SOURCE: Greenberg Traurig - Denver

January 18, 2007 09:00 ET

A 'Sleeper' Case, Merck v. Hi-Tech, Could Cut Length of Many Pharmaceutical Patents, Lead to Early Launch of Generic Drugs

Steven Hird, Patent Attorney at Greenberg Traurig in Denver, Available to Comment on Far-Reaching Nationwide Implications of Case

DENVER, CO -- (MARKET WIRE) -- January 18, 2007 -- Steven Hird, Ph.D., is a registered patent attorney at Greenberg Traurig, LLP in Denver with expertise in patent issues facing both innovator and generic pharmaceutical companies. He has been closely following Merck v. Hi-Tech and is available to comment on the far-reaching nationwide implications of the case.

BACKGROUND: It is often a risky proposition to rely on a single patent to protect a proprietary technology. For example, a competitor may make a minor and obvious modification to the invention in an attempt to "design around" the lone patent. To prevent this, innovators frequently file a series of further patent applications, each claiming obvious variations of the invention first claimed in the original patent. The Patent Office will allow applications claiming such obvious variations to issue as patents, but only on the condition that the patent owner agrees -- via a document known as a "terminal disclaimer" -- that the later patents will expire on the same day as the original patent. Thus, a terminal disclaimer effectively shortens the life of a later patent. In this way, the innovator is able to protect the invention comprehensively, but without extending the period of protection beyond the original patent's expiration date.

For patents that claim new drugs, however, the life of the patent can sometimes be extended to compensate the patent owner for delays in marketing the product while it was being reviewed by the FDA.

KEY ISSUE IN MERCK V. HI-TECH: The issue in Merck v. Hi-Tech is whether the extensions discussed above should be applied to drug patents that previously had their terms shortened by terminal disclaimers. In this case, Merck & Co., Inc. has sued Hi-Tech Pharmacal Co., Inc. to enforce a patent covering an active ingredient, dorzolamide, in response to Hi-Tech's application to the FDA seeking approval of generic versions of two Merck drugs containing the substance.

CURRENT STATUS OF CASE: Hi-Tech lost in the district court, and appealed to the U.S. Court of Appeals for The Federal Circuit. If the Federal Circuit sides with Hi-Tech, many pharmaceutical patents would lose their extensions, and therefore would expire earlier than expected. This could, in turn, permit the early launch of generic versions of the drugs covered by the original patents. Innovator drug companies could therefore lose billions of dollars in brand-name pharmaceutical sales.

INTERVIEWS: To arrange an interview with Steven Hird about the case, please contact Trent Freeman at Casey Sayre & Williams: 310.396.2400.

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