Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

AMGEN INTERLEUKIN-2 PATENT SUIT AGAINST CETUS

Executive Summary

AMGEN INTERLEUKIN-2 PATENT SUIT AGAINST CETUS seeks a declaratory judgement that three of Cetus' four interleukin-2 patents are invalid and/or not infringed by the interleukin-2 under development by Amgen, according to the Aug. 29 complaint filed in San Francisco Federal Court. The filing states that Amgen seeks "a declaration that U.S. [Patents 4,518,584, 4,530,787, and 4,569,790 are] invalid, unenforceable and not infringed by Amgen." The suit makes three citations: a patent entitled "Human Recombinant Interleukin-2 Muteins," issued May 21, 1985; a patent entitled "Controlled Oxidation of Microbially Produced Cystein-Containing Proteins," issued July 23, 1985; and a patent entitled "Process for Recovering Microbially Produced Interleukin-2 and Purified Recombinant Interleukin-2 Compositions," issued to Cetus Feb. 11, 1986. Cetus said it has a fourth interleukin-2 patent, related to the formulation of its product, which is not being challenged by the Amgen suit. Amgen alleges that the three patents "are each invalid: (a) for failure to satisfy one or more of the conditions for patentability specified in Chapter 10 of Title 35, United States Code, and/or (b) for failure to satisfy one or more of the requirements of Chapter 11 of Part II of Title 35, United States Code, and/or (c) for being otherwise in violation of one or more Sections of Title 35, United States Code." Cetus said it is currently the only company to hold U.S. patents for DNA-produced interleukin-2. The company noted that it has not filed patent infringement suits against Amgen regarding its interleukin-2 product. However, Amgen said that Cetus notified the company that it was violating certain of Cetus' interleukin-2 patents. The suit states that "on information and belief Cetus . . . has charged that certain recombinant human interleukin-2 products manufactured and sold by Amgen infringe [the three patents] and has threatened suit against Amgen under said patents." The patents "are not and have not been infringed by Amgen and/or are not enforceable against Amgen," the complaint states. Amgen, which is developing its interleukin-2 under a joint venture with J&J, and Cetus are among at least 11 companies, or joint venture/collaborative effort groups, working on the development of an interleukin-2 product. Those firms include: Genentech; Biogen; Roche/Immunex; Collaborative Research/Triton Biosciences; Chiron; Viragen; Liposome Technology; Quidel; and Sandoz/Genetics Institute. Six of the firms are currently in clinicals with their interleukin-2 products -- Cetus, Amgen/J&J, Genentech, Biogen, Collaborative Research/Triton Biosciences, and Roche/Immunex. Amgen's suit against Cetus marks one of the first patent infringement disputes in the biotech drug field to reach the courts. Earlier this year, Genentech filed a suit against Burroughs Wellcome in Britain alleging infringement of its tissue plasminogen activator patent in that country. Roche and Schering, however, took a different approach in addressing their potential patent conflict for related DNA products. Prior to the approval of their DNA-produced alpha interferons, the two firms agreed not to file patent infringement claims against each other ("The Pink Sheet" May 20, 1985, p. 3).

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1134025

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel