Patents Post Grant Blog

The USPTO has recently upheld Genetic Technologies Ltd.’s (GTG’s) patent for non-coding DNA technologies.  U.S. Patent No. 5,612,179 titled “Intron sequence analysis method for detection of adjacent locus alleles as haplotypes” claims a method for facilitating the detection of specific gene variations.

The third party initiated ex parte re-examination Control No. 90/010,318, was filed on October, 15, 2008 requesting that each of claims 26-32 be found invalid in view of a new reference, which was not previously cited in the prosecution of the ‘179 patent; namely a printed publication titled “Comparison of Multiple HLA-A Alleles at the DNA Level by Using Southern Blotting and HLAA-A-Specific Probes” by Beverly Koller et al. (“Koller I”).  The request submitted that Koller I raised a substantial new question of patentability and renders claims 26-30 and 32 of the ‘179 patent invalid as anticipated under § 102(b) and claim 31 invalid under § 103(a).  The request further argued that Koller I discloses characterizing the alleles of the multi-allelic HLA-A genetic locus using polymorphisms found in non-coding regions of that locus, including polymorphisms in introns and polymorphisms in flanking regions of the HLA-A locus.

In a reply filed July 24, 2009, GTG argued Read the rest of this entry »

In patent application prosecution, patent owners may  file an RCE or continuation to continue prosecution as a matter of right under 37 CFR 1.53(b) or 1.53(d) or 37 CFR 1.114.  However, these mechanisms are not available in patent reexamination.

There may be occasions when additional prosecution may be beneficial in reexamination.  For example, in certain situations special dispatch may be served by the submission of new evidence, prior art,  or amendments. So, is a final action the end of the line?

Read the rest of this entry »

Subsequent to the Ex Parte Tanaka BPAI decision (Appeal No. 2009-000234) on December 9, 2009, Judge Jose L. Linares of the U.S. District Court for the District of New Jersey granted partial summary judgment invalidating four claims in the Zetia Reissue Patent U.S. Reissue Patent No. RE37,721 that were added in the reissue application of U.S. Patent No. 5,767,115.  The reissued claims were directed to the active ezetimibe species, which was already encompassed by the original ‘115 patent claims to a genus of hydroxyl-substituted azetidinone compounds.  As we previously pointed out, reissue patent applications do not fix all errors. Here as in Tanaka, “bullet claiming” via patent reissue is once again disputed as an error that may be corrected by reissue.

The civil action, Schering Corp. et al. v. Glenmark Pharmaceuticals Inc. USA et al., (Case No. 2:07-cv-01334), was filed in 2007, after Mumbai based Glenmark filed an abbreviated new drug application Read the rest of this entry »

Patent reform changes to the post grant landscape seem inevitable with S.515 gaining traction.  As such, a brief review of other patent systems may shed some light on the mixture of provisions that may ultimately be offered in the U.S, and their degree of harmonization with other international post grant review mechanisms.

The following is a comparison of Reexamination/Invalidation Proceedings at the State Intellectual Property Office (SIPO) of the people’s republic of China to Inter Partes Re-examination Proceedings at the USPTO.  In contrast to the United States where invalidity can be determined by the Court or by the USPTO through Re-examination, the Chinese Patent Reexamination Board (PRB) has sole jurisdiction over patent validity issues in China.  The Courts do not have jurisdiction to invalidate a patent.  PRB decisions may, however, be appealed to the Beijing People’s Intermediate Court, and further appealed to the Beijing People’s High Court.

In Japan, since January 1, 2004, the Japan Patent Office (JPO) has conducted Read the rest of this entry »

Two weeks ago, it was widely reported that the BPAI upheld the reexamination rejection of the broadest claim of Pfizer’s US Patent 6,469,012 relating to Viagra®. Lost in the outrage over the 7 year pendency of the reexamination proceedings was the degree to which the Pharma industry stacked the deck against Pfizer, and how special dispatch seemingly ends at appeal.

The reexamination of the ‘012 patent was kicked off by the USPTO in 2003, identifying four substantial new questions of patentability (SNQs).  It is worth noting that in 2003, there was no such thing as a Central Reexamination Unit (CRU).  Instead, this patent reexamination went to the patent examining corps.  As most practitioners are aware, while the patent examining corps certainly has the technical expertise to handle such issues, special dispatch was far from assured. This deficiency, in part, led to the creation of the CRU in 2005. The CRU implemented a coordinated management of the USPTO’s reexamination caseload, and staffed reexamination proceedings with teams of three experienced primary examiners.

In addition to the initiation of the Viagra® reexamination in this period of USPTO transition, the Pharma industry implemented a strategy of Read the rest of this entry »

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 Read the rest of this entry »

On May 26, 2008, Troll Busters LLC (Troll Busters) filed a request for inter partes reexamination of U. S. Patent No. 6,869,779 (“the ‘799 patent”).  Originally, Troll Busters named itself as both the sole real party in interest and the third party requester.  However, as the PTO became aware of Troll Buster’s website, http://www.troll-busters.com, questions arose as to whether the actual real party in interest was correctly identified as required by 35 U.S.C. § 311(b)(1) and 37 C.F.R. 1.915(b)(8).

On their website, Troll Busters proclaims that “Troll Busters invalidates patents, not just any patents but patents being asserted by patent trolls, those ugly beasts who try to dominate the innovations of others….Troll Busters takes aim and fires in our own name.  The patent Troll will never know who or how many are behind the ‘hit’.” Read the rest of this entry »

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. Read the rest of this entry »