Timothy J. Shea

Timothy J. Shea

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

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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 Section 351(a) Section 351(k)(7)

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provided further clarity as to how it will evaluate applications for approval of biosimilars when it released a draft guidance document outlining the types of clinical...more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

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