Reexamination

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On December 7, 2009 at the IPO’s annual PTO Day Conference at the Reagan International Trade Center, Gregory Morse will be providing an update on the activities of his Central Reexamination Unit of the USPTO. I will be moderating panel discussions on the Supreme Court arguments in Bilski v. Kappos and the PTO’s interim guidelines…

 

Is it Possible to Comply with Larson Manufacturing?

Two weeks ago, we discussed the merger of concurrent post grant proceedings relating to the same patent at the USPTO.  In addition to concurrent proceedings of a same patent, it is also quite common for entire portfolios of a Patent Owner to be subject to reexamination.  In such cases, the reexamination of different patents (including direct continuations of one another) are not merged.  Likewise, there may also be ongoing continuation patent application examination (i.e., patent applications claiming subject matter directed to the same invention in applicant’s earlier filed patent and meeting the conditions of section 120 of the patent statutes) being examined concurrently with the parent patent in reexamination.  However, reexamination proceedings are not merged with non-reissue application examination.

In such concurrent proceeding situations, what are the obligations of the Patent Owner in satisfying the duties of disclosure, candor and good faith?
Continue Reading Concurrent Proceedings & Patent Owner Compliance with MPEP § 2282/2686

Third party use of patent reexamination can be thought of as both a “sword” and a “shield.” In the “shield context”, patent reexamination may function to shield an infringer from litigation costs if the reexamination filing results in the stay of a federal district court infringement litigation. Likewise, the reexamination of a patent immediately prior to an imminent litigation may cast enough of a cloud over a patent to avoid litigation altogether, or to re-calibrate the licensing expectations. In this way, the shielding of unwarranted litigation expenses gains the infringer significant settlement leverage. Conversely, the use of a patent reexamination may also serve as a “sword”, providing offensive value. Aside from the obvious intervening rights, prosecution estoppel, and non-infringement positions that may be created by ongoing reexamination prosecution, a timely initiated reexamination proceeding may utilized in a more generic fashion to demonstrate
Continue Reading Strategic Application of Patent Reexamination in Litigation –Avoiding a Preliminary Injunction–

(Clarification: This post analyzes patent reexaminations of a subject patent that claims the benefit of an earlier filed CIP and/or provisional application for priority purposes.  In such circumstances, intervening art presenting a Substantial New Question of patentability (SNQ) may be applied calling into question these priorty dates.  In such unique circumstances, enablement and written description issues pertaining to the originally issued patent claims will be considered by the USPTO for the purpose of detemining whether or not the priority claim is properly supported.  Of course, such an analysis of original patent claims is not performed outside of these limited circumstances). 

According the MPEP §§ 2258 and 2658, the USPTO during a reexamination proceeding will not consider 35 U.S.C. § 112, 1st paragraph issues with respect to the reexamination of original patent claims. It will, however, consider such issues where new or amended claims are presented or where any part of the disclosure is amended.

Nevertheless, where the patent subject to reexamination has claimed the benefit of the filing date of an earlier filed U.S. or foreign patent application, reexamination proceedings may be based on intervening patents or printed publications where the patent claims under reexamination may be entitled only to the actual filing date of the patent.

But can this strategy be used as a “back door” attack on the original patent claims’
Continue Reading Attacking a Patent in Reexamination for Lack of Written Description and Enablement?

Singulair is Merck’s best-selling drug, with sales of nearly $1.1 billion in the third quarter of 2009.  However, Merck’ patent covering Singulair has also been hotly contested in court, at the FDA, and, most recently, at the USPTO. The Singulair patent, U.S. Patent No. 5,565,473, issued in 1996, covers the basic compound as well as a method of treating asthma.  The ‘473 patent has been the subject of ongoing litigation between Merck and generic manufacturer Teva Pharmaceuticals.  Merck filed three suits against Teva in April of 2007, May of 2007, and January of 2009, all in the U.S. District Court for the District of New Jersey, claiming that Teva infringed the ‘473 patent by filing an ANDA for generic Singulair. Because the suits all asserted infringement of the ‘473 patent, the later two suits were stayed pending a final decision on the merits in the first suit. On August 19, 2009, Judge Garrett E. Brown of the U.S. District Court for the District of New Jersey ruled that Teva’s generic drug would infringe Merck’s ‘473 patent, and ordered the FDA to stay market approval of the generic version of Singulair pending expiration of the ‘473 patent in 2012. Unfortunately for Merck, the success in the District Court represents only one front of battle for defending the validity of the ‘473 patent.  On April 27, 2009, four months prior to Judge Brown’s ruling, an ex parte reexamination request was filed for the ‘473 patent by Article One Partners LLC, a global research community which rewards Advisors for finding prior art to invalidate patents. The ex parte examination request was submitted with eight prior art documents in which Article One set forth over 276 pages of obviousness arguments.  The request was granted by the USPTO on May 28, 2009.
Continue Reading Merck’s Singulair Patent Survives Reexamination

In the summer of 2005, responding to industry criticism on the efficacy of patent reexamination, the USPTO created the Central Reexamination Unit (CRU).  The CRU is formed of highly skilled primary patent examiners that have been specially selected from the Patent Examining Corps.  These examiners average more than 15 years of experience and have technical backgrounds that reflect the broad spectrum of technologies encountered in patent reexamination.  Many of the primary examiners chosen to work in the CRU have advanced technical and law degrees.

The mission of the CRU is to ensure high quality, objective and timely processing of reexamined patents.  The CRU endeavors to comply with the “special dispatch” requirements of the reexamination statutes.  Reexamined patents are assigned to examiners in the CRU who were not previously involved in the examination of the original patents or in prior reexamination proceedings of the patents.  The examiners work in teams of three including a Special Program Examiner (SPE).  Patentability review conferences are conducted at each point in the reexamination decision making process in order to reach
Continue Reading The USPTO’s Central Reexamination Unit

In the case of concurrent post grant proceedings at the USPTO, 37 CFR §§ 1.565(d) and 1.991 provide for a discretionary merger of reissue application examination with either ex parte or inter partes reexamination proceedings.  These rules provide that such merged proceedings will be conducted using the rules set forth for reissue application examination that are normally less restrictive than those applicable to reexamination.  As can be appreciated, such a merger would provide the patentee greater flexibility after final rejection and, in most situations, RCE practice and extensions of time as a matter of right; important procedural advantages.  But note that the USPTO may undo the merged proceedings if an RCE is filed in the reissue application (See MPEP §1452) and modify the response period/extension of time practice for reissue applications involved in a concurrent litigation (See MPEP §1442.03).

Moreover, although amendments to claims in reexamination can only be narrowing amendments, if the patent for which reissue is two years or less old, a broadened reissue application can be filed.  In this way, use of patent reissue together with merged reexamination proceedings may provide useful procedural and tactical advantages to a patent owner.Continue Reading Merged Post Grant Proceedings: To Reissue or not to Reissue?

The inter partes reexamination estoppel provision of 35 U.S.C. § 315(c) is a familiar one to many patent practitioners.  This provision is often cited as the primary justification for disfavoring inter partes reexamination over other post grant patent strategies. Yet, as ITC actions become increasingly utilized for their expediency in reaching a conclusion, further consideration should be given to the applicability of this estoppel to Federally created Agencies.Continue Reading Inter Partes Reexamination & The International Trade Commission (ITC)