News & Analysis as of

Breaking News: PTAB Grants One Petition and Denies Another for Review of Genentech’s Cabilly Patent

Merck Sharp & Dohme filed two petitions for inter partes review of Genentech’s U.S. Patent 6,331,415, one of the “Cabilly Patent,” which claims processes and materials broadly applicable to recombinant antibody manufacturing....more

BioCND to Develop Lucentis® Biosimilar

BioCND, a South Korean biopharmaceutical company, announced on Monday that it will begin clinical development in Korea of ranibizumab, a biosimilar of Genentech’s Lucentis® injection for patients with wet age-related macular...more

IPR Tracker: Genentech Files Preliminary Responses in IPR2016-01693 and IPR2016-01694

On December 16, 2016, Genentech filed preliminary responses in IPR2016-01693 and IPR2016-01694. Mylan filed both IPR petitions in August against patent 6,407,213, which covers humanized antibody polypeptides and methods for...more

Mylan-Biocon Publish Positive Results for Proposed Trastuzumab Biosimilar

Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American...more

Mylan and Biocon Partnership Updates

On November 8, 2016, Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). According to the Mylan press release, this submission is Mylan’s first for a biosimilar in...more

FDA Has Accepted Genentech’s BLA for Subcutaneous Rituximab

The FDA has accepted Genentech’s BLA for a subcutaneous formulation of rituximab. The drug is indicated to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate to severe rheumatoid arthritis, Wegener’s...more

First Circuit Affirms Stringent Rule 9(b) Particularity Requirement in False Claims Act Cases

On June 17, 2016, the First Circuit issued an opinion addressing, among other things, the particularity requirement that applies in False Claims Act (“FCA”) cases where the defendants are not alleged to have directly...more

The new “Pet” on the block: radio imaging with Zirconium-89

This is the third in a series of articles looking at the hot topic of the patenting of radiopharmaceuticals. In this article we are focusing on zirconium-89 (89Zr) labelled molecules, such as antibodies, and their use in...more

Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent

It has been four years since the first inter partes review proceedings were filed in the United States. The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the...more

Hospira Files a Petition for an IPR of Genentech’s Trastuzumab Patent

On September 16, Hospira filed a petition for an inter partes review of Genentech’s U.S. Patent No. 7,807,799 which is directed to methods of purifying proteins, including trastuzumab. Trastuzumab is marketed by Genentech...more

“Cabilly” and Other Foundational Patents in Biologic Drug Production

As we previously reported, over the past year several petitions requesting Inter Partes Review (IPR) of patents that claim foundational inventions for biologic drug production were filed. Here we discuss the scope of two of...more

Hospira Files an IPR Petition Challenging Genentech’s Bevacizumab Patent

On September 9, 2016, Hospira filed a petition for an IPR of U.S. Patent No. 7,622,115, owned by Genentech. The ‘115 patent claims methods of treating various cancers with bevacizumab, which is marketed by Genentech under...more

Board Institutes IPR of Genentech’s Cabilly Patent

On September 8, 2016, the Board instituted an IPR of U.S. Patent No. 6,331,415, one of the Cabilly patents owned by Genentech. The Petitioner in IPR2016-00710 is Mylan. The ’415 patent was the subject of two other IPRS that...more

IPR Update: Genentech Settles Two IPRs on Cabilly Patent

On September 2, 2016, the PTAB terminated IPR2015-01624 and IPR2016-00460, both of which challenged U.S. Patent No. 6,331,415, one of Genentech’s Cabilly patents. The Petitioners in those IPRs were Sanofi-Aventis and...more

PTAB Life Sciences Report - September 2016

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH - PTAB Petition: IPR2016-01665;...more

PTAB Life Sciences Report - August 2016

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Illumina, Inc. v. Scripps Research Institute - PTAB Petition: IPR2016-01619; filed...more

Mylan Files Two Petitions for IPR on Genentech’s Herceptin Patent

Yesterday, Mylan filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According the petitions, the patent is directed to humanized antibodies, and Mylan expects that Genentech will rely on...more

Celltrion Files Petition for IPR on Genentech’s Rituximab Patent

Yesterday, Celltrion filed a petition for inter partes review of Genentech’s U.S. Patent No. 7,976,838, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on...more

IPR Petition Filed on Genentech Patent Directed to Method of Producing Polypeptides

On August 16, bioeq filed a petition for inter partes review of U.S. Patent No. 6,716,602, titled “Metabolic rate shifts in fermentations expressing recombinant proteins.” The patent is owned by Genentech and is directed to...more

Biosimilars Development Updates

We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed...more

CJEU Confirms EU Competition Law Does Not Prevent Royalties for Revoked Patent Licences

On 7 July 2016, the Court of Justice of the European Union (CJEU) ruled that, provided that a licensee is free to terminate a licence agreement on reasonable notice, it can be obliged to pay royalties even after the patent...more

Merck Files DJ Complaint Against Genentech’s Cabilly III Patent

Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody...more

EU Court Rules That Royalties for Unpatented Technology Are Not Necessarily Anticompetitive

On 7 July 2016, the Court of Justice of the European Union (CJEU) handed down a judgment on whether Article 101 of the Treaty on the Functioning of the European Union (TFEU) must be interpreted as precluding effect being...more

CMS Posts Open Payment Data – $7.52 Billion in 2015

CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more

Prosecutors win $67 million settlement with pharma firms accused of deceit

Federal prosecutors have wrung $67 million in a settlement with two pharmaceutical companies accused of deceiving doctors to prescribe a drug that the firms knew would be ineffective in treating lung cancer patients....more

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