Hospira v. Genentech (IPR2017-00739): § 325(d) and a Priority Date the Examiner Decided

Section 325(d) is usually discussed in terms of prior art the examiner already saw. Hospira, Inc. v. Genentech, Inc., IPR2017-00739 (Paper 16, July 27, 2017), shows that it also reaches arguments the examiner already resolved, here a priority-date question on which every ground in the petition depended. It is listed here with the Board’s informative decisions. Designations can change, so check the USPTO’s current list of precedential and informative decisions.

The petition challenged claims 1–11 and 14–17 of Genentech’s U.S. Patent No. 7,892,549, which claims methods of treating HER2-overexpressing breast cancer with a combination of an anti-ErbB2 antibody, a taxoid and a further growth inhibitory or therapeutic agent. Hospira filed related petitions on the same and related patents.

Background

All three grounds were anticipation challenges based on references published after the 1997 provisional application and 1998 parent application to which the patent claimed priority. They could qualify as prior art only if the three-drug claims were limited to the 2003 filing date of the continuation. Hospira therefore argued that the earlier applications did not provide written description or enablement support for the three-part combination.

During prosecution, the examiner had addressed exactly that question. She initially found the three-part claims not entitled to the earlier dates and rejected them as anticipated by Nabholtz, the same reference Hospira used in its first ground. The applicant amended the claims, for example to recite a “further growth inhibitory agent,” and pointed to supporting passages in the parent application. After an interview and further amendment, the examiner found the claims entitled to the 1997 priority date and withdrew the Nabholtz rejection expressly on that basis.

What the Board decided

The Board first examined Hospira’s priority arguments on their own terms:

• Written description. Having reviewed the parent application and the prosecution record, the Board found that Hospira offered no further evidence that would justify a conclusion different from the examiner’s.
• Enablement. Hospira relied on an applicant statement that clinical data were needed to show agents could be usefully combined. Read in context, the Board found that statement was directed to patentability over the prior art, not an admission that the parent lacked enablement. Hospira also did not address the In re Wands factors. The Board distinguished Rasmusson v. SmithKline Beecham Corp. (Fed. Cir. 2005) because the parent application here included clinical results for two-drug combinations and multi-drug regimens were routine.

Turning to § 325(d), the Board described the balance between conserving Office resources and giving patent owners repose on one hand, and giving petitioners a chance to correct Office errors on the other. Because the examiner fully considered the priority issue and withdrew the Nabholtz rejection on that basis, Ground 1 raised the same or substantially the same art and arguments. And because the priority determination also decided whether the later references were prior art at all, the Board denied the other two grounds as well.

Why it matters

Hospira is a reminder that § 325(d) covers “arguments,” not only references. When a petition’s theory depends on overturning a determination the examiner made, such as priority entitlement, the petitioner must explain why the examiner was wrong with new evidence or analysis. Repeating the question the examiner already answered invites denial.

The case is also useful for anyone challenging biologic or pharmaceutical patents with long continuation chains, where priority fights are common; see IPR challenges to biopharmaceutical patents. For the factor-based approach the Board adopted later in 2017, see Becton, Dickinson v. B. Braun. For how discretion sits beside the institution threshold, see the different threshold standards.

Later developments

The Board’s later two-part framework in Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469 (Paper 6, 2020) (precedential), asks whether the same or substantially the same art or arguments were previously presented and whether the petitioner has shown material error by the Office. The USPTO’s discretionary-denial practice has changed repeatedly, so readers should check current USPTO guidance.

Key takeaways

• The Board denied institution under § 325(d) because the examiner had already decided the priority question that every ground depended on.
• Section 325(d) applies to previously presented arguments as well as prior art.
• A petitioner contesting an examiner’s priority finding needs new evidence or analysis showing the finding was unreasonable.
• An enablement challenge that ignores the Wands factors is unlikely to persuade.