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"The Interplay between Reexaminations, Preliminary Injunctions and Stays of Litigation" - by Dennis Crouch at PATENTLYO.COM

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Reexamination Filing Data – December 31, 2012

Ranbaxy Obtains Inter Partes Review of HIV Prodrug Patent

| March 19, 2013

Traditionally, most reexamination proceedings have involved electronic or mechanical inventions, and relatively few have concerned pharmaceuticals. Thus far, that pattern has continued with the new AIA inter partes review trials.

There have, however, been a few requests challenging pharmaceutical patents, and earlier this month the APJs decided to institute a trial in Ranbaxy Labs. v. Vertex Pharmaceuticals, IPR2013-00024, involving U.S. Patent No. 6,436,989. The ‘989 patent claims a set of HIV aspartyl protease inhibitors, specifically derivatives of an inhibitor known as “VX-478.” Also claimed are treatment methods involving the administration of the protease inhibitors. The ‘989 patent is the subject of the infringement action ViiV Healthcare Co. v. Mylan, Inc., Case No. 12-cv-1065 (D. Del.)).

In finding “a reasonable likelihood that the petitioner would prevail with respect to at least” one claim, the APJs undertook the customary “lead compound” analysis. They determined that the primary reference relied upon by the Petitioner Ranbaxy disclosed a protease inhibitor similar those claimed, except that the prior art compound did not have a solubilizing salt. They also found that the disclosed protease inhibitors were known to have a solubility problem and that various salts, including the patent owner Vertex’s preferred phosphate ester salt were known to improve solubility.

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Category: Inter Partes Review

Instructions from APJs on Rules of Evidence

| March 18, 2013

When the patent owner filed its Preliminary Response in LKQ Corp. v. Clearlamp, LLC, IPR2013-00020, it challenged three references, taken from the Internet and relied upon in the Request. These Internet references, the patent owner argued, were not authenticated, amounted to hearsay, and therefore should be excluded from the evidentiary record.

The APJs might simply have ignored the patent owners’ remarks, but chose instead to treat them as a motion to exclude the three references. That motion, the APJs found, was premature because it failed to follow the procedural steps required by the applicable rule. They explained:

When a party objects to evidence that was submitted during a preliminary proceeding, such an objection must be served within ten business days of the institution of trial. The objection to the evidence must identify the grounds for objection with sufficient particularity to allow correction in the form of supplemental evidence.

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Category: Inter Partes Review

Microsoft Resists Discovery in Inter Partes Review

| March 18, 2013

The APJs continue to show their resolve to keep a narrow focus in inter partes review proceedings. Last week, in Microsoft v. Proxyconn, IPR2012-00026 & IPR2013-00109, the APJs denied a motion by the patentee Proxyconn for additional discovery on the issue of secondary considerations, again demonstrating their distaste for expansive, litigation-style discovery requests.

Inter partes review proceedings entail two types of discovery, “routine” and “additional.” The former is defined narrowly in Rule 41.51(b)(1):

(i) Unless previously served or otherwise by agreement of the parties, any exhibit cited in a paper or in testimony must be served with the citing paper or testimony.

(ii) Cross examination of affidavit testimony is authorized within such time period as the Board may set.

(iii) Unless previously served, a party must serve relevant information that is inconsistent with a position advanced by the party during the proceeding concurrent with the filing of the documents or things that contains the inconsistency. This requirement does not make discoverable anything otherwise protected by legally recognized privileges such as attorney-client or attorney work product. This requirement extends to inventors, corporate officers, and persons involved in the preparation or filing of the documents or things.

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