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PTAB Not Always Bound By Previous Court Decisions Regarding Patent Validity

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Sections 102/103
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 … Continue Reading

Claim Construction Sends Duke’s Patent Back to PTAB for Reconsideration, In Part

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, Sections 102/103
In 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, … Continue Reading

CFAD Fails to Knock Out 4 Acorda Patents to Multiple Sclerosis Drug

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
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 … Continue Reading

Purdue Not Estopped From Raising Invalidity Contentions at Trial That Were Submitted But Not Instituted During IPR

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Biotechnology, Estoppel, Inter Partes Review, Sections 102/103
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 … Continue Reading

PTAB Denies Institution of 3 IPRS Against Biogen’s TYSABRI® (natalizumab)

By Katherine L. Neville, Ph.D. on Posted in Institution / Denial, Sections 102/103
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 … Continue Reading

PTAB Bar Association Officially Launched

By Sandip H. Patel and Katherine L. Neville, Ph.D. on Posted in PTAB
We are pleased to share that the new Patent Trial & Appeal Board (PTAB) Bar Association launched Friday, September 16, 2016.  The organization will provide a forum for communications between the legal community and PTAB officials and its Administrative Patent Judges (APJs), particularly to share best practices and stay abreast of the rule making, procedure and jurisprudence … Continue Reading

3 Is a Magic Number for Mylan: 3 Teva Copaxone Patents Struck Down in IPRs

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Biotechnology, Inter Partes Review, Sections 102/103
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 … Continue Reading

The Three-Front Assault: PeroxyChem Uses IPR, PGR and District Court to Challenge Opponent

By Katherine L. Neville, Ph.D. on Posted in Inter Partes Review, Post Grant Review, Section 101, Section 112, Sections 102/103
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 … Continue Reading

Federal Circuit Confirms PTAB Can Cite Prior Art in IPR Final Decision That Was Not In Grounds Of Institution

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Institution / Denial, Inter Partes Review, Sections 102/103
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. … Continue Reading

Patent Ineligibility Under §101 Continues Slow Ooze Over More Territory

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Appeals, Biotechnology, Section 101
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 … Continue Reading

Another “Reasonable” Re-Interpretation by the Federal Circuit

By Katherine L. Neville, Ph.D. on Posted in Amendments, Appeals, Claim Construction
In 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., … Continue Reading

Cross-Pollination of Information From Litigation to IPR Can Lead to Trouble for Parties

thumbnail image of DNA strandBy Katherine L. Neville, Ph.D. on Posted in Biotechnology, Discovery, Inter Partes Review
In a recent order by the magistrate judge in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (NJD, Jan. 22, 2016), defendants Amneal Pharmaceuticals and Par Pharmaceuticals were reprimanded and threatened with sanctions and monetary fines for trying to use confidential information from the litigation to move for additional discovery in a related IPR proceedings.  The judge … Continue Reading

Coalition for Affordable Drugs PTAB Scorecard

By Katherine L. Neville, Ph.D. on Posted in Institution / Denial, Inter Partes Review
In the ongoing saga of the Coalition for Affordable Drugs (CFAD) vs. the pharmaceutical industry, there has been quite a bit of movement recently by the PTAB on institution of many of CFAD’s earliest-filed IPR petitions.  To date, CFAD has filed 33 petitions for IPR, some of them multiple petitions against the same patent, and … Continue Reading

PTAB Requests Further Briefing on Petition for Sanctions Against Hedge Fund Coalition

By Katherine L. Neville, Ph.D. on Posted in Inter Partes Review, Real Party-in-Interest
The PTAB recently revisited Patent Owners’ requests to file motions for sanctions against the Petitioner, Coalition for Affordable Drugs (“CFAD”).  The CFAD was started in conjunction with hedge fund manager Kyle Bass, who has been accused of filing IPRs in order to manipulate company stock price for his hedge fund’s monetary gain.  Recently, in Coalition … Continue Reading

Does Frequent Denial Of Motions To Exclude Evidence In IPRs Encourage Evidence Dumping?

By Katherine L. Neville, Ph.D. on Posted in Inter Partes Review
Exclusion of evidence before the Patent Trial and Appeal Board in an Inter Partes Review is governed by the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, (Aug. 14, 2012), which states that a motion to exclude “must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used … Continue Reading

Evidence of Denial of IPR Institution Allowed in District Court Infringement Action

By Katherine L. Neville, Ph.D. on Posted in Institution / Denial, Inter Partes Review
On June 19, 2015 the District Court for the Middle District of Florida denied Defendants’ motion in limine requesting the exclusion of evidence relating to a denial of an IPR institution from the Patent Trial and Appeal Board (Stoneeagle Services, Inc. v. Pay-Plus Solutions, Inc. et al, 8-13-cv-02240 (FL MD)).  This decision contradicts recent decisions … Continue Reading

PTAB Allows Motion to Amend After it Rejects Original Patent Claims Directed to BioDiesel Fuel

By Katherine L. Neville, Ph.D. on Posted in Inter Partes Review
On June 5, 2015, the Board issued a final written decision in Reg Synthetic Fuels Llc, V.Neste Oil Oyj, IPR2014-00192, rejecting all challenged claims of U.S. Patent No. 8,278,492, but confirming the patentability of substitute claims submitted by Patent Owner. The ‘492 patent is directed to a process for the manufacture of biodiesel fuel comprised … Continue Reading
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