Biologics / Biosimilars

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Headaches in Claiming Antibody-based Inventions Broadly

Recent Federal Circuit decisions call into question the value of patents broadly claiming inventions on antibodies and their function in treating debilitating diseases. The decisions in these cases originated in district courts and arguably swept aside the merits of scientific breakthroughs because the inventions claimed were not enabled or were otherwise insufficiently described to justify their broad breadth.* In Teva Pharmaceuticals Int’l GmbH v. Eli Lilly and Company, Appeals 2020-1747, -1748, and -1750 (Fed. Cir. Aug. 16, 2021), the Federal Circuit again dealt with patents broadly claiming antibodies.
Continue Reading The Headaches in Claiming Antibody-based Inventions Broadly

On June 13, 2018, Senator Orrin Hatch (R-UT) introduced to the Senate Judiciary Committee an amendment to restore the careful balance sought in the Hatch-Waxman Act, which provided incentives for both pharmaceutical innovation and drug affordability. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would modify the IPR process for pharmaceuticals—under Hatch-Waxman and the BPCIA—and would amend sections of the Federal Food, Drug and Cosmetic Act that provide abbreviated pathways for generic drug and biosimilar product approval.
Continue Reading Proposed Hatch-Waxman Amendment Would Effectively Eliminate IPR Challenges by Generics

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’ failure to establish the prior art status of the product label for RITUXIN®, which contains rituximab.
Continue Reading Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication”

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

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 from the parties’ competing expert witnesses in favor of the Petitioner (Eli Lilly and Company), thus highlighting how the PTAB’s scientific acumen can be leveraged to effectively short-circuit an otherwise expensive and time-consuming lawsuit.
Continue Reading Eli Lilly Successfully Challenges U Penn Erbitux® Claims at PTAB, Derailing Infringement Suit

Illustration and Painting

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 discretion to terminate three reexaminations filed against patents also challenged by IPR in Ariosa Diagnostics, Inc. v. Illumina, Inc., IPR2014-01093, Paper 81 (May 24, 2016).  In the pending appeal, the stage is set for the Federal Circuit to consider the extent of the PTAB’s discretion in terminating post-grant proceedings in these circumstances.  Case Nos. 2016-2388, 2017-1020 (Fed. Cir.).
Continue Reading PTAB Exercised Discretion to Terminate Ex Parte Reexaminations in Ariosa v. Illumina; CAFC to Review

Glass vials for liquid samples. Laboratory equipment for dispensing fluid samples. Shallow depth of field.

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

A breaking chain link can symbolise failure or success. It?s a strong image expressing the famous weakest chain link, breaking free from a bad habit or finally succeeding / failing in a project.

IPR2015-00291 decided a petition filed by Daiichi Sankyo Co. Ltd. against USPN 8,168,181 owned by Alethia Biotherapeutics, Inc.  The ‘181 patent issued from a continuation-in-part of the U.S. national phase of a PCT application and contains claims drawn to methods of impairing osteoclast differentiation, useful in treating various bone diseases.  The Board denied the Patent Owner’s priority claim and found an attempt to antedate intervening art inadequate, leading to a holding that the ‘181 claims were unpatentable under 35 U.S.C. § 102(a).  The decision illustrates the potential of intervening art not considered during prosecution and also illustrates the shifting legal view of the patentability of antibody-based technologies.
Continue Reading Priority Claims Unchallenged In Prosecution Can Be Weak Links

US Patent and Trademark Office in Alexandria, VA.

On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided a status report on Inter Partes Review/Post Grant Review in the Biotechnology and Chemical Technology Center 1600 during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference.  The statistics discussed during this BCP Conference are current as of May 31, 2016. 
Continue Reading Status Report on IPR Statistics for the Biotech/Pharma Technology Center

A businessman panics after realizing he's painted himself into a corner.

The PTAB has continued the trend of pushing the -“antibody exception” to written description into an ever-smaller corner. Claims to methods of using antibodies that bind Siglec-15 to impair osteoclast differentiation and inhibit bone resorption were deprived of priority because the parent application failed to disclose the “antigenic regions useful for generating antibodies having the desired functional properties.” Consequently, the claims were anticipated by the cited reference under 35 U.S.C. §102(a), and Patentee’s other evidence of prior conception, diligence and reduction to practice was insufficient to antedate the reference. Daiichi Sankyo Co., Ltd. v. Alethia Biotherapeutics, Inc., IPR2015-00291 (Paper No. 75, June 14, 2016) (final written decision).
Continue Reading Squeezing the ‘Antibody Exception’ to Written Description into a Corner

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.