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For clients seeking patent protection in all areas of biotechnology and pharmaceuticals, Katherine L. Neville, Ph.D. delivers guidance to secure their inventions worldwide. She calls on her advanced studies in microbiology and immunology and over a decade of patent prosecution experience to advance their business goals. In addition to counseling clients in strategic management of worldwide patent rights, her extensive experience includes patent preparation, opinions, due diligence analyses for clients interested in partnering, and various patent proceedings, including interference, reexamination and opposition proceedings. Read full bio here.

In Novartis AG v. Noven Pharm. Inc., Appeal 2016-1678-1679 (April 2017), Novartis appealed two PTAB decisions holding claims of two patents obvious over cited prior art (IPR2014-00549 and IPR2014-00550), arguing that previous judicial holdings of non-obviousness should control the PTAB’s factual findings and that the claims should have been held non-obvious.

The two Novartis patents at issue (U.S. Patent Nos. 6,316,023 and 6,335,031) were from the same patent family and are directed to a pharmaceutical composition comprising rivastigmine (Exelon®) and an antioxidant for the treatment of Alzheimer’s disease.  
Continue Reading PTAB Not Always Bound By Previous Court Decisions Regarding Patent Validity a recent appeal from a PTAB final written decision, the Federal Circuit reversed the Board’s determination that all claims of a Duke patent were unpatentable (Duke Univ. v. BioMarin Pharm. Inc., Appeal No. 2016-1106 (Fed. Cir., April 25, 2017). The court concluded that certain of the Board’s claim constructions were incorrect, and that others, while appropriate, were mis-applied and reversed the Board’s decision on anticipation, as well as obviousness of some claims.
Continue Reading Claim Construction Sends Duke’s Patent Back to PTAB for Reconsideration, In Part

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A recent set of final written decisions in four IPRs against Acorda Therapeutics puts more marks in the loss column for Kyle Bass and the Coalition for Affordable Drugs.  In IPRs 2015-01850, -01853, -01857 and -01858 (Coalition for Affordable Drugs v. Acorda Therepuatics Inc.), the Coalition for Affordable Drugs (CFAD) requested review of Acorda Therapeutics U.S. patents U.S. 8,440,703, U.S. 8,007,826, U.S. 8,663,865, and U.S. 8,354,437, respectively, directed to sustained release formulations of fampridine (4-AP) and methods for administering the drug to treat neurological disease, such as multiple sclerosis (MS).  Certain aspects of the inventions in the four patents are directed to methods of increasing walking speed of patients with MS by administering 4-AP twice daily for at least two weeks, in a dose of about 10 to 15 mg of 4-AP.  The PTAB instituted review of the issued claims in each of the four patents as potentially obvious in view of a combination of prior art, including an SEC filing by Acorda that included reference to ongoing clinical trials. 
Continue Reading CFAD Fails to Knock Out 4 Acorda Patents to Multiple Sclerosis Drug

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Recently, the Federal District Court for the District of New Jersey allowed Purdue Pharma to assert invalidity arguments in the litigation that were previously submitted in an IPR petition, but upon which IPR review was not instituted. See Depomed Inc. v Purdue Pharma LP, Civil Action 13-571, Order (D.N.J. Nov. 4, 2016). The Court rejected the patent owner’s arguments that Section 315(e) of Title 35 estopped Purdue from raising these argument.
Continue Reading Purdue Not Estopped From Raising Invalidity Contentions at Trial That Were Submitted But Not Instituted During IPR

Failure Concept

On October 17, 2016, the PTAB denied institution of three IPRs [IPR2016-00912, IPR2016-00915, and IPR2016-00916] petitioned by Swiss Pharma AG against three patents owned by Biogen IDEC directed to its anti-α4 integrin antibody product, TYSABRI (natalizumab), marketed to treat multiple sclerosis and Crohn’s disease. The PTAB weighed the Petitioner’s assertions of routine experimentation against the Patent Owner’s arguments of unpredictability in deciding the outcome.Continue Reading PTAB Denies Institution of 3 IPRS Against Biogen’s TYSABRI® (natalizumab)

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In a series of unfortunate events for Teva Pharmaceuticals, three patents covering methods for administering the blockbuster multiple sclerosis (MS) drug Copaxone® (glatiramer acetate) (owned by Yeda Research and Development Co.) were struck down by the PTAB in recent IPR decisions (IPR2015-00830, IPR2015-00643, and IPR2015-00644).  These patents are directed to methods for administering Copaxone in a 40 mg dosage form, 3 times per week to treat relapsing-remitting MS:  U.S. Patent Nos. 8,232,250, 8,399,413 and 8,969,302.
Continue Reading 3 Is a Magic Number for Mylan: 3 Teva Copaxone Patents Struck Down in IPRs

Victory comes if you are lucky on dices

In what could become a common patent challenge strategy, PeroxyChem, a chemical company that sells products useful in water and soil remediation, has employed a three-front assault—combining the relatively young post-grant review procedure, with an IPR and litigation–to take on one of its competitors, Innovative Environmental Technologies (IET).  Litigation together with an IPR has become a rather common means to challenge a competitor’s patent. However, post grant review is gaining in popularity among litigants, adding to the available strategies of overcoming potential barriers to market entry for companies.  For example, while 12 Petitions for PGR were filed in all of 2015, 15 have been filed so far in the first half of 2016. 
Continue Reading The Three-Front Assault: PeroxyChem Uses IPR, PGR and District Court to Challenge Opponent

In a recent appeal from a PTAB final written decision, the Federal Circuit determined that a patentee was not denied notice or an opportunity to respond to references cited in the final written decision as representing the state of the art,  but that were not the basis for a grounds for institution.  (Genzyme Therapeutic Prods. Ltd. v BioMarin Pharm. Inc., Appeal Nos. 2015-1720, -1721 (Fed. Circ., June 14, 2016)).  The court concluded that there is no requirement, either in the PTAB’s regulations, in the Administrative Procedure Act (APA), or as a matter of due process, for the institution decision to anticipate and set forth every legal or factual issue that might arise during the trial, and that the PTAB acted properly in citing the additional references. 
Continue Reading Federal Circuit Confirms PTAB Can Cite Prior Art in IPR Final Decision That Was Not In Grounds Of Institution

Bottle of Ooze

Biotech companies have increasingly found themselves the target of IPRs, and we have discussed this in some of our past posts.  Meanwhile, in the District Courts, biotech companies are defending against a new wave of challenges to the patent-eligibility of their inventions under 35 U.S.C. § 101.  While challenges under § 101 cannot be raised as grounds in an IPR, the PTAB has required proof of eligibility where patent owners have sought to amend their claims during IPRs.  In at least two final written decisions in IPRs, the PTAB denied motions to amend claims because the PTAB concluded the amended claims recited subject matter ineligible for a patent under § 101 and in view of previous rulings in related district court proceedings that claims of similar scope were ineligible subject matter. 
Continue Reading Patent Ineligibility Under §101 Continues Slow Ooze Over More Territory

Bat vs BatIn a recent decision appealing the PTAB’s finding of claims unpatentable in two different, but related re-examination proceedings, the Federal Circuit vacated and remanded the Board’s decisions based on reinterpretation of claim terms construed under the PTAB’s broadest reasonable interpretation (BRI) standard during the re-examination process (In re Varma, Appeal 2015-1502 and 2015-1667, Fed. Circ., March 10, 2016).  This decision is one of several recent decisions in which the Federal Circuit has taken the opportunity to reinterpret the PTAB’s broadest “reasonable” interpretation of the claims during a post grant proceeding and change the interpretation to be more “reasonable” in light of the specification and actual claim language.
Continue Reading Another “Reasonable” Re-Interpretation by the Federal Circuit