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Heather R. Kissling

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Heather R. Kissling draws from over fifteen years of experience securing biotechnology patents to develop worldwide filing and prosecution strategies that further her clients’ business objectives. She actively collaborates with bench scientists, business development personnel, and in-house counsel to maximize protection of biotechnology innovations in a broad range of technologies. Her background in interference and opposition proceedings also benefits clients seeking advice with respect to competitor patent positions and third party challenges in the patent office. Read full bio here.

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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, and Pfizer, all with competing biosimilar candidates, have filed IPR petitions challenging patents reportedly covering trastuzumab.  Recently, the PTAB granted a petition filed by Hospira (subsidiary of Pfizer) to institute IPR of U.S. Patent No 7,807,799 (“the ’799 patent”), directed to protein A affinity chromatography.  Hospira, Inc. v. Genentech, Inc., IPR2016-01837, Paper No. 19 (April 7, 2017).
Continue Reading PTAB Grants Hospira Petition to Institute IPR of Genentech Antibody Purification Patent

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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 institute phase, the PTAB ultimately determined in its Final Written Decision that the Petitioner did not meet its burden in proving the unpatentability of the challenged claims.
Continue Reading Another VIMOVO® Patent Survives Challenge by Coalition for Affordable Drugs – Updating the CFAD Scorecard

Phenylephrine Hydrochloride (resized)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 petitioners to rely on arguments commonly used to invalidate biotechnology and pharmaceutical patents in litigation.  Here, however, the PTAB instituted PGR based only on obviousness grounds, and ultimately determined that the petitioner did not meet its burden in proving the unpatentability of the challenged claims.
Continue Reading PTAB Issues First Biotech/Pharma Post-Grant Review Final Written Decision – All Claims Survive

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 in B.R.A.H.M.S. Gmbh v. Becton, Dickinson & Co., PGR2016-00018.

The petitioner requested PGR of claims 1-12 of U.S. Patent No. 9,091,698, directed to a method for the advanced detection of sepsis in a systemic inflammatory response syndrome (SIRS)-positive subject involving measuring procalcitonin levels and one or more clinical markers over multiple time points, wherein an increase in the amount of procalcitonin from a previous amount over a 24-hour interval detects sepsis. 
Continue Reading PTAB Institutes Third Biotech/Pharma Post-Grant Review

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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 if at first you don’t succeed, try again at the Federal Circuit.  Husky Injection Molding Systems Ltd. v. Athena Automation Ltd., 2015-1726, 2015-1727 (Fed. Cir. Sep. 23, 2016). (As we will discuss separately, on the Patent Owner’s cross-appeal, the Federal Circuit determined that it lacked authority to review the PTAB’s refusal to extend the equitable doctrine of assignor estoppel to PTAB proceedings.)
Continue Reading PTAB Failed to Properly Apply Incorporation by Reference Standard for Anticipation

Equal Arm _ Balance ScaleThe 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 properly weigh certain facts found in reaching its decision.  On the other hand, the Federal Circuit will not hesitate to vacate and remand PTAB decisions where the PTAB does not adequately describe its reasons for concluding a claimed invention is obvious. 
Continue Reading Federal Circuit Refuses to Reweigh Factual Findings, But PTAB’s Conclusory Statements Are Insufficient

stamp denied with red text on whiteWe 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 En Banc Rehearing Petition Denied – PTAB Retains Authority to Institute IPR and Issue Final Decision

Gavel and a PulleyThe 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 highlight an attractive grounds for appealing a PTAB’s final written decision.
Continue Reading Federal Circuit to PTAB – Explain yourself!!

The PTAB’s final written decision in Ariosa Diagnostics, Inc. v. Illumina, Inc., IPR2014-01093, should serve as a reminder to Petitioners challenging claims under 35 U.S.C. § 102(e) – take care to establish that your reference is prior art. 
Continue Reading Failure to Establish Published U.S. Application is Prior Art Dooms IPR under Dynamic Drinkware

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

Resources & Info

Arthrex and the Supreme Court Resource Center

In United States v. Arthrex, Inc., the Supreme Court has heard whether 125+ PTAB decisions rendered through October 2019 must be remanded for new decisions. Read about how that issue developed through our post.

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Our Team

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.