Posts Tagged: "justice breyer"

It seems undeniable that Alice missed many opportunities to score easy points. Indirect arguments were made by Alice that didn’t seem very persuasive. Indeed, if one is to predict the outcome of the case based on oral arguments alone it did not go well for Alice today. Only three things give Alice supporters hope after this oral argument as far as I can tell. First, the government seems to be asking the Supreme Court to overrule precedent in Bilski that is not even four years old, which simply isn’t going to happen. Second, the egregious overreach and outright misleading nature of the CLS Bank argument should raise a legitimate question or two in the mind of the Justices. Third, the reality simply is that at least the systems claims recite numerous specific, tangible elements such that it should be impossible to in any intellectually honest way find those claims to cover an abstract idea.

In this case, the Supreme Court considered an arrangement by which brand firm Solvay paid generics Watson (now Actavis) and Paddock roughly $30 to $40 million to delay entering the market with generic versions of testosterone gel. The Eleventh Circuit upheld the activity, concluding that “absent sham litigation or fraud in obtaining the patent, a reverse payment settlement is immune from antitrust attack so long as its anticompetitive effects fall within the scope of the exclusionary potential of the patent.” The court explained that “[p]atent holders have a ‘lawful right to exclude others from the market’” and that a patent “conveys the right to cripple competition.”

The Supreme Court reversed the Eleventh Circuit, concluding that, while a valid patent allows a patentee to charge “higher-than-competitive” prices, “an invalidated patent carries with it no such right.” The Court recognized the policy encouraging settlements. But for five reasons, it found that that policy did not dictate immunity for pay-for-delay settlements.

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.

While one can never know for certain how the Supreme Court will rule, even a casual observer has to conclude that the Supreme Court seems poised rule in favor of Monsanto. Seconds after Bowman’s attorney started Chief Justice Roberts interrupted asking why anyone would ever patent anything if Bowman were to prevail. Shortly thereafter Justice Breyer openly concluded that Bowman infringed in a matter of fact way. It later may have seemed Breyer was probing for a response he didn’t get more so than announcing his view of the case. Nevertheless, if Bowman loses Breyer he has no chance.

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?

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.

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.