Who Will Win Ampyra Patent Fight - Acorda Or Kyle Bass?

(RTTNews) - Patents are the lifeline of any pharmaceutical company. A patent holding company will fight tooth and nail if its patents are challenged by competitors. Patent litigation is often a long drawn-out process in which sometimes the defendant may win or the plaintiff may emerge victorious or the defendant and plaintiff may arrive at a settlement.

Now, as a case in point, let's look at Acorda Therapeutics Inc. (ACOR) and the patent infringement lawsuits related to its multiple sclerosis drug Ampyra.

Ampyra is covered by 5 patents, giving it protection up to May 2027, according to Acorda.

Approved by the FDA in January 2010, Ampyra was made commercially available in the U.S. in March 2010. The drug is marketed as Fampyra outside the U.S. by Biogen International GmbH under a license and collaboration agreement between the two companies.

Ten generic drug makers namely, Accord Healthcare Inc., Actavis Laboratories FL Inc., Alkem Laboratories Ltd., Apotex Inc., Aurobindo Pharma Ltd., Mylan Pharmaceuticals Inc., Roxane Laboratories Inc., Teva Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Ltd., and Par Pharmaceutical Inc., have sought approval to market generic versions of Amypra.

Between 2015 and 2016, Acorda reached settlement agreements with six of the generic companies namely, Actavis, Aurobindo, Alkem and Accord, Sun Pharma and Par Pharma. A settlement agreement related to Ampyra was reached with Apotex Inc. as recently as February 8, 2017.

A bench trial against the remaining three generic companies was completed in September 2016 and the Court's decision is awaited.

Seeking to invalidate patents through the inter partes review (IPR) process, hedge fund Hayman Capital's Kyle Bass, in 2015, filed petitions with the U.S. Patent and Trademark Office, to review four out of five patents covering Acorda's Ampyra.

Although in 2015, the Patent Trial and Appeal Board (PTAB) denied the IPR petitions filed by Bass against Acorda, the following year, i.e. in March 2016, the PTAB granted Kyle Bass' request to review the Ampyra patents.

The annual sales of Ampyra have increased over the years, as can be seen from the numbers - $133 million in 2010; $210 million in 2011; $266 million in 2012; $302 million in 2013; $366 million in 2014; $436 million in 2015; and $493 million in 2016. Looking ahead, the company expects Ampyra could hit annual sales in the range of $535 million to $545 million in 2017.

Will the Patent Trial and Appeal Board uphold the Ampyra patents or will Acorda lose the patent validity challenge in the inter partes review?

The decision on the IPR related to Ampyra is expected this month. Keep an eye out for it...

Acorda shares have gained nearly 45% year-to-date, and trade around $27.25.