During the week of October 15-19, the Board issued one decision in Technology Center 1600, instituting inter partes review. The decision is as follows:
Mylan Pharmaceuticals Inc. v. Bristol-Meyers Squibb Co., No. IPR2018-00892 (Decision Entered October 15, 2018). In ground 1 of the Petition, Mylan Pharmaceuticals Inc. (“Petitioner”) challenged claims 1–38 of U.S. Patent No. 9,326,945 (“the ’945 patent”) as obvious over the references of Carreiro, Wei, and the FDA Dissolution Guidance. IPR2018-00892, Paper 24 at 5. In ground 2, Petitioner challenged claims 1–38 as obvious over the references of Carreiro, Wei, Rudnic, and the FDA Dissolution Guidance. Id. In ground 3, Petitioner challenged claims 1–38 as obvious over the references of Pinto, Wei, and the FDA Dissolution Guidance. Id. at 6. In ground 4, Petitioner challenged claims 1–38 as obvious over the references of Pinto, Wei, Rudnic, and the FDA Dissolution Guidance. Id. Bristol-Meyers Squibb Company and Pfizer, Inc. (“Patent Owner”) filed a Preliminary Response. Id. at 2.
In the Preliminary Response, Patent Owner argued that the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Patent Owner argued that Petitioner relied on identical portions of the Wei reference considered by the Examiner during prosecution. Id. at 7. Additionally, Patent Owner argued “that ‘the portions of the Carreiro reference and [Pinto] asserted in the Grounds are cumulative to the Nause reference cited by the Examiner for substantially the same information.’” Id. at 7 (quoting Prelim. Resp. at 16, 19 (internal citations omitted)). The Board “agree[d] with Patent Owner that Wei was considered and relied on by the examiner during prosecution, however, [the Board was] not persuaded that Carreiro and Pinto are cumulative of Nause.” Id. at 10. Accordingly, the Board declined to deny institution based on Section 325(d). Id. at 11.
The ’945 patent describes “[c]ompositions comprising crystalline apixaban particles having a D90 equal to or less than 89 µm, and a pharmaceutically acceptable carrier[.]” Id. at 2 (quoting U.S. Patent No. 9,326,945 at Abstract). The dispute between the parties centered on “whether a person of ordinary skill in the art would have combined the teachings of Carreiro or Pinto with the teachings of Wei to achieve a solid pharmaceutical composition comprising crystalline apixaban particles having a D90 equal to or less than about 89 µm with a reasonable expectation of success.” Id. at 24. The Board agreed with Patent Owner that Petitioner did not “establish that apixaban’s lack of ionizable groups equates to poor solubility.” Id. at 25. However, the Board also agreed with Petitioner that, while “Wei does not expressly disclose apixaban as a ‘sparingly soluble’ compound[,]” it does imply as much. Id. Moreover, the Board found that one of skill in the art would have been motivated by Wei to produce small apixaban crystals because “Wei discloses that reducing the particles of a drug to small crystals can improve the bioavailability of a drug and then discloses the product of small crystals of apixaban as the example provided in the references.” Id. at 25–26.
Patent Owner additionally challenged the status of three prior art references as printed publications under 35 U.S.C. § 102(b). Id. at 27–28. With respect to the Carreiro reference, Patent Owner argued that the exhibit did not have a library stamp and indicated on its face that it was downloaded in August 2017—over seven years after the priority date for the ’945 patent. Id. at 28. Patent Owner additionally contended that the copyright date of 2008 alone was insufficient to establish that the Carreiro reference is a “printed publication.” Id. The Board weighed the evidence and concluded that there was a reasonable likelihood that Carreiro is a printed publication because: (1) copyright date provides some evidence of publication; (2) the reference appeared to be published by an established publisher so there was “no reason to suspect it would not have been publicly available to one skilled in the art absent evidence to the contrary”; and (3) the board found Patent Owner’s argument that “Carreiro’s copyright notice suggests that ‘any availability of the document was limited’” unpersuasive. Id. at 29–30.
Next, Patent Owner argued that the Petition presented no evidence, other than the document itself, that the FDA Dissolution Guidance was a printed publication. Id. at 30. The Board weighed the evidence and concluded that it was reasonably likely that the FDA Dissolution Guidance was publicly available before the priority date for purposes of the present decision because “[t]he paper is dated August 1997 and provides that additional copies are available from the ‘Office of Training and Communications’ and provides relevant contact information, which includes an address, phone number, and URL directing the reader to a FDA webpage.” Id. at 31.
Finally, Patent Owner asserted that Rudnic—chapter ten of the fourth edition of a book—is not a printed publication because the exhibit: (1) does not have a library stamp; (2) “the face of the exhibit does not appear to be a photocopy of a hardcopy textbook”; (3) the pages of the exhibit “include markings in the footer and headers of the documents that are not on the first three pages of the Exhibit—suggesting that the document is an aggregate that was compiled by Petitioner”; and (4) the table of contents for the 2002 edition supplied by Patent Owner show the relevant chapter beginning on page 287, whereas the exhibit shows the relevant chapter begins on page 333. Id. at 32–33. First, the Board observed that, “even if Patent Owner can show that Rudnic is not a printed publication, we are persuaded that Petitioner has established a reasonable likelihood that it will prevail with Grounds 1 and 3, which do not rely on Rudnic.” Id. at 33. Second, because Patent Owner did not supply a copy of the relevant chapter in the 2002 edition, the Board was “unable to make any comparison to reach a definitive conclusion on whether the information provided in Ex. 1010 was indeed published in 2002 or at some other time.” Id.
Upon consideration of all the art and arguments presented, the Board concluded that Petitioner demonstrated a reasonable likelihood that it would succeed on at least one of the asserted grounds. Id. at 34. Accordingly, the Board instituted inter parties review. Id. at 35.