News & Analysis as of

Amgen and Allergan Submit European Application for Avastin® Biosimilar

We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more

Claim Terms Are Construed In Erythropoietin Case

Andrews, J. Claim construction opinion issues regarding two terms from one patent. A Markman hearing took place on September 21, 2016. The disputed technology relates to pharmaceutical compositions containing isoforms...more

BPCIA Litigation Roundup (Fall 2016)

Below is our Fall 2016 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 update...more

Apotex Files Reply in Support of Its Petition for Certiorari

On November 21, 2016, Apotex submitted a reply brief in support of its petition for certiorari. A procedural note: the case was also distributed on November 21 for consideration at the Supreme Court’s private conference...more

Scheduling Order Entered in AbbVie v. Amgen

On Thursday, Judge Robinson entered a scheduling order in the AbbVie v. Amgen (adalimumab) case. Among other things, the order sets a 20-day bench trial beginning November 4, 2019....more

Amgen Crystallizes Disagreement in Appeal of Discovery Row

Amgen advanced further arguments in a November 8, 2016 brief before the Federal Circuit, crystallizing the point of disagreement between it and defendant-appellee Hospira. The issue before the court is whether, during...more

Amgen Opposes Apotex’s Petition for Certiorari

On November 8, 2016, Amgen asked the Supreme Court to deny Apotex’s September 9, 2016 petition for review in Apotex v. Amgen, No. 16-332. Apotex had asked the High Court to clarify 42 U.S.C. § 262(l)(8)(A) of the Biologics...more

Amgen and Allergan Submit BLA for Avastin® Biosimilar

As we previously reported, Amgen and Allergan are currently collaborating on four oncology biosimilars, including an Avastin® (bevacizumab) biosimilar, ABP 215. Yesterday, the companies announced the submission of a...more

New Developments in AbbVie’s BPCIA Suit Targeting Amgen’s Humira® Biosimilar

On August 4, 2016, AbbVie filed a complaint against Amgen alleging that Amgen’s Humira® biosimilar Amjevita® infringes ten AbbVie patents. Humira® received FDA approval in 2002 to treat rheumatoid arthritis, juvenile...more

Amgen Files Opposition to Apotex’s Petition for Certiorari

On November 8, 2016, Amgen submitted a brief in opposition to Apotex’s petition for certiorari challenging the Federal Circuit’s application of its holding in Amgen v. Sandoz that subsection (l)(8)(A) of the BPCIA allows an...more

FDA Approves Expanded Use of Amgen’s Enbrel®

Amgen recently announced that the FDA has approved its supplemental Biologics License Application for the expanded use of Enbrel® (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque...more

Hospira Files Responsive Appeal Brief in Amgen v. Hospira Litigation

As we previously reported, Amgen filed an appeal brief challenging the district court’s resolution of its discovery dispute with Hospira and addressing the issue of whether the Federal Circuit had jurisdiction to hear the...more

ABBVIE V. AMGEN: Amgen Agrees To Comply With The BPCIA Notice Of Commercial Marketing Requirements

Today, in the AbbVie v. Amgen adalumimab case, Judge Robinson entered a stipulated order that dismissed Count XI of AbbVie’s Complaint. With its Count XI, AbbVie sought an order compelling Amgen to comply with the “notice of...more

ABBVIE V. AMGEN: The Parties Request A Bench Trial In November 2019

Today, in the AbbVie v. Amgen adalumimab case, the parties filed a joint proposed scheduling order. The parties jointly proposed a bench trial commencing the week of November 4, 2019, with completion of fact discovery by...more

Hospira Fires Back in Appeal of BPCIA Discovery Dispute

In a corrected brief filed October 25, 2016, defendant-appellee Hospira responded to Amgen’s opening brief on the merits seeking to overturn a discovery ruling that kept Hospira’s cell culture media information secret. ...more

Amgen: Unlikely to Launch Amjevita® Biosimilar Before 2018

At yesterday’s earnings call for Q3 2016, Amgen indicated that, due to its ongoing litigation with AbbVie, Amgen is unlikely to launch Amjevita® (adalimumab-atto), its FDA-approved biosimilar of Humira®, before 2018. Amgen...more

Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Mylan and the Biosimilars Council Urge Supreme Court to Overturn Amgen v. Apotex

On October 14, 2016, Mylan Pharmaceuticals and the Biosimilars Council, a subsidiary of the Generic Pharmaceuticals Association (GPhA), filed amicus briefs in support of granting review in Apotex v. Amgen, No. 16-332. As...more

UPDATE: Mylan Files Amicus Brief in Support of Apotex’s Petition in Amgen v. Apotex

Earlier this week, we reported on the amicus curiae brief filed by the Biosimilars Council in support of Apotex’s petition in Amgen v. Apotex. Mylan Pharmaceuticals Inc. has also filed an amicus brief in support of...more

Biosimilars Council Files Amicus Brief in support of Apotex’s Petition for Certiorari in Amgen v. Apotex

As we covered in a previous post, Apotex has filed a cert. petition asking the Supreme Court to review the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex. Last week, the Biosimilars Council...more

Amgen v. Hospira (epoetin alfa): District Court Lets in New Infringement Theories, Not New Defendants

As we previously reported, Amgen has sought to amend its complaint regarding Hospira’s planned epoetin alfa biosimilar to add three new defendants and two theories of infringement. On October 3, 2016, Judge Andrews...more

Litigation Update in Abbvie v. Amgen: AbbVie’s Answer Filed in Response to Amgen’s Counterclaims

Last Friday, AbbVie filed its Answer and Defenses to Amgen’s counterclaims of invalidity and noninfringement for each of the patents-in-suit. Of note, AbbVie stated that it lacked “sufficient knowledge and information to...more

FDA Accepts Coherus’s aBLA for Neulasta® Biosimilar

In August, we reported that Coherus Biosciences, Inc. submitted an aBLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Last week, Coherus announced that FDA has accepted its aBLA. ...more

Amgen v. Apotex: Amgen Appeals Non-Infringement Judgment in Filgrastim/Pegfilgrastim Dispute

Last week, Amgen filed a notice of appeal to the Federal Circuit from the district court’s judgment of non-infringement. The Federal Circuit has docketed the appeal as Case No. 17-1010. Amgen’s opening brief will be due in...more

Amgen Appeals Loss of Neulasta® and Neupogen® Litigation

On October 3, 2016, Amgen filed a Notice of Appeal in the U.S. District Court for the Southern District of Florida and thereby laid the groundwork for its next move in the ongoing Amgen v. Apotex dispute. (D.I. 272.)...more

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