Posts Tagged: "association of molecular pathology"

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.

Social policy concerns have influenced the AMP v Myriad debate. The Supreme Court, to the extent it must make a ruling for our times, informed by societal context, should dispassionately consider all the available empirical evidence, from the academic work cited here, to the claim scope limits resulting from massive sequence publication projects and recent court cases, and the thriving innovation ecosystem in personalized medicine at and among for profit and not for profits, and render a clear forward compatible decision for us all.

As the patent community waits to see whether the United States Supreme Court will deal a significant, perhaps fatal blow, to the patenting of many genetic related innovations in Association of Molecular Pathology v. Myriad Genetics, announcement came this morning of a newly issued U.S. patent. This patent was issued to St. Jude Children’s Research Hospital. The invention relates to compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults.

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.

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.

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.”

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.”

So maybe the Federal Circuit won’t find “preemption” to be useful in deciding this appeal; we’ll know soon enough. I, for one, can’t make sense of the DOJ’s fixation on “tying up.” In Flook, the Supreme Court made clear that a claim’s patent-eligibility does not turn on the range of uses that are preempted versus those that remain in the public domain. Even in Mayo, the Supreme Court discussed preemption explicitly only as an underlying policy concern, as a justification for an outcome that, to the Court, seemed right and just – not as a test that distinguishes a “law of nature” from a man-made process. By elevating “tying up” to the status of an actual analytical tool, DOJ proposes an unworkable test that fails to distinguish “products of nature” from man-made inventions and leads to absurd outcomes. It asks the Federal Circuit to rely on asserted facts and unstated claim constructions. It requires strained interpretations of leading precedent. It is evasive and avoids the hard work of construing the claims and applying them to the activities believed to be “tied up” – lawyer work that, if undertaken, may or may not show that the preemptive scope of these claims isn’t all it’s trumped up to be.

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.

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.

Some will undoubtedly view the Chief Judge’s basis in Ultramercial for distinguishing the ruling in CyberSource as being “slight of hand” and using “mirrors,” but it certainly illustrates the wide gulf of views between the various members on the Federal Circuit on the patent-eligibility question. I wouldn’t be surprised (and frankly it needs to happen) if both Ultramercial and CyberSource ended up before the en banc Federal Circuit. As I’ve noted previously, we’ve currently got what appear to be irreconcilable decisions in the Classen, Prometheus, and AMP cases in determining the patent-eligibility of certain medical (e.g., diagnostic) methods. With what appears to be similarly conflicting decisions in Ultramercial and CyberSource, the gauntlet has truly been thrown down. An en banc Federal Circuit needs to step in soon, or the conflagration that currently exists in the patent-eligibility “war” might soon consume us all.

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.

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.

Richard M. Marsh, Executive Vice President and General Counsel for Myriad Genetics is on the panel. He started off his presentation explaining that he really wants to talk about the case and the issues, but given that the case is ongoing and the future is uncertain regarding whether it will continue to be appealed, go back to trial or be dismissed altogether he might be unable to answer all questions. He did say clearly that the biotechnology industry “is under attack.” Marsh explained that the industry needs to be proactive because “if we sit back and idly do nothing there could be grave consequences.” Marsh explained that Myriad was able to do what it did thanks to the patents by giving it the time, money and incentive to innovate. I couldn’t agree with him more.