Gerchen Keller Capital’s Neptune Generics LLC today, June 3, won institution of an inter partes review petition challenging an Eli Lilly & Co. patent for its Alima vitamin regimen before the Patent Trial and Appeal Board.

The PTAB’s decision to institute IPR 2016-00237 suggests that the patent will be invalidated after a trial. The PTAB typically invalidates about 80 percent of patents at issue in IPRs that have been instituted, though IP Navigation Group founder Erich Spangenberg and J.Kyle Bass’s Hayman Capital Management institution rate in challenging drug patents has been about 50%.

Spangenberg has been an adviser to Neptune on IPRs but not on the the one against Eli Lilly's '209 patent.

The ‘209 patent refers to a treatment for cancer, which involves a method of administering an antifolate to a mammal in need thereof, comprising administering an effective amount of said antifolate in combination with a methylmalonic acid lowering agent.

The method is said to improve the therapeutic utility of antifolate drugs by administering a methylmalonic acid lowering agent, such as vitamin B12, to the host undergoing treatment. The ’209 patent also states that a combination of a MMA lowering agent, such as B12, and folic acid reduces the toxic events associated with the administration of antifolate drugs.

The ’209 patent is the subject of litigation in the U.S. District Court in the Southern District of
Indiana, including Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., et al. Additionally, the ’209 patent also was challenged in IPR2013-00356 by Accord Healthcare Inc., as well as in IPR2016-00240 by Neptune Generics, and in IPR2016-00318 by Sandoz Inc.

The PTAB decision held that the petition establishes that there is a reasonable likelihood that petitioner would prevail in demonstrating unpatentability of claims 1–22.”

The board said it has not yet made a final determination of the patentability of any of claims 1–22 of the ’209 patent.

Neptune Generics was represented n the petition by Sarah Spires and Parvathi Kota of the law firm of Skiermont Derby LLP. Spires and Kotha couldn't be reached.

Eli Lilly is represented by Dov Grossman and David Cranky of the law firm of Williams and Connolly LLP, as well as James Leeds of Eli Lilly. Grossman, Cranky and Leeds also couldn't be reached.

Eli Lilly said in an emailed statement that it expects "final written decisions on the merits will be issued by the USPTO by mid-2017."

Lilly continues to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. Intellectual property rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs.

“We are pleased that the PTAB found that Neptune's petitions demonstrate a reasonable likelihood of invalidity, and look forward to the proceedings that follow,” said Ashley Keller, managing partner of Gerchen Keller in an emailed statement.

—To reach the reporter responsible for this story please contact Dan Lonkevich aT 707 318-7899 or at dan@thepatentivnestor.com