WASHINGTON - The FDA's decision to permit pioneer drugmakers to retain their patent protection for three additional years isbeing hailed by some members of the prescription drug and biotechindustry as another victory for full patent protection. (See BioWorldToday, May 25, 1995, p. 1.)

However, the generic drug industry is furious that the FDA grantedpharmaceutical houses an extra three years on their monopoly tomarket certain products.

The resulting controversy has already stirred up promises from Sen.David Pryor (D-Ark.) that he will try to rush legislation throughCongress to override the FDA's May 25 decision. Sen. Orrin Hatch(R-Utah), Senate Judiciary Committee chairman, which hasjurisdiction over patent law, told the FDA on Jan. 19 that he supportsthe interests of the pioneer drug manufacturers.

Several biotechnology products have received patent protection onlywithin the past few years and so the issue of loss of patent protectionseems remote.

However, two lawyers for biotech companies and pharmaceuticalcompanies who asked to remain anonymous are taking the longerview. They anticipate that legislation will result from the controversyunleashed by the FDA's decision. That legislation would open theway for Congressional action on a number of patent issues importantto the biotech industry, a biotech lawyer told BioWorld Today.

The lawyers are hopeful they will be able to convince Congress tomitigate any legislation or international trade agreements that erodethe terms of patent protections. Japanese patents are targeted becausethey are drawn very narrowly and offer U.S. firms little or noprotection, according to an industry attorney.

However, such legislation must be built on support from the membersof the Biotechnology Industry Organization (BIO) andPharmaceutical Research Manufacturers of American (PhRMA).While biotech firms' interests are more homogeneous, PhRMAmembers also include many big generic drug manufacturers and somay be divided on their support for further patent protections.

At issue are the provisions that were added to the Food, Drug &Cosmetic Act through the Drug Price Competition and Patent TermRestoration Act of 1984, known as the Hatch-Waxman Amendmentsnamed after their sponsors Sen. Hatch and Rep. Henry Waxman (D-Calif.). Also involved is the Uruguay Round Agreements Act(URAA) of the General Agreement on Tariffs and Trade (GATT).

The Hatch-Waxman amendments were intended to make low costdrugs more available by establishing a generic drug approvalprocedure for pioneer drugs first approved after 1962, according to aSenate Labor and Human Resources Committee report.

The amendments also provided incentives for increased expendituresfor research and development of drugs by restoring some of the timelost in a patent's life while the product awaited premarket approval atFDA, the report state.

Under the Hatch-Waxman amendments, pharmaceutical companiesseeking to market pioneer drugs must first obtain FDA approvalthrough the filing of a new drug application (NDA). In addition tosupplying data demonstrating the safety and efficacy of the drug, theNDA must include information on any patent which claims the drugor a method of using such a drug for which a claim of patentinfringement could reasonably be asserted.

Further, the amendments specifically anticipate that patents may issueafter approval of the NDA and provides for submission ofinformation to FDA on those patents.

The FDA is required by law to publish the patent informationsubmitted to it by the NDA holder in what is commonly called the"Orange Book."

URAA which was approved by Congress in late 1994 and executedin the May 25 FDA policy statement, would achieve a much differenteffect, said Bill Schultz, FDA deputy commissioner for policy.

URAA's provisions amend federal law to provide that patents issuedafter June 8, 1995 will have a term of 20 years from the date onwhich the application was applied for and under certaincircumstances, the date of the earliest patent application filing.

The effect is to both block a patent term extension for certain pioneerdrug products and block the FDA from approving generic versions ofthose drugs until the extended patent terms have expired, Schultzsaid.

When the House and Senate debated the Uruguay trade treaty, noconsideration was made to its impact on the 1984 Hatch-WaxmanAmendments. Schultz in a May 25 letter noted that Congress did not"understand " the contradictory effects of the URAA.

Nevertheless, FDA sided with the "strong argument" that theWaxman-Hatch amendments represent a "careful balance" betweenthe interests of generic drug makers and the pioneer companies andshould not be disregarded lightly, according to the Schultz letter.

The industry lawyers said they will try to amend Hatch-Waxman toimprove the patent protections for pioneer drug and biotechmanufacturers. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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