Our home state of New Jersey was front and center in the sports world this year for Super Bowl XLVIII. But, from an industrial standpoint, New Jersey is often viewed as a leader in one particular business: pharmaceuticals. On January 17, 2014, Judge Joel A. Pisano of the District of New Jersey sided with Warner Chilcott Co. LLC (“Warner”), a pharmaceutical titan, in its lawsuit against two generic pharmaceutical companies: Lupin Pharmaceuticals, Inc. (“Lupin”) and Amneal Pharmaceuticals (“Amneal”).
Both Lupin and Amneal developed plans for generic versions of Warner’s successful birth control drug Lo Loestrin®. Warner, owner of U.S. Patent 5,552,394 for the ultra low-dose method of contraception, filed a patent infringement suit. A patent affords its owner the exclusive right to make, use, sell and offer to sell a patented invention. Warner accused Lupin and Amneal of submitting abbreviated new drug applications (“ANDA”s) which would trample on the invention covered by Warner’s patent. Warner alleged that Lupin and Amneal’s generic drugs, as disclosed in the ANDAs infringed Warner’s patent rights in Lo Loestrin®. The trial occurred in October 2013 and Judge Pisano issued his ruling last month.
Judge Pisano agreed that neither Lupin nor Amneal should be allowed to make, use, sell or offer to sell any drug that would be a generic equivalent of Lo Loestrin®. Both Lupin and Amneal admitted to infringing Warner’s patent. Lupin and Amneal argued that Warner’s patent was directed to obvious matter – that is, contending that the art in the field of contraceptive drugs already anticipated or taught Warner’s invention at the time when Warner invented the drug. Judge Pisano disagreed, holding that Warner’s patented invention was sufficiently non-obvious. Each of Warner’s patent claims survived the obviousness challenge from Lupin and Amneal.
What does this mean for the pharmaceutical community? Here in New Jersey, where pharmaceutical companies have gained a strong foothold, this ruling underscores the unquestionable importance of understanding the risks associated with developing new generic drugs and applying for FDA approval in connection therewith. Should those new drugs infringe upon patented drugs from another party, the generic developer stands to lose quite a bit of capital. In this case, Lupin and Amneal are in the industry of releasing generic drugs. But they jumped the gun a bit too early, hoping they could survive Warner patent’s coverage on their obviousness argument. Instead they lost the gamble, and so ends yet another battle in the long line of wars fought over pharmaceutical patents in this state.
Do you have a question about protecting your patented invention against generics? The McHattie Law Firm can help!
(Neeraj Joshi)