Saturday, September 11, 2010

"Through A Glass, Darkly": SeekingAlpha's Temodar® '291 Patent Spat Predictions

Many here will recall that I've been reporting on the Temodar® patent spats for almost two years now -- as the so-called '291 patent, licensed to Merck, wends its way through our federal trial, and appellate, court systems. Most will also recall that Merck struck a pay-to-delay deal with Teva, to 2013, to keep Teva from launching in the US, in return for undisclosed payments -- while the appeals are sorted out. Teva is already selling a generic version of temozolomide (the chemical name for Temodar) in the United Kingdom.

Last night, a patent lawyer, and lecturer, at the Cardozo School of Law published a Temodar '291 patent spat opinion piece over at SeekingAlpha (do go read it all), in which -- based largely on his feelings about the meta-trends in such litigation -- he concluded that Merck would win on appeal, and thus he wrote "I expect Merck will win the appeal and thus be able to keep Teva's generic version of the drug off the market until 2013. . . ." Interesting. I have just a few problems with his "prediction" analysis, here.

First -- as I pointed out above, Merck has already bought that right, contractually from Teva, in a pay for delay deal; but more importantly, the '291 patent (with extensions) runs through late-2014 -- not 2013.

So his "prediction" is actually. . . only an affirmation of past-fact -- the fact that Merck already bought Teva off through 2013. Next, rather than discussing the law -- he spends most of his column space describing the personalities and politics of the case -- openly suggesting that this decision will be made as "largely a beauty contest and we all know that beauty lies in the eye of the beholder. . ." Personally, I believe federal appellate decisions are made on the law -- not the personalities. That's enough said, about that. He reaches a "Merck will win" conclusion, despite the fact that -- at oral argument, on August 4, 2010 -- Merck's lawyer never even got "out of the gate", before the three judge panel effectively tattooed him with very-hostile questioning, about Merck's licensor having engaged in a nine year delay in prosecuting the '291 patent. A delay the lower court found to be evidence of laches and inequitable conduct. The three-judge panel specifically asked about "the public's right" here -- to avoid paying higher prices for what would amount to 32 years, for Temodar. Yes, I think the law -- as suggested by the oral argument dialogue -- will decide this case. Judge Sue L. Robinson will be affirmed on appeal.

Even though the SeekingAlpha author comes out in favor of Merck, he does devote the end of his column to describing why he might be wrong -- in predicting a Merck win. Here's that portion -- but do go read all of his piece, for yourself:

. . . .The '291 patent application process took roughly 10 years and during that time, CRT was not providing substantive responses to rejections being made by the PTO. The District Court judge was not unjustified in holding that such was an unreasonable delay. Just because I disagree with her, does not mean I think her finding was ludicrous or outlandish. It's a judgment call and reasonable minds can disagree. Similarly, the District Court judge's decision on inequitable conduct is based on how meaningful she thought the omitted study was to the merits of the patent application. She thought it was very meaningful, and I think not so much. The Court of Appeals judges could very well side with the District Court judge. And, in fact, Court of Appeals judges often give deference to District Court judges, because District Court judges spend much more time with a case when it is going through the trial stage than appellate court judges spend with it at the appeals stage, so often District Court judges have a better sense of all the details of the case and can make better judgment calls as to which witnesses are more believable, trustworthy, etc. . . .

As ever, I'll keep you posted. Here is a direct link to the mp3 file -- of the oral argument, from August 4, 2010. Once you arrive, click the Oral Arguments Audio Recordings bar, at the bottom -- then, on the resulting screen, in the search box, type the word "Barr". Choose the first result -- and listen right in (a 40 minute audio file). Then, make your own call, based on the arguments. It's that easy.

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