News & Analysis as of

Genentech

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

Genentech and Roche Secure FDA Approval of Multiple Sclerosis Drug Ocrevus

On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Ocrevus (ocrelizumab) in treating multiple sclerosis (MS). Ocrevus is a new biologic and is the first drug approved by the FDA to treat...more

FDA Approves Genentech’s Ocrevus (ocrelizumab)

by Goodwin on

FDA announced today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”). Ocrevus is the first drug...more

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

by Goodwin on

Celltrion has filed two additional petitions for inter partes review of Genentech patents related to trastuzumab: IPR2017-01139, challenging U.S. Patent 6,627,196, and IPR2017-01140, challenging U.S. Patent 7,371,379....more

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

by Goodwin on

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

by Goodwin on

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

by Goodwin on

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

by Goodwin on

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

by Goodwin on

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?

by Foley & Lardner LLP 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

by Goodwin on

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

by Goodwin on

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

by Goodwin on

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

by Goodwin on

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

by Goodwin on

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)

by Goodwin on

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

by Goodwin on

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

by Goodwin on

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

by Goodwin on

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

65 Results
|
View per page
Page: of 3
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
Feedback? Tell us what you think of the new jdsupra.com!