Posts Tagged: "prometheus"

The view of the USPTO now is that a claim to purified amazonic acid is not patent-eligible because there is no structural difference between the purified acid in the claim and the acid in the leaves, and the claim does not include features that demonstrate that the recited product is markedly different from what exists in nature. … It is, to say the least, unclear why the USPTO, without public consultation seeks to remove the patent-eligibility of isolated or purified natural products of new medical or other utility, which has been taken as a given in the US for 100 years and is consistent with practice in Europe and other major industrialised countries.

Now the Patent Office and the courts have the unenviable task of trying to figure out what the Supreme Court really meant in Mayo v. Prometheus. If Diehr remains good law, which it clearly does, and Mayo v. Prometheus is good law, which it has to be as the last pronouncement, then it becomes clear that the proper statutory analysis is to go step by step through the statute analyzing patentability under the separate and distinct patentability requirements of 101, 102, 103 and 112. That is unless there is something that allows for the short-circuiting of the appropriate analysis as in Mayo v. Prometheus. What is that something?

A decision with the right outcome but for the wrong reasons can confound jurisprudence nearly as much as a decision that is entirely wrong. It is difficult to avoid the conclusion that all that found its way into the Siedman patents was the results of the very research that had been recommended in the 1996 paper and which Prometheus had been prompted to under-write. The more natural objection which, unfortunately, was not pursued was therefore lack of inventive step under 35 USC §103. It is submitted that this should have been enough to dispose of the issue between the parties, arguably even in a motion for summary judgment, but unfortunately it was not how the case was pleaded and argued.

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.

The Prometheus decision shows that you can never know for sure what the outcome will be once you arrive at the Supreme Court. We also know that the Supreme Court is taking more patent cases now than ever, and those decisions have significant implications for the entire industry above and beyond the patent claims at issue and the parties involved. Your patent portfolio may be at risk because some other company obtained poorly written claims and the Supreme Court has taken the opportunity to decide not only the issues before them but to make decisions based on overarching concerns about the entire patent system.

The reasoning in Mayo Collaborative Services makes no patent law logical sense on numerous grounds, including disregarding an important paragraph in the Supreme Court’s 1981 case of Diamond v. Diehr that is not only binding precedent, but also tells us that Breyer’s opinion repeatedly does what this paragraph from Diehr says not to do in an analysis of method or process claims under 35 U.S.C. § 101. But the question now becomes what do we do to keep the reasoning in Mayo Collaborative Services from exploding into completely irrational, as well as patent law insane doctrine? The way forward to patent-eligibility rationality, as well as sanity, is through the remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC. Put differently, there may yet be “light” in this currently “dark” patent-eligibility tunnel.

Unlike many in the biotech community I do not think the Prometheus decision will break the biotech industry or even seriously affect it. Much like the car mechanic in a small Caribbean island told me when my engine light came on in my rental car, “no worries, no problem!” I believe the holding in Prometheus prevents what could be a future legal quagmire, where overly-broad patents could serve to block entire fields of practice and create an enforcement nightmare in which ghosts of legal uncertainty and licensing ambiguities would haunt hospital hallways, R&D labs, boardrooms, and investment entities throughout the country. If the Prometheus decision would have gone the other way, it would not have been status quo, but rather been fairly harmful to future innovation.

You could attribute what happened here to “selective precedent amnesia.” But frankly such mishandling of binding Supreme Court precedent in Mayo Collaborative Services is a huge problem. (As one commentator has astutely noted, we now have Supreme Court precedent going off in two diametrically opposed directions on essentially the same patent-eligibility issue.) Any persuasiveness (or balance) in the opinion in Mayo Collaborative Services is greatly undermined by failing to directly (and fairly) address Diehr.

From this perspective, (and setting aside considerations of novelty or obviousness) one might conclude that, rather than claiming some methods with reference to anything that looks like a law of nature in a claim, thus raising the specter of §101, it may be better to claim some methods more broadly so as to avoid such issues – maybe obtaining broader claim scope in any event.

Those supporting the reasoning in Breyer’s opinion repeatedly “crow” that Mayo Collaborative Services was a 9-0 decision. But the fact that 9 technologically-challenged Justices reached a unanimous decision based on nonsensical, as well as logically and legally-flawed, reasoning does not impress me, or persuade me. That those 9 Justices simply chose to trounce the Federal Circuit’s decision without leaving any understandable guidance in its place for us mere mortals, chose to deliberately ignore a thoughtful suggestion from the U.S. Solicitor General, and simply determined patent-eligibility under 35 U.S.C. § 101 in a vacuum divorced from any consideration of the relevant context of other patent statutes just makes Breyer’s opinion result-driven and despotic. Such patent law despotism does not earn my respect, only my scorn.

Well, Justice Breyer, the writer of the dissenting opinion in Laboratory Corp. v. Metabolite Laboratories, Inc., finally got his wish. Writing the opinion for a unanimous Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Breyer ruled that a claimed drug dosage calibration method based on previously unknown “precise correlations between metabolite levels [of administered thiopurine drugs] and likely harm or ineffectiveness” was patent-ineligible under 35 U.S.C. § 101 because it “adds nothing to the laws of nature that is not already present when the steps [of the claimed method] are considered separately.” While I’m not surprised that Breyer ruled the claimed method patent-ineligible, his reasoning in Mayo Collaborative Services is, in my view, often nonsensical, and is fraught with unfortunate statements that could potentially eviscerate the patent-eligibility of drug testing methods generally under 35 U.S.C. § 101.

The sky is falling! Those who feel the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is terrible are right, although many won’t likely fully apprehend the gravity of the situation at first. Those in the biotech, pharmaceutical and chemical industries have just been taken out behind the woodshed and summarily executed by the Supreme Court this morning. An enormous number of patents will now have no enforceable claims. Hundreds of billions of dollars in corporate value has been erased. But that might be a good thing. Immediate attention now must turn to Congress. Thank goodness that the technical amendments to the America Invents Act are outstanding. This will provide a perfect opportunity for Congress to save an industry that employs many millions of people, while at the same time undoing a pathetic, narrow-minded decision of the Supreme Court.

This was a very interesting discussion, although I was surprised at how little Bilski was mentioned. Although the hearing did digress on some tangents, the Justices’ questioning was generally on point and indicative of the difficult questions a case like this presents. Surely, the Court will be thinking of the impact a decision might have on the healthcare industry, as well as the information technology industry. Also, Justices are no doubt aware of other pending cases which may find their way to the Supreme Court, such as AMP v. USPTO, Classen v. Biogen, and the divided infringement cases of McKesson and Akamai. I will leave the reader to reach their own conclusions, but my best guess is that the Court is leaning toward the position that §101 should be a coarse filter and that §102 and §103 would be more appropriate to challenge the validity of the claims in this case. We will learn the answer in the spring.

All in all it seemed to me that the majority of the court seemed more skeptical about the Mayo position and more supportive of the Prometheus position. That being said, it is extremely troubling to contemplate the possibility that Chief Justice Roberts was more in tune with the thinking of Justice Breyer. It is also disheartening to see such a fundamental misunderstanding of patent law on the part of the Chief Justice. At the end of the day the Justices of the Supreme Court will say what the law is on this issue, but sometimes it is hard to imagine a less qualified bunch to opine on a patent issue.