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May 22, 2007


If you have a patent on a particular pharmaceutrical salt, formulation, or enantiomer, this case should make you very nervous.

"If you have a patent on a particular pharmaceutrical salt, formulation, or enantiomer, this case should make you very nervous."

Of course, one should have been nervous about such narrow patents that are grounded solely in the alleged "unpredictability" of the chemical arts long before this decision.

The likelihood of such patents crashing in litigation has always been high, i.e., one skilled in the art of litigating would "reasonably expect" them to be found invalid.

Dear Neener:

"Alleged?" Not so - it is the nature of biology and chemistry to be unpredictable compared with mechanical and electrical arts. It is no coincidence that KSR was an electromechanical case, because the type of "common sense" expectation occurs in these arts. If we ignore the fact that making salts etc. can be (not has to be) unexpected we lose the advantages of further development of new formulations of old drugs.

And, if you are worried about the types of activities characterized by Nexium, or (fill in the blank)-SR type drugs, remember that people used Prilosec for years, and when it went off patent there was the Schwarz Pharma generic and then the OTC, so no one was forced to take Nexium. The Pfizer case is an anomaly since the District Court found non-obviousness. Provided there is a patentable advantage to a new formulation it should be patentable, unless (as the CAFC found in Apotex), the resulting salt worked precisely as it was expected to.

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