Takeaway: To anticipate a later-claimed species, a pattern of preferences or other related teaching or suggestion must lead to a genus small enough that a person of ordinary skill in the art would at once envisage the claimed species.

In its Decision, the Board declined to institute inter partes review of claims 1-13, 20-27, and 34-61 of the ’208 patent because Petitioner had not established that there is a reasonable likelihood Petitioner would prevail with respect to at least one of the claims challenged in the Petition.

As stated by the Board, the “’208 patent is directed to genus, sub-genus, and species claims for lactam-containing compounds, pharmaceutical compositions, and methods of treatment, particularly including a compound called ‘apixaban.’”

Petitioner alleged that claims 1-13, 20-27, and 34-61 of the ’208 patent are anticipated by Fevig I or Fevig II. Patent Owner argued that the claimed compounds can be “derived from the Fevig references only by selecting particular substituent groups from among numerous alternative choices at a number of different locations on the generic chemical structure identified by Petitioner.” The Board, citing Sanofi-Synthlabo v. Apotex, Inc. stated that “to anticipate a later-claimed species, a pattern of preferences or other related teaching or suggestion must lead to a genus small enough that a person of ordinary skill in the art would at once envisage the claimed species.”

The Board determined that “Petitioner’s factual assertion that apixaban is specifically disclosed in Fevig I is based solely on Dr. Burton’s hindsight reconstruction of the apixaban structure from the appropriately disclosed alternative for each variable of [Structure 4 that] results in apixaban.” (internal quotations removed). The Board agreed with Patent Owner that the preferred general compound structures identified in Fevig I do not indicate any preference for a lactam ring as substituent B. Thus, the Board concluded that Petitioner does not show how a single species, apixaban, could be derived, without hindsight, from the general formula taught by Fevig I. The Board stated, “The Petition and Dr. Burton’s Declaration do not indicate a disclosure in Fevig I that would lead one of ordinary skill in the art to “at once envisage” the claimed lactam genera or the apixaban species.” The Board concluded that Petitioner had not shown Fevig I and Fevig a reasonable likelihood of prevailing on its assertion that the challenged claims in the ’208 patent are anticipated by Fevig I or Fevig II.

Petitioner also alleged that the challenged claims are obvious over Fevig I or Fevig II. The Board stated that “Petitioner does not offer a proper obviousness analysis, relying instead on a perfunctory reference to its anticipation argument, and arguing that the facts of the present case are “directly analogous to the facts in Merck.” The Board stated that the facts of Merck had little relevance to the facts of the instant case. Thus, the Board concluded that Petitioner had not “provided sufficient evidence to show a reasonable likelihood of prevailing on its assertion that at least one claim would have been obvious to one of ordinary skill in the art over Fevig I or Fevig II, at the time the ’208 patent claims were filed.”

COALITION FOR AFFORDABLE DRUGS IX LLC v. BRISTOL-MYERS SQUIBB COMPANY, IPR2015-01723

Paper 10: Decision on Institution

Dated: February 22, 2016

Patent 6,967,208 B2

Before: Grace Karaffa Obermann, Brian P. Murphy, and Tina E. Hulse

Written by: Murphy