Johnson & Johnson (J&J) is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886. J&J filed for a patent on 9th June, 1999 which was granted to them on 10th April, 2001. The patent was US6214815 titled, “Triphasic oral contraceptive”.

Lupin Pharmaceuticals Inc. a subsidiary of Lupin Limited works in US and is dedicated to deliver high-quality, branded and generic medications trusted by healthcare professionals and patients across geographies. Lupin in 2008 filed an Abbreviated New Drug Application (ANDA) 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.

J&J sued Lupin for patent infringement in 2008. 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.

Lupin Pharmaceuticals Inc. was granted ANDA by US FDA in July, 2012 for manufacture and marketing of generic equivalent of Ortho Tri-cyclen Lo.

On 11th September, 2012 J&Jwas victorious 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 US patent US6,214,815 is valid.

Judge Stanley R. Chesler ruled that Lupin failed to prove the asserted claims of the ’815 patent are invalid.

“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,” Judge Cheslersaid.

With this judgment in favor of J&J, Lupin lost a huge potential market for its generic version of oral contraceptive drug. This resulted in decrease in the price of the shares of Lupin. Now, Lupin Pharmaceuticals Inc. have to wait for 2016 to launch its version of oral contraceptive drug whereas other companies who have settled with J&J will launch the generic version of th drug in December, 2015.