Hospira, Inc. v. Genentech, Inc., Case IPR2017-00739 (July 27, 2017) (Paper 16)

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Takeaway (Informative):

The Board has broad discretion to deny institution to the extent that an IPR petition is based on a position that contradicts a finding previously made by the Office (such as in the context of the original prosecution of the patent at issue).


Petitioner Hospira, Inc. (“Hospira”) filed a filed an IPR petition challenging claims 1–11 and 14–17 of U.S. Patent No. 7,892,549 B2 (“the ’549 patent”). Hospira’s petition asserted the following grounds of unpatentability:


Ground Reference(s) Claim(s)
§102(b) Nabholtz 1–8, 10–11, and 14–17
§102(a) Leyland-Jones 1–11 and 14–17
§102(a) Yardley 1–11 and 14–17

Patent Owner Genentech, Inc. (“Genentech”) filed a Preliminary Response to the Petition.

During the prosecution of the ’549 Patent, the examiner had rejected then-pending claims as anticipated by the Nabholtz reference. The applicant overcame the rejections by amending the claims and successfully arguing that the amended claims were supported under 35 § USC 112 by a parent application. The examiner concluded that amended claims were entitled to the benefit of the parent application’s priority date, and withdrew the rejection over Nabholtz because Nabholtz did not qualify as prior art in view of the parent application’s priority date. The amended claims issued in the ’549 Patent.

In its IPR petition, Hospira asserted that Nabholtz, Leyland-Jones, and Yardley qualify as prior art, premised on the argument that the challenged claims are not entitled to the priority date of the parent application because the parent application does not satisfy the written description and enablement requirements of 35 U.S.C. § 112, first paragraph, with respect to the challenged claims. In other words, Hospira thought that the examiner who handled the prosecution of the ’549 Patent was wrong to give the amended claims the benefit of the priority date of the parent application.

The Board exercised its discretion under § 325(d) to decline to institute IPR. The Board concluded that the examiner’s priority determination during prosecution of the ’549 Patent was not unreasonable. Regarding whether the parent application provided adequate written description of the claims at issue, the Board concluded that “Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” Regarding the issue of enablement, the Board noted that Hospira failed to address the Wands factors in its enablement analysis. The Board also concluded that the Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1324 (Fed. Cir. 2005) decision that Hospira cited does not require that an inventor provide experimental proof that her invention could be effective in treating cancer in order to support claims directed to an “effective” use of a cancer drug treatment at least where determining the effective amount would be a matter of routine experimentation within the general knowledge and skill set of a POSITA.

Matt Jonsen

Matt Jonsen

Matt's practice focuses on emerging biotechnology and pharmaceutical companies.

Clint Conner

Clint Conner

Clint’s practice focuses on intellectual property with an emphasis on patent litigation, inter partes reviews, and patent enforcement strategies. Although he has remained focused on U.S. intellectual property law throughout his career, he brings an international perspective, having spent nearly five years representing companies in U.S. patent litigation while living and working in Tokyo. Before attending law school, Clint was an engineer for three years with Lucent Technologies’ Bell Labs (now Alcatel-Lucent).

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