briansereno.com

If any of you have an interest – or even an ability – to read and make sense of legal rulings, knock yourself out with the legalese below.  As for me, I’m grateful to have well-educated friends like Brad, who can make heads-and-tails of this apparent foreign language, and who not only forwarded this to my attention but also broke it down for me in a way that my simple mind can understand.  I guess when you’re great friends with a lawyer, they’re not so bad.

Anyway, in Brad’s own words to me on January 27^th…below is “an article discussing a ruling by the District Court for Delaware regarding Temodar.  Yesterday, a federal judge invalidated Merck’s patent covering Temodar for uses in connection with GBM, thereby paving the way for Teva (a generic drug manufacturer) and other companies to begin selling generic versions of the drug, despite Merck’s patent still having a number of years remaining in its term.  Whether you see this as a good thing or a bad thing depends on who you work for/with, and whether you take a long or short term view of its ramifications.  On the bright side, Temodar will likely become available to those who need it at a much lower price (although the real price decreases won’t be seen for about 180 days, when generics other than Teva are allowed to flood the market and thereby drive the price down).  On the negative side, the huge loss in revenue that Merck will be faced with means that some portion of their ongoing R&D activities will no longer have the necessary funding.  It’s a tricky game; this invalidating of patents…but I thought you would be very interested in this ruling.”

Brad, I sure am interested in this ruling, and I’m honored that you thought to send it to me.  Keep ‘em coming.  For anyone else that is interested, please read below.

Teva Triumphs Over Merck In Temodar Patent Spat

By Melissa Lipman

Law360, New York (January 26, 2010) — In a blow to Merck & Co. Inc., a federal judge upheld Teva Pharmaceutical Industries Ltd.’s claims Tuesday that the patent for brain tumor treatment Temodar is unenforceable due to prosecution laches and inequitable conduct.  Judge Sue L. Robinson of the U.S. District Court for the District of Delaware sided with the generic-drug maker, which inherited the first filed abbreviated new drug application for the drug when it acquired rival Barr Pharmaceuticals Inc. in 2008.

Merck, which picked up an exclusive licensing agreement for the patent for temozolomide when it bought Schering Corp. in late 2009, vowed to appeal the decision in a statement Tuesday.

In response to the suit originally filed by Schering and patent holder Cancer Research Technology Ltd., a British research company, in mid-2007, Teva had argued that CRT had improperly delayed the prosecution of U.S. Patent Number 5,260,291 until it became profitable for the company to receive the patent.

Judge Robinson agreed, ruling that CRT had not provided any credible justification for the delay caused by the 11 patent applications, 10 abandonments and lack of any substantial prosecution of the cancer treatment patent for a decade.

Though two patent examiners rejected the application based on a lack of human data, the judge pointed out that CRT failed to challenge that incorrect requirement until it reached a licensing agreement with Schering that made receiving the patent profitable. The company likewise did not provide any “contemporaneous evidence substantiating its position” or showing that it had tried to develop the necessary technology before the licensing deal, according to the opinion.

“It is the court’s conclusion that the ‘ends’ — commercialization of a very successful cancer drug — do not justify the ‘means’ employed by [CRT] in this case,” Judge Robinson wrote.  The judge likewise upheld Teva’s claim that inequitable conduct further renders the ‘291 patent unenforceable. The generics maker had argued that the inventor and CRT failed to submit a variety of data regarding the drug to the U.S. Patent and Trademark Office during the prosecution of the applications.

“The court agrees that something was awry, insofar as not a single piece of data or prior art, positive or negative, was provided to the PTO in over 11 years (despite over a decade’s worth of research on the technology),” the judge wrote.

Teva has already received tentative approval from the U.S. Food and Drug Administration to market a generic version of Temodar, which had $369 million worth of sales in the U.S. in 2009, the company said Tuesday. As the first to file an ANDA with a paragraph IV certification, Teva would have a 180-day marketing exclusivity for the brain cancer treatment.

But Bruce N. Kuhlik, executive vice president and general counsel at Merck, said Tuesday that the company still believed the ‘291 patent is valid and enforceable.  Describing the ruling as “a step in the lengthy patent litigation process,” Kuhlik said Merck would appeal the ruling.

The patent-in-suit covers the “compound, composition and use” of Temodar, which is used to treat adults with glioblastoma multiforme or refractory anaplastic astrocytoma, types of malignant brain tumors.

Teva has already conceded infringement of several claims of the ‘291 patent, and the court held a trial in late March and early April of 2009 on the two unenforceability defenses, according to the opinion.

The patent-at-issue is U.S. Patent Number 5,260,291.

GBM