The Medicare Modernization Act of 2003:The Effect on Entry of Generic Drugs into the Marketplace
April 01, 2005
The Hatch-Waxman Act, enacted in 1984, first permitted the marketing of generic pharmaceuticals based on a showing of bioequivalence, not safety and efficacy, through the use of an Abbreviated New Drug Application ("ANDA"). By significantly lowering the barrier to entry for generics, this change provided the impetus for rapid growth of the generic pharmaceutical industry in the United States. In exchange for this barrier lowering, Congress provided the holder of the previously approved new drug application ("NDA") with patent term extensions based on FDA regulatory delay.
IP News
February 25, 2005
Highlights of the latest intellectual property news from around the country.
You're Not Exhausted: U.S. Patent Rights Are Not Exhausted By Foreign Sales
February 25, 2005
Your client International Marketers, Inc. (IMI) owns U.S. and foreign patents for an improved football. IMI wants to license the patent and make direct sales of identical balls around the world, while making its own sales to the U.S. market. However, IMI knows that the price consumers will pay for its football is much higher in the United States than elsewhere. IMI is concerned that footballs sold by it and its licensees to distributors outside the United States might be purchased by third parties and imported back into the United States at a price below what it hopes to charge distributors in the United States.
'Add-on Patents': Innovation or Sham?
February 25, 2005
Some recent estimates suggest that by 2007 brand name pharmaceutical companies will lose more than $80 billion in drug sales because of patent term expirations. Patent term expirations, of course, usher the entry of generic drugs into the marketplace. On average, the market share for branded products decreases by 15% to 30% when a first generic version reaches the market, and as much as 75% to 90% when subsequent generics launch. Such significant losses provide incentive to extend patent life and maximize the period of market exclusivity for a patented drug.
Patent Reissue after Eggert: Reclaiming the Ring
February 25, 2005
When considering a broadening reissue application, patent owners often confront a recurring issue: Can a limitation added or argued during prosecution of an original patent to gain allowance over prior art later be broadened during reissue? Recent developments in case law at the Federal Circuit Court of Appeals and U.S. Patent and Trademark Office ("USPTO") suggest a way to permissibly broaden such limitations through reissue and still avoid recapture. We call it reclaiming the ring.
The Wrong Box: <i>U.S. v. Martignon</i> Not a Copyright Case
January 27, 2005
A prominent court, the U.S. District Court for the Southern District of New York, has rendered what may become a prominent opinion in the copyright arena, <i>U.S. v. Martignon</i>, No. 03 Cr. 1287 (S.D.N.Y. Sept. 27, 2004). Unfortunately, the analysis in the decision misses the essential point that the issue was not really one of copyright.
IP News
January 27, 2005
Highlights of the latest intellectual property news and cases from around the country.
Expanded Protection Under 35 U.S.C. '103(c) via the CREATE Act
January 27, 2005
On Dec. 10, 2004, 35 U.S.C. '103(c) was amended to expand the common ownership exception for prior art available under ''102(e), (f) and (g). <i>See</i> Cooperative Research and Technology Enhancement Act of 2004, Pub. L. 108-453, 118 Stat. 3596 (2004) (CREATE Act). The U.S. Patent and Trademark Office (USPTO) has published proposed rules to implement the CREATE Act and is currently accepting comments until Feb. 10, 2005. Changes to Implement the Cooperative Research and Technology Enhancement Act of 2004, 70 Fed. Reg. 1818 (2005) (proposed Jan. 11, 2005).
Fair Use Defense: No Burden on Defendant to Prove Absence of Confusion
January 27, 2005
On Dec. 8, 2004, the U.S. Supreme Court held that a party raising the statutory affirmative defense of fair use to a charge of trademark infringement does not have an independent burden to negate the likelihood of any confusion as to the source or origin of the trademark accused of infringement. <i>KP Permanent Make-Up, Inc. v. Lasting Impression I, Inc.</i>, 543 U.S. ___, 2004 U.S. LEXIS 8170 (2004). The decision resolved a split between the circuits on the statutory, or "classic," fair use defense to trademark infringement.
Avoid and Overcome Descriptive Objections under Section 2(e) of the Lanham Act
December 30, 2004
Section 2(e) of the Lanham Act provides that no trademark shall be refused registration unless it consists of a mark which when used on or in connection with the goods or services of the applicant is merely descriptive or deceptively misdescriptive of them. Despite this caveat, trademark owners gravitate toward descriptive marks because they easily convey to the intended user something about the nature or characteristics of the goods or services. Because of that easy association, some trademark owners believe that they can obtain "exclusive" rights to a mark without having to expend the large amounts of money typically required to educate consumers of the connection between a mark and the goods or services with which it is associated when a less descriptive mark is adopted. For those who are keen to register marks that have some descriptive qualities but also hold the capacity for distinctiveness, taking appropriate precautions in preparing the application and presenting evidence of distinctiveness to the Patent and Trademark Office may greatly increase the likelihood of obtaining a Principal Register registration.
