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ARIAD v. LILLY – A Modest Proposal – Should Screening be Enough?

As the Fed. Cir. prepares to issue an en banc opinion on the existence and role of the written description requirement in section 112, it seems like a time for reflection. After taking the position that enablement should suffice for many years, it seems that at least the first part of Ariad’s brief requesting rehearing should resonant more fully, but it didn’t: “the measure of the sufficiency of the written description in meeting the conditions of patentability in paragraph 1 of that statute depends solely on whether it enables any person skilled in the art … to make and use the claimed invention…..” But should that be the interpretation of the statute that gets carved into stony precedent. What will it unleash?

Let’s try to walk in Ariad’s shoes (or actually, wear the lab coats of the MIT, Harvard and Whitehead group) as it uncovered the NF-kB signaling pathway in the 80’s. The group of eminent researchers realized that down-regulating the pathway would be useful to treat a variety of conditions, but they didn’t have any agents in hand that would work, at least not in a practical manner, e.g., as marketable drugs.  So what they had just prior to filing their first application in 1986 was a very useful research tool. But instead of quickly obtaining claims to a method to screen for drugs that would inhibit the NF-kB pathway, they pursued broad claims to reducing NF-kB activity in cells by, in some cases, reducing binding of NF-kB to NF-kB recognition sites on genes which are regulated by NF-kB. Treating certain pathologies is also claimed, but no NF-kB agents are recited in the claims up on appeal.

The attorneys for these institutions refile the application in various forms about ten times, before receiving US Pat No 6,410,526 in 2002. In the intervening years, Lilly uses the (unpatented) screening method to identify drugs, including Xigris, which is used to treat sepsis. Soon after the ‘526 patent issues, Ariad sues Lilly and wins a jury verdict that is promptly reversed by a panel of the Fed. Cir. The panel essentially relied on the 2004 decision in U. of Rochester v. Searle, in which another “mechanism of action” claim was invalidated for failure to meet the WDR, since, like the U. of Rochester, “Ariad must still describe some method of performing the claimed methods.” In the Rochester decision, the court also noted the early-on presence of screening claims, by which specific COX-2 inhibitors could be identified, and suggested that they would have been valid. Fed. Cir. panels have been pretty clear on this standard for some time now. In re Alonso, 88 USPQ2d 1849, the panel endorsed a Board decision which reasoned that, to meet the WDR, “it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the invention”.

I think there is a separate written description requirement in 112, that is separate, not from enablement, but from the requirement that the specification teach how to make and use the invention. Apart from pharma/biotech, consider a patent on a new golf club head that has a series of figure showing the configuration of the various surfaces of the club head. Now anyone can make and use that club head, without a single word of written description. But in the world of pharma/biotech, Rochester and Ariad are arguing that if we teach how to identify and use a drug that affects mechanism-of-action x, we have done enough, and are entitled to a claim that will dominate claims to drugs developed in the future and the use and sale of drugs developed before we obtained mechanism-of-use claims that don’t even recite that drugs are used, let alone specific drugs.

What is the alternative? Not all mechanism-of-action claims are as “naked” as the Rochester or Ariad claims. Often there are some working examples. The elevation of the WDR began with UC v Lilly, but there is no doubt that that decision would be decided differently today, even if history will decide that it was decided correctly at the time. The University of California had cDNA encoding mouse insulin and tried to claim cDNA encoding human insulin. The specification adequately taught how to make and use. The panel held that the specification failed to meet the WDR because the claimed cDNA was not adequately described, but factually this was just wrong. A claim to cDNA encoding x (when the structure of x is known) is not a purely functional claim. Today that claim would be invalid as obvious over the structure of x and the Cloning Manual, if the structure of x (or even x per se) was in the prior art. But I think UC adequately described what they were claiming and taught how to make and use – ergo, enablement. Read the elegant and lengthy specification of the ‘526 patent and the description part of the invention just is not there, or at least, there is not enough “there there”. Not “‘nuff said.”

I will leave you with a final question. I think it is the one that Judge Linn, is his opinion in the Ariad panel decision, wants the court to address. The hypothetical specification has 100 working examples of what we will call  YBY antagonist agents, all structurally set forth. They are useful to treat sepsis. The claim at issue reads: A method of treating sepsis by administering an effective amount of a YBY antagonist agent to a human afflicted with, or at risk of, sepsis. I have already discussed why this type of claim can be called a Hail Mary claim (it may encompass anticipatory prior art). But given that it also encompasses  and dominates any YBY antagonist that will be developed for, say, the next 15 years, IS THIS TYPE OF CLAIM EVER VALID? I face for your answer. It may come soon.

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