Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
INCYTE CORPORATION V. SUN PHARMACEUTICAL INDUSTRIES, LTD. - Before Moore, Prost and Hughes. Appeal from the United States District Court for the District of New Jersey. A district court erred in issuing a preliminary...more
United Therapeutics Corp. (UTC) and Liquidia Technologies Inc. have been battling for close to a decade over their respective inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treatment of...more
Ingenico Inc., et al. v. IOENGINE, LLC, No. 2023-1367 (Fed. Cir. (D. Del.) May 7, 2025). Opinion by Hughes, joined by Dyk and Prost. Ingenico filed a declaratory judgment action against IOENGINE relating to two patents owned...more
Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge’s questions, as reported...more
The enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010 established for the first time ever in the US an abbreviated pathway for obtaining FDA approval of a new biological product that is deemed...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
On July 6, 2017, Hospira filed a publically available redacted version of its brief responding to Amgen’s motion for a preliminary injunction (PI). As we previously reported, following the Supreme Court’s decision in Sandoz...more
Yesterday, in Amgen v. Hospira, Amgen filed a redacted copy of Amgen’s amended opening brief in support of its motion for preliminary injunction (PI). As we previously reported, Amgen filed a revised brief because the Supreme...more
On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more
In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more
Yesterday’s unanimous ruling by the U.S. Supreme Court in Sandoz v. Amgen injects much needed certainty into a difficult statute and streamlines the process for biosimilar products to enter the marketplace following FDA...more
In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more
The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more
In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more
Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more
WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more
As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...more
In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more
As we posted on July 5, 2016, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of...more
Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval July 06, 2016 According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars....more
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016. A year prior to the approval, Janssen filed a motion for summary judgment and...more
The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more
In Amgen v. Apotex, Judge Cohn of the Southern District of Florida recently enjoined Apotex from selling its proposed biosimilar of Amgen’s Neulasta for 180 days following FDA approval. In Amgen v. Sandoz, 794 F.3d 1347...more
Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the...more