J&J Birth Control Patent Upheld In Infringement Suit V. Lupin

California — Johnson & Johnson unit Janssen Pharmaceuticals Inc. was vindicated Tuesday in its efforts to prevent Lupin Pharmaceuticals Inc. from making and marketing a generic version of J&J’s popular birth control drug Ortho Tri-Cyclen Lo, as a New Jersey federal judge ruled that the underlying patent is valid.

J&J sued Lupin for patent infringement in 2008 after the generic drug maker filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for an unbranded version of Ortho Tri-Cyclen Lo. Lupin filed an accompanying certification asserting that U.S. Patent Number 6,214,815 is anticipated, obvious and invalid.

Based on the evidence presented at a bench trial earlier this year on Lupin’s patent invalidity defenses to infringement, Judge Stanley R. Chesler ruled Tuesday that Lupin failed to prove the asserted claims of the ‘815 patent are invalid.

In 2010 the court entered a consent order in which J&J and Lupin stipulated that the filing of the ANDA constitutes an act of infringement, should the patent be found valid. Accordingly, Tuesday’s ruling effectively counts as an infringement finding against Lupin.

“In making their anticipation case, defendants rely on a key unsupported proposition: if a prior art reference discloses a genus containing a large number of species, a challenger may reduce the size of the genus by asking which species would have ‘stood out’ to the skilled artisan,” Judge Chesler said. “Defendants’ anticipation case turns entirely on this proposition, and they have shown no legal support for it.”

As far as obviousness is concerned, Lupin did not lay an adequate legal foundation for the proposition that the failure to provide scientifically valid evidence that Ortho Tri-Cyclen Lo exhibits unexpected results should lead the court to find the patent invalid as obvious, the judge said.

“In short, for any number of reasons, defendants’ attack on the scientific validity of the evidence of unexpected results fails to show this court any basis to find the ‘815 patent invalid as obvious,” he said.




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