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PTAB Exercised Discretion to Terminate Ex Parte Reexaminations in Ariosa v. Illumina; CAFC to Review

Third parties seeking to challenge pre-AIA patents in the USPTO often choose between IPR and ex parte reexamination.  In some cases, petitioners pursue both proceedings, sequentially or in parallel, taking advantage of different timelines to completion, different standards for institution, and using insights gained in one proceeding in the other.  The PTAB recently exercised its … Continue Reading

PTAB Grants Hospira Petition to Institute IPR of Genentech Antibody Purification Patent

IPRs are an attractive option for biosimilar applicants to clear the patent landscape before delving into litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which is still in its infancy.  Roche’s Herceptin® (trastuzumab) is a prime target for biosimilar makers, accounting for sales of over $6.5 billion in 2015.  Mylan, Celltrion, … Continue Reading

Another VIMOVO® Patent Survives Challenge by Coalition for Affordable Drugs – Updating the CFAD Scorecard

In the spirit of “if at first you don’t succeed, try, try again,” the Coalition for Affordable Drugs (CFAD) challenged a fourth Orange Book-listed patent relating to VIVOMO®, Horizon Pharma’s naproxen/ esomeprazole product.  While denying CFAD’s previous three petitions, the PTAB instituted inter partes review for U.S. Patent No. 8,945,621.  Despite CFAD’s success at the … Continue Reading

PTAB Issues First Biotech/Pharma Post-Grant Review Final Written Decision – All Claims Survive

The first final written decision in a post-grant review of a patent arising from Art Unit 1600 issued November 14, 2016, in Altaire Pharm. Inc.. v. Paragon Bioteck, Inc., PGR2015-00011.  PGRs allow challenge based on enablement, written description, indefiniteness, and subject matter eligibility, in addition to the novelty and obviousness bases available in IPRs, permitting … Continue Reading

PTAB Institutes Third Biotech/Pharma Post-Grant Review

To date, only 43 petitions for Post-Grant Review have been filed with the PTAB.  Nine PGR petitions (21% of total petitions) have been filed to challenge patents arising from Art Unit 1600, which examines applications directed to biotechnology and organic chemistry subject matter.  The PTAB recently instituted the third ever PGR for a biotech-related patent … Continue Reading

PTAB Failed to Properly Apply Incorporation by Reference Standard for Anticipation

This blog previously referenced Athena Automation Ltd. v. Husky Injection Molding Systems Ltd., IPR2013-00290 as an example of the Board granting a request for rehearing, but ultimately confirming its original decision.  On appeal, the Federal Circuit vacated the Board’s decision on the particular issues raised by the Petitioner in the request for rehearing, suggesting that … Continue Reading

Federal Circuit Refuses to Reweigh Factual Findings, But PTAB’s Conclusory Statements Are Insufficient

The Federal Circuit’s precedential decision in In re: Warsaw Orthopedic, Inc., No. 2015-1050, 2015-1058 (Fed. Cir. Aug. 9, 2016), highlights recurring themes in appeals of PTAB IPR decisions.  On one hand, the Federal Circuit is reluctant to overturn a PTAB decision canceling claims for obviousness based on Patent Owner’s assertions that the PTAB failed to … Continue Reading

En Banc Rehearing Petition Denied – PTAB Retains Authority to Institute IPR and Issue Final Decision

We previously reported on the Federal Circuit’s decision that neither the AIA nor the Constitution precludes the same PTAB panel from rendering both institution and final decisions in Ethicon Endo-Surgery, Inc. v. Coviden LP, No. 2014-1771 (Fed. Cir. 2016).  Last week, in a 10-1 decision, the Federal Circuit denied Ethicon’s petition for rehearing en banc.… Continue Reading

Federal Circuit to PTAB – Explain yourself!!

The Federal Circuit recently vacated or reversed-in-part two PTAB final written decisions on the basis that the PTAB did not adequately describe its reasons for concluding the claimed invention is obvious.  In both instances, the court criticized the Board’s “broad, conclusory statements” regarding one of ordinary skill’s motivation to adjust prior art teachings.  These decisions … Continue Reading

PTAB Revises Claim Construction in Final Written Decision, But Still Finds Claims Invalid

On January 11, 2016, the PTAB issued a final written decision in ABS Global, Inc. et al. v. XY, LLC, IPR2014-01161, holding claims 1 and 3 of U.S Patent No. 7,195,920 invalid for obviousness.  The IPR is part of a long-running dispute between the parties involving multiple issues and multiple patents, as reported previously. … Continue Reading

Federal Circuit Affirms PTAB Panel’s Authority to Institute IPRs and Issue Final Decision

The AIA explicitly bestows the USPTO Director with the authority to institute IPRs and the PTAB with the authority to decide the ultimate question of patent validity.  The Director delegated the authority to institute IPRs to the Board, but is it proper to assign the decision to the same APJs that render a final decision?  … Continue Reading

CAFC Confirms Constitutionality of Inter Partes Review

The Federal Circuit rejected a patentee’s appeal arguing that inter partes review is unconstitutional for violating Article III and the Seventh Amendment right to a jury trial.  MCM Portfolio LLC v. Hewlett-Packard Co., No. 2015-1091 (Fed. Cir. December 2, 2015).  The precedential decision affirms the PTAB’s authority to adjudicate the validity of issued patents.… Continue Reading

IPR Institution Decision Precluded as Evidence in Litigation, Again

No precedential Federal Circuit decision addresses the effect of an IPR institution decision on parallel litigation tried before a jury. As a result, some district courts have allowed IPR institution decisions regarding a patent-in-suit to be presented as evidence in a pending litigation (see Evidence of Denial of IPR Institution Allowed in District Court Infringement Action), … Continue Reading

USPTO Proposes Single APJ Pilot Program for IPR Institution

Citing an interest in improving efficiency, the USPTO published a request for comments on a proposed pilot program that would change the way Inter Partes Review petitions are decided.  Currently, a panel of three administrative patent judges (APJs) consider IPR petitions and determine whether to institute and conduct a trial.  The trial is then conducted … Continue Reading

BRI is Here to Stay: Federal Circuit Confirms Broadest Reasonable Interpretation Standard of Claim Construction for IPRs

A sharply divided Federal Circuit denied Cuozzo Speed Technology’s petition for rehearing en banc on the Broadest Reasonable Interpretation (BRI) standard used in Inter Partes Review (IPR).  Chief Judge Prost and Judges Newman, Moore, O’Malley, and Reyna voted for en banc review, but could not persuade Judges Lourie, Dyk, Wallach, Taranto, Chen, and Hughes to … Continue Reading

Recent Decisions Denying Stay of Litigation Highlight Importance of IPR Petition Timing

Defendants in litigation seeking to take advantage of IPR must file a petition within one year of the date of service of the complaint alleging patent infringement.  Defendants may be tempted to delay filing the IPR petition to avoid revealing strategy early in the litigation proceeding.  Delaying the filing, however, may risk the granting of … Continue Reading

Real Party in Interest – A Strategy For Attacking IPR Petitions.

Recent statistics suggest that approximately two thirds of claims challenged in IPR proceedings are held to be invalid by the PTAB.  For PTAB trials instituted on petitions filed in Art Unit 1600 at the U.S. Patent and Trademark Office, which examines patent applications in the biotechnology and pharmaceutical arts, 100% of the final decisions rendered … Continue Reading
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