Tag Archives: Biologics / Biosimilars

The Headaches in Claiming Antibody-based Inventions Broadly

thumbnail image of DNA strandBy Sandip H. Patel on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
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 … Continue Reading

Proposed Hatch-Waxman Amendment Would Effectively Eliminate IPR Challenges by Generics

By Chelsea M. Murray on Posted in Amendments, Inter Partes Review, Legislation
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 … 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

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

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

Priority Claims Unchallenged In Prosecution Can Be Weak Links

thumbnail image of DNA strandBy William K. Merkel, Ph.D. on Posted in Biotechnology, Inter Partes Review, Post Grant Review
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 … Continue Reading

Status Report on IPR Statistics for the Biotech/Pharma Technology Center

thumbnail image of DNA strandBy Sharon M. Sintich, Ph.D. on Posted in Biotechnology, Inter Partes Review, Post Grant Review
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

Squeezing the ‘Antibody Exception’ to Written Description into a Corner

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Inter Partes Review, Section 112
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 … Continue Reading

Supporting Evidence, Not Counter-Punching, May Be Needed In An IPR

thumbnail image of DNA strandBy William K. Merkel, Ph.D. on Posted in Biotechnology, Inter Partes Review, Post Grant Review, Sections 102/103
In IPR2015-01537, Momenta petitioned for IPR of claims 1-15 of U.S. Patent No. 8,476,239 owned by Bristol-Myers Squibb (BMS) on grounds of obviousness over three references: Cohen, Shire, and Carpenter.  Petitioner also relied on expert testimony.  The claims recite formulations containing CTLA4Ig, which is a stabilized form of a negative regulator (checkpoint inhibitor) of the … Continue Reading

On the Clock: Appellate Standard of Reviewing PTAB’s AIA Trial Decisions

By Sandip H. Patel on Posted in Appeals, Inter Partes Review
Now that Cuozzo Speed Techs., LLC v. Lee has been submitted to the Supreme Court, the next issue that may well make its way to the Court is the propriety of the Federal Circuit’s standard of reviewing the PTAB’s AIA trial decisions. Currently, the Federal Circuit reviews these decisions for substantial evidence. At least four … 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

PTAB Dismisses Biosimilar Company’s IPR Petition Without Prejudice, When Petitioner Loses its Expert

thumbnail image of DNA strandBy Marshall Gerstein on Posted in Biotechnology, Estoppel
The PTAB recently granted Celltrion’s motion to dismiss its IPRs without prejudice, after Celltrion suddenly lost its ability to rely on a key expert declaration.  Celltrion had filed IPR petitions against two patents covering use of Rituxan®, and had sought joinder with pending IPRs filed by Boehringer Ingelheim (BI) against the same patents.  Although Celltrion … Continue Reading

Pharma industry continues efforts to exempt patents from IPR

thumbnail image of DNA strandBy John R. Labbé on Posted in Biotechnology, Inter Partes Review, Legislation
The pharmaceutical industry continues its efforts to exempt pharmaceutical and biotechnology patents from inter partes review (IPR). Neither the House’s Innovation Act nor the Senate’s PATENT Act currently contain any provisions that would exempt particular patents from these proceedings. But as we reported in June, some members of the Senate judiciary committee appear sympathetic to … Continue Reading

Put Away The Blunderbuss – Attention to Detail and Thoroughness Are Needed in Preparing an IPR Petition

By William K. Merkel, Ph.D. on Posted in IPR, Post Grant Review, PTAB
Boehringer Ingelheim filed three petitions attacking patents generally drawn to methods of treating RA patients with rituximab.  The decisions on two of those petitions, i.e., IPR2015-00415 and IPR2015-00417, have been addressed elsewhere.  In IPR2015-00418, the PTAB declined to institute an IPR on the petition’s challenges to the lone claim of U.S. Patent No. 8,329,172, drawn … Continue Reading

Gamble At Your Own Risk – The Danger Of Petition Overkill

thumbnail image of DNA strandBy William K. Merkel, Ph.D. on Posted in Biotechnology, Claim Construction, Institution / Denial, Inter Partes Review, Post Grant Review, Sections 102/103
Boehringer Ingelheim filed the petition at issue in IPR2015-00417 concurrently with the petitions at issue in IPR2015-00415 and IPR2015-00418 to challenge patents protecting methodologies for treating rheumatoid arthritis (RA) with rituximab, an FDA-approved antibody for treating certain cancers.  The IPR2015-00417 petition specifically challenged the fourteen claims of U.S. Patent No. 7,976,838, which are drawn to … Continue Reading

Grinning Patentees Get A Mulligan

thumbnail image of DNA strandBy William K. Merkel, Ph.D. on Posted in Biotechnology, Institution / Denial, Inter Partes Review, Post Grant Review, Sections 102/103
Filed concurrently with the petitions at issue in IPR2015-00417 and IPR2015-00418, Boehringer Ingelheim filed the petition at issue in IPR2015-00415 seeking review of U.S. Patent No. 7,820,161 owned by Genentech and Biogen Idec.  The Board’s institution decision steadily whittled down Boehringer’s varied attacks on the patent.  Ultimately, IPR was granted on 2 of the 36 … Continue Reading

Hatch-Waxman and BPCIA Patents May Be Exempted from Post-Grant Proceedings Under Pending Senate Legislation

thumbnail image of DNA strandBy John R. Labbé on Posted in Biotechnology, Legislation
On Thursday, June 4, the Senate Judiciary Committee approved the Protecting American Talent and Entrepreneurship (PATENT) Act. We previously reported the significant provisions of the bill. Several members of the Judiciary Committee expressed support for a further proposal that would exempt from PTO post-grant proceedings patents that are subject to the Hatch-Waxman or Biologics Price … Continue Reading
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