Obviousness Biotechnology

News & Analysis as of

An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar

On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Double Patenting Decision Delivers Bitter Pill To Antibody Patent

In a recent decision on obviousness-type double patenting, Judge Wolf shortened the shelf life of a dispute between Janssen Biotech, Inc. (“Janssen”) and Celltrion Healthcare Co. Inc. (“Celltrion”), relating to a...more

Packing Your Patent Application for Europe: Avoiding Problems Under European Patent Law

Planning an extended European vacation for your patent application? A lengthy stay in Munich with possible outings to The Hague, Berlin, Vienna, or Brussels? While your patent application won’t be strolling through the...more

Federal Circuit Offers Path Through Section 101 Thicket for Biotech Method Patents

In its July 5, 2016 decision in Rapid Litigation Management Ltd and In Vitro, Inc. v. CellzDirect, Inc. and Invitrogen Corp., the Federal Circuit held that patent claims directed to an improved method of cryopreserving...more

United States BioPharma Patents - Quick Tips and News - Nov/Dec 2013

A. Three Tips for Overcoming U.S. Obviousness Rejections - 1) Argue no PFO first: Always argue down existence of an Examiner-asserted presumption of prima facie obviousness (PFO), before going on to second-step...more

Federal Circuit Upholds Board Determination That Biotechnology Invention Was Obvious

In In re Droge, the Federal Circuit upheld the decision of the USPTO Board of Patent Appeals and Interferences that found that claims directed to recombinant biotechnology methods were obvious. At 8 pages, the decision is one...more

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