By Scott A. McKeown
| December 23, 2009
In an earlier post, we commented on the case of Sigram Schindler Beteilungsgesellschaft mbH v. Kappos, No. 1:09-cv-935-TSE-IDD (E.D. Va.), which raised the issue of whether the USPTO's interpretation of Public Law 107-273, section 13202(d), codified at 35 U.S.C. § 306, was proper.  The USPTO interprets 35 U.S.C. § 306 as prohibiting a patent owner in an ex parte reexamination from obtaining judicial review of a decision of the Board of Patent Appeals and Interferences (BPAI) by filing a civil suit against the USPTO in federal district court.  Under the USPTO interpretation, codified at 37 C.F.R. § 1.303 and discussed in MPEP § 2279, the patent owner may only seek judicial review in an ex parte reexamination filed on or after November 29, 1999, by appealing the decision of the BPAI to the Federal Circuit.  This is significant to patent owners because civil suit against the USPTO in district court results in de novo review of the BPAI decision and affords the patent owner an opportunity to take third party discovery.

On Friday, December 18, 2009, Judge T.S. Ellis, III, issued an opinion that declined to adjudicate the USPTO’s interpretation of 35 U.S.C. § 306. Judge Ellis decided that Sigram Schindler did not present a justiciable case or controversy to invoke the court’s jurisdiction to reach the merits of whether 37 C.F.R. § 1.303 contravenes 35 U.S.C. § 306. Instead, Judge Ellis granted summary judgment in favor of the USPTO, finding Sigram Schindler’s declaratory judgment action unripe because (i) the BPAI has not yet rendered an adverse decision that would allow Sigram Schindler to seek court review of that determination, making the purported hardship contingent and speculative; (ii) Sigram Schindler has not demonstrated that the challenged regulation creates an immediate, direct, and significant hardship altering its day-to-day activities; and (iii) any hardship is remediable by 28 U.S.C. § 1631. He dismissed Sigram Schindler’s complaint without prejudice.

Sigram Schindler had argued that its declaratory judgment action was necessitated by the Hobson’s choice presented by a decision from the BPAI: appealing to the Federal Circuit and waiving the right to file a district court action or filing a district court action and risking expiration of the sixty-day deadline for appealing to the Federal Circuit while the district court weighed jurisdictional issues.  That Hobson's choice may present itself, when and if the BPAI issues a decision adverse to Sigram Schindler.
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Many district courts have complained that the length of inter partes reexamination proceedings is a significant deterrent to granting a stay of patent litigation. Consequently, district courts typically deny a stay request where there is a newly filed inter partes reexamination request that could result in an indefinite delay in court action prejudicial to a Patent Owner. The Northern District of California however, appears to have deviated from this approach. In Advanced Analogic Technologies, Inc. (“AATI”) v. Kinetic Technolgies, Inc. (“KTI”) (Case No. 09-CV-01360), Judge Maxine Chesney of the U.S. District Court for the Northern District of California granted an indefinite stay of a patent infringement suit pending the outcome of inter partes reexamination of AATI’s semiconductor patent-in-suit. The patent-in-suit is U.S. Patent No. 7,127,631 entitled “Single Wire Serial Interface Utilizing Count of Encoded Clock Pulses with Reset.” Both AATI and KTI make semiconductors used in computers, cameras and smart phones that employ integrated circuits with light-emitting driver circuits. Interestingly, the stay was granted despite the fact that the USPTO has not even reviewed KTI’s inter partes reexamination request . A trial date had been set for March 2011 and significant discovery had been completed. In the order staying the litigation Judge Chesney indicated that the stay would allow narrowing and clarifying claim construction via the reexamination proceedings. However, both parties agreed, that when accounting for appeals at the USPTO, the inter partes reexamination proceedings could take seven to eight years to conclude. The parties are required to file annual joint status reports on the progress of the inter partes reexamination proceedings.
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On December 15, 2009 the USPTO issued a ‘Notice of Intent to Issue an Ex Parte Reexamination Certificate’ confirming the patentability of Merck’s billion dollar Singulair patent, U.S. 5,565,473.  This development effectively concludes the reexamination of the Singulair patent.  In initiating the reexamination, the USPTO issued a single nonstatutory obviousness-type double patenting reexamination rejection.  Double patenting rejections relate to the ability of a Patent Holder to obtain multiple patents on obvious variations of a single invention.  This rejection, if maintained by the Office would not have invalidated the patent, but instead, could have potentially shortened the term of the Singulair patent.  However, the rejection was withdrawn by the USPTO.

The reexamination was initiated by a third party, Article One.  Article One claimed to have uncovered highly relevant prior art and alleged in 276 pages worth of obviousness rejections, the invalidity of the Singulair patent.  As noted above, the USPTO did not agree with the submitted invalidity arguments.

At issue in the double patenting rejection was whether an articulable rationale existed for one of ordinary skill in the art would have replaced the alkane linker (-CH2CH2-) of a prior Merck patent (The ‘033 Patent) with an olefinic linker (-CH=CH-) to arrive at the compounds of the ‘473 Patent.  Merck argued that at the time of the invention, compounds with the olefinic linker were known to undergo possible photoisomerization that would lead to undesirable pharmacological properties and phototoxicity.  Merck provided a side-by side comparison of an instantly claimed compound vs. the closest compound of ‘033 to illustrate that the shift value (ratio of a compound’s potency in the presence and absence of human serum albumen) of the ‘473 compound is unexpectedly much lower than that of the comparative ‘033 compound.

As explored in a previous post on Singulair’s patent term, although a terminal disclaimer was filed during the reexamination, this filing should not impact the patent term.  Furthermore, this terminal disclaimer will not affect the 430-day extension granted under § 156 for delays in FDA regulatory review, which are added on after the terminal disclaimer date.  Merck & Co. v. Hi-Tech Pharmacal Co., 82 USPQ2d 1203, 1208 (Fed. Cir. 2007).

This is not good news for Teva.  The reexamination ruling follows on the heels of a ruling by Judge Garrett E. Brown of the U.S. District Court for the District of New Jersey on (August 19, 2009) that Teva’s generic drug would infringe Merck’s ‘473 patent, ordering the FDA to stay market approval of the generic version of Singulair pending expiration of the ‘473 Patent in 2012.  Teva has appealed the District Court’s ruling and is due to file its brief in January 2010.

Absent appeal relief Singulair will remain protected by the ‘473 Patent until February 3, 2012.
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By Scott A. McKeown
| December 21, 2009
On October 30, 2009, in Ex parte Senju Metal Industry Co. the Board of Patent Appeals and Interferences ("BPAI") affirmed a rejection of non-original patent claims in a reexamination proceeding directed to soldering flux for soldering elements. As a predicate to its decision, the BPAI explained the rationale behind application of the broadest reasonable interpretation rule in administrative proceedings within the USPTO. "This longstanding principle is based on the notion that 'during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.' That is, a patent applicant has the opportunity and responsibility to remove any ambiguity in claim term meaning by amending the application. 'Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.' '[A]s applicants may amend claims to narrow their scope, a broad construction during prosecution creates no unfairness to the applicant or patentee.'". During the reexamination proceeding the patent examiner determined that the claim term "volatile organic solvent conventionally used in a soldering flux" failed to meet the definiteness requirement of 35 U.S.C. §112, 2nd paragraph because the description of the invention did not recite this language, "let alone any disclosure that would enlighten one skilled in the relevant art as to what solvents are covered by the [term]." The appellants in an effort to overcome the rejection filed a declaration averring that a person skilled in the relevant art would understand "volatile" to mean "evaporating or passing off readily in the form of a vapor and that solvents in the [patent at issue] fall under this definition." Appellants argued that "[o]ne skilled in the art of preparing soldering fluxes would understand what solvents are conventionally used in soldering flux." Agreeing with the patent examiner, the BPAI observed that the limitation "volatile organic solvent" cannot be found in the patent specification. Also the appellants used the term in a "manner contrary to the ordinary meaning of the term" urging that ethylene glycol, which has a boiling point of 197°C, is covered by the claim. The BPAI then held that the "use of terms contrary to their ordinary meanings, in and of itself, does not render a claim indefinite, for [p]atentees are free to act as their own lexicographers … one skilled in the relevant art would not be able to ascertain whether an organic solvent with a boiling point of, e.g., 200°C would be covered by the disputed claim terms." The BPAI determined that the specification "does not reasonably apprise the full scope of what Patentees mean by 'volatile organic solvent conventionally used in a soldering flux.'" Compare this decision with the our November 18, 2009 posting Attacking a Patent in Reexamination for Lack of Written Description and Enablement?
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By Scott A. McKeown
| December 19, 2009
The face of patent litigation in the U.S. has evolved greatly in the last 5 years with respect to patent reexamination. For patent litigators, throughout the U.S. and especially the Northern District of Illinois, the emergence of this now seemingly reliable strategic option is an important case management consideration. Indeed, if not adequately considered in the course of litigation counseling, reexamination ignorance may create malpractice opportunities for unsuccessful defendants.

For a more detailed discussion of these issues, see my guest post on ChicagoIpLitigation.com
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