Biotech/Pharma Docket

    By James DeGiulio --

Midland Settles with Life Technologies in Fluorescence Probe Infringement Suit

Midland Certified Reagent Co. Inc. has resolved an infringement suit brought by Applied Biosystems LLC and parent company Life Technologies Corp. over five patents covering a fluorescence probe used in biotechnology assays.

Applied Biosystems and Life Technologies originally filed suit against Biosearch Technologies Inc. in September, alleging that it had infringed U.S. Patent Nos. 5,538,848, 5,723,591, 5,876,930, 6,030,787, and 6,258,569 (see "Court Report," September 27, 2009).  The plaintiffs amended their complaint in November by adding defendants Bio-Synthesis Inc., Eurofins MWG Operon Inc., and Midland.  The amended complaint claimed that each defendant manufactured self-quenching fluorescence probes that infringe the asserted patents.  Biosearch, Eurofins, and Bio-Synthesis responded to the complaint in January, raising affirmative defenses and counterclaims for declaratory judgments of invalidity, noninfringement, and unenforceability of the asserted patents.  Later, Midland responded by arguing that the amended complaint failed to state a claim on which relief could be granted and requested similar declaratory judgment relief.

On June 24, Midland and Applied Biosciences' joint motion to dismiss all claims and counterclaims between them with prejudice was granted by Judge T. John Ward of the U.S. District Court for the Eastern District of Texas.  Each side was ordered to bear its own costs and attorneys' fees.

Judge Ward's order can be viewed here.

Zydus Admits Infringing Meda's Astelin Patent, Agrees Not to Market Generic

Zydus Pharmaceuticals USA Inc. has admitted to infringing Meda Pharmaceuticals Inc.'s patent covering nasal spray Astelin, and has consented not to attempt to market a generic version without Meda's consent.

The litigation began when Meda filed a complaint on March 22, following Zydus' ANDA seeking approval to bring their azelastine hydrochloride generic to market before the expiration of Meda's U.S. Patent No. 5,164,194 (see "Court Report," March 28, 2010).

According to the June 24 order, approved by Judge Mary L. Cooper of the U.S. District Court for the District of New Jersey, Zydus admitted that its ANDA filing was a technical act of patent infringement.  The order enjoins Zydus from making or selling the proposed generic during the life of the '194 patent without Meda's consent, unless all of the '194  patent claims are deemed invalid or unenforceable in a final court decision.

Judge Cooper's order can be found here.

AstraZeneca's Crestor Patent Found Valid

AstraZeneca enjoyed a major victory in its Crestor patent infringement dispute following a ruling that the company's reissued patent covering the cholesterol drug is valid and enforceable.

The litigation began in December 2007, when AstraZeneca filed suits against several generics, including Mylan, Teva, Sun, Aurobindo, Par, Cobalt, Sandoz, and Apotex, claiming their plans for marketing a generic rosuvastatin would infringe AstraZeneca's U.S. Patent No. RE37,314 (see "Court Report," December 16, 2007).  In June 2008, these suits were consolidated into multidistrict litigation in the District of Delaware.  Defendants Mylan, Sun, Par, Aurobindo, Cobalt, and Teva admitted that they had infringed claims 6 and 8 of the '314 patent, but they contended that these claims were invalid and unenforceable since the patent claims were obvious, fraudulently obtained, and improperly reissued.

On June 29, Judge Joseph Farnan of the U.S. District Court in Delaware ruled that the defendants had failed to prove any of their allegations, finding that the '314 patent was valid and enforceable.  Judge Farnan rejected the defendant's obviousness argument, noting evidence that significant work was needed to develop rosuvastatin and instead finding that the defendants' obviousness arguments were driven by hindsight.

Judge Farnan also ruled that defendants failed to establish invalidity due to improper reissue of U.S. Patent No. 5,260,440.  Judge Farnan found that that the plaintiff's broad claim in the original patent was due to mere mistake or oversight rather than deliberate conduct.  Finally, Judge Farnan found that the defendants failed to show that the patent is unenforceable due to inequitable conduct.  He rejected the argument that three individuals intentionally failed to disclose to the U.S. Patent and Trademark Office two highly material prior art patent applications, instead finding that inexperience and overburdening workload was an equally plausible explanation for the failure to cite these references.

Judge Farnan's order can be found here.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and a graduate of Northwestern University School of Law.  Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at [email protected].