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

PROCESS PATENT LEGISLATION, WITHOUT PARTIALLY PROCESSED PRODUCT PROVISION, WILL BE CONSIDERED BY CONFEREES; DISCLOSURE ISSUE PENDING

Executive Summary

Process patent legislation without a provision on partially processed products is expected to be considered by a House/Senate conference committee shortly. An agreement to remove the provision was reached by staffers for the conferees at a March 2 meeting. The provision was contained in the Senate version of the bill, but not the House version. The legislation is targeted for floor consideration by the end of March. The provision would have allowed retailers or distributors to avoid patent infringement penalties for partially manufactured products in transit or already in possession when notice of infringement is served. The loophole had been criticized by PMA as an incentive for stockpiling. Other changes in anticipation of the conference include an adoption of the Senate language in provisions relating to notice of infringement and limitations to liability for product "users." The Senate version imposes less of a burden on patent owners giving notice of infringement. It stipulates that notice be based on information "sufficient to persuade a reasonable person" that it is "likely" a product was made by an infringing process. The House language had required "actual knowledge" or notice of a "substantial likelihood" that a product was made by an infringing process. Both versions limit infringement penalties against users or retailers by requiring that remedies against importers and non-retail sellers be exhausted first. However, the Senate language, which has been adopted, also defines users as non-commercial entities. One major discrepancy between the House and Senate bills that has yet to be resolved is the disclosure requirement. Senate and House legislation on the infringement of process patents are part of HR 3, the omnibus trade bill. The disclosure requirement, which appears only in the Senate bill, states that patent owners may be asked by an importer to identify all process patents owned or licensed which would be reasonably asserted as grounds for infringement. The Senate bill also stipulates that patent owners must respond to such a request within 60 days. Although Senate staff reportedly has offered to alter certain aspects of the disclosure requirement, they have expressed a determination to keep the provision in the legislation. Another aspect of the trade bill which is due for conference reconciliation is the Senate provision to extend the patent of Warner-Lambert's Lopid (gemfibrozil) for five years, to 1994. The extension for the lipid-lowering drug is not in the House bill. That provision continues to meet with opposition from Rep. Kastenmeier (D-Wis.) and is therefore not likely to be reconciled at the staff level. To satisfy Kastenmeier's earlier concern that the legislation be considered in the House prior to the conference committee stage, a separate bill was introduced by Rep. Derrick (D-S.C.) and discussed at an Oct. 8 hearing held by the House Judiciary/Courts subcommittee, which Kastenmeier chairs. Kastenmeier has indicated he retains the additional concern that the Lopid extension will be viewed as a precedent by other drug companies despite assurances to the contrary. The subcommittee has yet to mark up the Derrick bill.

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

LL1133990

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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