Genentech

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Celltrion Files Two Additional Petitions for IPR on Genentech’s Trastuzumab Patents

Celltrion has filed petitions for inter partes review of two patents related to Genentech’s trastuzumab: IPR2017-01121, challenging U.S. Patent 7,846,441, and IPR2017-01122, challenging U.S. Patent 7,892,549. According to...more

PTAB Institutes Two IPRs in Hospira v. Genentech Avastin Dispute

Bevacizumab (Avastin®) is the subject of the widely watched “patent dance” dispute between Genentech and Amgen regarding Amgen’s proposed biosimilar. Hospira, however, (now owned by Pfizer) has chosen a different path in...more

BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more

PTAB Institutes IPR of Genentech’s Bevacizumab Patent

The PTAB has instituted inter partes review of Genentech’s U.S. Patent 7,622,115, granting Hospira’s petition in IPR2016-01771. According to the institution decision, the patent is directed to methods for treating cancer in...more

PTAB Institutes IPR in Hospira’s Challenge to Genentech’s Trastuzumab Patent

The PTAB has instituted IPR2016-01837, in which Hospira challenges Genentech’s U.S. Patent 7,807,799. The institution decision extends to all challenged claims, claims 1-3 and 5-11. ...more

Mylan and Genentech Reach Settlement on Cabilly Patent IPR

As we reported yesterday, Mylan announced that it has reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. relating to trastuzumab, which extended to Mylan agreeing to withdraw its IPR challenge to U.S. Pat....more

Mylan Obtains Global License to Trastuzumab in IPR Settlement

Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As...more

Will The Avastin Biosimilar Patent Dance Go On?

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more

IPR Tracker: Mylan and Genentech Settle Humanized Antibodies IPRs

We have been following the IPRs filed by Mylan against Genentech’s U.S. Patent No. 6,407,213, which relates to humanized antibody polypeptides and methods for their preparation and use. On Tuesday, March 7th, the parties...more

Genentech’s BPCIA Complaint Against Amgen Dismissed

Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that...more

Delaware District Court Dismisses Genentech v. Amgen

As we previously reported, yesterday Judge Sleet, United States District Court for the District of Delaware, heard arguments on Amgen’s motion to dismiss in Genentech v. Sandoz. The court orally granted Amgen’s motion under...more

Genentech v. Amgen: Amgen Seeks Dismissal Under Amgen v. Sandoz

As we previously reported, Genentech earlier this month filed a declaratory judgment action against Amgen. In this litigation, Genentech claims that Amgen has violated the patent dance provisions of the BPCIA by disclosing...more

Celltrion Files Petition for IPR of Genentech’s Trastuzumab Patent

Celltrion has filed a petition for inter partes review (IPR2017-00959) of Genentech’s U.S. Patent 8,591,897. According to the petition, the patent is directed to methods of treating a sub-type of breast cancer with a regimen...more

PTAB Denies Institution of IPR on Genentech’s Protein Folding Patent

The PTAB has denied institution of IPR2016-01608, in which Bioeq IP AG sought review of Genentech’s U.S. Patent 6,716,602. That patent is directed to methods for increasing the yield of a heterologous recombinant protein...more

BPCIA Litigation Roundup (Midwinter 2017)

Below is our midwinter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

Hospira Files Two Petitions for Inter Partes Review of Genentech’s Trastuzumab-Related Patents

Hospira filed two petitions for inter partes review of Genentech’s U.S. Patent 7,371,379 (IPR2017-00805) and U.S. Patent 6,627,196 (IPR2017-00804). According to the petitions, these patents are directed to methods of treating...more

Petitioner Must Show Actual Injury to Establish Standing to Appeal PTAB Final Written Decision

In this case, the Federal Circuit determined that in its nearly 35-year history, it had not established the legal standard for demonstrating standing in an appeal from a final agency action. The underlying dispute arose from...more

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

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