Biotech Values

[DewDiligence]

AGN received a US formulation patent on Restasis and is submitting a new CP arguing against generic competition:

http://www.sec.gov/Archives/edgar/data/850693/000119312514010270/d655835d8k.htm

On January 14, 2014, the United States Patent and Trademark Office …issued U.S. patent number 8,629,111, which covers the specific formulation of Allergan, Inc.’s Restasis (cyclosporine ophthalmic emulsion) 0.05% product. The Company has submitted the ‘111 Patent for listing in the United States Food and Drug Administration (the “FDA”) publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The ‘111 Patent will expire in August 2024.

In addition, on or about January 15, 2014, the Company plans to submit a Citizen Petition to the FDA regarding the FDA’s published draft guidance that proposes certain approaches for demonstrating bioequivalence in abbreviated new drug applicationsreferring to the new drug application related to the Restasis product.

Formulation patents generally don’t prevent generic competition, but AGN thinks this one is an exception.