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Genentech

Genentech’s Complaint Against Amgen Regarding MVASI® (bevacizumab-awwb)

by Goodwin on

We reported earlier this month that, in early October, Genentech filed a complaint under seal against Amgen in the District of Delaware based on Amgen’s FDA-approved aBLA for MVASI® (bevacizumab-awwb), a biosimilar of...more

Under What Circumstances Can a Private Qui Tam Plaintiff Overrule Government Agency Experts' Use of Administrative Discretion to...

• How have appellate courts applied the Supreme Court’s ruling in Escobar? • If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more

Genentech Files a Complaint Against Amgen in Delaware Regarding MVASI® (bevacizumab-awwb)

by Goodwin on

We previously reported that on October 6, 2017, Amgen filed a declaratory judgment action against Genentech regarding Amgen’s recently approved biosimilar of Avastin® (bevacizumab-awwb). On the same day, Genentech filed a...more

Amgen Files DJ Complaint Against Genentech Regarding Mvasi® (bevacizumab-awwb)

by Goodwin on

On Friday, October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that Mvasi® (bevacizumab-awwb), Amgen’s recently approved biosimilar of Avastin®, does not...more

Samsung Files Petition for IPR on Genentech Carter Patent

by Goodwin on

Last Friday, Samsung Bioepis filed IPR2017-02139 and IPR2017-02140, directed to Genentech’s U.S. Patent No. 6,407,213. According to the petitions, the ’213 patent claims are directed to “humanized antibodies with non-human...more

Recent IPR Updates

by Goodwin on

The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

FDA Approves Amgen’s Biosimilar of Avastin®

by Goodwin on

Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of...more

BPCIA Litigation Roundup (Summer 2017)

by Goodwin on

Below is our summer 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

Samsung Bioepis Files for Joinder With Hospira Petitions Against Genentech Patents

by Goodwin on

Samsung Bioepis has filed three petitions for IPR challenging Genentech patents related to the use of Herceptin® (trastuzumab): IPR2017-01958, challenging U.S. Patent 6,627,196; IPR2017-01959 challenging U.S. Patent...more

Hospira Finds Mixed Results in Instituting IPRs Against Genentech Patents for Herceptin®

by Knobbe Martens on

Hospira (owned by Pfizer) filed five IPR petitions against Genentech patents that Genentech asserted were directed to Herpceptin® (trastuzumab). The PTAB has now instituted IPRs in three of the five petitions and denied the...more

Genentech to Defend 3 of 4 Herceptin® Patents Challenged by Hospira

by Jones Day on

At least 19 IPRs have been filed against seven of Genentech’s patents covering its blockbuster antibody drug Herceptin® (trastuzumab). On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. (a subsidiary of Pfizer)...more

Board Grants Hospira Mixed Results on its Five Petitions for IPR of Genentech’s Trastuzumab Patents

by Goodwin on

The Board granted Hospira a mixed result in its numerous challenges to Genentech’s patents directed to different aspects of Genentech’s trastuzumab product: ...more

Pfizer Files Two Petitions for IPR of Genentech’s Trastuzumab Patent

by Goodwin on

Pfizer has filed two petitions for IPR of U.S. Patent 8,591,897, owned by Genentech: IPR2017-01726 and IPR2017-01727. According to the petitions, the ‘897 patent is directed to methods for treating patients with...more

Third Circuit Recognizes Escobar “Heightened Materiality Standard” in Dismissal of False Claims Act Case Tied to Avastin

In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower...more

Pfizer files two IPR petitions on Genentech’s Patent Directed to Methods of Making Humanized Antibodies

by Goodwin on

Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized...more

BPCIA Litigation Roundup (Spring 2017)

by Goodwin on

Below is our spring 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

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

by Goodwin on

Earlier this week, Celltrion filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According to Celltrion’s petitions, the patent is directed to humanized antibodies. ...more

Baxalta Sues Genentech & Chugai for Infringment of Patent Relating to Emicizumab

by Goodwin on

On Thursday, May 4, 2017, Baxalta, a wholly-owned subsidiary of Shire, filed a complaint (available here) against Genentech and Tokyo-based Chugai Pharmaceutical in the U.S. District Court for the District of Delaware. The...more

Escobar in Action – Materiality is a Tall Hurdle to Clear

by Butler Snow LLP on

In the recent Third Circuit decision United States of America, ex rel. Gerasimos Petratos, et al. v. Genentech Inc; et al., No. 15-3805, 2017 WL 1541919 (3d Cir. May 1, 2017), the Third Circuit addressed a “false...more

Merck Sharpe & Dohme and Genentech Jointly Move to Terminate Cabilly IPR

by Goodwin on

Merck Sharpe & Dohme and Genentech have filed a Joint Motion to Terminate IPR2016-00710, relating to U.S. Patent No. 6,331,415. As we reported earlier, the ‘415 patent is known as one of the “Cabilly” patents, and is...more

Third Circuit joins other circuits in enforcing Escobar's strict materiality requirement

by DLA Piper on

The Third Circuit has affirmed the district court's dismissal of a relator's claims in United States ex rel. Petratos, et al. v. Genentech Inc, et al, a False Claims Act (FCA) case alleging that the defendants-appellees...more

Third Circuit Weighs in on Materiality for First Time Since Escobar

by Pepper Hamilton LLP on

A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more

Delaware Court Declines to Enter “Judgment” in Genentech v. Amgen

by Goodwin on

We have previously reported on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint. In its letter, Genentech requested entry of judgment without...more

Amgen Responds to Genentech’s Letter in Bevacizumab Case

by Goodwin on

As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of...more

Genentech Will Not File Amended Complaint in Case Against Amgen

by Goodwin on

As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal...more

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