Posts Tagged: biosimilars


Did the Federal Circuit doom Amgen’s Enbrel® monopoly?

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned …
By Zachary Silbersher
1 month ago 1

IP Strategy is a Tricky Balancing Act for Pharmaceuticals

The 20 years of protection afforded by a patent is intended to promote innovation by allowing inventors a chance to recoup development costs and derive a profit from …
By Shai Jalfin
4 months ago 2

CAFC denies Amgen discovery in biosimilar patent dispute

In a patent infringement case governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Federal Circuit found that it lacked jurisdiction to compel discovery …

SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(…

Industry Reaction to SCOTUS decision in Sandoz v. Amgen

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry …
By Gene Quinn
6 months ago 2

Understanding the BPCIA Litigation Pathway to Avoid Expensive, Incurable Mistakes

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, …

Courts Answer Key Questions Over the Reach of the BPCIA

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal …

Biologics Applicant Must Give Post-Approval Notice to Reference Product Sponsor

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would …

The Amgen Quagmire: Federal Circuit Rules Patent Dance Does Not Excuse Biosimilar Applicants from Providing Notice of Intent to Market

The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation …

Clinical Trials and Tribulations: Why IP Protection is Critical to the Future of Biologic Medicine

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the …
By Dr. Kristina Lybecker
2 years ago 3

IP Protection for Biologics in the TPP: Trading Away Future Treatments and Cures

Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. …
By Dr. Kristina Lybecker
2 years ago 5

Trans-Pacific Partnership – What do IP practitioners need to know?

Trade partners negotiating the Tans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been released, and likely will not be submitted to Congress …
By Gene Quinn
2 years ago 4

Obama Administration Caves on Data Exclusivity in Historic TPP Trade Deal

In order to reach an agreement the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently the United …
By Gene Quinn
2 years ago 3

The Need for Regulatory Data Protection in the TPP: Why Australia’s Got it All Wrong

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe …
By Dr. Kristina Lybecker
2 years ago 1

The Sticking Point that Shouldn’t Be: The Role of Pharmaceutical Patents in the TPP Negotiations

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. …
By Dr. Kristina Lybecker
2 years ago 2