Thursday, May 11, 2006

Divergences between Ariad/Lilly and Searle/Rochester

There have been some suggestions that Ariad v. Lilly is like Searle v. Rochester. This idea is not correct. Rochester's problem was that it had no COX-2 inhibitor or a reasonable plan to make one. Ariad's problem is apt to be that there are too many prior compounds that fall within the scope of the method claims.

The New York Times wrote:

Some experts said judges might not uphold a patent as broad as Ariad’s. They point to a case in which a federal judge in 2003 invalidated a patent that the University of Rochester claimed covered all pain drugs that worked through a particular mechanism. The judge ruled the patent invalid because Rochester had not actually developed such a drug or shown specifically enough how to do it.

“No compound, no patent,” said Gerald P. Dodson, the attorney who represented Rochester. He said that Ariad might “have the same hurdles that we had” but would be helped by having won a favorable jury verdict, which Rochester never did.

The Rochester patent was held invalid on summary judgment, not because it was TOO BROAD, but because there were no disclosures of ANY species of COX-2 inhibitors (or reasonable ways to identify them.) The MIT/Harvard patent is possibly TOO BROAD only in the sense it may ensnare PREVIOUS KNOWN COMPOUNDS within its method claims. Recall under current law on inherent anticipation it matters not at all that some mechanism was NOT UNDERSTOOD at the time of patent application filing, as long as the knowledge would be understood at a later date.

**In passing, note that Lilly wrote an amicus brief supporting Searle in the COX-2 case, and that other academic bodies (including UCal) wrote briefs supporting URochester.

**Forbes wrote:

Patenting big swaths of important biochemical pathway space has the potential to turn drug development into even more of an expensive nightmare than it already is," pharmaceutical chemist Derek Lowe wrote in his blog, In The Pipeline, last month. Lowe, who works for a major pharmaceutical firm, was writing specifically about the Ariad case. Since making that statement, Lowe had posted that he had shorted Ariad's stock ahead of the ruling.

Ariad is not the first company to try to patent a broad swath of biology. Pfizer has asserted that it has patents covering the chemical path by which Viagra works--so far without having an effect on the profitability of rivals Levitra or Cialis. The University of Rochester lost a case in which it said it was owed a percentage of sales of Pfizer's [Searle's] Celebrex because its researchers had first patent the idea of making painkillers by targeting the enzyme COX-2, the one hit by Celebrex.

The fear is that such broad patents will keep drugmakers away from what could be fertile territory for discovering new medicines. However, Ariad's Berger says that his company's main goal will be to get licenses from already marketed drugs. He says basic scientists are free to inspect the pathway, but that Ariad expects a "reasonable royalty" for commercially available drugs that impact NF-kappa-B.

**some comments from "in the pipeline":

[MIT/Harvard/Whitehead] patented potential methods to block NF-Kb targets, not the pathway.

Ariad has never, to my knowledge, submitted a compound for final FDA approval, and if they're spending their money on things like this it's not something I'd be expecting any time soon.

Take as jurors eight Boston laymen with little or no knowledge, add two Nobel Laureate inventors, season with the cachet of Harvard and MIT, stir in antipathy for a big pharma based far away, and voila! A lousy decision that is an excellent bet to be reversed and remanded by the Court of Appeals for the Federal Circuit.

Among other nuggets, Lilly argued that sunlight and red wine each affects the NF-kappaB pathway, as does estrogen administered to post-menopausal women. So their argument - and it is a compelling one - was that people have long been practicing the claimed method of regulating NF-kappaB activity, even though they didn't know it. (Cue the history of aspirin here.) Finding out the mechanism of action of a known therapy makes for a great paper but not for a valid patent.

Evista (raloxifene) was developed because of its effects on the estrogen receptor. Lilly thought that an estrogen ligand that didn't full-on or full-off the receptor might have beneficial effects on osteroporosis and other diseases, without giving the full estrogen profile.

After NF-kB was discovered, its role in a very wide variety of cell pathways was gradually worked out. Some of these do indeed cross over with pathways that are regulated by (among other things) the estrogen receptor, but I strongly doubt that Evista could be said to work solely through these. Hitting a steroid receptor generally is a guarantee of modulating the expression of dozens, hundreds, perhaps even thousands of genes.

So it's not a case of Evista coming on the market and then being applied to an NF-kB related disease. It's a case of the drug being developed against estrogen receptor signaling for osteoporosis and coming on the market for that purpose. Meanwhile, as soon as Ariad's patent issues, they decide to sue Lilly as a test case because they have two drugs whose mechanisms, at some point, could cross NF-kB pathways. (As do dozens, hundreds of others - it's probably impossible to do anything with inflammation, immunity, or cell death without wandering into something, at some point, that's regulated through NF-kB signaling).

Raloxifene's NF-kappaB activity, such as it is, is inherent in the compound, and its use predates Ariad's patent application by approximately 20 years. That, in a sentence, is Lilly's argument, and I think to anyone with an opposable thumb, it's a crushing one. US 4,133,814, the patent covering raloxifene (the active constituent of Evista) was filed in 1976.

but you can safely bet that Ariad lawyers used the fact that Lilly was attempting to patent a new use of Xigris in treating patients who suffer from a disease induced by NF-kB, and Lilly's patent claims involving the use of Evista to modulate NF-kB to undermine the apparent 'bogus' approach that SRC says is patently obvious to anyone with a normal size brain.

Question 5 of the jury verdict form: Are one or more of the asserted claims of the '516 patent invalid because the claimed process was anticipated by prior public use?

Question 6: Are one or more of the asserted claims of the `516 patent invalid for failing to satisfy the enablement requirement?

Question 7: Are one or more of the asserted claims of the `516 patent invalid for failing to satisfy the written description requirement?


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