Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

GENENTECH PROTROPIN PATENT COVERS DNA PROCESS

Executive Summary

GENENTECH PROTROPIN PATENT COVERS DNA PROCESS used in the production of the human growth hormone, Genentech maintains. Hoffmann-LaRoche and Hormone Research Foundation sued Genentech for patent infringement in California District Court on Sept. 5. Genentech contends that it has a process patent covering DNA production of Protropin. According to Genentech, the Roche suit is based on a patent held by Hormone Research that covers only human growth hormone synthesized through chemical means. The Roche suit asserts that Genentech is infringing Hormone Research's December 1974-issued patent entitled "Synthetic Human Growth-Promoting and Lactogenic Hormones and Method of Producing Same." According to the complaint, Hormone Research, a not-for-profit research group based in Berkeley, California, granted Roche exclusive rights to the patent in 1982. The patent was filed in 1971. The complaint alleges that Genentech is infringing the patent by "conducting clinical trials on synthetic human growth hormone formulated in pharmaceutical preparations designated 'Protropin' and submitting [an NDA for the product] to obtain arpproval . . . for the commercial manufacture, use or sale of such pharmaceutical preparations before the expiration of [Hormone Research's patent] and/or by making, using and/or selling pharmaceutical preparations designated 'Protropin' as well as synthetic human growth hormone that is used in formulating such compositions." Protropin (methionyl human growth hormone) was approved in October 1985. In less than three months of marketing in 1985, Genentech reported Protropin sales of approximately $5 mil. With sales of approximately $17 mil. during the first six months of 1986, Protropin volume is annualizing at between $30-$40 mil. Roche and Hormone Research are requesting that Genentech be "permanently restrained and enjoined from further infringement of U.S. Patent 3,853,833." The suit also seeks a damage award "to compensate plaintiffs for defendant's infringement of said patent." Genentech noted in a press release that it "had previously rejected Roche's offer of a license under the patent because the company does not believe the patent is infringed."

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS010756

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