Posts Tagged: "patentability requirements"

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.

Trying to divine what Mayo Collaborative Services v. Prometheus Laboratories, Inc. means for the future in judging the patent-eligibility of claimed methods and processes under 35 U.S.C. § 101 is like using a Ouija board. The first inkling came 10 days after Mayo Collaborative Services in a motion for partial summary judgment in SmartGene, Inc. v. Advanced Biological Laboratories, SA, a case from the District Court of Columbia. When I first read this case, my initial reaction was “oh no, here comes the collateral damage we feared would come from Mayo Collaborative Services.” But having reflected on this case some more, and especially the claims involved, I think Judge Howell’s ultimate conclusion of patent-ineligibility of the claimed process and system under 35 U.S.C. § 101 is defendable. Even so, the reasoning expressed in Judge Howell’s opinion for reaching that conclusion gives pause for concern about the impact of Mayo Collaborative Services on rendering consistent and objective determinations of patent-eligibility under 35 U.S.C. § 101.

Just over three weeks ago the United States Supreme Court issued a decision in Mayo Collaborative Services v. Prometheus Laboratories, which sent much of the patent world into a whirlwind. In that decision the Supreme Court unanimously found that the claims at issue did not exhibit patent eligible subject matter because the additional steps that were added to the underlying law of nature were well known in the industry. A curious ruling for many reasons, and one that will have to be digested over many years as the United States Patent and Trademark Office and the Federal Circuit struggle to figure out how Diamond v. Diehr remains good law (it was not overruled) and remains consistent with a ruling that seems completely inapposite. To continue to provide a variety of perspectives on this landmark ruling what follows is the reactions of those in the industry.

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.

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.

That there was a majority (and a dissenting) opinion in the remand of Classen wasn’t surprising. But that there was yet a third “additional views” opinion would likely not have been predicted by anyone. And it is that “additional views” opinion, along with the majority and dissenting opinions, that will certainly generate a “firestorm” through the Federal Circuit, and which may eventually reach the Supreme Court. The judicial donnybrook on the question of what the standard is (or should be) for patent-eligibility under 35 U.S.C. §101 is about to begin in earnest.

This week marks the first anniversary of the Supreme Court issuing its decision in Bilski v. Kappos. The decision held that the machine-or-transformation test is not the exclusive test for patent eligibility, and that the three traditional exclusions of natural phenomena, abstract ideas, and laws of nature still apply. The summary of cases prepared by Attorneys Holoubek and Sterne is excellent! It is absolutely must reading for attorneys prosecuting and litigating in this space.

The United States Constitution grants to the Congress the power to grant patents; this power residing in the Congress is found in Article I, Section 8, Clause 8. Unlike most of the enumerated powers granted to Congress in the Constitution, the Intellectual Property Clause is a qualified grant of power, which does limit Congressional discretion in significant ways. The Congress does not have free reign to decide that patents should be easily or freely given, but rather must limit their exercise of power to the dictates of the clause itself. See Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 146 (1989). See also Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 5 (1966) (“The clause is both a grant of power and a limitation. This qualified authority, unlike the power often exercised in the sixteenth and seventeenth centuries by the English Crown, is limited to the promotion of advances in the ‘useful arts.’”).