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USPTO to Patent Owners – Don’t Forget About Reexams and Reissues

By Heather R. Kissling on Posted in Amendments, Ex Parte, Inter Partes Review, IPR, Reexamination
Recently updated statistics from the USPTO provide little comfort for patent owners seeking to amend claims during an IPR proceeding.  The Motion to Amend Study, Installment 5 through FY2018, updated March 2019, reports that patent owners have filed a motion to amend in 326 of the 3,599 completed trials (9%) and in 90 of the … Continue Reading

Trade Show Publication Dooms Patent in IPR Appeal Despite Contrary Decision in ITC Appeal

By Heather R. Kissling on Posted in Inter Partes Review, Printed Publication, Sections 102/103
Inter partes review not only provides a faster and cheaper way to challenge patent validity, but also expands the Patent Office’s ability to develop law on esoteric issues relating to prior art. The Federal Circuit’s decision Nobel Biocare Services AG v. Instradent USA, Inc. is another in a line of cases arising out of IPR … Continue Reading

PTAB Issues First Biotech/Pharma PGR Final Written Decision Based On Written Description Challenge

By Heather R. Kissling on Posted in Post Grant Review, Section 112
The Patent Trial and Appeal Board has received 37 petitions for post grant review of patents issuing from examination conducted by the Patent Office’s Group Art Unit 1600. The Board has issued four final written decisions thus far.  We discussed the first final written decision here, where all claims were upheld in the face of … Continue Reading

Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication”

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, Sections 102/103
A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018). The PTAB determined that the Petitioners failed to establish that the challenged claims of the patent were obvious over prior art, in part, because of the Petitioners’ … Continue Reading

First Derivation Proceeding Instituted by PTAB

By Heather R. Kissling on Posted in Institution / Denial
March 13, 2018, marked the fifth anniversary of the transition from the previous “first to invent” system to the AIA’s “first to file” regime.  The PTAB seemingly marked the occasion by instituting the first ever derivation proceeding one week later in Anderson Corporation v. GED Integrated Solutions, Inc., Case DER2017-00007, Paper 32 (March 21, 2018). … Continue Reading

PTAB Defines Further Limitation to Sovereign Immunity Defense

By Heather R. Kissling on Posted in Inter Partes Review
PTABWatch Takeaway: Sovereign immunity is not available to dismiss an IPR challenge where the Patent Owner has filed an infringement action against the Petitioner. Ericsson v. Regents of the University of Minnesota, IPR2017-01186, -01197, -01200, -01213, -01214, and -01219 (Dec. 19, 2017). The Eleventh Amendment was rarely mentioned in the same breath as patent law … Continue Reading

Eli Lilly’s Pemetrexed Therapy Claims Survive Challenge At PTAB

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
The Federal Circuit’s decision in Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) attracted much attention for applying the theory of divided infringement in the context of pharmaceutical therapeutic regimen claims.  Before the Federal Circuit decision, a scrum of petitioners successfully petitioned for IPR of the Lilly patent, … Continue Reading

Assertion of “Routine Optimization” Without Additional Reasoning Insufficient to Support Obviousness Conclusion

By Heather R. Kissling on Posted in Appeals, Sections 102/103
Recent Federal Circuit decisions reversing or remanding PTAB holdings of obviousness have faulted the Board for failing to clearly articulate its reasoning.  See our previous posts here and here.  In In re Stepan Co., No. 2016-1811 (Fed. Cir. Aug. 25, 2017), a split CAFC panel vacated a PTAB ex parte appeal decision affirming an obviousness … Continue Reading

Eli Lilly Successfully Challenges U Penn Erbitux® Claims at PTAB, Derailing Infringement Suit

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
The PTAB recently canceled the University of Pennsylvania’s U.S. Patent No. 7,625,558, a potentially fatal blow to the University’s suit against Eli Lilly and Company alleging its cancer therapeutic Erbitux® (centuximab) infringes the patent.  Eli Lilly and Co. v. Trustees of the Univ. of Penn., Case IPR2016-00458 (July 13, 2017). The PTAB’s decision resolved testimony … Continue Reading

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

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, IPR
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

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
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

By Heather R. Kissling on Posted in Inter Partes Review, IPR, Sections 102/103
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

By Heather R. Kissling on Posted in Post Grant Review, Sections 102/103
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

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Post Grant Review, Section 112
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

By Heather R. Kissling on Posted in Appeals, Inter Partes Review, IPR, Sections 102/103
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

By Heather R. Kissling on Posted in Inter Partes Review, Sections 102/103
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

By Heather R. Kissling on Posted in Institution / Denial, Inter Partes Review
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!!

By Heather R. Kissling on Posted in Appeals, Inter Partes Review, Sections 102/103
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

thumbnail image of DNA strandBy Heather R. Kissling on Posted in Biotechnology, Sections 102/103
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

By Heather R. Kissling on Posted in Institution / Denial, Inter Partes Review, Legislation
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

By Heather R. Kissling on Posted in 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

By Heather R. Kissling on Posted in Inter Partes Review
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

By Heather R. Kissling on Posted in Institution / Denial, Inter Partes Review
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
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