Timothy J. Shea

Timothy J. Shea

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Contact  |  View Bio  |  RSS

Latest Publications


Amgen v. Apotex – what is the outcome when biosimilar applicants actually dance?

On August 6, 2015, Amgen sued Apotex in the US District Court for the Southern District of Florida for patent infringement related to Apotex’s pegfilgrastim product, which is purported to be biosimilar to Neulasta®. What is...more

8/17/2015 - Amgen Apotex Biosimilars BPCIA Commercial Marketing Patent Dance Patent Infringement Patents

Act II: Oral Argument in Amgen v. Sandoz is heard at the Court of Appeals for the Federal Circuit

The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument...more

6/5/2015 - Amgen Appeals Biosimilars BPCIA Commercial Marketing Exclusive Remedy FDA Notice Requirements Oral Argument Sandoz Sandoz v Amgen Statutory Interpretation

FDA releases additional draft guidance regarding implementation of BPCIA

On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of...more

5/26/2015 - Biosimilars BPCIA Draft Guidance FDA Generic Drugs Pharmaceutical Industry

Federal Circuit Grants Injunction Keeping Sandoz’s Biosimilar Version of Neupogen Off Market Until Appeal Decided

The Federal Circuit yesterday granted Amgen’s motion for a preliminary injunction to keep Sandoz’s biosimilar form of Neupogen off the market until the Court renders its decision on the merits of the appeal. The parties had...more

5/7/2015 - Amgen Appeals Biosimilars BPCIA FDA Preliminary Injunctions Sandoz Sandoz v Amgen

FDA Finalizes Guidance Documents on Biosimilarity

On Tuesday, and over three years after the initial guidance documents were released, the US Food and Drug Administration released final versions of three guidance documents discussing how FDA will evaluate applications for...more

5/4/2015 - Biosimilars FDA Final Guidance

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

3/23/2015 - Amgen Biologics BPCIA Commercial Marketing Conversion Dismissals FDA FDA Approval Notice Requirements Patent Infringement Patent Litigation Patents Preemption Preliminary Injunctions Sandoz Sandoz v Amgen Unfair Competition

FDA Approves First US Biosimilar but Court Action Could Delay Market Entry

On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more

3/12/2015 - Amgen Biosimilars BPCIA FDA Preliminary Injunctions Prescription Drugs Sandoz Sandoz v Amgen

Federal Circuit’s Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

On Friday, December 5, the U.S. Court of Appeals for the Federal Circuit rendered its decision in Sandoz v. Amgen, No. 2014-1693, a case with major implications for the emerging U.S. biosimilars industry. The decision...more

12/10/2014 - Appeals Biosimilars BPCIA FDA Patents Pharmaceutical Patents Sandoz

FDA Releases Guidelines for 12-Year Period of Reference Product Exclusivity for Section 351(a) Biologics

The U.S. Food and Drug Administration (“FDA”) has released its latest “Guidance for Industry” regarding the FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which established an...more

8/15/2014 - Biologics Biosimilars Exclusive Use FDA Guidance Update Product Exclusivity

FDA Releases New Guidance for Biosimilar Applications

Yesterday, the U.S. Food and Drug Administration provided further clarity as to how it will evaluate applications for approval of biosimilars when it released a draft guidance document outlining the types of clinical...more

5/14/2014 - Biosimilars BPCIA FDA Guidance Update

7 Intellectual Property Mistakes Startup Entrepreneurs Often Make

What’s the biggest mistake startup entrepreneurs make with respect to their intellectual property, and what can they do to fix it? That’s the question we recently put to IP attorneys writing on JD Supra, knowing that the...more

2/3/2014 - Business Formation Copyright First-to-File Legal Perspectives Patents Startups Trademarks USPTO

11 Results
View per page
Page: of 1

"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 to create your digest using LinkedIn*

*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.