Allergan, Inc. and Duke University v. Apotex Inc. et al. and Allergan, Inc. and Duke University v. Watson Pharmaceuticals, Inc. et al.

Docket Nos. 2013-1245, -1246, -1247, -1249

June 10, 2014

Brief Summary: DC determination that two patents relating to the use of the prostaglandin F-2-alpha (PGF) analog bimatoprost to grow eyelash hair were not obvious reversed and vacated.

Summary: Apotex/Watson (appellants) appealed DC finding that Allergan’s US Pat. Nos. 7,388,029 and 7,351,404 relating to Latisse, a 0.3% bimatoprost (synthetic prostaglandin F-2-alpha (PGF) analog) ophthalmic solution for treating eyelash hypotrichosis (hair loss). Bimatoprost is a 17-phenyl PGF analog originally sold by Allergan as Lumigan® for treating glaucoma (approved in 2001). Another type of 17-phenyl PGF analog (latanoprost) was developed and marketed as Xalatan® in the 1990s. The ‘029 patent resulted from an application filed after the inventor noticed latanoprost and other analogs caused glaucoma patients to grow “much longer and denser eyelash hair”. The appellants argued that the ‘029 specification requires the method of “treating hair loss” to “include[] arresting hair loss or reversing hair loss, or both, and promoting hair growth” (emphasis added) because of the “use of the conjunctive ‘and’”. The FC panel disagreed and affirmed the DC conclusion that use of “includes” in the definition and ambiguity in other parts of the specification meant that the method could promote hair growth without also treating hair loss. Regarding anticipation of the ‘029 patent, the FC agreed with the DC that the “very limited disclosure” of the cited art (“too sparse and ambiguous”) did not anticipate the claims (noting that it has previously held that “[a] prior art composition that ‘optionally includes’ an ingredient anticipates a claim for the same composition that expressly excludes that ingredient” (Upsher-Smith, FC 2005); also discussing inherent anticipation (SmithKline, FC 2005 and Atlas Powder, FC 1999, and noting that whether a reference that “disparages” or “teaches away” is not considered in an anticipation analysis). It also found the DC erred in its finding that the ‘029 claims were not obvious because it did not consider the full scope of the claimed subject matter (e.g., focusing only on one species of the covered compounds) and failed to recognize the prior art had “specifically taught that PGF analogs that were effective glaucoma drugs could grow hair” (citing In re O’Farrell (FC 1988), Pfizer (FC 2007), and Altana (FC 2009)). The ‘404 patent issued from an application filed after observations of hair growth were made for Lumigan®. The opinion first explained that one of the cited references was prior art because a prior date of invention could not be conclusively determined (only inventor testimony, no corroborating evidence (Shu-Hui, FC 2003)) and authorship could not be conclusively attributed to the ‘404 inventors (In re Katz, CCPA 1982). The combination of this reference with the same prior art invalidating the ‘029 patent rendered the ‘404 claims obvious as well since “a person of skill in the art would have had substantial motivation to follow [the prior art] and use topical application of bimatoprost to grow eyelash hair” (the prior art showing that a latanoprost eyedrop “making topical contact with the eyelid” caused eyelash growth). The DC finding that the ‘404 claims were not obvious was therefore reversed. Judge Chen’s dissent these conslusions were incorrect because the prior art only “serves up a menu of seemingly unlimited possibilities” (“not a situation in which there are a finite number of identified, predictable solutions” (KSR, US 2007)).

This entry was posted in Anticipation (35 USC 102), Claim Construction, Generics / ANDA, Obviousness. Bookmark the permalink.

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