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Abbott court loss prompts review of patent-ruling standards
Bloomberg News
Published: 4/26/2010 1:58 PM
Abbott Laboratories' dispute with Becton, Dickinson & Co. over a glucose monitor design prompted a U.S. appeals court review of the standard judges use to determine if inventors committed fraud to obtain patents.

The U.S. Court of Appeals for the Federal Circuit said in an order today that all active judges will hear arguments on whether to change the rules on determining if inequitable conduct such as deception was used to obtain patents. Patents can be deemed unenforceable if a court finds the inventor misled the U.S. Patent and Trademark Office.

Raising the bar for making that determination would cut off so-called unenforceability arguments that generic-drug makers and medical device companies are using more often to defend themselves in patent infringement cases. A ruling of unenforceability is an extreme punishment that precludes a patent owner from stopping anyone from using the invention.

Sanofi-Aventis SA's patent on a $4 billion-a-year drug, the blood-thinner Lovenox, was ruled unenforceable when an appeals court in 2008 found the company misled the patent office. The court said Sanofi withheld information on studies that compared the active ingredient of Lovenox with a related compound to ensure the patent office believed the two were different.

Courts in patent cases must decide how important withheld information was, and how much evidence there is of intent to deceive, with each factor weighed against the other. If the information is key to obtaining the patent, then intent matters less. If there is clear evidence of deception, the material nature of the information is less important.

The Federal Circuit, which specializes in patent law, asked lawyers to argue whether the current test should "be modified or replaced" and "if so, how?"

A decision may have less impact on the case before the court. Becton, Dickinson -- which has since sold its glucose monitoring business -- and Nova Biomedical Corp. won a ruling that the aspects of the patent that were in the case were invalid and that issue won't be reconsidered.

The case is Therasense Inc. v. Becton, Dickinson & Co., 2008-1511, -1512, -1513, -1514, -1595, U.S. Court of Appeals for the Federal Circuit (Washington).