PTAB Declines to Review Ampyra Patents

August 31, 2015

A drug pricing watchdog was rebuffed last week in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February.

Hayman Capital founder Kyle Bass formed the coalition earlier this year to block pay-for-delay deals between brand and generic drugmakers by challenging the validity of drug patents using the USPTO’s new inter partes review process. He believes that firms improperly extend patent protection by making changes to packaging and taking other actions to keep drug prices inflated.

Celgene, which is the target of five of the petitions, has complained to the USPTO that Bass and the coalition are abusing the IPR process, which allows third parties to challenge patents on the basis of “prior art” consisting of earlier patents or printed publications. The hedge fund owner has been accused of making money by betting against the companies he challenges.

In Acorda’s case, Bass petitioned the USPTO seeking a review of Acorda’s ’685 and ’826 patents on Ampyra (dalfampridine). He claimed the patents were obvious because of two posters the drugmaker cited in its patent applications.

The Patent Trial and Appeal Board disagreed, saying Acorda’s mention of the posters in information disclosure statements didn’t constitute an admission that the posters were printed publications. The posters must also have been publicly available, and this wasn’t the case since there’s no evidence they were presented at any scientific meeting, and the material was too complex for people to capture its information, according to the PTAB.

Whether a reference is a “printed publication” must be determined case by case based on the facts and circumstances surrounding its disclosure to the public, the PTAB says.

To obtain an IPR review, petitioners must show that there is a reasonable likelihood that they will prevail with respect to at least one of the claims being challenged.

Ampyra is also facing a number of patent challenges from generics makers looking for a slice of its market. An oral hearing is scheduled for September 2016.

ISI Group analyst Mark Schoenebaum says Monday’s ruling could help Acorda’s case “as the courts typically look at the PTAB decision, and a generics filer may not be able to use the same argument.”  

Acorda reported $105.5 million in revenues from Ampyra in the second quarter of this year, up 20.7 percent from the same period a year ago. The drug is marketed outside the U.S. by Biogen under the brand name Fampyra.

Bass can request a reconsideration within 30 days, but will face the same three-judge panel that made Monday’s ruling.

Read the decision on the ’685 patent at www.fdanews.com/08-26-15-685.pdf and the ruling on the ’826 patent at www.fdanews.com/08-26-15-826.pdf. — Meg Bryant