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Merck v. Hi-Tech: Steven Hird, Patent Attorney at Greenberg Traurig in Denver, Available to Comment as Ruling Halts Early Launch of Generic Drug

Merck v. Hi-Tech: Steven Hird, Patent Attorney at Greenberg Traurig in Denver, Available to Comment as Ruling Halts Early Launch

DENVER, CO -- (MARKET WIRE) -- 03/29/07 -- Steven Hird, Ph.D., a registered patent attorney at Greenberg Traurig, LLP in Denver, has been following the Merck v. Hi-Tech case and can comment on the implications of the decision today in which a federal appeals court sided with Merck & Co.

If the U.S. Court of Appeals for The Federal Circuit had sided with Hi-Tech, many pharmaceutical patents would have lost their extensions and expired earlier than expected. This could, in turn, have permitted the early launch of generic versions of the drugs covered by the original patents. Innovator drug companies could have lost billions of dollars in brand-name pharmaceutical sales. Innovator pharmaceutical companies will therefore be breathing a sigh of relief now that the Federal Circuit has sided with Merck.

Hird has expertise in patent issues facing both innovator and generic pharmaceutical companies.

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 was whether the extensions discussed above should have applied to drug patents that previously had their terms shortened by terminal disclaimers. In this case, Merck & Co., Inc. 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. In siding with Merck, the Federal Circuit has stamped their approval on the practice of obtaining extensions of patents with terminal disclaimers.

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

About Greenberg Traurig, LLP

Greenberg Traurig, LLP is an international, full-service law firm with 1,600 attorneys and governmental affairs professionals in the U.S., Europe and Asia. The firm is ranked seventh on The American Lawyer's Am Law 100 listing of the largest law firms in the U.S., based on number of lawyers.

Greenberg Traurig serves clients from offices in: Albany, NY; Amsterdam, The Netherlands; Atlanta, GA; Boca Raton, FL; Boston, MA; Chicago, IL; Dallas, TX; Denver, CO; Fort Lauderdale, FL; Houston, TX; Las Vegas, NV; Los Angeles, CA; Miami, FL; Morristown, NJ; New York, NY; Orange County, CA; Orlando, FL; Philadelphia, PA; Phoenix, AZ; Sacramento, CA; Silicon Valley, CA; Tallahassee, FL; Tampa Bay, FL; Tokyo, Japan; Tysons Corner, VA; Washington, D.C.; West Palm Beach, FL; Wilmington, DE; and Zurich, Switzerland. Additionally, the firm has strategic alliances with the following independent law firms: Olswang, London and Brussels; Studio Santa Maria, Milan and Rome; and Hayabusa Asuka Law Offices in Tokyo.

For additional information, please visit the firm's Web site at www.gtlaw.com.

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Trent Freeman
Casey Sayre & Williams
[email protected]

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