Independent claims 271-272 and 181, 203, 225,
and 247 are neither anticipated nor rendered obvious
by the alleged PMA . . . .
Board Brief 12 (emphasis in original). In re Morsa, 713
F.3d 104 (Fed. Cir. 2013) (Morsa I) included the issue of
anticipation; that was the sole issue on remand, and now
the subject of this appeal.



Of anticipation by a press release:


Claims 271 and 272 had been rejected by the Board on
the ground of “anticipation” by a third person’s press
release. The press release was short on detail, and in
Morsa I this court remanded for a determination of
whether the disclosure in the press release was enabled.
On remand, the Board reaffirmed its rejection for anticipation,
and Mr. Morsa again appeals.

The claims demonstrate the issue, for the press release
does not mention all of the steps and limitations of
the claims:

(...)

The Board recognized that some of the claim steps are not
described in the press release. The Board solved this
dilemma by taking what it called “Official Notice” of the
missing subject matter. And my colleagues solve this
dilemma by finding the missing subject matter in the
Morsa specification by stating that since the specification
states that a person skilled in the art would know how to
“implement” the claimed system, that person would have
“knowledge” to fill the gaps in the prior art. However, we
are directed to no disclosure in the prior art of all the
claim elements and steps. “Anticipation” is not established
in accordance with law.

“Official Notice” is not anticipation

The Board took “Official Notice” that the claim steps
missing from the press release must have been performed.
However, the law of patent “anticipation” is not so permissive.
The law “requires the presence in a single prior
art disclosure of all elements of a claimed invention
arranged as in the claim.” SynQor, Inc. v. Artesyn Technologies,
Inc., 709 F.3d 1365, 1375 (Fed. Cir. 2013). This
presence must be found as fact, and when missing elements
are stated to be “necessarily present, or inherent,
in the single anticipating reference,” Schering Corp. v.
Geneva Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003), “the
mere fact that a certain thing may result from a given set
of circumstances is not sufficient to establish inherency.”
Scaltech Inc. v. Retec/Tetra, L.L.C., 178 F.3d 1378, 1384
(Fed. Cir. 1999).

The Board’s “Official Notice” of the existence of undisclosed
steps and claim elements is not an acceptable
substitute for examination and citations of prior art and
reasoning, in the rigors and high stakes of innovation and
patenting. The Board failed, for example, to show that
the undisclosed features were inherently present in the
database referred to in the cited press release. Instead,
the Board took “Official Notice” of how “databases” function
without showing that the database in the press
release necessarily was the same as the database in the
Morsa claims or even the same as “databases” generally.
This is insufficient to establish either inherent description
or inherent enablement of the explicitly claimed subject
matter.

The majority compounds the Board’s error by rewriting
the claims to match the reference. Maj. Op. at 5. The
press release does not say how the system operates, only
the final result. The Board called it “Official Notice” of
how databases work. Such an assumptio


Can what an inventor says in the specification come back
to hurt the inventor?



An inventor’s statement in the patent application that
a particular step may be performed by procedures known
to persons of skill in the field of computer programming
does not place that step in the context in which the inventor
used it into the prior art.

The panel majority fills the gaps in the press release
by referring to Morsa’s statement that various steps of his
invention may be conducted by procedures known to
persons of skill in computer-implemented methods. The
issue on remand was not whether Morsa enabled his
invention, indeed, that was not challenged by the PTO.
However, Morsa’s enablement of his invention does not
enable the prior art press release, or fill gaps needed to
anticipate the Morsa system. “The standard for what
constitutes proper enablement of a prior art reference for
purposes of anticipation under section 102, however,
differs from the enablement standard under section 112”
whereby the claimed invention must be enabled by the
disclosure in the specification. Rasmusson v. SmithKline
Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir. 2005).



Can the inventor's specification enable prior art?


“[A] patent claim ‘cannot be anticipated by a prior art
reference if the allegedly anticipatory disclosures cited as
prior art are not enabled.’” Verizon Servs. Corp. v. Cox
Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010)
(quoting Amgen Inc. v. Hoechst Marion Roussel, Inc., 314
F.3d 1313, 1354 (Fed. Cir. 2003)).

The question on the Morsa I remand was whether the
subject matter of the press release is enabled by the
description in the press release: “[The] reference must . . .
enable one skilled in the art to make the anticipating
subject matter.” PPG Indus., Inc. v. Guardian Indus.
Corp., 75 F.3d 1558, 1566 (Fed. Cir. 1996). My colleagues
use the information in the Morsa specification to enable
the press release. That is improper. The gaps in the prior
art cannot be filled by the invention at issue; it is improper
to transfer Mr. Morsa’s teachings into the press release
in order to enable the press release.
These flaws confound the laws of anticipation and obviousness
and enablement, defying precedent, and adding
to the complexities of patenting. The issues should be
decided on the correct law. Thus I respectfully dissent.



The majority deemed statements in the specification to
be admissions:


Here, the Board
properly held that the application’s specification made
numerous admissions as to what one skilled in the art at
the time of the invention would have known. For example,
the Board found that the specification discussed that
central processing units and memories were “well known
to those skilled in the art,” that central processing units
and memories were “used in conventional ways to process
requests for benefit information in accordance with stored
instructions,” that the system as described in the patent
“can be implemented by any programmer of ordinary skill
in the art using commercially available development tools
. . . ,” and that “search routines for accomplishing this
purpose are well within the knowledge of those of ordinary
skill in the art.” Appellee’s App. 38, 40.



AND the majority noted


Mr. Morsa additionally argues that the information
provided by PMA is not sufficient to make the claimed
invention and thus would require undue experimentation.
We disagree. As discussed above, the specification made
clear that a skilled computer artisan would readily know
how to use conventional computer equipment and how to
program it; thus, only ordinary experimentation would be
needed to make the claimed program.

Finally, we do not use portions of the patent specification
as prior art, but instead affirm the Board’s use of one
section in the specification solely as it relates to the
knowledge of a person of ordinary skill in the art. There
is a crucial difference between using the patent’s specification
for filling in gaps in the prior art, and using it to
determine the knowledge of a person of ordinary skill in
the art. Here, the Board did only the latter. Mr. Morsa,
amongst other things, admitted in the specification that
the system as described in the patent “can be implemented
by any programmer of ordinary skill . . . ,” thus allowing
him to avoid having to teach the public this very
concept. Therefore, by using Mr. Morsa’s admissions, the
Board simply held him to the statements he made in
attempting to procure the patent.



Descriptive arguments are not new arguments:


Mr. Morsa’s principal argument is that the statements
made by the Board appearing before the enablement
analysis show reversible error as they constitute
undesignated new grounds of rejection. We disagree.
These statements—such as the statement that databasesearching
is old and well known and thus the focus on the
present application is not on searching databases generally,
but on the specific type of data used and the specific
searches performed—were merely descriptive.


One commenter at PatentlyO wrote:


I do feel as if Judge Newman’s understanding of how computer-implementers game the system has improved slightly over the years but she spectactularly misses the boat here. She’s plainly suffering from a bad case of “I Was Born Yesterday” syndrome, that a devastating illness that afflicts susceptible individuals whenever they see “computers” mentioned in a patent claim.

my colleagues solve this dilemma by finding the missing subject matter in the Morsa specification by stating that since the specification states that a person skilled in the art would know how to “implement” the claimed system, that person would have “knowledge” to fill the gaps in the prior art.

That’s 100% correct. When the claim describes a pear butter and quince jam sandwich and the applicant’s specification teaches (and nobody disputes) that “making and eating butter and jam sandwiches is popular and easy for the whole family”, the PTO doesn’t need to find a reference that expressly teaches you how to open a cupboard. The PTO also doesn’t need to find a reference that teaches you how get out of bed and put your clothes on. The PTO doesn’t need to find a reference that teaches you how to open up a cupboard. The PTO doesn’t need to find a reference that teaches you how to open the refrigerator door. The PTO doesn’t need to find a reference that teaches how to identify the jar you’re looking for and pick it up off the shelf. The PTO doesn’t need to find a reference that teaches how to move the jar from the shelf to the counter. The PTO doesn’t to need a reference that expressly teaches you how to open a jar. The PTO doesn’t need to find a reference teaching how to find a loaf of bread and identify whether it needs slicing, or how to slice it. The PTO doesn’t need to find a reference that teaches putting butter or jam on a knife and spreading it onto slices bread without destroying bread. The PTO doesn’t need to find a reference telling you how to put the slices of bread together to make a sandwich.



link: http://patentlyo.com/patent/2015/10/applicant-admissions-application.html

Lockout: ‘Escape From New York’ in space"; copyright infringement found in France

See the post in Variety John Carpenter Wins Plagiarism Case vs. Luc Besson Over ‘Lockout’ on alleged borrowing from
"Excape from New York" that appears in "Lockout."

In a ruling made public on 15 October 2015, the French court “noted many similarities between the two science-fiction films: Both presented an athletic, rebellious and cynical hero, sentenced to a period of isolated incarceration – despite his heroic past – who is given the offer of setting out to free the President of the United States or his daughter held hostage in exchange for his freedom.”

Also in the Variety post: Multiple critics noted “Lockout’s” resemblance to “Escape From New York.” The setup is basically ‘Escape From New York’ in space,” wrote Variety‘s Justin Chang.

Recall, as noted by Wikipedia, there was a potential third Snake Plissken film entitled Escape from Mars .


***Separately, note IPBiz is, according to Blawgsearch, the most popular "intellectual property blog" for the last month, ranking 64 overall, to IPKat's 69.

link: http://blawgsearch.justia.com/blogs/categories/intellectual-property-law?page=1&sortby=popularity&dispmode=expanded&popmode=month

The order of inventors on the WARF patent that Apple infringed: the professor was last

Forbes discussed the UW patent involved in the litigation loss by Apple to WARF:


"We believed our technology was ahead of its time," said UW research Professor Gurindar Sohi in a statement released by the university. "Almost two decades ago we tried to anticipate how computers would need to operate today. Our team invested the equivalent of more than 11 years of work to solve this problem."

The foundation registered the patent in 1998 on behalf of Sohi and three graduate students (Andreas Moshovos, Scott Breach, Terani Vijaykumar), the group says.



link: http://www.usatoday.com/story/tech/2015/10/18/jury-orders-apple-pay-university-234-million-patent-infringement-suit/74175228/ .

IPBiz notes the patent issued in 1998 and was assigned to WARF.


The listed inventors on the WARF patent:


Moshovos; Andreas I. (Madison, WI), Breach; Scott E. (Madison, WI), Vijaykumar; Terani N. (Madison, WI), Sohi; Gurindar S. (Madison, WI).



One notes that Professor Sohi is listed last on the issued patent.

Buzz on Apple's patent litigation loss to WARF

The BBC noted:



The Wisconsin Alumni Research Foundation, the patent licensing arm of the University of Wisconsin-Madison, said the verdict was important to guard its inventions from unauthorised use.

The jury had earlier decided that Apple incorporated patented microchip technology into some iPhones and iPads without permission.

Apple said it would appeal.



link: http://www.bbc.com/news/technology-34559232

The Christian Science Monitor on Apple's loss to WARF:


Apple has won patent infringement lawsuits against other companies, but its Friday loss to a university could have significant impacts on other university researchers concerned about their intellectual property rights.




link: http://www.csmonitor.com/USA/Education/2015/1017/Is-Apple-patent-defeat-a-victory-for-universities

"Poster child for hindsight reasoning"

Judge Lourie's text in Otsuka v. Sandoz, 678 F.3d 1280 :


In summary, the district court's careful analysis exposed the Defendants' obviousness case for what it was—a poster child for impermissible hindsight reasoning.



showed up the district court.

The drug in question: Aripiprazole is the active ingredient in the antipsychotic drug marketed by Otsuka Pharmaceutical Co., Ltd. ("Otsuka") under the brand name Abilify.

When the correct "IP lawyer response" does not play well

Alfred Valrie made a suggestion to AT&T. NBC News mentioned what happened next:


Instead of a simple "thank you for your suggestions" reply, Valrie instead got a letter from AT&T's Thomas A. Restaino, a lawyer who handles intellectual property issues, according to a business column published Tuesday in the Times. After thanking Restaino for being a lifelong customer, according to the column, Restaino then wrote:

"AT&T has a policy of not entertaining unsolicited offers to adopt, analyze, develop, license or purchase third-party intellectual property ... from members of the general public.

"Therefore, we respectfully decline to consider your suggestion."



Getting a lawyer letter can "put off" some:


"I just wanted to give him something to mull over," Valrie was quoted as saying. "I never thought I'd get a letter from a lawyer."

Stephenson on Wednesday admitted the company goofed big time.

"At AT&T, our top priority is to treat our customers to a premium experience every time they interact with us, and our consistent award-winning service demonstrates we usually get it right," he wrote.

"Unfortunately, we don't meet our high standards 100 percent of the time."



And of course


AT&T rival T-Mobile, never one to refrain from stirring the pot, was quick to jump into the fray. Its flamboyant CEO, John Legere, chided his AT&T counterpart and said he would personally welcome suggestions from AT&T customers.



Link: http://www.nbcnews.com/business/consumer/we-blew-it-t-ceo-apologizes-lawerly-response-customers-email-n445416

Movement in the MS drug market

SeekingAlpha talked about the price drop in Biogen shares


Its EVP of sales has resigned suddenly with no successor, and a competitor unveiled strong data on its late-stage pipeline candidate, ocrelizumab.




link: http://seekingalpha.com/article/3568226-biogen-drops-again-a-reassessment-of-the-bull-and-bear-investment-cases

***
One notes the general downward trend was seemingly NOT influenced by the IPR petition by Kyle Bass on Tecfidera, which petition ultimately was not granted.

***

On October 9, 2015, the Daily Mail noted:


Described as a game changer' by scientists, ocrelizumab is the first drug shown to slow the progression of the disease for the 10 per cent of MS patients with a form known as primary progressive'.

And for those with another form called relapsing MS - which affects around 85 per cent of patients - it is nearly 50 per cent more effective than existing treatments.

(...)

The results from the trial were presented last night at the European Committee for Treatment and Research in Multiple Sclerosis conference in Barcelona. Professor Gavin Giovannoni of Barts Hospital in London, commenting on the results, said the drug was a game changer'. These data demonstrate that B-cell targeting can significantly modify the disease,' he said.

Drugs giant Roche, which makes the treatment, plans to submit a licensing application to the European Medicines Agency next year.

If it is approved as safe, and the UK health service then agrees to fund it, patients could get it on the NHS as soon as 2017.



***
BMI Research had written on July 1, 2015:


A significant unmet medical need remains in the treatment of progressive MS, which is thought to represent a multi-billion dollar market opportunity. Results from a Phase III study of ocrelizumab in people with primary progressive MS are expected later this year; success and approval in progressive MS alone would ensure blockbuster sales.



***
The compound ocrelizumab is mentioned in 2012 U.S. Dist. LEXIS 14802

.

Apple loses jury trial in Madison, WISC to WARF

Forbes, and others, have discussed Apple's patent loss to WARF.


A U.S. federal jury [in Madison, WISC; docket 14-62, U.S. District Court for the Western District of Wisconsin (Madison)] has ruled that Apple used technology owned by the licensing arm of the University of Wisconsin on some of the chips that found their way into recent iPads and iPhones.

The jury has yet to decide on damages but the University has been seeking as much as $862 million for patent infringement.




link: http://www.forbes.com/sites/parmyolson/2015/10/14/apple-862-million-patent-lawsuit/

Bloomberg noted:


The [WARF] patent, issued in 1998, relates to the design of a processor chip to improve its performance. The Wisconsin foundation claimed that Apple was using the invention in its A7 processors for the iPhone 5s and iPad. A separate suit was filed in September claiming newer models of the iPhone also use the invention.

The federal jury in Madison found Tuesday [13 Oct. 2015] that Apple infringed the patent and rejected claims it was invalid. The case is now in the second phase, to determine how much Apple should pay. Closing arguments in the case are likely to be heard Friday.

The foundation argues that it’s entitled to about $2.74 for each device, which it said is based on the contribution to the value of Apple’s integrated circuits. Apple contends the figure is closer to the 7 cents per unit that Intel paid.
The Intel settlement was based on 1.5 billion processors sold while Apple has sold 150 million, Apple’s lawyer, William Lee of WilmerHale, told the jury. The partial transcript doesn’t include the exact amount Apple contends is fair.



link: http://www.bloomberg.com/news/articles/2015-10-14/university-seeking-400-million-from-apple-in-patent-dispute

CNET added:


There could be more bad news for Apple. The research foundation launched a second lawsuit last month taking aim at Apple's newest processors, the A9 and A9X found in the iPhone 6S and 6S Plus and the forthcoming iPad Pro.



link: http://www.cnet.com/uk/news/apple-faces-862-million-fine-after-losing-processor-patent-punch-up/

***
The patent in question seems to be US 5,781,752.

The first claim is


In a processor capable of executing program instructions in an execution order differing from their program order, the processor further having a data speculation circuit for detecting data dependence between instructions and detecting a mis-speculation where a data consuming instruction dependent for its data on a data producing instruction of earlier program order, is in fact executed before the data producing instruction, a data speculation decision circuit comprising:

a) a predictor receiving a mis-speculation indication from the data speculation circuit to produce a prediction associated with the particular data consuming instruction and based on the mis-speculation indication; and

b) a prediction threshold detector preventing data speculation for instructions having a prediction within a predetermined range.



There was government funding:


This invention was made with United States government support awarded by the following agencies:

ARPA Grant No. DABT63-95-C-0127;

ONR, Grant No. N00014-93-1-0465; and

NSF, Grant Nos.: CCR-9303030 and MIP-9505853.



The listed inventors: Moshovos; Andreas I. (Madison, WI), Breach; Scott E. (Madison, WI), Vijaykumar; Terani N. (Madison, WI), Sohi; Gurindar S. (Madison, WI).

****
From 2015 U.S. Dist. LEXIS 110068:

In this patent lawsuit, plaintiff Wisconsin Alumni Research Foundation ("WARF") alleges that defendant Apple Inc. infringes U.S. Patent No. 5,781,752 ("the '752 patent"). Before the court is WARF's emergency motion to strike so-called "supplemental" reports prepared by Dr. August and Ms. Davis (dkt. #214), on which an expedited telephonic hearing was held yesterday. For the reasons explained during that hearing and as set forth below, the court will grant WARF's motion to strike.

Apple served the two expert reports at issue on August 17, 2015, mere days before Ms. Davis's and Dr. August's previously scheduled depositions on August 19 and August 21, respectively. After WARF moved to strike both reports, Apple withdrew Ms. Davis's report. Dr. August's report -- titled, "Supplemental Expert Report of David August, Ph.D. Regarding U.S. Patent Application No. 13/464,647" (dkt. #211) -- remains in play.

(...)

Courts consider four factors to determine if a failure to timely disclose was harmless: "(1) the prejudice or surprise to the party against whom the evidence is offered; (2) the ability of the party to cure the prejudice; (3) the likelihood of disruption to the trial; and (4) the bad faith or willfulness involved in not disclosing the evidence at an earlier date." Tribble v. Evangelides, 670 F.3d 753, 760 (7th Cir. 2012). Here, all four factors support WARF's motion to strike.

Patents as an incentive for professors and students

The article The politics of patents in Commonwealth has some discussion of "who is who" in the patent reform debate.

There is some discussion of Bob Brown, the president of Boston University, including


For the universities, protecting the patent system is not so much about the money. Brown says that BU can make several million dollars in any given year but just as likely could lose money. More important, he says, is the incentive it provides for faculty and students. “It drives their research from the bench to the free market on the other side,” he says. “That’s a very major thing in the culture of the university.”



Ironically, James Bessen also resides at Boston University.

Kyle Bass IPR petition against Lialda granted for review of U.S. Patent No. 6,773,720

From the National Law Review:


After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally has made it over the first hurdle. The USPTO Patent Trial and Appeal Board (PTAB) decided to institute IPR proceedings against U.S. Patent No. 6,773,720, which is listed in Orange Book for Lialda®. This is bad news for Shire, since this is the only Orange Book-listed patent for Lialda®, and also bad news for pharmaceutical companies who hoped Kyle Bass would get discouraged and stop his campaign again pharmaceutical patents. -



One notes that not all of Bass's petitions have been denied. Some are pending.


link: http://www.natlawreview.com/article/ptab-institutes-kyle-bass-lialda-patent-ipr

"Moment of nature" on CBS Sunday Morning on 11 October 2015

The "moment of nature" segment of CBS Sunday Morning on October 11 was a bit unusual in featuring a private enterprise,
DeSoto Caverns located on 5181 DeSoto Caverns Pkwy Childersburg, AL 35044.

Of relevance to Civil War history, DeSoto Caverns became a gunpowder-mining center toward the end of the Civil War.

Wikipedia notes:


Cave soil, often rich in calcium nitrate (Ca (NO3)2 " 4H20), called saltpeter, can be processed into potassium nitrate, or niter (KNO3). Niter makes up 75% of what we call gunpowder. The mining of saltpeter required a lot of water, which DeSoto Caverns with its spring-fed well had, in abundance.

A wooden vat was constructed so that when water was added, the soil in the vat became thoroughly saturated. The nitrate-enriched water would filter out the bottom of the vat into a leaching trough. The water was allowed to stand so that the soil's impurities would settle out. The nitrate water was then carried in buckets out of the cave and boiled in large kettles where it was mixed with potash or wood ashes.

This process converted the calcium nitrate into potassium nitrate or niter. Finally, the water was boiled off leaving niter crystals usable, after drying, for making gunpowder. The actual well, leaching trough, and a reconstructed vat used in this operation are on display in the caverns.




Wikipedia also notes an issue in the history of Desoto Caverns as to lower-priced labor in Mexico:


Studies were made and the caverns proved to be a "gold mine" of onyx. All the partners expected to become millionaires from the mining operation. However, Mexican Onyx became popular about this time, and labor costs in Mexico were very low.



link: https://en.wikipedia.org/wiki/DeSoto_Caverns

In passing, one notes the definition of saltpeter is a bit ambiguous. From Britannica:


Saltpetre, also spelled Saltpeter, also called Nitre, or Niter, any of three naturally occurring nitrates, distinguished as (1) ordinary saltpetre, or potassium nitrate, KNO3; (2) Chile saltpetre, cubic nitre, or sodium nitrate, NaNO3; and (3) lime saltpetre, wall saltpetre, or calcium nitrate, Ca(NO3)2. These three nitrates generally occur as efflorescences caused by the oxidation of nitrogenous matter in the presence of the alkalis and alkaline earths.




And, as to the patent connection, recall US Patent No. 1, issued in 1790 to Samuel Hopkins, for a better way to make potash.

Potash was a war material.

Design patent damages stuck in the year 1887?

An opinion piece in ComputerWorld suggests that Samsung/Apple litigation may alter patent law.

--
Samsung questioned why it should have to pay the large judgment immediately. Not only had one of the key patents been invalidated, but Samsung also publicly stated it was appealing to the Supreme Court. It argued that the order of immediate payment could result in irreparable harm, and on Friday a judge issued an emergency temporary stay of the judgment.

This particular case may seem narrow and petty, but larger issues are at stake. The applicable 1887 law giving rise to the majority of the hundreds of millions of dollars in damages, for example, says an infringer is liable “to the extent of his total profits.” But if Apple infringed an unimportant patent of a tiny firm, could that firm be awarded Apple’s “total profits” of tens of billions of dollars? It’s not at all clear in today’s modern economy of highly complex products that “total profit” refers to the entire product, if it ever did. The phrase “to the extent” appears to be an important modifier. So is additional text noting that any award shouldn’t exceed “twice the profit made from the infringement.” Isn’t a plain reading that any award related to the harm of the infringement? Put another way, if the infringement isn’t shown to cause the harm, the remedy doesn’t make sense.


--

link: http://www.computerworld.com/article/2991912/technology-law-regulation/will-the-apple-samsung-battle-help-modernize-patent-law.html

EtCentric had discussed the 1887 law:


•“The no apportionment language (i.e. disgorgement of infringer’s ‘total profits’) was placed in the Patent Act in 1887 in response to a 1886 U.S. Supreme Court case regarding infringement of a design patent on a carpet design, whereby the Court said the design patentee was only entitled to 6 cents in damages — the portion of the damages attributable to the design,” Carani explains.
•“In response to that holding, a holding that members of Congress felt was a miscarriage of justice, the 1887 Patent Act was enacted and provided a remedy for ‘total profit’ without apportionment for design patent infringement,” he adds.




link: http://www.etcentric.org/apples-2-billion-claim-against-samsung-impacted-by-1887-patent-law/

LA Times on university patent revenue

The LA Times articles quotes an AUTM report, which noted Northwestern University topped the royalty income list,
at $360 million. The UCalifornia system and Stanford University came in around 108 million.


Of note is a quote by William T. Tucker that patent royalties are NOT a solution to the financial woes of
universities.


link: http://www.latimes.com/local/education/la-me-uc-patents-20151011-story.html

Mass plagiariam of Ph.D. theses

Back in 2007, IPBiz discussed events of copying on college admission essays, with one identical "story" appearing in many essays:


The "red flag" was the appearance of hundreds of applications mentioning "burning a hole in pyjamas at age eight" working with a chemistry set.




link: http://ipbiz.blogspot.com/2007/03/is-everyone-burning-their-pajamas-at.html

Now, in 2015, TimesHigherEd reports on a troubling "extension" of this practice to Ph.D. theses:


Mass-production of PhDs is generally centred in Moscow and St Petersburg, where “conveyor units” were found for “PhDifying” politicians, public officials and teachers, he says.

A series of dissertations on ground beetles identified by Dissernet, all defended at the same university, also exhibited this hallmark of dissertation exchange, Professor Rostovtsev says.

Each of the PhD theses claimed to examine the various beetles found in sand dunes in the same part of Russia, but they all shared the same basic structure, standard conclusion and bibliography, he explains.

“Certainly the arthropoda of each and every dune deserve to be studied. Yet such work is nothing more than that of a research assistant who merely collects necessary specimens, therefore such dissertations are rather poor in terms of contents,” he says.




link: https://www.timeshighereducation.com/news/mass-produced-phds-lie-heart-russias-plague-doctoral-fraud

Of the text --nothing more than that of a research assistant who merely collects necessary specimens --, one ponders the significance of Ph.D. theses based simply on reporting results of surveys.

Nvidia loses at ITC in suit against Samsung

In a suit at the ITC, Nvidia asserted that Samsung and Qualcomm infringed its patents with Qualcomm's Snapdragon processors and Samsung's Exynos processors and was seeking to prevent the import of several Samsung products, including its Galaxy smartphones and tablets.

On Friday, Oct. 9, Judge Thomas Pender ruled that Samsung did not infringe two Nvidia patents, and while it did infringe a third, he held that the relevant claims of the patent were invalid.

Link to Reuters: http://www.reuters.com/article/2015/10/09/us-nvidia-samsung-elec-idUSKCN0S32AF20151009

NBC News doing reports on drug costs

On 7 October 2015, NBC Nightly News had a piece on drug pricing, which included the pricing of the Vertex drug Orkambi for cystic fibrosis:



Dr. Brian O'Sullivan, a cystic fibrosis specialist at University of Massachusetts Medical School, said there was no doubt these drugs could change the lives of his patients, most of whom have a life expectancy somewhere in their 40s.

"My first feeling was anger," he told NBC News. "To see a price like this was a kick in the gut. It was really hard to take. I knew it would be an expensive drug. I thought it was going to be 10,000 dollars a year, not 300,000 dollars a year."

Developing a drug is risky business that can cost more than a billion dollars. Both Orkambi and Kalydeco are made by Vertex, a Boston-based pharmaceutical firm, which did not respond to NBC News' request for an explanation of its prices.



link: http://www.nbcnews.com/nightly-news/they-put-price-my-life-cost-cystic-fibrosis-drugs-sky-n440321


***Separately,

--
Data on the MS drug Aubagio will be presented on October 10, 2015 at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

Results to be presented include:


By month 12, median percent reduction from baseline in brain volume was 0.39, 0.40, and 0.61 for Aubagio 14 mg, 7 mg, and placebo, respectively. This change was lower for both Aubagio groups vs. placebo: 14 mg by 36.9 percent, p=0.0001; 7 mg by 34.4 percent, p=0.0011.

The significant difference in reduction of brain atrophy for Aubagio vs. placebo was maintained at month 24. Median percent reduction in brain volume from baseline was 0.90, 0.94, and 1.29 for Aubagio 14 mg, 7 mg, and placebo, respectively. This change was lower for both Aubagio groups vs. placebo: 14 mg by 30.6 percent, p=0.0001; 7 mg by 27.6 percent, p=0.0019.
Brain atrophy is the result of the destructive pathological processes that occur in MS. It is seen from the earliest stages of disease and leads to irreversible neurological and cognitive impairment.

--
link: http://www.marketwatch.com/story/new-analysis-suggests-aubagio-teriflunomide-slows-brain-atrophy-in-people-with-relapsing-multiple-sclerosis-2015-10-07
--

CNN noted in the post -Promising new therapies have come out for multiple sclerosis, and they carry price tags that match.-

A recent analysis found that the cost of new oral MS drugs such as Aubagio has risen between 8% and 12% each year since they were approved by the FDA several years ago. And these new drugs may have paradoxically driven up the cost of older MS drugs, from about $8,000 to $11,000 in 1993 to $60,000 a year in 2015.

--

Also: http://www.medscape.com/viewarticle/845475

AND

http://www.fool.com/investing/general/2015/09/02/will-incoming-competitive-threats-sink-biogen.aspx


***
NBC News had done a report on Bard's IVC filter in September 2015.
See for example

http://www.drugwatch.com/2015/09/14/nbc-investigates-ivc-filter-controversy/

Trolls in the automotive business?

An article in the National Law Review suggests the following entities might be trolls working the automotive sector:


American Vehicular Sciences, who has sued OEMs on a number of patents allegedly covering “heads up displays” with elements of motion detection, voice recognition, and user interface features;

Innovative Display Technologies which has asserted a series of patents relating to “light emitting panel assemblies” asserted against LCD displays; and

Beacon Navigation bringing a series of suits in federal court and the International Trade Commission against numerous OEMs relating to automotive GPS navigation systems.



link: http://www.natlawreview.com/article/perfect-storm-automotive-patent-disputes#sthash.09n3AKNj.dpuf

**Separately, the National Law Review also discusses trade secret issues in the Trans Pacific Partnership.

link: http://www.natlawreview.com/article/secret-trade-agreement-includes-agreement-trade-secrets

US 6368268: used in troll attack?

Simply for humor, see the Ars Technica post titled
“Teledildonics” patent troll backs down from lawsuit against Kickstarter

The title of the patent in question is -- Method and device for interactive virtual control of sexual aids using digital computer networks --, which is US 6368268 .

The prosecuting law firm was Blank Rome Comisky & McCauley LLP.

The first listed "Other reference" is FUFME, Fuck U Fuck Me Product Info, 1999 .

The first claim is to a "system":


A stimulation system comprising:

a display device;

a user interface connected to said display device, said user interface causing an image to be displayed on said display device and outputting a control signal; and,

a stimulation device receiving the control signal from the user interface, said stimulation device imparting stimulation to the user in response to the control signal.



The novelty is asserted to be in remote control; from the specification:


Nonetheless, these prior art devices all have the disadvantage that the operator must be in close proximity to the recipient. Medical communication systems are known that enable medical personnel located at a central station to monitor devices located at a patient via computer control over an existing telephone network. Medical communications systems are shown, for instance, by U.S. Pat. Nos. 5,462,051, 5,544,649 and 5,467,773 to Oka et al., David et al., and Bergelson et al., respectively. However, these medical communication systems are not readily suitable for use for sexual stimulation aids. Thus, no system enables an operator to control a stimulation aid from a location remote from the recipient.


Accordingly, it is a primary object of the invention to provide a system that permits an operator to have interactive control of a sexual aid used to stimulate a recipient that is remotely located from the operator.

Not believing in the status quo can direct one to a Nobel prize

GEN noted of one of 2015's Chemistry Nobel laureates:


Thomas Lindahl, Ph.D., emeritus scientist at the Francis Crick Institute in London, was recognized for his discoveries in base excision repair—the pathway that constitutes the bulk of DNA restoration during the cell cycle from alkylation, methylation, and oxidative stress. In the early 1970s, many scientists believed that DNA was an extremely stable molecule, but Dr. Lindahl demonstrated that DNA decays at a rate that ought to have made the development of life on Earth impossible. This insight led him to discover the base excision repair mechanisms.



link: http://www.genengnews.com/gen-news-highlights/nobel-prize-in-chemistry-awarded-to-dna-repair-researchers/81251830/


Some of Lindahl's work is cited in patent application: PCT/GB1995/000064. ANNUAL REVIEWS OF BIOCHEMISTRY, vol.57, 1988, PALO ALTO, CA, US pages 133 - 157 THOMAS LINDAHL ET AL. 'Regulation and Expression of the Adaptive Response to Alkylating Agents'


Note also: Lindahl and R.D. Wood. Quality control by DNA repair. Science 286, 1897-1905 (1999)

Forbes on the Wall Street Journal on pharma patents

From a piece by Tim Worstall in Forbes about an article in the WSJ.

-->
Here’s the WSJ:

Demand for a drug called Avonex has declined every year for the past 10.

Not a problem for its manufacturer. U.S. revenue from the drug has more than doubled in that time, to $2 billion last year.

The key: repeated price increases. The multiple sclerosis drug’s maker, Biogen Inc., raised its price an average of 16% a year throughout the decade—21 times in all.

It is an example of drug companies’ unusual ability to boost prices beyond the inflation rate to drive their revenue, even when demand for the drugs doesn’t cooperate.

Well, let’s leave aside the most obvious point here. That a rise in the price of something is highly likely to lead to a fall in unit demand for it. We do generally think that demand curves slope downwards, don’t we?

Actually, we can be more subtle than that and we will be in a moment after we’ve dealt with the public goods point.

A public good is not something that is good for the public, a good supplied to the public nor even something the public thinks it would be good to have. It’s something which meets two specific tests, that of non-rivalry and that of non-excludability. Say, Newton’s equations. Now they’ve been published there’s no way to exclude someone from using them to calculate the route to the Moon and there’s also no way that someone elses’ use reduces the amount of Newton that I can use to plot my own journey to the Moon. The problem with things like this is that it’s extremely hard to make money out of them. This is as true of a big budget movie as it is of a new drug. OK, the first might cost $100 million, the second $1 billion, but all of the money is being spent up front in the original development. The costs of showing it to an extra person, making an extra dose, are between trivial and nothing.

(...)

So, it is confusing that the WSJ is complaining about the patent system enabling drug companies to profit. Because the very point and purpose of the patent system is to enable the drug companies to profit.

<--

Which tool of capitalism is getting the patent system right?


link: http://www.forbes.com/sites/timworstall/2015/10/06/wall-street-journal-surprised-that-pharma-cos-make-out-like-bandits-from-patent-system/

TownHall gives take on Mark Cuban on patents

Seton Motley at TownHall on Mark Cuban-->

In the initial part of the post:


Well, Mark Cuban has a problem with patents. Specifically “dumbass,” “stupid” patents. He has said: “Dumbass patents are crushing small businesses. I have had multiple small companies I am an investor in have to fight or pay trolls for patents that were patently ridiculous.” He has co-endowed a Chair at the Electronic Freedom Foundation: “The Mark Cuban Chair to Eliminate Stupid Patents.”



But later in the article:


So in 2012, Cuban was painting himself the noble “patent troll.” Waging lawsuit war to revolutionize the system. But that does not explain why he is today more than happy to yet again use the exact same system. Rightly - as it was intended. To righteously defend his patent - from someone allegedly using it without permission or payment.

How very “troll”-like. Which is why when you hear “patent trolls” - think “people protecting their private property.” People like Mark Cuban.







Link: http://townhall.com/columnists/setonmotley/2015/10/06/mark-cuban-when-he-isnt-denouncing-patent-trolls--he-is-one-n2061919

ParkerVision loses at CAFC

Footnote 1 of ParkerVision v. Qualcomm begins:



This is ParkerVision’s third attempt to explain away
the inconsistencies in Dr. Prucnal’s testimony.


Within the opinion:


No evidence supports ParkerVision’s newly minted
theory that the signal coming out of the double-balanced
mixer is not the baseband, but instead is a baseband
being “modulated” or “carried” on the carrier signal. As
noted in the panel opinion, Dr. Prucnal repeatedly identified
the output of the mixer as the baseband, see, e.g.,
A10944:1-9 (identifying the output of the crisscrossed
circuit structure shown on page A6992 to be “the baseband”);
A11052:12-13 (identifying the “baseband output”
of the mixer which is shown on A6992); A10988:8-14
(agreeing that the “baseband was coming out of the mixer”
shown on A6992); nowhere did he describe the mixer
output as a baseband being “modulated” or “carried” on a
carrier signal. Contrary to ParkerVision’s assertion, Dr.
Prucnal admitted that the carrier signal (i.e., the RF
signal) has been “eliminated” at the mixer output. See
A10949:2-11.

ParkerVision seizes upon an exchange during trial in
which Qualcomm’s attorney asked Dr. Prucnal to confirm
that “the output of the mixer includes the baseband
signal.” See Pet. at 6 (citing A10943:7-12). At most, that
testimony suggests that something other than the baseband
exists at the output of the mixer; it does not prove
that the carrier signal is part of the output of the mixer,



The petition for re-hearing was denied.

link: http://www.cafc.uscourts.gov/sites/default/files/sPARKER%20VISION%202014-1612%20OPINION_PETITION%20FOR%20REHEARING.pdf

The CAFC affirms D. Nev. in Spectrum case on Leucovorin

From SPECTRUM PHARMACEUTICALS, INC. v. Sandoz, concerning the
drug Leucovorin, which is used to ameliorate the toxic effects
of methotrexate.

-->
Spectrum Pharmaceuticals, Inc. (“Spectrum”) appeals
from the decisions of the United States District Court for
the District of Nevada holding claims 1–2 of U.S. Patent
6,500,829 (“the ’829 patent”) invalid as obvious, and
finding claims 5–9 of the ’829 patent not infringed by the
submission of an Abbreviated New Drug Application
(“ANDA”) by Sandoz Inc. (“Sandoz”). Spectrum Pharm.,
Inc. v. Sandoz Inc., No. 2:12-cv-00111, 2015 WL 794674
(D. Nev. Feb. 25, 2015) (“Trial Order”); Spectrum Pharm.,
Inc. v. Sandoz Inc., No. 2:12-cv-00111, 2014 WL 7368845
(D. Nev. Dec. 29, 2014) (“Summary Judgment Order”).
Because the district court did not err in concluding that
claims 1–2 are invalid, and additionally did not clearly err
in finding claims 5–9 not infringed by Sandoz’s ANDA
product, we affirm.
B

<-- This case involves a molecule with optical activity: Due to an asymmetric C6carbon, leucovorin may exist as a 50/50 mixture of two diastereoisomers, the (6S) and (6R) isomers. The (6S) diastereoisomer is also known as levoleucovorin or l-leucovorin, and is the isomer with the desired biological activity. In the prosecution,
During prosecution of the application that became the ’829 patent, the examiner rejected the application’s claims as anticipated by or obvious over an article disclosing an enzymatic synthesis technique by which 0.91 grams of lleucovorin had been synthesized.




At trial:


Sandoz stipulated to infringement of claims 1 and 2, and the district court subsequently conducted a bench trial only on the validity of those claims. The court found that the prior art disclosed: (i) leucovorin as a mixture of (6R) and (6S) diastereoisomers; (ii) that the therapeutic usefulness of leucovorin derives wholly from the (6S) isomer; and (iii) a rationale for investigating a purified (6S) isomer product for use in 5-FU combination therapy. Trial Order at *6–8, *13–14. The court also found that preparations of purified (6S) isomer by an enzymatic synthesis method and by separation methods had been publicly reported before the ’829 patent’s priority date. Id. at *6–7. In particular, the court analyzed two related prior art references that disclosed a process for separating the diastereoisomers using the solubility differential of the (6S) and (6R) isomer salts, i.e., fractional crystallization. See id. at *11–13 (findings relating to Donna B. Cosulich, Diastereoisomers of Leucovorin, 74 J. Am. Chemical Soc’y 4215–16 (1952) and U.S. Patent 2,688,018 (collectively, “Cosulich” or “the Cosulich references”)).



The arguments in this case are a bit unusual:



Sandoz responds that the district court correctly found that one of skill would have been motivated to make substantially pure (6S) leucovorin starting with the 50/50 mixture to have a more effective pharmaceutical treatment, and would have reasonably expected to succeed in doing so. Sandoz contends that it had no burden to show a motivation to contaminate the prior art pure (6S) isomer compound, because the court’s analysis began with the 50/50 mixture and rejected Spectrum’s arguments on the inoperability of the prior art. Moreover, Sandoz argues, the court found no patentable difference between the claimed substantially pure compound and the prior art pure compound, which presented a prima facie case of obviousness that Spectrum failed to rebut.

Most issues relating to purified diastereoisomers or enantiomers involve the question whether a pure, resolved compound would have been obvious over the corresponding mixture. See, e.g., Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301–03 (Fed. Cir. 2007);

(...)

This case is unusual in involving a slightly different question, namely, whether a substantially pure compound would have been obvious when both the 50/50 mixture and the pure compound were known in the art. We agree with the district court that the claimed substantially pure compound would have been obvious over both the 50/50 mixture and the pure (6S) isomer compound in the prior art. First




Spectrum’s position here, that the 92–95% pure material was nonobvious over the known pure material—that position, despite its superficial appeal, is not persuasive.

(...)

In the face of that evidence of obviousness, Spectrum did not provide any evidence of unexpected results for the substantially pure compound as compared to the 50/50 mixture or the 100% pure compound.



Note:



We owe the district court’s factual findings considerable deference on appeal, and we see no clear error based on the record before us. Based on those findings, we affirm the district court’s conclusion that Sandoz proved by clear and convincing evidence that claims 1 and 2 of the ’829 patent are invalid as obvious.


link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1407.Opinion.9-30-2015.1.PDF