Acorda Therapeutics, Inc. (ACOR - Free Report) received encouraging news with the U.S. Patent and Trademark Office (USPTO) Patent Trials and Appeal Board declining to institute the inter partes review (IPR) related to two patents – U.S. Patent Nos. 8,663,685 (the '685 patent) and 8,007,826 (the '826 patent) – protecting the company’s lead drug, Ampyra. We expect investors to react positively to the news.
We remind investors that a hedge fund had filed two separate IPR petitions with the USPTO challenging the ‘685 and ‘826 patents, two of the five Ampyra Orange Book-listed patents. The '685 and '826 patents are slated to expire in 2025 and 2027, respectively.
Meanwhile, Acorda remains entangled in patent infringement litigation for Ampyra with several companies including Allergan plc (AGN - Free Report) and Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) among others. All are seeking approval for their generic versions of Ampyra. The company has initiated patent infringement lawsuits against all these companies. The U.S. District Court for the District of Delaware has scheduled a Markman hearing for Mar 2016 and a trial date for Sep 2016. Moreover, patent infringement lawsuits related to Ampyra are ongoing in the EU.
Ampyra is Acorda’s flagship product and is currently approved in the U.S. for the improvement of walking in multiple sclerosis patients. Ampyra is available outside the U.S. under the trade name Fampyra. Acorda has a licensing agreement with Biogen (BIIB - Free Report) for Fampyra in markets outside the U.S.
Currently, Acorda is working on expanding Ampyra’s label into additional indications. A phase III study evaluating a twice-daily formulation of Ampyra in patients suffering from chronic post-stroke walking deficits after experiencing an ischemic stroke is currently ongoing. The company is also looking to include a once-daily formulation (being developed with different external partners) in future post-stroke studies.
Acorda currently carries a Zacks Rank #3 (Hold). Teva is a better-ranked stock in the health care sector carrying a Zack Rank #2 (Buy).
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