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August 26, 2021

Comments

I am somewhat surprised that no one (yet) has offered up the 'solution' to the underlying "uncertainty" (based on the art being a so-called unpredictable art), that with AI, the degree of unpredictability more approaches the vanishingly small levels more often associated with the computing arts.

(not that such avoids OTHER potential issues)

“[T]he scope of claims relating to antibodies (and soon perhaps more mundane chemical species) will likely be limited to… what you… disclose expressly…, which will… allow copyists to piggyback on others' inventions to make their own competing species of valuable therapeutic agents.”

That depends on FDA law. If the FDA insists on strict molecular identity of a candidate for biosimilar approval, then even a narrow “picture” claim will prevent generic competition. If the FDA takes a more loosy-goosey view of what counts as “biosimilar,” however, then this stricter standard for patent enforceability will—as you say—make generic competition much more vigorous.

I have asked dozens of FDA lawyers by now how they read the law and regulations around “biosimilarity” on this point. Is strict molecular identity necessary (as it would be for a bioequivalence analysis) or not? They all tell me the same thing—no one knows yet. We will have to wait for a biosimilar candidate to bring this question into live contention.

Greg; agreed unless competitors are willing to file independent BLAs which, according to how lucrative the market is, may not be out of the question. Particularly if FDA takes the stringent position on amino acid sequence.

Thanks for the comment

Mr. Noonan's analogy to pointilism and abstract expressionism is particularly apt, but he is too kind. The panel's result was correct, no doubt. But the opinion is so randomly pixelated with unequivocal contradictions and bizarre syllogisms that practitioners are left no better off in predicting the outcome of written description questions in biopharmaceutical claims. The lost opportunity to clarify the Court's written description jurisprudence is now almost characteristic. Unnecessary commentary in this opinion assures that sophisticated (in the Greek sense) lawyers will use this decision to support precisely the opposite of its apparent holding. How sad. A proper treatment of this opinion would take many pages. But I won't add to the muck. I'll remain optimistic that the future might bring light, even if through a glass darkly, to the written description problem in biological practice.

The problem, Disappointed, is that this IS the state of written description jurisprudence on the Court, one that is very unlikely to change (the Supreme Court will never take a written description case, if only because the exquisitely factual nature of the inquiry is outside their purview of rendering broad-brush interpretations of the proper scope of Congress's patent power). The only answer, as it always has been, is to determine ways to provide claims having proper scope while avoiding written description-based invalidity.

For antibody claims per se, as Greg noted above, this may be limited to therapeutic antibodies that rely on FDA regulations requiring identical amino acid sequences in biosimilars products (although the Federal Circuit's rejuvenated doctrine of equivalents decisions suggest that simple changes in amino acid sequence, like substituting all the valines for isoleucine or vice versa) might give some comfort. The scope problem can be limited (with regard to the "billions and billions" rhetoric) by defining antibodies by their CDRs, which provide somewhat less opportunity for mischief.

Another possibility is claiming the antigenic specificity as an inherent property (analogous to ways Sec 101 challenges may be avoided in diagnostic methods tied to particular treatments). In this case, for example, the claim could read:

1. A T cell or progeny thereof that specifically binds a tumor-specific antigen expressed at a tumor cell surface, the T cell having been genetically engineered to comprise a nucleic acid encoding a chimeric T cell receptor [or a polypeptide if that is more appropriate], said chimeric T cell receptor [or simply] comprising
(a) a zeta chain portion comprising the intracellular domain of human CD3 ζ chain, and
(b) a costimulatory signaling region,
wherein the costimulatory signaling region comprises the amino acid sequence encoded by SEQ ID NO:6.

There might be an issue with utility but that law is perhaps more certain than written description case law.

My point is that the "clever draftsperson" Justice Breyer warned against in Mayo is alive and well and always will be. Sometimes patent law reminds me of all those English rules from various cases that illustrate clever ways the nobles attempted to avoid having to pay taxes to the King; at other times, Whack-A-Mole.

But in any case I think this is how the cases will shake out, the Federal Circuit evincing no inclination to change the deleterious effects their decisions are having on innovation in the biotechnology space.

Sadly, not only do I concur with the statement of, "My point is that the "clever draftsperson" Justice Breyer warned against in Mayo is alive and well and always will be" - but the broader point in a member of the Judicial Branch USING that statement as an excuse for the ultra vires usurping of the Constitutional delegation of authority to WRITE patent law will ALSO remain "alive and well" until enough people take note and rise the cry as to the mess created BY the Supreme Court and their fervent desire to keep their fingers in the wax nose of patent law.

The Supreme Court COULD remove themselves from their own created Gordian Knot (through the use of the Kavanaugh Scissors), but that just does not seem likely.

We are left then with waiting for someone in Congress with enough gumption to eradicate the mess created by the Court, reset eligibility (and with that, other collateral messes such as 112 and 103, not to mention reinvigorating the very nature of the patent right and that negative nature through restoration of injunctive remedy as a DE FACTO best restoration of an aggrieved patent holder), REMOVE the Supreme Court through jurisdiction stripping (seeing as patent cases do NOT fall to the original jurisdiction of the Supreme Court), and cap it off by eradicating and resetting a NON-whipped patent court to replace the very-whipped Court of Appeals for the Federal Circuit.

I fear that ONLY upon these events, will we put an end to the (current) endless circus, and once again place US Patent Law as the gold standard in protecting innovation.

“… unless competitors are willing to file independent BLAs…”

Sure, that amounts to possible competition, but not the sort that should make a biological innovator lose much sleep. (1) A competitor who would file an independent BLA must do the clinical trials. That takes several years, during which the original innovator has the field exclusively. (2) The cost of the independent BLA also means that the new market entrants have serious capital costs to recoup (unlike a traditional generic), so their ability to undercut the original innovator’s price is fairly constrained.

In other words, this new state of §112[a) law is not a significant threat to biological innovation *if* the FDA insists on strict molecular identity for biosimilars. Whether FDA will do so, however is anyone’s guess.

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