ALLERGAN SALES, LLC v. SANDOZ, INC.
- Aug 29 2019 |
- Category: CAFC Updates
Allergan sued Appellants Sandoz and Alcon, asserting that Sandoz’s Abbreviated New Drug Application (“ANDA”) for a generic version of Allergan’s ophthalmic drug Combigan® infringes Allergan’s U.S. Patent Nos. 9,770,453, 9,907,801, and 9,907,802 relating to the topical ophthalmic use of brimonidine in combination with timolol for treatment of glaucoma or ocular hypertension. The district court found limiting a number of “wherein” clauses in the patents because they are material to patentability and express the inventive aspect of the claimed invention, and granted Allergan’s motion for a preliminary injunction. Sandoz appeals, arguing, inter alia, that: (1) the “wherein” clauses merely state the intended results of administering Combigan® twice daily; and (2) the recited results are not “material to patentability.” The CAFC finds that both Allergan and the Examiner explicitly relied on the “wherein” clauses to distinguish the claimed methods over the prior art during prosecution, and that the “wherein” clauses were neither unnecessary nor irrelevant, but were instead material to the Examiner’s patentability determination. Accordingly, the CAFC affirms. Judge Prost concurs, agreeing with the majority’s conclusion, but emphasizing that the claim language on its face confirms that these clauses give meaning and purpose to the other manipulative steps of claim 1, and no part of the specification justifies reading out the express language of the “wherein” clauses defining the claimed invention.