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Posts Tagged: "aclu"

Other Barks & Bites, Friday, October 11: IPWatchdog Celebrates, USPTO Meets Pendency Goals, SCOTUS Denies IP Cases and ACLU Opposes CASE Act

This past week in Other Barks & Bites: the Federal Circuit issued precedential decisions affirming the invalidation of patent claims covering osteoarthritis treatments and a costs award to Facebook, but reversed the PTAB on a reasonable expectation of success finding; the U.S. Supreme Court issued orders denying certiorari to several intellectual property cases; North Korea acceded to the Geneva Act of WIPO’s Lisbon Agreement; the Dollywood theme park was hit with a copyright suit over use of the Peanuts’ “Christmas Time is Here”; Nokia announced 2,000 patent families declared as 5G SEPs; former CAFC Chief Judge Rader has called on China to move forward with promised pharmaceutical patent reforms; 2019’s third quarter showed growth in the global PC market; and the USPTO announced that it has met its patent application pendency goals as well as a new senior-level position for an AI expert.

U.S. Companies and Groups to Congress: the Section 101 Reform Draft is Good and Genes are Safe

Seventy-two companies and organizations, ranging from Tivo to Bristol-Myers Squibb and from the American Conservative Union to the Alliance of U.S. Startups & Inventors for Jobs (USIJ)— as well as retired Federal Circuit Chief Judge Paul Michel—have sent a letter to Senators Thom Tillis and Chris Coons and Representatives Hank Johnson, Doug Collins, and Steve Stivers in support of the current draft language to reform Section 101 of the U.S. Patent Act. The letter comes as the patent community eagerly awaits a new version of the bill, following three hearings and 45 witnesses in which most voiced their general support for the approach taken in the draft, but several sticking points were identified. The next iteration is expected soon after Congress’ July 4 recess.

Sherry Knowles Responds to ACLU’s Urgent Phone Briefing and Letter Opposing Reform to Section 101

This morning, the American Civil Liberties Union (ACLU), which will be represented in Wednesday’s hearing on Section 101 reform by Senior Legislative Counsel Kate Ruane, announced an urgent phone briefing for members of Congress and staff to address the contention that the “Proposed Patent Bill Would Jeopardize Health Care and Harm Medical Research.” The phone briefing, which all interested stakeholders should join, takes place today at 2:30 pm EST and will be jointly held by representatives from the ACLU, the Association for Molecular Pathology, a breast cancer survivor and patient, My Gene Counsel, and Invitae. Anyone who would like to listen should dial in to the number provided here. Below, Sherry Knowles, a well-known patent attorney, policy expert and also a breast cancer survivor, rebuts the arguments made in both the ACLU’s briefing announcement and associated letter to Congress on this topic.

Supremes Rule Isolated DNA and Some cDNA Patent Ineligible

You can expect a near complete cessation in many areas of personalized medicine. If creating something in a lab, such as a composite cDNA, does not make the underlying claims patent eligible because what results is indistinguishable from what appears in nature that means that the fledgling and potentially promising technologies to grow organs for transplantation will shrivel up and die. The whole point is to create an organ that is indistinguishable from what appears in nature so that it can be transplanted into a human body to prolong life. Given the breadth of this opinion and the uncertainty it will cause funding will dry up in the U.S.

Supreme Court Hears Myriad Gene Patent Challenge

If cDNA is patent eligible subject matter, as it seems likely based on the tone of the oral argument, that should be very good news for Myriad. As Justice Breyer recognized during questioning of Mr. Hansen (representing AMP), the Myriad claim says they want “the isolated DNA of claim 1 wherein said DNA has the nucleotide sequence set forth in SEQ ID No. 1.” If you look at SEQ ID No. 1 clearly states that the molecule type is cDNA, thus cDNA seems to be a part of the claim, not to mention that the cDNA used by Myriad was a consensus sequence made from hundreds of different patients. Thus, if cDNA is patent eligible then the Supreme Court must find that at least some genes are patent eligible and must also find the Myriad claims patent eligible. Whether the Supreme Court Justices really captured that nuance remains in doubt. It seemed at times that Justices Sotomayor and Kagan were openly arguing the AMP/ACLU case. Sadly, at times it was apparent that the Supreme Court doesn’t understand even the most basic and fundamental patent law concepts.

Patent Pending: Corporations, the Constitution, and the Human Gene

The Honorable Alex Kozinski immediately posed the question—by way of an analogy to scientists who stare at the stars—of why should someone be able to get a gene patent just because there was a significant amount of effort put in to discover that gene. Throughout the event, Judge Kozinski took on the role of the generalist judge, who would need to be convinced that the invention in the lab is anything other than a product of nature. Professor David Winickoff of UC Berkeley followed that question up by discussing James Watson’s amicus brief and the idea that genes are both symbolic in our culture and shared by all humans, thus making them a unique item in our world.

No One is Patenting Your Genes: The Ripple Effect if Isolated DNA Claims Are Made Patent Ineligible

One side in the “gene patent war” has nevertheless convinced the Supreme Court to weigh in on the issue of whether DNA sequences derived from the human genome are patentable, in Association for Molecular Pathology (AMP) v. Myriad Genetics, while disingenuously labeling the patents at issue as “human gene patents.” Let’s set the record straight.

AMP v. Myriad: SCOTUS Must Remember What Case Is Not About*

As Myriad has correctly pointed out in its brief in opposition to the grant of certiorari, the question posed by the ACLU/PubPat (“Are Human Genes Patentable”) is absolutely the wrong one to answer: “The first question presented [by the ACLU/PubPat] bears no relation to the uncontroverted facts of this case.” (Myriad’s brief in opposition has also pointed out at least 4 other significant factual and legal “misstatements” made in the petition for certiorari by ACLU/PubPat.) As much as the ACLU/PubPat (and others) want to make the Myriad case into about “Who Owns You,” what Myriad has claimed does nothing of the sort. In fact, a “yes” answer to the question posed by the ACLU/PubPat does not automatically lead to Myriad’s claimed “isolated” DNA sequences being patent-ineligible. Those claimed “isolated” DNA sequences are not “genes” by any standard molecular biology definition of what that term actually means. Instead, and as accurately characterized by Judge Lourie, these claimed “isolated” DNA sequences are “novel biological molecules.”

AMP v. USPTO Remand: Déjà Vu as Federal Circuit Majority Reaffirms Myriad’s Isolated DNA Sequences Are Patent-Eligible*

The other point that also bears repeating (and quoting) from the majority opinion in the AMP remand is Judge Lourie’s response to the so-called “preemption” question: “Plaintiffs argue here that they are preempted from using the patented DNA molecules. The answer to that concern is that permitting patents on isolated genes does not preempt a law of nature. A composition of matter is not a law of nature. Moreover, as indicated earlier, a limited preemption is inherent in every patent: the right to exclude for a limited period of time.”

Federal Circuit Panel Rehears ACLU, Myriad Gene Patent Case

Although predictions on the outcome of an unusual case such as this are probably worthless, I think that it is most likely that this panel will rule in 2012 the same way that it ruled in 2011. It is probably safe to presume that the judges are fairly entrenched in their positions. In my view, no arguments were presented which show that Mayo was a game-changer with respect to the isolated DNA claims and the screening method claim. In particular, AMP’s main point about the relevance of Mayo—the preemption argument—was harshly criticized by Judge Moore. Among the three members of the panel, Judge Moore would appear to be the most likely to change sides, and I do not see this happening. Thus, I expect the same outcome as last year. However, the long-term outcome is much murkier, with an en banc hearing and/or a Supreme Court appeal almost certain.

Debunking the Gene Patent Mythology: Professor Holman’s Supplemental Brief in the AMP Remand*

Professor Holman not only teaches patent law at UMKC, but has a Ph.D. in biochemistry and molecular biology, as well as well as some post-doctoral drug discovery research experience. In other words, Professor Holman speaks as one who understands both the patent law and the technology involved in the AMP case. And what Professor Holman’s supplemental brief does is debunk the “gene patent mythology” fabricated by ACLU, PubPat, (and others), as well as “ a number of assumptions regarding the nature of the claimed subject matter” made by the original Federal Circuit panel which he characterizes as “unsupported at best, and in some instances clearly mistaken.”

Chakrabarty Controls on Isolated DNA Sequences, not Mayo*

Unfortunately this unspecific remand by the Supreme Court in AMP vacates as well the two-to-one ruling by this same Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) that the claimed isolated DNA sequences were also patent-eligible under 35 U.S.C. § 101. What, pray tell, does Mayo Collaborative Services change with regard to that ruling in the original AMP decision? For those, like the plaintiffs in AMP (including the ACLU), who would like to upset this “applecart,” they’re likely to be very disappointed. I can describe what should be the impact of the ruling (and reasoning) in Mayo Collaborative Services on the claimed isolated DNA sequences in three short monosyllabic words: NONE AT ALL. And the Federal Circuit can (and should) say likewise, perhaps in far more words.

Myriad: Isolated DNA claims from “ball bats in trees,” and “kidneys” to “magic microscopes.”

The basic argument in Myriad is whether DNA that is isolated from the chromosomes is statutory subject matter, or whether it is a product of nature. The stakes are high in the Myriad case, since the isolated DNA claimed by Myriad encodes mutated BRCA1 and BRCA2 proteins that can be used to detect breast cancer. Myriad has the only test offered in the United States because of its aggressive enforcement of its several patents. The numerous plaintiffs in the case speak to the core of the patent versus non-patent debate: whether patents actually “promote the progress of science and useful arts” as required in the U.S. Constitution. Myriad and other companies heavily reliant on biotechnology patents, would support the argument that strong patent enforcement allows companies which have invested millions or billions in assay or drug development for clinical use to recoup their investment and provide a return for investors. The plaintiffs would argue that such patents not only hinder the useful arts, but also endanger lives and/or drives up the cost of providing potentially life-saving testing and treatment.

As Predicted, Federal Circuit Rules Isolated DNA Patentable

After much anticipation, the United States Court of Appeals for the Federal Circuit earlier today issued a decision in Association for Molecular Pathology v. Myriad Genetics. The decision on first glance will seem to be a split decision, particularly by Federal Circuit standards. The majority opinion was written by Judge Lourie, Judge Moore wrote a concurring opinion and Judge Bryson concurred in part and dissented in part. Having said that, the outcome largely seems to be what was predicted by the patent community. On the major substantive issue — are isolated DNA molecules patent eligible subject matter — the Federal Circuit reversed the decision of the district court and ruled that isolated DNA molecules do constituted patent eligible subject matter. The Federal Circuit also ruled that methods relating to the screening for potential cancer therapeutics are, likewise, patent eligible subject matter. All three Judges also found the “comparing” and “analyzing” claims to be ineligible for patent protection because they were not transformative, and thus were merely abstract mental steps.

Reviewing the ACLU and Myriad Oral Arguments at the CAFC

The ACLU lead plaintiffs have a real predicament relative to standing. It does not sound as if the Federal Circuit believed any single plaintiff could satisfy both prongs required to bring a Declaratory Judgment Action, and rather were trying to say we have some plaintiffs with first prong evidence and some with second prong evidence. Simply put, that dog doesn’t hunt, at least not under current law relative to standing. Thus, there seems a real chance that the entire case could be thrown out because no plaintiff has standing.