Proposal for unsuccessful patent applicants to pay higher fees?

In discussing PatCon6, the writtendescription blog has an interesting discussion about a proposal -- forcing unsuccessful patent applicants to pay higher application fees --:


For example, in his paper, "Loser Pays" in Patent Examination, Neel U. Sukhatme argues that we should create incentives for patent applicants themselves to improve the quality of their applications by forcing unsuccessful patent applicants to pay higher application fees, thereby subsidizing successful applicants. By importing the "loser pays" concept from litigation, Sukhatme argues, we can create "an efficiency-enhancing chilling effect that disincentives weak applications and improves application quality."

Sukhatme's project nicely compliments R. Polk Wagner's analysis several years ago in Understanding Patent-Quality Mechanisms. In Wagner's view circa 2009, bad incentives on the part of applicants (as well as PTO examiners) was a root cause of the problem of low patent quality. Low patent quality, Wagner wrote, "is supported by a series of powerful incentives, including incentives that encourage patentees to draft patent applications that effectively obscure the true scope of the invention and its relationship to the prior art." Sukhatme's suggestion to require applicants to pay for their drafting failures follows Wagner's advice for improving patent quality: ensure that patentees have "strong, unequivocal incentives to seek patents that clearly meet the standards of patentability, that are explained in the context of the prior art, and that draw clear and unambiguous lines around their subject matter[.]" So maybe we're making Progress.




link: http://writtendescription.blogspot.com/2016/04/a-trend-at-pat-con-regulating-patents.html

This "discouragement" would only make sense if a large fraction of patent applicants were deliberately obfuscating their claim drafting.

Fluorosamine for myelin regeneration?

See Multiple sclerosis: Drug boosts myelin regeneration in mice raising hope of future treatments for MS


Note the paper -- Changes in chondroitin sulfate proteoglycans in experimental autoimmune encephalomyelitis -- in Journal of Neuroimmunology, Volume 275, Issues 1–2, 15 October 2014, Pages 175, with text


Multiple sclerosis (MS) is an inflammatory neurodegenerative disease of the central nervous system involving a profound destruction of myelin and oligodendrocytes that form focal areas of demyelination. MS also involves global changes in the extracellular matrix, including alterations in chondroitin sulfate proteoglycans (CSPGs). CSPGs may play detrimental roles in MS through their ability to reduce oligodendrocyte precursor cell recruitment, as well as promote local immune responses. However, the effects of CSPGs on MS pathology remain to be determined, as well as the role of specific CSPG members. (...)

Experimental autoimmune encephalomyelitis (EAE) was induced in C57Bl/6 mice, and animals were also treated with the glucosamine derivative fluorosamine that reduces CSPG production from cells in culture.

(...)

Treatment of mice with fluorosamine alleviated EAE clinical severity correspondent with decreased versican transcripts in the spinal cord. In active lesions of EAE as well as MS characterized by inflammatory perivascular cuffs, versican was detected on cellular and non-cellular profiles in the perivascular space.



The word "fluorosamine" appears in US Patent 4,621,059 : In this case, when luminol is used as the luminescent substance, iron ion is used for accelerating the luminescence. When the DNPO or TCPO is used as the luminescent substance, porphyrin, fluorosamine or dansyl compound may be used.




**Separately, from blawgsearch on 29 April 2016

Legal decisions must rest on factually accurate information

One takes note of the post at PatentDocs entitled
The Fantastical World of Justice Stephen Breyer

As a side comment to the text ["The tragedy, first explored by Stephen Jay Gould in "Carrie Buck's Daughter," The Flamingo's Smile (1985)..." ]. one notes that the 1961 movie Judgment at Nuremberg raised the issue
[wikipedia: He [Hans Rolfe (Maximilian Schell) ] also suggests that the United States has committed acts just as bad or worse as those the Nazis perpetrated. He raises several points in these arguments, such as: U.S. Supreme Court Justice Oliver Wendell Holmes, Jr.'s support for the first eugenics practices (see Buck v. Bell )]

As to the confusion of facts issue


Justice Holmes rendered his opinion based on this factual inaccuracy and, according to Mr. Cohen, his own prejudices about race and class as a Boston Brahmin of the turn of the 20th Century. While the Justice had more than adequate help in coming to the wrong conclusion, ultimately Mr. Cohen shows that the combination of predilection and factual error informed one of the cruelest aphorisms in American jurisprudence (which remains good law today).

It is easy for this example to come to mind when reading the questions and assertions from current Associate Justice Stephen Breyer, author of the Court's unanimous decision in Mayo v. Prometheus, regarding his understanding and concerns with the patent system and its discontents.



one also recalls a similar confusion of facts issue in the Dred Scott decision, as brought up by dissenting judge
Benjamin Curtis. Although Taney applied a "what was the status (of African Americans) at the time of the signing of the Constitution" to infer "not citizens then or now", Curtis pointed out, as a factual matter, this simply was not true.

AND

see also, Lawrence B. Ebert, Obtaining Sure and Reliable Information, Intellectual Property Today (2000), which begins


"When invention is rife and rights so precarious as they now are under the administration of the patent office, every person ought to have some sure and reliable information in relation to his legal rights before he ventures upon application." n2 "There is scarcely any subject out of which grows more law-suits than that of patents. Every one therefore interested should know what to avoid and what to do." n3 Although words of contemporary wisdom, this advice was actually given about 150 years ago. The problem remains: where to get sure and reliable information?




endnote 2: From The United States Democratic review, Volume 29, Issue 158, page 192 (August 1851) reviewing Inventor's Manual: or Legal Principles, and Guide to the Patent Office by George Ticknor Curtis, brother of Benjamin Curtis, U.S. Supreme Court Justice who authored the opinion in Winans v. Deomead, which crystallized the "doctrine of equivalents."

CAFC addresses venue, personal jurisdiction in Heartland case

The issues:


Heartland argues that it is entitled to a writ of mandamus
based on two legal theories. First, it argues that it
does not “reside” in Delaware for venue purposes according
to 28 U.S.C. § 1400(b). Second, it argues that the
Delaware district court lacks specific personal jurisdiction
over it for this civil action. We conclude that a writ of
mandamus is not warranted. The arguments raised
regarding venue have been firmly resolved by VE Holding,
a settled precedent for over 25 years. The arguments
raised regarding personal jurisdiction have been definitively
resolved by Beverly Hills Fan, a settled precedent
for over 20 years. As a panel, we are bound by the prior
decisions of this court.




Of venue:


Heartland argues that the “law” otherwise defined corporate residence
for patent cases and therefore the statutory definition
found in § 1391(c) is no longer applicable to patent
cases. As Heartland itself acknowledges, “most special
venue statutes have not been held to encompass particular
rules about residency, and thus subsection (c) can
apply to such statutes wherever they are found in the
U.S. Code.” Pet. 7–8. The patent venue statute, 28
U.S.C. § 1400(b), provides in its entirety: “Any civil action
for patent infringement may be brought in the judicial
district where the defendant resides, or where the defendant
has committed acts of infringement and has a regular
and established place of business.” It is undisputed that
the patent venue statute itself does not define corporate
residence and thus there is no statutory “law” that would
satisfy Heartland’s claim that Congress intended in 2011
to render § 1391(c)’s definition of corporate residence
inapplicable to venue for patent cases.

(...)

In VE Holding, we found that
the Supreme Court’s decision in Fourco with regard to the
appropriate definition of corporate residence for patent
cases in the absence of an applicable statute to be no
longer the law because in the 1988 amendments Congress
had made the definition of corporate residence applicable
to patent cases. 28 U.S.C. § 1391(c) (1988) (“For the
purposes of venue under this chapter”). In 1988, the
common law definition of corporate residence for patent
cases was superseded by a Congressional one. Thus, in
2011, there was no established governing Supreme Court
common law ruling which Congress could even arguably
have been codifying in the language “except otherwise
provided by law.”

Heartland cites to a single sentence in a footnote in
the Supreme Court’s decision in Atlantic Marine Construction
Co. v. United States District Court for the Western
District of Texas, 134 S. Ct. 568, 577 n.2 (2013), to
argue “the Supreme Court showed its belief that § 1391 is
not applicable to patent cases, and § 1400 is.” Reply 9.
Heartland’s argument misses its mark. The Supreme
Court’s footnote states in its entirety: “Section 1391
governs ‘venue generally,’ that is, in cases where a more
specific venue provision does not apply. Cf., e.g., § 1400
(identifying proper venue for copyright and patent suits).”
Atl. Marine Constr. Co., 134 S. Ct. at 577 n.2. It is undisputed
that § 1400 is a specific venue provision pertaining
to patent infringement suits. But what Heartland
overlooks, and what Atlantic Marine does not address, is
that § 1400(b) states that venue is appropriate for a
patent infringement suit “where the defendant resides”
without defining what “resides” means when the defendant
is a corporation.




Of personal jurisdiction


Heartland’s argument regarding personal jurisdiction
in this case is, as the Magistrate Judge noted, difficult to
follow.3 Heartland appears to be arguing that 1) the
Supreme Court’s recent decision in Walden v. Fiore, 134
S. Ct. 1115, 1121 n.6 (2014), makes clear that specific
personal jurisdiction can only arise from activities or
occurrences taking place in the forum state, and
2) Federal Circuit case law makes clear that each act of
patent infringement gives rise to a separate cause of
action, such that 3) the logical combination of these two
points of law means that the Delaware district court has
specific personal jurisdiction over Heartland for allegedly
infringing acts that occurred in Delaware only, not those
occurring in other states.4 Applied to the facts of record,
under Heartland’s argument, the Delaware district court
would only have specific personal jurisdiction over the
approximately 2% of Heartland’s 2013 sales of the accused
product (i.e., 44,707 cases of the accused product
that generated at least $331,000 in revenue) that Heartland
shipped into Delaware. Thus, to resolve nationwide
the same issues as in this Delaware infringement suit,
Kraft would have to bring separate suits in all other
states in which Heartland’s allegedly infringing products
are found. Alternatively, under Heartland’s argument,
Kraft could opt to bring one suit against Heartland in
Heartland’s state of incorporation.5

(...)

Heartland’s arguments are foreclosed by our decision
in Beverly Hills Fan. In that case, we held that the due
process requirement that a defendant have sufficient
minimum contacts with the forum was met where a nonresident
defendant purposefully shipped accused products
into the forum through an established distribution channel
and the cause of action for patent infringement was
alleged to arise out of those activities. Beverly Hills Fan,
21 F.3d at 1565; see also Acorda Therapeutics Inc. v.
Mylan Pharm. Inc., Nos. 2015-1456, 2015-1460, 2016 WL
1077048, at *7 (Fed. Cir. Mar. 18, 2016) (determining that
the minimum contacts requirement was met where a
defendant contracted with a network of independent
wholesalers and distributors to market the accused product
in Delaware, the forum state). Such is the case here.
Heartland admits that it shipped orders of the accused
products directly to Delaware under contracts with what
it characterizes as “two national accounts” that are headquartered
outside of Delaware. And Heartland does not
dispute that Kraft’s patent infringement claims arise out
of or relate to these shipments. This is sufficient for
minimum contacts.



general link: http://www.cafc.uscourts.gov/opinions-orders

The Register wrote of the venue issue:


The court denied the appeal, reaffirming a 1990 ruling that allows a company doing business nationally in America to be sued in any US district court. This, in turn, means that plaintiffs can hand-pick the courts they use to bring forward patent infringement suits – and they usually pick the courts that back those alleging infringement.

The case has been closely followed by technology companies due to the precedent TC Heartland would have set had its appeal been successful. Intellectual property law reformers hoped that a ruling in Heartland's favor would restrict the practice of "patent trolling" by preventing IP-holding firms from using plaintiff-friendly courts (such as the Eastern Texas District Court) to file infringement claims in hopes of winning a decision or striking a settlement.



link: http://www.theregister.co.uk/2016/04/30/score_one_for_the_patent_trolls/

The CAFC had written that
VE Holding Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574 (Fed. Cir. 1990)
remained good law after the 2011 Congressional amendments.


In VE Holding, this court held that the
definition of corporate residence
in the general venue statute, § 1391(c), applied to the patent venue statute, 28
U.S.C. §1400. The 2011 amendments
to the general venue statute relevant to
this appeal were minor.

The journal Science does "The growing problem of patent trolling" in April 29, 2016 issue

Back in the year 2014, IPBiz discussed some work by Lauren Cohen on "patent trolls" [see
Lauren Cohen et al. go after "patent trolls" ].

Flash forward to 2016, and Cohen is talking about patent trolling in the journal Science. The summary states


The last decade has seen a sharp rise in patent litigation in the United States; 2015 has one of the highest patent lawsuit counts on record (1). In theory, this could reflect growth in commercialization of technology and innovation—lawsuits increase as more firms turn to intellectual property (IP) protection to safeguard their competitive advantages. However, the majority of recent patent litigation is driven by nonpracticing entities (NPEs), firms that generate no products but amass patent portfolios for the sake of “enforcing” IP rights (2). We discuss new, large-sample evidence adding to a growing literature (3–7) that suggests that NPEs—in particular, large patent aggregators—on average, act as “patent trolls,” suing cash-rich firms seemingly irrespective of actual patent infringement. This has a negative impact on innovation activity at targeted firms. These results suggest a need to change U.S. IP policy, particularly to screen out trolling early in the litigation process.



Science 29 Apr 2016:
Vol. 352, Issue 6285, pp. 521-522
DOI: 10.1126/science.aad2686





The site phys.org previews the paper by Cohen (with Umit Gurun and Scott Duke Kominers ) about to appear in the journal Science. See New study exposes growing problem of patent aggregators and negative impact on innovation .

Within the phys.org piece, one has the text


H.R. 9, the "Innovation Act," which is currently on the docket, provides for mandatory fee-shifting for patent lawsuits that the courts determine are not "reasonably justified." In reality, however, the average costs of patent litigation are large ($1 million to $4 million) and the process is drawn out. Even with the prospect of post-trial fee shifting, patent litigation targets may thus find it cost-effective and less disruptive to simply settle with NPEs, even in unfounded lawsuits. According to the authors, this is not a sufficient solution.





The text skips over the fact that the burden is on the loser to show the case was "reasonably justified." The text of the bill requires courts to award prevailing parties reasonable fees and other expenses incurred in connection with such actions, unless: (1) the position and conduct of the nonprevailing party was reasonably justified in law and fact; or (2) special circumstances, such as severe economic hardship to a named inventor, make an award unjust.

This reversal of burden over the present law is the source of much opposition to the Innovation Act.

The phys.org piece also notes


So what should be done? Cohen, Gurun, and Kominers say that policies should screen out trolling at or before the time of patent assertion. The authors recommend advance review procedures that would provide preliminary evaluation as to whether the plaintiff's infringement claims are reasonable and whether the asserted patents are of high quality. Such advance review could cripple trolling, they conclude; pre-litigation review can separate good NPEs (and, more generally, good patent lawsuits) from bad. Legitimate infringement claims will be encouraged, whereas trolling will be screened out. This would greatly benefit innovative companies and help them propel the U.S. economy to greater heights.

Further thoughts on the Taney statue matter in Baltimore

There is a recommendation to "de-access" the statue of (former) Supreme Court Chief Justice Taney, who, among other things, authored the "Dred Scott" decision. One notes that seven justices concurred in that decision, with only two firmly opposing it, one of whom later resigned from the court (Benjamin Curtis).

As a footnote to previous posts on this Taney matter, recall that there were slaves resident in the executive mansion during the time of George Washington. From wikipedia:


In late May 21, 1796 one of Martha Washington's slaves, Oney Judge, escaped from the Executive Mansion in Philadelphia, where she lived with the Washingtons during his presidency, serving as Martha's chambermaid



link: https://en.m.wikipedia.org/wiki/Oliver_Wolcott_Jr.

Wolcott, who succeeded Alexander Hamilton to become the second Secretary of the Treasury, was involved in the matter.
Wolcott went to the Litchfield Law School, which produced three justices of the Supreme Court. Curtis, who graduated from Harvard Law, is considered the first Supreme Court justice to have graduated from a now-existent law school (as presently understood). Litchfield also produced two vice-presidents, Burr and Calhoun.


**Separately, from wikipedia, on Taney:


George Ticknor Curtis, one of the lawyers who argued before Taney on behalf of Dred Scott, held Taney in high esteem despite his decision in Dred Scott. In a volume of memoirs written for his brother Benjamin Robbins Curtis, who sat on the Supreme Court with Taney and dissented in Dred Scott,

He was indeed a great magistrate, and a man of singular purity of life and character. That there should have been one mistake in a judicial career so long, so exalted, and so useful is only proof of the imperfection of our nature. The reputation of Chief Justice Taney can afford to have anything known that he ever did and still leave a great fund of honor and praise to illustrate his name. If he had never done anything else that was high, heroic, and important, his noble vindication of the writ of habeas corpus, and of the dignity and authority of his office, against a rash minister of state, who, in the pride of a fancied executive power, came near to the commission of a great crime, will command the admiration and gratitude of every lover of constitutional liberty, so long as our institutions shall endure



**Separately, there is an allusion to Taney's Dred Scott decision in

http://www.lexology.com/library/detail.aspx?g=ec7f85ca-8736-4736-b763-159862ebfbdc

Merck v. Gnosis: No en banc review of "substantial evidence" standard in IPRs

Judge Newman's dissent in the denial of en banc review of Merck v. Gnosis is worth a look.

link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1779.Order.4-22-2016.1.PDF

Pro se appellant Celorio loses in appeal of results of ex parte re-exam

Among other arguments in his appeal of a PTAB decision, pro se appellant argued that the Board was prejudiced against
pro se Hispanics.

The appellant lost.

link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1007.Opinion.4-22-2016.1.PDF

Largan loses at CAFC; its circumstantial evidence of direct infringement was insufficient

Appellant Largan Precision, represented by Donald Dunner, lost its appeal at the CAFC, with the CAFC finding that no reasonable jury could have found induced infringement.

Genius Electronics argued that there was no evidence of DIRECT infringement by Apple, and thus there could be no induced infringement. [See Epcon v. Bauer, 279 F.3d 1022].

Largan's evidence of direct infringement was circumstantial, and, here, insufficient to establish a prima facie case.

link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1695.Opinion.4-25-2016.1.PDF

Of the appellant's counsel:


DONALD ROBERT DUNNER, Finnegan, Henderson,
Farabow, Garrett & Dunner, LLP, Washington, DC,
argued for plaintiff-appellant. Also represented by
ANDREW JOSEPH VANCE; GARY MA, MING-TAO YANG, Palo
Alto, CA.



Of the matter of evidence:


We hold that the district court properly granted
summary judgment of no induced infringement because
Largan failed to offer evidence of direct infringement by
Apple. Largan did not offer evidence that any Apple
product sold in the United States contained an accused
Genius lens. Instead, Largan only presented evidence
that Genius lenses are incorporated in some Apple products
manufactured in Asia and that some Apple products
are sold in the United States. Given the evidence of
record, which includes the volume of Largan and Genius
lenses supplied for Apple’s worldwide distribution of
products, Largan supplies such a large volume of lenses in
the relevant Apple products that all of those products sold
in the United States could contain Largan lenses.1

Chance to reconsider use of COX-2 inhibitor rofecoxib?

US Patent 6,063,811, assigned to Merck, has claims covering methods for the use of VIOXX:


1. A method of treating a disease susceptible to treatment with an non-steroidal anti-inflammatory agent comprising:

administration orally once a day to a human patient in need of such treatment 12.5 or 25 or 50 mg of 3-phenyl-4-(4-methylsulfonyl)phenyl)-2-(5H)-furanone.

2. A method according to claim 1 for the treatment of non-chronic headache, pain or swelling.

3. A method according to claim 1 for the treatment of osteoarthritis.

4. A method according to claim 1 for the treatment of rheumatoid arthritis.

5. A method according to claim 1 for the treatment of pain.

6. A method according to claim 1 for the treatment of fever.

7. A method according to claim 1 for the treatment of dysmenorrhea.

8. A method according to claim 1 for the treatment of Alzheimer's disease.



The priority cases are almost 20 years old


This is a National phase U.S. application of PCT/US97/08041, filed May 13, 1997, which claims priority from U.S. Provisional Application 60/017,878, filed May 17, 1996 and British application GB 9612063.9, filed Jun. 10, 1996.

This application is also a continuation of U.S. Ser. No. 08/851,756, filed May 6, 1997 now abandoned, which claims priority from U.S. Provisional application 60/017,878, filed May 17, 1996.



Merck removed VIOXX from the market. As noted in IPBiz at the time [ http://ipbiz.blogspot.com/2004/10/merck-recalls-vioxx-on-sept-30-2004.html ], this was a voluntary recall by Merck.

For details of the history see

https://en.m.wikipedia.org/wiki/Rofecoxib

http://www.npr.org/templates/story/story.php?storyId=5470430

http://www.nejm.org/doi/full/10.1056/NEJMp048286

**Separately, from L.B. Ebert, Increasingly Aggressive Efforts at Patent Enforcement, Intellectual Property Today (June 2000) page 22 (available LEXIS) -->

endnote 9:


n9 Curiously, shortly AFTER approval [of Celebrex], a scientific paper was published which raised issues with Celebrex. According to a report from the group of Dr. Ganet A. FitzGerald in the Proceedings of the National Academy of Science, 1999, 96:272-277, the drug may increase the risk of heart attack, stroke and blood clotting disorders. Many older people who may want to take COX-2 inhibitors for conditions like arthritis could be at risk for developing heart and blood vessel problems from the drug. Dr. Saul Bloomfield said that taking COX-2 inhibitors might be a matter of exchanging a gastrointestinal risk from one painkiller to a cardiovascular risk for another. See also Wall St. Jour., April 20, 1999. On April 27, 2000, there was a Reuters release "Merck's Vioxx seen facing FDA scrutiny on heart attacks." [Vioxx (rofecoxib) is a different COX-2 inhibitor.] On April 28, 2000, PR Newswire reported results of a study in which Pharmacia found even at very high doses, Celebrex showed no increases in stroke or heart attack with or without aspirin. [See Hoover's Online]

The statue of Chief Justice Taney in Baltimore, Dred Scott, and patent law

Of the dispute over the "de-accession" of a statue of former Supreme Court Chief Justice Taney in Baltimore, wherein a mayoral task force has recommended Taney's statue go elsewhere, one does note that Taney's statue should not be considered a "Confederate" statute. Taney was not a Confederate. And, in fact, there are at least two Taney statues:


The Taney statue is a direct copy of the one that sits on the grounds of the [Maryland] State House
(...)
The original Taney statue was commissioned by the state of Maryland and unveiled in 1872,
a year before Congress would approve placing his bust among those of the nation's previous Supreme Court chief justices.



[link: http://www.baltimoresun.com/news/opinion/editorial/bs-ed-confederate-monuments-20160119-story.html ]

There is an interesting irony about referencing the Taney statue as a Confederate statue.

The majority decision in Dred Scott (authored by Taney) held that neither Scott nor any other person of African descent—whether or not emancipated from slavery—could be "citizen of a state", and therefore was unable to bring suit in federal court on the ground of diversity.

BUT, toward the end of the Civil War, when issues arose of how to count African American soldiers in prisoner exchanges, even the Confederates acknowledged that emancipated African-Americans had to be treated as prisoners, rather than as property (in contrast to Taney's viewpoint).

Although some commentators have mistakenly referenced Taney as a Confederate (he was on the US Supreme Court during the Civil War, and was not part of the Confederacy), Taney's view was more extreme than taken by the Confederacy in the prisoner exchange matter.

The vote in Dred Scott was basically 7-2, with Benjamin Curtis not only dissenting but also resigning from the Court shortly thereafter.

Curtis was the only Whig appointee to the Supreme Court, and was the first law school graduate (Harvard) to serve on the Supreme Court. Curtis authored the classic decision on patent law's "doctrine of equivalents" (Winans v. Denmead,56 U.S. 330 (1854); Taney was on the opposite side) and Curtis' brother was a patent lawyer.

See for example, Lawrence B. Ebert, Obtaining Sure and Reliable Information, Intellectual Property Today (2000), which begins


"When invention is rife and rights so precarious as they now are under the administration of the patent office, every person ought to have some sure and reliable information in relation to his legal rights before he ventures upon application." n2 "There is scarcely any subject out of which grows more law-suits than that of patents. Every one therefore interested should know what to avoid and what to do." n3 Although words of contemporary wisdom, this advice was actually given about 150 years ago. The problem remains: where to get sure and reliable information?




endnote 2: From The United States Democratic review, Volume 29, Issue 158, page 192 (August 1851) reviewing Inventor's Manual: or Legal Principles, and Guide to the Patent Office by George Ticknor Curtis, brother of Benjamin Curtis, U.S. Supreme Court Justice who authored the opinion in Winans v. Deomead, which crystallized the "doctrine of equivalents."

Possible patent challenge to Biogen's Tysabri

FiercePharma noted of Biogen's prospects:


India’s Swiss Pharma International has filed a petition for inter partes review of one of Tysabri’s patents--and another two petitions are on the way, Leerink Partners analyst Geoffrey Porges wrote in a note to clients on Monday. The move could potentially put sales of the drug, which tallied $1.89 billion in 2015, in jeopardy, he noted.



link: http://www.fiercepharma.com/pharma/ms-patent-challenges-put-billions-biogen-sales-at-risk

Novantrone for secondary progressive multiple sclerosis

Mitoxantrone (tradename Novantrone)is used to treat multiple sclerosis (MS), most notably the subset of the disease, known as secondary-progressive MS. As no cure for multiple sclerosis exists yet, it must be understood mitoxantrone will not cure the disease, but rather is effective in slowing the progression of secondary-progressive MS and extending the time between relapses in both relapsing-remitting MS and progressive-relapsing MS. [from Wikipedia)

Although Novantrone was approved by the FDA for secondary progressive multiple sclerosis, because of the significant risks associated with Novantrone, it is rarely used at this time.

Note the abstract for US Patent 7,968,511:


The subject invention provides a method of treating a subject afflicted with a form of multiple sclerosis comprising periodically administering to the subject an amount of glatiramer acetate and an amount of mitoxantrone, wherein the amounts when taken together are effective to alleviate a symptom of the form of multiple sclerosis in the subject so as to thereby treat the subject. The subject invention also provides a package comprising glatiramer acetate, mitoxantrone and instructions for use of the together to alleviate a symptom of a form of multiple sclerosis in a subject. Additionally, the subject invention provides a pharmaceutical composition comprising an amount of glatiramer acetate and an amount of mitoxantrone, wherein the amounts when taken together are effective to alleviate a symptom of a form of multiple sclerosis in a subject. The subject invention further provides a pharmaceutical combination comprising separate dosage forms of an amount of glatiramer acetate and an amount of mitoxantrone, which combination is useful to alleviate a symptom of a form of multiple sclerosis in a subject.



Separately, US 8,454,965 notes that

Multiple sclerosis (MS) is a chronic, neurological, autoimmune, demyelinating disease. MS can cause blurred vision, unilateral vision loss (optic neuritis), loss of balance, poor coordination, slurred speech, tremors, numbness, extreme fatigue, changes in intellectual function (such as memory and concentration), muscular weakness, paresthesias, and blindness. Many subjects develop chronic progressive disabilities, but long periods of clinical stability may interrupt periods of deterioration. Neurological deficits may be permanent or evanescent. In the United States there are about 250,000 to 400,000 persons with MS, and every week about 200 new cases are diagnosed. Worldwide, MS may affect 2.5 million individuals. Because it is not contagious, which would require U.S. physicians to report new cases, and because symptoms can be difficult to detect, the incidence of disease is only estimated and the actual number of persons with MS could be much higher.

The pathology of MS is characterized by an abnormal immune response directed against the central nervous system. In particular, T-lymphocytes are activated against the myelin sheath of the neurons of the central nervous system causing demyelination. In the demyelination process, myelin is destroyed and replaced by scars of hardened "sclerotic" tissue which is known as plaque. These lesions appear in scattered locations throughout the brain, optic nerve, and spinal cord. Demyelination interferes with conduction of nerve impulses, which produces the symptoms of multiple sclerosis. Most subjects recover clinically from individual bouts of demyelination, producing the classic remitting and exacerbating course of the most common form of the disease known as relapsing-remitting multiple sclerosis.

MS develops in genetically predisposed individuals and is most likely triggered by environmental agents such as viruses (Martin et al., Ann. Rev. Immunol. 10:153-187, 1992). According to current hypotheses, activated autoreactive CD4+ T helper cells (Th1 cells) which preferentially secrete interferon-gamma (IFN-.gamma.) and tumor necrosis factors alpha/beta (TNF-.alpha./.beta.), induce inflammation and demyelination in MS (Martin et al., supra). Available data suggest that the predisposition to mount a Th1-like response to a number of different antigens is an important aspect of MS disease pathogenesis. Proinflammatory cytokines (such as IFN-.gamma., TNF-.alpha./.beta.) and chemokines secreted by Th1 cells contribute to many aspects of lesion development including opening of the blood-brain-barrier, recruitment of other inflammatory cells, activation of resident glia (micro- and astroglia) and the effector phase of myelin damage via nitrogen and oxygen radicals secreted by activated macrophages (Wekerle et al., Trends Neuro Sci. 9:271-277, 1986) (Martin et al., supra).

(...)



Secondary-progressive multiple sclerosis is a clinical course of MS that initially is relapsing-remitting, and then becomes progressive at a variable rate, possibly with an occasional relapse and minor remission.


and which includes claims

1. A method of treating a human subject suffering from relapsing remitting multiple sclerosis, comprising administering daclizumab monthly to the subject in a unit dose ranging from about 150 mg to about 400 mg, wherein the subject is not concurrently treated with interferon-.beta..

2. The method of claim 1, wherein the daclizumab is administered for a year.

3. The method of claim 1, wherein the daclizumab is administered indefinitely.

4. The method of claim 1, wherein the daclizumab is formulated as a solution containing from 1 wt % to 15 wt % or 20 wt % daclizumab.

5. The method of claim 1, wherein the daclizumab is administered is administered as monotherapy.

6. The method of claim 1, wherein the daclizumab is administered in an amount effective to reduce the rate of increase of the subject's disability score.

AND, from StreetInsider on 20 April 2016:


New data presented today [April 20] show that investigational therapy ZINBRYTATM (daclizumab HYP) provided improvements on cognitive outcome measures in people living with relapsing forms of multiple sclerosis (RMS). Additional data offer insight into ZINBRYTA’s targeted mechanism of action (MOA), demonstrating that it did not cause broad immune cell depletion and its effects on total lymphocyte counts were reversible within approximately 8 to 12 weeks upon treatment discontinuation. These results were presented by Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) at the 68th annual meeting of the American Academy of Neurology (AAN) in Vancouver, Canada



link: http://www.streetinsider.com/Corporate+News/Biogen+(BIIB),+AbbVie+(ABBV)+Present+Data+at+AAN+Highlighting+Impact+of+ZINBRYTA+on+Cognitive+Outcomes+and+Targeted+MOA/11521564.html

CAFC affirms that hair-cutting claims are not within 35 USC 101 scope in Holly Brown case

The CAFC affirmed a 101 decision of PTAB in the case of U.S. Patent Application No.
09/795,210, because the claims cover only abstract ideas coupled with routine
and conventional hair-cutting steps.

link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1852.Opinion.4-20-2016.1.PDF

CAFC vacates decision of ED NC in Mankes case based upon Akamai IV

The decision of ED NC in Mankes v. VIVID SEATS LTD.,
FANDANGO, LLC was vacated because of Akamai IV.

link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1500.Opinion.4-20-2016.1.PDF

Color trademarks in Europe

A tiff between Nestle and Cadbury. SOCIÉTÉ DES PRODUITS NESTLÉ S.A. vs. CADBURY UK LIMITED. [2012] EWHC 2637 (Ch)

The general issue:

In what circumstances can a colour be registered as a trade mark? In this appeal the answer turns on two of the legislative requirements, as judicially interpreted: a trade mark must be (i) "a sign" and (ii) "graphically represented." Applications and registrations of the less conventional kind of subject matter, such as colour, are potentially problematical, especially if they cover a multitude of different visual forms.

Some relevant law:

Libertel Groep BV v. Benelux-Merkenbureau Case C-104/01 [2003] ECR 1-3793

The point was whether Libertel, a telecommunications company, could register the colour orange as a trade mark for telecommunications goods and services. It was held that a colour not spatially defined is capable of being registered as a trade mark, provided that it satisfies the three conditions of (i) being a sign, (ii) being capable of graphical representation, and (iii) being capable of distinguishing the goods or services of one undertaking from another.


As to the 2012 case:


The judge concluded at [63] that single colours are capable of being signs, of being represented graphically and of distinguishing; and that the description of the mark in this case was capable of being a sign within Article 2. He said that the case was covered by Libertel. The wording in the description of the Cadbury's mark had to be considered. It did not have the effect of making the case different from the single colour mark considered in that case.



link:
http://www.bailii.org/ew/cases/EWCA/Civ/2013/1174.html

See also IPKitten post: Cadbury suffers another blow in the battle to protect purple trade marks

**Separately

Plagiarism scandal at Daily News attributed to editing, but, in the end, judgment based on results, not intentions?

Withing a post at the NY Times titled Daily News Editor Is Fired After Plagiarism Accusations , one finds the text:


He [Shaun King] was confident that the plagiarism accusations were false because, he said, he had not been told by editors at The Daily News that his article had been altered. He added that he has a “verbal agreement” with the tabloid that any changes to his work, beyond grammar or punctuation, require his approval and that his writing customarily gets a “light edit.”

“I didn’t see these changes,” Mr. King said. “I wasn’t told, ‘Hey, we deleted this attribution line and made you look like you said it.’ ”




CNN gave further details:


In a post published Thursday on Medium, Jotham Sederstrom explained why he removed attribution from columns written by the activist Shaun King.

According to Sederstrom, those edits -- which Daily News editor-in-chief Jim Rich called "egregious and inexplicable" -- were the result of a faulty publishing system and fatigue.

"In all honesty, the controversy -- a f*** up on my part, to put it bluntly -- comes down to two unintentional, albeit inexcusable, instances of sloppy editing on my part and a formatting glitch that until Tuesday I had no idea was systematically stripping out large blocks of indented quotations each time I moved Shaun's copy from an email to The News' own Content Management System, or 'CMS' as it's called in media parlance," Sederstrom wrote.

"In those two cases where no citation or hyperlink appeared in the column, I believe I likely cut attribution from the top of Shaun's quoted text with the intention of pasting them back inside the block -- only to get distracted with another of the many responsibilities I juggled as an editor," he added.



link: http://money.cnn.com/2016/04/21/media/shaun-king-daily-news-jotham-sederstrom/

And see the Daily News:

http://nypost.com/2016/04/20/daily-news-fires-editor-amid-shaun-king-plagiarism-allegations/ giving a quote:

Daily Beast Executive Editor Noah Shachtman:


“In the end, we are judged not by what’s in our raw copy but what goes up on the printed page or on a website,” he said. “So while I appreciate that there may have been an effort to do attribution, ultimately we are judged by our results, not our intentions.”

Ocrelizumab and rituximab for multiple sclerosis {MS]

Within medpagetoday on ocrelizumab :



It remains to be seen whether ocrelizumab beats out rituximab at slowing disease activity in MS, although this is a trial that isn't likely to be done given that Roche/Genentech manufacture both products.

The companies are no strangers to having two competing drugs for a single condition, with one offered at a significantly cheaper price. Roche/Genentech manufacture both bevacizumab (Avastin) and ranibizumab (Lucentis) for a host of ophthalmic conditions, and physicians have long preferred the less costly bevacizumab, especially after studies largely showed equal efficacy and safety profiles between the two.

Whether such a situation will arise with rituximab-ocrelizumab remains speculative, but biosimilars for rituximab are expected to be introduced eventually, at which point market pressures may force Roche/Genentech to drop the price for rituximab.



from post
Novel Drug Bests Interferon at Halting MS Activity
Nearly half of patients on ocrelizumab achieved no evidence of disease activity (NEDA)

from a report by Anthony Traboulsee of the University of British Columbia in Vancouver, reported at the American Academy of Neurology meeting in Vancouver in April 2016.

Roger B. Taney monument in Mount Vernon Place, Baltimore to be "de-accessed"

See the post Ta-ta to two of Baltimore’s Confederate monuments?

Is this a first for a former Supreme Court Chief Justice?

CAFC narrows BRI in MAN MACHINE INTERFACE

According to the CAFC, PTAB's BRI was unreasonably broad in IN RE: MAN MACHINE INTERFACE
TECHNOLOGIES LLC.

Teva was mentioned, but had no impact:


“[W]e review the Board’s ultimate claim constructions
de novo and its underlying factual determinations involving
extrinsic evidence for substantial evidence.” Prolitec,
Inc. v. Scentair Techs., Inc., 807 F.3d 1353, 1358
(Fed. Cir. 2015) (citing Teva Pharm. U.S.A., Inc. v.
Sandoz, Inc., 135 S. Ct. 831, 841–42 (2015)). In this case,
“because the intrinsic record fully determines the proper
construction, we review the Board’s claim constructions
de novo.” Microsoft Corp. v. Proxyconn, Inc., 789 F.3d
1292, 1297 (Fed. Cir. 2015). In reexamination, claims are
given their broadest reasonable interpretation (“BRI”)
consistent with the specification. In re Yamamoto, 740
F.2d 1569, 1571 (Fed. Cir. 1984). “While the Board must
give the terms their broadest reasonable construction, the
construction cannot be divorced from the specification and
the record evidence.” In re NTP, Inc., 654 F.3d 1279, 1288
(Fed. Cir. 2011).



Of BRI, the CAFC noted:



This court’s cases on
BRI make clear that the proper BRI construction is not
just the broadest construction, but rather the broadest
reasonable construction in light of the specification.
Proxyconn, 789 F.3d at 1298 (“A construction that is
unreasonably broad and which does not reasonably reflect
the plain language and disclosure will not pass muster.”
(internal quotation marks and citations omitted)).

(...)

As we have
explained, “[a]bove all, the broadest reasonable interpretation
must be reasonable in light of the claims and
specification.” PPC Broadband, Inc. v. Corning Optical
Commc’ns RF, LLC, No. 2015-1364, 2016 WL 692369, at
*5 (Fed. Cir. Feb. 22, 2016). Thus we reject the Board’s
unreasonable construction, instead construing “thumb
switch being adapted for activation by a human thumb” in
view of the specification to mean “thumb switch being
made or designed for activation by a human thumb.”



Of briefing issues, footnote 2:

We cannot consider the obviousness rejections of
claims 7, 9, and 17 because neither party introduced those
arguments on appeal besides challenging the claim constructions
on which they are based. Accordingly, we
vacate those rejections and remand for the Board to
consider the obviousness rejections of claims 7, 9, and 17
in view of the correct claim constructions.


link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1562.Opinion.4-15-2016.1.PDF

Sport Dimension v. The Coleman Company: CAFC speaks to design patents and expert witnesses

Coleman Company, Inc. appeals from a stipulated
judgment of noninfringement entered by the United
States District Court for the Central District of California.
Coleman challenges the district court’s claim construction
on which the stipulated judgment was based and its
exclusion of Coleman’s expert. For the reasons stated
below, we vacate the judgment, affirm the court’s exclusion
of Coleman’s expert, and remand for proceedings
consistent with this opinion.




A design patent is at issue:


Coleman owns United States Design Patent
No. D623,714 (“D’714 patent”). It claims “[t]he ornamental
design for a personal flotation device,”

(...)

Words cannot easily describe ornamental designs. See
Dobson v. Dornan, 118 U.S. 10, 14 (1886) (explaining that
a claim “is better represented by the photographic illustration
than it could be by any description, and a description
would probably not be intelligible without the
illustration”). A design patent’s claim is thus often better
represented by illustrations than a written claim construction.
Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d
665, 679 (Fed. Cir. 2008) (en banc). Also, detailed verbal
claim constructions increase “the risk of placing undue
emphasis on particular features of the design and the risk
that a finder of fact will focus on each individual described
feature in the verbal description rather than on the
design as a whole.” Id. at 680.

Even so, a district court may use claim construction to
help guide the fact finder through issues that bear on
claim scope. Id. We have often blessed claim constructions,
for example, where the court helped the fact finder
“distinguish[] between those features of the claimed
design that are ornamental and those that are purely
functional.” Id. (citing OddzOn Prods., Inc. v. Just Toys,
Inc., 122 F.3d 1396, 1405 (Fed. Cir. 1997)). Of course, a
design patent cannot claim a purely functional design—a
design patent is invalid if its overall appearance is “dictated
by” its function. Id. at 668.



Of OddzOn:


In OddzOn, for example, we considered a design patent
on a rocket-shaped football and endorsed the district
court’s construction that distinguished between functional
and ornamental aspects of the design. The design patent
disclosed a football with a large tail fin that added stability
for the ball in flight. Id. at 1406. The fins also produced
an “overall ‘rocket-like’ appearance of the design.”
Id. at 1405. We agreed with the district court’s finding
that the fins were functional. Nevertheless, we approved
of the court’s construction that took the fins into account.
We praised the court for “carefully not[ing] the ornamental
features that produced the overall ‘rocket-like’ appearance
. . . [and] properly limit[ing] the scope of the patent
to its overall ornamental visual impression, rather than to
the broader general design concept of a rocket-like tossing
ball.” Id.

We followed a similar line of analysis in Richardson.
597 F.3d at 1293–94.



There is good news and bad news for Coleman:


Coleman disputes the court’s ultimate construction
and its finding that the armbands and tapered torso are
functional. While we agree with Coleman that the court’s
ultimate construction was improper under our law, we
disagree with Coleman’s assertion that the armbands and
side torso tapering do not serve a functional purpose. As
the district court correctly pointed out, Coleman’s armbands
and tapered side torso designs meet several of the
factors we announced in PHG Technologies, LLC v.
St. John Cos., for determining whether a design claim
was dictated by function, including:
whether the protected design represents the best
design; whether alternative designs would adversely
affect the utility of the specified article;
whether there are any concomitant utility patents;
whether the advertising touts particular
features of the design as having specific utility;
and whether there are any elements in the design
or an overall appearance clearly not dictated by
function.

(...)

Nonetheless, even though we agree that certain elements
of Coleman’s design serve a useful purpose, we
reject the district court’s ultimate claim construction. The
district court eliminated the armbands and side torso
tapering from the claim entirely, so its construction runs
contrary to our law. Here, as in Ethicon, “the district
court’s construction of the Design Patents to have no
scope whatsoever fails to account for the particular ornamentation
of the claimed design and departs from our
established legal framework for interpreting design
patent claims.” Ethicon Endo-Surgery, 796 F.3d at 1334.
Moreover, design patents protect the overall ornamentation
of a design, not an aggregation of separable elements.
Richardson, 597 F.3d at 1295 (noting that “discounting of
functional elements must n



***Of the expert witness matter:


Coleman also challenges the district court’s exclusion
of its expert, Peter Bressler. We review a district court’s
exclusion of expert testimony under the law of the regional
circuit, here the Ninth Circuit. Proveris Sci. Corp. v.
Innovasystems, Inc., 536 F.3d 1256, 1267 (Fed. Cir. 2008).
The Ninth Circuit reviews a district court’s exclusion of
an expert for an abuse of discretion. Cabrera v. Cordis
Corp., 134 F.3d 1418, 1420 (9th Cir. 1998).
District court judges perform a gatekeeping role for
expert testimony. They must ensure that expert testimony
is reliable and that the testimony “relate[s] to scientific,
technical or other specialized knowledge, which does
not include unsubstantiated speculation and subjective
beliefs.” Diviero v. Uniroyal Goodrich Tire Co., 114 F.3d
851, 853 (9th Cir. 1997) (citing Daubert v. Merrell Dow
Pharm., Inc., 509 U.S. 579, 590 (1993)); see also
Fed. R. Evid. 702.

The district court here excluded Mr. Bressler, an industrial
design consultant with four decades of industry
experience, because he had “no experience whatsoever in
the field of [personal flotation devices].”



There are some messages for proper expert witness
presentation in this case:


Mr. Bressler,
when asked to evaluate Sport Dimension’s expert’s
testimony on one aspect of the device’s function, stated:
“I’m not an expert on personal flotation devices.” Appellee’s
Br. 45. His proposal for alternative armband designs,
by Mr. Bressler’s admission, was based on his
“imagination.” Id. at 45–46. And he further admitted
that he had no work experience with wearable buoyancy
devices before serving as an expert. Id. at 45–47. In light
of Mr. Bressler’s admitted inexperience and unfamiliarity
with the very subject on which Coleman sought to rely on
his testimony, the district court did not abuse its discretion
in excluding his testimony. See Cabrera, 134 F.3d at
1420.



link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1553.Opinion.4-15-2016.1.PDF

Motley Fool notes Phase 3 data for ocrelizumab being presented 17-21 April 2016 at AAN meeting

From the Fool:


Although a bit more expensive than AbbVie on a PEG ratio basis, Roche's rock solid product line is on more stable ground. That said, I feel it's about to launch upwards when and if Ocrevus, formerly ocrelizumab, reshapes the multiple sclerosis space. Another first-in-class candidate, Roche will be presenting phase 3 Ocrevus data at the American Academy of Neurology April 17 through 21, that Biogen investors will want to watch.

It's early, but it seems Ocrevus may have Biogen's blockbuster multiple sclerosis treatment Tecfidera beat in terms of both safety and efficacy. If approved, sales could move the needle significantly for the Swiss pharma giant.



link: http://www.fool.com/investing/general/2016/04/17/4-healthcare-stocks-that-are-looking-cheap.aspx

The word ocrelizumab is the generic name for the monoclonal antibody. Wikipedia noted: In February 17th, 2016, the Food and Drug Administration granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab for the treatment of people with primary progressive multiple sclerosis

**Separately, note

http://theweek.com/articles/618141/big-science-broken

CBS Sunday Morning on April 17, 2016

Charles Osgood introduced the stories for April 17, 2016. The cover story is by Barry Petersen on the country of Bhutan, where love and compassion are values and the goal is "gross national happiness." Second, Tracy Smith on Bonnie Raitt. Third, Lee Cowan on Kathy Bates. Fourth Anna Werner on Quidditch. Conor Knighton on Key Biscayne Park.

Headlines. 7.8 magnitude earthquake in Ecuador. Japanese earthquakes. The Pope visits Lesbos, Greece.

Of the Bhutan story, the top tourist attraction is Tigers Nest. The goal of Bhutan is obtaining a balance of economic and emotional well-being. The male dress of Bhutan is the gho. Picture of golden langer monkeys.

Almanac. April 17, 1937. Daffy Duck appears for the first time in "Porky's Duck Hunt."

National Law Review giving bad patent drafting advice?

The National Law Review has some advice for patent drafters [ Key Lessons from Patent Litigation for Drafting and Prosecuting Utility Patent Applications ], which includes this puzzling text:


The claimed invention should be sufficiently described in the application to teach a layman how to reproduce that invention.

On June 2, 2014, the U.S. Supreme Court held in Nautilus v. Biosig that “a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” The Court also indicated that “a patent must be precise enough to afford clear notice of what is claimed, thereby ‘appris[ing] the public of what is still open to them.’” This is the evenhanded result because a patent provides a patentee with monopoly over a claimed territory; this monopoly is a property right; and “like any property right, its boundaries should be clear” (quoting Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.).


link: http://www.natlawreview.com/article/key-lessons-patent-litigation-drafting-and-prosecuting-utility-patent-applications#sthash.miZd6Zok.dpuf

First, given that a layman is a person who is not a member of a particular profession, one observes that a layman is NOT one of ordinary skill in the art (the particular profession). The use of the word "layman" is simply wrong.

Second, Indefiniteness is not about "reproducing" the invention.

Very careless and erroneous work at the National Law Review.

Teva has new drug composition for treating multiple sclerosis [MS]

Business-standard reports on a patent application from Teva related to a new MS drug:


The patent application, titled Stable Laquinimod Preparations, is for a pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt of it and meglumine and a pharmaceutically acceptable carrier. The company claims that it has unexpectedly found that this pharmaceutical composition provides a superior stabilisation effect. It has also amended some of the claims to include the ratio range of the ingredients used in the composition, in order to address the objections raised by the examiner of Patent Office.



The report suggests allowance has been given:


srael-based Teva Pharmaceuticals has received patent approval for a product related to multiple sclerosis drug Laquinimod. According to reports, Laquinimod is developed by Teva Pharma in collaboration with Active Biotech AB, a Swedish biotechnology company which has focus on neurodegenerative/ inflammatory diseases and cancer.



link: http://www.business-standard.com/article/companies/teva-gets-patent-for-invention-related-to-multiple-sclerosis-drug-116041600202_1.html

See for example published US application 20140024678 [notice of allowance mailed 19 Jan 2016], with first published claim:


14. A process for the manufacture of a sealed package comprising a pharmaceutical composition of N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-- 3-carboxamide or a pharmaceutically acceptable salt thereof comprising obtaining the pharmaceutical composition and packaging said pharmaceutical composition in a container under conditions containing less oxygen than standard atmospheric conditions.



Published example 1:


EXAMPLE 1

Laquinimod Sodium Capsules Comprising Sodium Carbonate

[0065] Capsules were made which corresponded to 0.3 mg of laquinimod acid (LA) per capsule and 0.6 mg of laquinimod acid per capsule using the following excipients as shown in Table 1:

TABLE-US-00001 TABLE 1 Component 0.3 mg LA/capsule 0.6 mg LA/capsule Laquinimod Sodium 0.32 0.64 Mannitol USP 151.08 302.16 Sodium carbonate 4.55 9.10 anhydrous USP Sodium Stearyl 1.6 3.2 fumarate NF Total Weight 157.55 315.1

[0066] The capsules were made using the following steps: [0067] 1. Mannitol and 99% of the total desired anhydrous sodium carbonate were placed into a high shear granulating mixer and were mixed for 30 seconds. [0068] 2. A solution of laquinimod sodium, 1% of the total desired anhydrous sodium carbonate and purified water was prepared in a mixer until dissolved. [0069] 3. The solution from step 2 was added to the contents of the high shear granulating mixer of step 1 and was mixed to form a suitable granulate. [0070] 4. The granulate was dried in a fluid bed dryer with the inlet air temperature of 50.degree. C. and outlet air temperature of 40.degree. C. [0071] 5. The dry granulate was milled using a 0.8 mm screen, and blended with sodium stearyl fumarate. [0072] 6. The mixture from step 5 was filled into size 1 hard gelatin capsules (0.5 mL volume) for the 0.6 mg laquinimod acid dose and into size 3 hard gelatin capsules (0.3 mL volume) for the 0.3 mg of laquinimod acid dose.




This is related to issued US patent 8,545,885 .

Plagiarism episode ends badly for chemistry grad student at UNLV

See the ReviewJournal post titled Appeals court rules against ex-UNLV student in plagiarism case.

From the unpublished CA9 opinion [ 2016 U.S. App. LEXIS 6371 ]


Gamage argues that the district court erred in granting summary judgment to the defendants because she raised genuine issues of material fact about whether she plagiarized a draft of her dissertation. We disagree. Gamage admitted that she failed to conform to the University of Nevada - Las Vegas's plagiarism policy in parts of her dissertation and that she made "mistakes." She received more process than was due. See, e.g., Goss v. Lopez, 419 U.S. 565, 581, 95 S. Ct. 729, 42 L. Ed. 2d 725 (1975) (holding that procedural due process requires that a student suspended for disciplinary reasons "be given oral or written notice of the charges against [her] and, if [she] denies them, an explanation of the evidence the authorities have and an opportunity to present [her] side of the story.").1



The underlying case [ 2013 U.S. Dist. LEXIS 184162 ]

had named a chemistry professor:



In 42 U.S.C. §1983 actions, qualified immunity protects a government official sued in his personal capacity from civil liability when performing discretionary acts, so long as those acts do not violate clearly established statutory or constitutional rights of which a reasonable person would have known. Harlow v. Fitzgerald, 457 U.S. 800, 817-18, 102 S. Ct. 2727, 73 L. Ed. 2d 396 (1982).



See also KAASS LAW, Appellant, v. WELLS FARGO BANK, N.A, 799 F.3d 1290; 2015 U.S. App. LEXIS 15127

There is no "world-wide" patent

The NY Times has an interesting piece titled Lifting the Patent Barrier to New Drugs and Energy Sources.

Related to the text


The Obama administration, spurred by the drug industry, insisted that patent protections should be tightened further around the world. But several other countries argued that they raised excessive barriers for poor countries, costing lives.


one notes that patent protection is national, not worldwide. Thus, if an inventor has not filed in country X, but in country y, somebody in country X can practice in country X the invention filed in country y.

This observation is also relevant to the text in the NYT article:


A group of countries led by India argued for transferring intellectual property rights for clean energy technologies to developing nations to accelerate their diffusion. Professor Stavins offers a counterargument: “In the long term, if there are no property rights, it will destroy the incentive to develop the next generation of technologies.”



There may be an incentive to protect an invention in country y (lots of money to be made) but not in country x. But the information about the invention is publicly available.

As to TRIPS, it defines the scope of available patent protection that member states must provide [e.g., Patents must be granted for "inventions" in all "fields of technology" provided they meet all other patentability requirements (although exceptions for certain public interests are allowed (Art. 27.2 and 27.3)[6] and must be enforceable for at least 20 years (Art 33). ] BUT the inventor still must file in the relevant countries.

TRIPS does not create a "world patent." (compare NYT text: the world’s first enforceable deal to protect patents globally. ]

IPBiz has mentioned the work of Bronwyn Hall elsewhere:


Academics still running amok in IP: VCs and patents


***Separately, from blawgsearch on April 13, 2016

U.S District Judge R. Gary Klausner rejects "falsification of history" claim but the case against Led Zeppelin will proceed

An NPR post titled 'Stairway To Heaven' Plagiarism Suit Heads To Trial includes the text:


Among the claims in the lawsuit against Led Zeppelin: that the band perpetrated a "falsification of Rock n' Roll History." In his order, Klausner finds that claim "inventive—yet legally baseless," saying that he diligently sought out anything that might support the theory.



IPBiz is reminded of the Dastar case.

AND


The "Stairway to Heaven" trial is set to begin on May 10, and the plaintiff's attorney, Francis Alexander Malofiy, has said that he's seeking a songwriting credit for Wolfe. A favorable finding could also bring a share of the song's profits — by 2008, it had reportedly earned $562 million.

More on on All Prior Art database of Alexander Reben; the USPTO responds (sort of)

Further to an earlier IPBiz post Supreme patent silliness reported by Jamie Condliffe at Gizmodo: a (randomized) prior art generator , Laura Sydell at NPR has a post on All Prior Art of Alexander Reben.

Within Sydell's text:


If someone tries to patent an invention and the idea has already been published, the U.S. Patent and Trademark Office won't grant them a patent. Reben's project is trying to cut down on the number of frivolous patents by publishing lots and lots of ideas, and he thinks his database could be used by patent examiners to challenge frivolous patents.

An explanation on Reben's site says the system works "by pulling text from the entire database of U.S.-issued and published (unapproved) patents and creating prior art from the patent language. While most inventions generated will be nonsensical, the cost to create and publish millions of ideas is nearly zero — which allows for a higher probability of possible valid prior art."

Reben says his program generates about 36,000 new ideas a minute. But, it's a bit more than pure random words.



It is doubtful that Reben's approach will be a source of prior art useful to the patent office. As a first point, Reben's "art" is better characterized as "combinations of old ideas" rather than a source of "new ideas."

Along this line, because, by definition, it creates only combinations of elements, each of which is KNOWN in the prior art, it is unlikely to be of help in obviousness rejections, which require a motivation to combine
[e.g., MPEP 2143.01 ]. It is unlikely that the USPTO will find much motivation for one of ordinary skill in a database which randomly combined fragments of known art. Does the artificial act of randomly combining into "one document" overcome this? Likely not.

Separately, in the off-chance that Reben's database created "one document" which has all the elements of a patent claim (arguably compressing an obviousness issue into an anticipation issue), would the USPTO accept this as "prior art"? An anticipatory prior art patent document is presumptively enabled, but do combinations of elements from many patent documents enjoy this? Likely not. And further: the prior art needs to enable the portions of its disclosure alleged to anticipate the claimed invention. [Antor Media (CAFC 2012)]

Sydell's post also included text of a response from the USPTO


Asked whether the agency would actually look at the All Prior Art site to help decide whether to grant a patent, USPTO Press Secretary Paul Fucito emailed this statement:

"High-quality patents enable certainty and clarity of rights, which fuels innovation and reduces needless litigation. To ensure we continue issuing high-quality patents well into the future, we established the Enhanced Patent Quality Initiative (EPQI). We are strengthening work products, processes, services, and how we measure patent quality at all stages of the patent process.

"In terms of wider access to prior art, the USPTO has a Third-Party Preissuance Submission program which provides a mechanism for third parties to submit patents, published patent applications, or other printed publications of potential relevance to the examination of a patent application with a concise description of the asserted relevance of each document submitted."




link to Sydell article: http://www.npr.org/sections/alltechconsidered/2016/04/12/473880115/can-silly-patents-help-fight-frivolous-lawsuits

**Comments posted

http://www.infoworld.com/article/3060284/intellectual-property/how-do-you-stop-patent-trolls-this-algorithm-just-might-do-the-trick.html

http://www.pcworld.com/article/3060106/how-do-you-stop-patent-trolls-this-algorithm-just-might-do-the-trick.html#comments

Emojis on baseball bats to send messages

There is a certain issue arising with the bats of Bryce Harper, who has placed an emoji on the end:


For those of you who aren't hip with Millennials, it carries two meanings in this case. The obvious is that it's the number 100 and Harper's next career home run will be No. 100.

The less obvious, at least for those not up on their emojis, is that the symbol in question means "keep it 100." That phrase means "to keep yourself real and true, to be honest and stick to the way you are, no matter what any one else thinks," according to Urban Dictionary.



BUT


Major League Baseball implemented new rules just prior to the start of the season stating that bat decals could only contain a team logo or the player's number. This appears to be in violation of that rule.



link: https://www.yahoo.com/sports/blogs/mlb-big-league-stew/bryce-harper-has-some-new-bat-decals-that-celebrate-his-next-homer-025612098.html

Reasons for abandoning trademark applications

From an article about trademarking "Model E"


Robin Bren, trademark Attorney and Partner at Intellectual Property Law Firm Oblon, Spivak, McClelland, Maier & Neustadt, had earlier explained that companies usually abandon trademark applications for two reasons: that the company may not be planning on using the name anymore, or that the company might be "mitigating" risk.



link: http://www.techtimes.com/articles/148939/20160411/if-ford-did-not-block-trademark-for-model-e-tesla-would-have-completed-a-word-after-model-s-model-x.htm

Of journals editing authors' submissions, and things vanishing from the internet

A family flare-up between the son and daughter of Lee Kuan Yew in Singapore brings up some IP issues from the past. In the text


In an article submitted to the Straits Times last month, she [Dr. Lee Wei Ling, daughter of Yew] had said Lee Kuan Yew would have "cringed at the hero worship just one year after his death". The newspaper did not publish the article and she posted it online.

Straits Times Editor Warren Fernandez said the newspaper's editors were working with her to get it ready for print. "But some concerns arose, including over the plagiarized paragraphs. In addition, we found her ultimatum to either print her piece unedited or she would go online, totally unacceptable."

In a Facebook post detailing her exchanges with the newspaper's editors, which has since been removed, the sister said, using the initials of her brother and father




link: http://www.reuters.com/article/us-singapore-politics-idUSKCN0X803X

** Of periodicals doing editing, recall the matter of Colleen Chien's essay in the Wall Street Journal [-- According to Chien, the emphasis and framing in the WSJ essay were the result of heavy WSJ editing-- from
http://patentlyo.com/patent/2015/11/professor-nuanced-arguments.html ]. In the Yew matter, rather than accept editing, Ling published on Facebook.

Of Chien, see also: http://ipbiz.blogspot.com/2015/11/further-on-chienrisch-wsj-op-ed-on.html

** Of the Facebook publication, it did vanish. IPBiz has referred to such deletion as a "Sikahema" in reference to Vai Sikahema's outburst "Rutgers is Wrong" which quickly vanished from the internet. Sikahema was right about Rutgers, but wrong about the general idea that only the Ohio State's of the world can be football powers.

Supreme patent silliness reported by Jamie Condliffe at Gizmodo: a (randomized) prior art generator

At Gizmodo, Jamie Condliffe reports in the post This Website Is Using Math to Create Every Possible Patent on work by Alexander Reben.

As a first point, the title is misleading. Reben's work slices and dices prior patents and patent applications (allegedly) to create prior art, not possible patents:


The system works by pulling text from the entire database of US issued and published (un-approved) patents and creating prior art from the patent language.



The comments are about as inane as the work being reported. For example:


Yeah, he’s very right. Nothing in his database will prevent a patent from being issued. It wouldn’t have before, but now that we’ve moved to first-to-file, it definitely won’t.

It might be usable to invalidate a patent if you can get the judge not to laugh you out of court when you explain you’re using random data as your evidence, but you won’t be able to afford to get to that point in the process anyway.



Of the above comment, IPBiz notes that true "prior art" can be used by an examiner to reject claims from an application prior to issue. Of course, whether or not sliced/diced fragments from earlier patents/applications, randomly combined, would be recognized as prior art can be questioned.

Reben's effort is a fool's errand.

Condliffe links to an article by Brian Barrett. One wonders if Barrett remembers why the "cold war" was called cold. After discussing actually patent litigations, there is text:


The lawsuits that Apple and HTC and Samsung and Nokia and everyone else with skin in the mobile game are throwing at each other, though? Those are dangerous. They're dangerous because Apple doesn't want cash; they've got more than the entire US government. Neither does anyone else, really. What they're all gunning for is market advantage. Which, in the most extreme case, means pulling the Galaxy Tab 10.1 off EU and Aussie shelves altogether. They're not playing Monopoly anymore. They're playing Highlander.

I spoke with Venture Capitalist and author of the influential tech blog Above the Crowd Bill Gurley, who pointed out that "The [patent] Cold War aspect basically defines certain markets as 'out of bounds.' You can't do mobile OS now. CPU is likely tough. Video CODECs are a mess." Three crucial areas, cut off from from disruptive progress because of our system's failings.



The first paragraph might seem to be about the difference between damages and injunctions. Otherwise, one might think
"market advantage" means "cash." Of the second paragraph, the presence of patent litigations (actual war) is not what the "cold war" was about (the threat of MAD foreclosed actual war).

The comments are inane.

No idea of patent maintenance fees:


something similar for tech would be a nice middleground? just make a patent last 3 yrs (or so) and renewable to a max of 12yrs. every renewal with 3yrs would cost a lot of money. This would be an incentive to innovate and invent rather than keep legacy hardware/software around because it wouldn't be easy money anymore.



Gary Kildall forgotten:


As has already been mentioned, code is covered under copyright. The issue I have with that is where do you draw the line? If I want to print "Hello, world." there are only so many ways to do that, and theoretically already covered by somebody else's copyright.

You'd have to define at what point a chunk of code becomes copyrightable (and have to follow some sort of "obviousness" test, as exists in patent law).



And a patent lawyer, apparently unfamiliar with small inventors, said:


One suggestion I think might alleviate a lot of the current problems: Implement a "use it or lose it" provision. Under the current rules, you can patent something and do nothing with it, thus locking up an invention for almost 20 years. It's this provision that provides full employment for patent trolls, and also results in these huge bidding wars for vast libraries of (largely unused) patents. If you were required to develop and market your invention within some set period of time (say, 3-5 years) or lose it, that would remove the incentive for a lot of this abuse and litigation.



The lawyer also did not understand differences between trademarks (which protect consumers as to articles IN COMMERCE)
and patents (which protect inventions hopefully going INTO commerce):


As Talia notes, there is precedent in trademark law (which, admittedly, I am not an expert on). You have to file periodic affidavits with the USPTO, showing that you have used your trademark in commerce, or your registration lapses. I don't think it would be too hard to implement a similar system for patents.



Of loser pays:


"As for litigation, Gurley recommends moving to a system—similar to what the UK and France already have in place—where the losing party pays."

Let's see; first of all, I will assume that the poster was advocating for a statutory change (just the IP system) as opposed to changing the entire legal landscape, because that would be seriously stupid. But let's examine it in the best possible light-

If we change it to "loser pays" for just IP, without reforming the laws, then-

1. We're stuck with the current system, which is horribly unfavorable to defendants.

2. We will have a system that favors rich litigants at the expense of poor litigants. Imagine if you're random content creator, and you're told that your work violates some IP by MegaCorp. If you lose, not only do you have to pay up, *but you have to pay MegaCorp's massive legal fees.* And then you're told that the law is against you. Fun!

3. Imagine you're a company, say, that sounds like Brainal Adventures. Do you bring litigation as your company? Or do you assign the rights to the litigation to some shell company with few assets? On the off chance Shell Company, LLC, loses, then Brainal Adventures owes nothing (unless there's some piercing the veil, yeah, right). If you win, then the company you sue pays Shell Company, LLC legal fees to initiate more litigation, and you have precedent on your side.



Of -- the current system, which is horribly unfavorable to defendants--, patentee-plaintiffs lose more than 50% of the time.

From what groups do patent citations come from?

There is a communication relating to patent value, based on work by ADAM R. CASTOR , now about to get a Ph.D. at Penn and formerly at the University of Wyoming, with a B.S. Mathematics & Economics, May 2002


The paper titled “Cognitive Neighborhoods and the Valuation of Innovation: A Cross-National Analysis,” asserts that a patent's value can be correlated with the classification code assigned by the USPTO. Yes, patent citations appear:
Castor reported that the difference in terms of what technologies get cited more often than not comes from citations outside the class.

Castor noted:


So I think it’s clear that the classes are important; the next step is to understand exactly how much agency, and what can applicants do in order to ensure that their applications are going to be funneled into the classes that they want, and be seen by the proper examiners.


Taylor Wry noted:


The only thing I would add to that is that, I think one of the unique things about this work that we are doing is instead of looking at individual categories or individual classifications, which is the traditional approach in the academic literature, we are really highlighting the influence of the properties of the classification system.



link: http://knowledge.wharton.upenn.edu/article/location-location-location-adds-patents-valuation/

LBE has commented on the lack of value of patent citation statistics. See for example:

http://ipbiz.blogspot.com/2004/09/there-they-go-again-patent-citation.html

http://ipbiz.blogspot.com/2010/08/citations-found-in-patents-do.html

Flashback to 1970: We can't have all Brandeises, Frankfurters and Cardozos

Related to some discussion about the next Supreme Court pick [link below], IPBiz recalls a quote from 1970:


"Even if he were mediocre, there are a lot of mediocre judges and people and lawyers. They are entitled to a little representation, aren't they, and a little chance? We can't have all Brandeises, Frankfurters and Cardozos


link to 2016 talk at Brooklyn Law: http://m.stltoday.com/news/state-and-regional/sotomayor-court-needs-greater-diversity-in-several-ways/article_e8165969-8f6d-55cf-8dbd-4042ba96c98f.html

CBS Sunday Morning on April 10, 2016

Anthony Mason was the host for the money issue on April 10.

The bank meltdown in Iceland. From the cover story by Martha Teichner:


Historian Magnus Sveinn Helgason conducts walking tours during which he explains what went wrong when Iceland's bankers and businessmen set out to turn their country of only 330,000 people into a world financial capital:

"When the three big Iceland banks collapsed, all three would have ranked among the ten largest bankruptcies in U.S. history had they been U.S. companies," he said. (...)

"A lot of people seemed to be getting very rich, very fast, and a lot of people wanted to join in on that," said Katrin Jakobsdottir. She is one of the members of Parliament who decided on Iceland's hardline response when this whole house of cards built on debt came tumbling down.

"Even though the banks also were responsible, as a whole, I think it was the conviction that also the individuals within the banks had done this," Jakobsdottir said. (...)

Between 20 and 30 bankers have gotten jail sentences. Siguron Arnason, former CEO of Landsbanki, will begin serving a five-year prison sentence in the fall.



link: http://www.cbsnews.com/news/iceland-not-too-big-to-jail/

A story on the Thiel Foundation by John Blackstone included criticism:



"It breaks my heart when some of the most promising students don't fulfill their potential because they're chasing rainbows," said Vivek Wadhwa, a fellow at Stanford University, who has been a critic of the Thiel Fellowship from the beginning." (...)

"Everyone does the same thing: It's social media, it's photo sharing apps. Today it's sharing economy," Wadhwa said. "It's 'Me, too,' 'More of the same.'"


BUT


"There are some opportunities that come up that you would regret turning down," Kramer said. "Workflow was definitely one of those."

"It's kind of like making your own apps that save you time," Weinstein said.

When Workflow launched, it was the number one bestseller on Apple's App Store -- and has since won several awards.

They've just hired their newest employee, Tim Hsia, a graduate of Stanford's business and law schools and an Army vet. He's 33-years-old and says he doesn't mind taking orders from a teenage boss.




There is a New Jersey connection to Workflow. From a 2014 post: (Kramer, 18, is from Cherry Hill, Weinstein is from Mt. Airy).

Of the Wadhwa debate, see also

http://www.intelligencesquaredus.org/iq2us-blog/item/979-thiel-vs-wadhwa-the-higher-education-debate-continues

And from pbs.org, Wadhwa saying:


One good question Thiel often raises is whether you need to learn what’s taught in college. My dean at Duke University, Tom Katsouleas, has a great answer. He tells the story of a high school teacher whose students confronted him with the same question: “Why do we need to learn this?” The teacher replied, “You don’t. You need to learn to ask just one question.” The piqued students implored him to tell what that was. His answer: “Would you like fries with that?”


link: http://www.pbs.org/newshour/making-sense/the-pernicious-myth-that-you-d/

** Lee Cowan interviews Hugh Jackman on coffee.
See Hugh Jackman: Changing lives, one cup of coffee at a time

The moment of nature included two buck mule deer near Wilson, Wyoming. ["two bucks" for the money issue]

link: https://www.youtube.com/watch?v=kWQrRtSDPwk

[The "money issue" in 2014: Snow geese and tundra swans in Lehigh Valley, Pa. Many "bills."]

Academic assertion: patent classification system affects the way that an innovation is going to be viewed

IPBiz takes note of the paper mentioned in the text:


According to the paper, “Cognitive Neighborhoods and the Valuation of Innovation: A Cross-National Analysis,” if a patent’s assigned technology class is closely related to other classes, that patent will itself end up being more valuable.



And, yes, patent citation is mentioned:


Tyler Wry: Something that is interesting to keep in mind when we are looking at patents and classification, and the valuation of intellectual property, is that there is an assumption that the number of citations that a patent gets in future innovation is a reflection of its value. And what Adam has done really nicely in this paper is show that it’s not just a reflection of the quality of the patent that is driving its valuation, but it really is where it gets slotted into the classification system.




More later.

Link: http://knowledge.wharton.upenn.edu/article/location-location-location-adds-patents-valuation/

New logos for Tokyo 2020 Olympics being considered; copyright issues addressed

The original design for the 2020 Tokyo Olympics logo, presented by Kenjiro Sano, was withdrawn last summer after Belgian artist Olivier Debie claimed that it copied prior design for the Theatre de Liege.

Four replacement designs are being considered. Note:


"All of these designs have all been cleared of copyright both domestically and abroad," Tokyo Emblem Committee Chairman Yohei Miyata told reporters.



link: http://www.nbcnews.com/news/world/tokyo-2020-olympic-logo-shortlist-unveiled-after-plagiarism-scandal-n552851

Osram loses at CAFC in appeal of unfavorable IPR result

Osram lost an appeal at the CAFC, with merely a per curiam affirmation under Fed. Cir. R. 36.

PTABTrialBlog had noted of the IPR decision:


The Board did not construe the term “crystallographic plane surfaces” in the Decision to Institute, but requested a construction at final hearing. The Board agreed with Patent Owner that the language of claim 1 requires that “crystallographic plane surfaces” result from crystallographic etching, and thus construed “crystallographic plane surfaces” to mean “a smooth plane surface resulting from crystallographic etching.” Petitioner had alleged that the term means what was disclosed in the prior art references.




Relevant information on the underlying IPR:

OSRAM GmbH v. E. Fred Schubert, IPR2013-00459
Paper 28: Final Written Decision
Dated: January 21, 2015
Patent: 6,294,475 B1
Before: Jennifer S. Bisk, Gregg I. Anderson, and Matthew R. Clements
Written by: Anderson
Related Proceedings: E. Fred Schubert v. OSRAM GmbH., Case No. 12-cv-923-GMS (D. Del.) and E. Fred Schubert v. Koninklijke Philips Electronics N.V., Case No. 12-cv-924-GMS (D. Del.)

link: http://ptabtrialblog.com/final-written-decision-ipr2013-00459/

GENETIC TECHNOLOGIES LIMITED loses appeal at CAFC; 101 issues resolved in 12(b)(6) motion

The outcome:



Genetic Technologies Limited (“GTG”) brought suit
against Merial L.L.C. (“Merial”) and Bristol-Myers Squibb
(“BMS”) (together, “appellees”). GTG alleged that appellees
had infringed U.S. Patent No. 5,612,179 (“the ’179
patent”), which relates to methods of detecting genetic
variations. The district court granted appellees’ motions
to dismiss for failure to state a claim and entered final
judgment that claims 1–25 and 33–36 of the ’179 patent
are ineligible for patenting under 35 U.S.C. § 101. For
purposes of this appeal, the parties have stipulated that
claim 1 is representative of all of the invalidated claims.
Because we agree that claim 1 is directed to unpatentable
subject matter, we affirm.




This is a 12(b)(6) case


We review de novo the dismissal for failure to state a
claim under Rule 12(b)(6). Content Extraction & Transmission
LLC v. Wells Fargo Bank, Nat’l Ass’n, 776 F.3d
1343, 1346 (Fed. Cir. 2014); Sands v. McCormick, 502
F.3d 263, 267 (3d Cir. 2007). Patent eligibility under
35 U.S.C. § 101 is a question of law that we review de
novo. OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d
1359, 1362 (Fed. Cir. 2015); Content Extraction, 776 F.3d
at 1346.

We have repeatedly recognized that in many cases it
is possible and proper to determine patent eligibility
under 35 U.S.C. § 101 on a Rule 12(b)(6) motion. See, e.g.,
OIP Techs., 788 F.3d at 1362; Content Extraction, 776
F.3d at 1351; buySAFE, Inc. v. Google, Inc., 765 F.3d
1350, 1355 (Fed. Cir. 2014). In many cases, too, evaluation
of a patent claim’s subject matter eligibility under
§ 101 can proceed even before a formal claim construction.
“[C]laim construction is not an inviolable prerequisite to a
validity determination under § 101.” Bancorp Servs.,
L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687
F.3d 1266, 1273 (Fed. Cir. 2012); see also Content Extraction,
776 F.3d at 1349. Here, there is no claim construction
dispute relevant to the eligibility issue.



The issue


Claim 1 recites a method of detecting an allele of interest
at a multi-allelic locus (i.e., a location on the chromosome
where multiple variations of a particular gene
are known) by amplifying a sequence of non-coding region
DNA known to be linked with the allele and then analyzing
the non-coding region to detect the allele. In somewhat
plainer terms, claim 1 covers a method of detecting
a coding region of a person’s genome by amplifying and
analyzing a linked non-coding region of that person’s
genome.
Claim 1 covers any comparison, for any purpose, of
any non-coding region sequence known to be linked with a
coding region allele at a multi-allelic locus. The ’179
patent states that “[t]he method can be used to detect
alleles of genetic loci for any eukaryotic organism,” ’179
patent col. 4 ll. 12–13, and “is generally applicable to
detection of any type of genetic trait,” id. at col. 46 ll. 8–9.
The ’179 patent does not limit its scope to methods of
detecting any particular alleles linked to any particular
non-coding sequences, although the specification does
provide some examples of linked alleles known to be
diagnostic of inherited diseases such as cystic fibrosis and
muscular dystrophy. See generally, ’179 patent col. 43
l. 43–col. 46 l. 6. Claim 1 broadly covers essentially all
applications, via standard experimental techniques, of the
law of linkage disequilibrium to the problem of detecting
coding sequences of DNA.

The product of the method of claim 1 is information
about a patient’s natural genetic makeup—at least one
coding region allele.



The outcome



The similarity of claim 1 to the claims evaluated in
Mayo and Ariosa requires the conclusion that claim 1 is
directed to a law of nature. The sole function of the
“primer pair defining a DNA sequence which is in genetic
linkage with [a multi-allelic] genetic locus” is to amplify a
sequence of non-coding DNA in linkage disequilibrium
with a sequence of coding DNA of interest. ’179 patent
col. 59 ll. 60–62. “The method comprises amplifying
genomic DNA with a primer pair that spans an intron
sequence and defines a DNA sequence in genetic linkage
with an allele to be detected.” Id. at col. 4 ll. 37–39. The
claim is directed to a natural law—the principle that
certain non-coding and coding sequences are in linkage
disequilibrium with one another.2 We hold that claim 1 is
directed to unpatentable subject matter at the first step of
the Mayo/Alice test.

We thus proceed to step two of the Mayo/Alice analysis.
At step two, after identifying a claim directed to
unpatentable subject matter, “we must examine the
elements of the claim to determine whether it contains an
inventive concept sufficient to transform the claimed
abstract idea [or law of nature] into a patent-eligible
application.” Alice, 134 S. Ct. at 2357 (internal quotation
marks omitted) (citing Mayo, 132 S. Ct. at 1294, 1298).
“The question . . . is whether the claims do significantly
more than simply describe [a] natural relation[].” Mayo,
132 S. Ct. at 1297. (...)

Claims directed to laws of
nature are ineligible for patent protection when, “(apart
from the natural laws themselves) [they] involve wellunderstood,
routine, conventional activity previously
engaged in by researchers in the field.” Mayo, 132 S. Ct.
at 1294.
We conclude that the additional elements of claim 1
are insufficient to provide the inventive concept necessary
to render the claim patent-eligible.



An allusion to Mayo:


Mayo itself considered and rejected diagnostic and
therapeutic method claims that combined routine and
conventional physical implementation of a law of nature
with a simple mental process step.
(...)
Mayo held that the “‘wherein’ clauses
simply tell a doctor about the relevant natural laws, at
most adding a suggestion that he should take those laws
into account when treating his patient.” Id. at 1297.
That is, “these clauses tell the relevant audience about
the laws while trusting them to use those laws appropriately
where they are relevant to their decisionmaking
(rather like Einstein telling linear accelerator operators
about his basic law and then trusting them to use it
where relevant).” Id.
Here, the phrase “to detect the allele” in claim 1 of the
’179 patent also merely informs the relevant audience—
e.g., doctors or others seeking to make a genetic diagnosis—
to apply a law of nature for a purpose—detecting a
polymorphism within a coding region of an allele of interest.



An allusion to BRCA:


Our decision in In re BRCA1- & BRCA2-Based Hereditary
Cancer Test, 774 F.3d 755 (Fed. Cir. 2014), is also
instructive. Claim 8 of U.S. Patent No. 5,753,441 evaluated
in that case recited a method of screening for alterations
of the BRCA1 gene that included the steps of
“amplifying all or part of a BRCA1 gene from [a] sample
using a set of primers to produce amplified nucleic acids
and sequencing the amplified nucleic acids” and “comparing”
the sequence with wild-type BRCA1. Id. at 761–62.
We held that claim to be invalid because it was directed to
an abstract idea and did not add enough to distinguish it
from a claim to the abstract idea. Id. at 762–65. An
aspect of our analysis there supports our analysis of the
law-of-nature issue here.



UPDATE: see also
http://www.natlawreview.com/article/methods-exploiting-junk-dna-may-be-useful-lack-patent-eligibility