PATENT | Is
it harder to enforce pharmaceutical patents?
In the area of enforcement of pharmaceutical patents,
2005 and the first eight months of 2006 are proving to be among the
worst in memory. Why? Because in the last 20 months, the Federal
Circuit has completely or partially invalidated or held
unenforceable nearly every pharmaceutical patent it has
Schulman/Special to The National Law Journal|August 28, 2006 at 12:00 AM|The original version of this story was published on National Law Journal
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For those who practice in the area of enforcement of pharmaceutical patents (i.e., patents directed to compounds, compositions or methods for treatment or prevention of disease, or maintenance of health), 2005 and the first eight months of 2006 are proving to be among the worst in memory. Why? Because in the last 20 months, the U.S. Court of Appeals for the Federal Circuit has completely or partially invalidated or held unenforceable nearly every pharmaceutical patent it has reviewed-more than two dozen in all, with only one upheld. If one assumes that the survival rate of pharmaceutical patents was higher in years past (which it was-as discussed below), then there are two logical inferences one might draw. The first inference is that this is a mere statistical coincidence not indicative of any ax the Federal Circuit has to grind with the pharmaceutical industry. Perhaps it has been a bad crop of patents that has made its way to the Federal Circuit for review. Maybe the pharmaceutical industry has been driven to enforce more marginal patents than it would have enforced in past years. This could denote a lack of new blockbuster drugs and increased reliance on incremental improvements to existing drugs that are only marginally patentable at best. Another plausible explanation is that the U.S. Patent and Trademark Office has become too lax in its review of pharmaceutical patent applications, thereby necessitating this well-deserved rebuke by the Federal Circuit to exercise more discipline in applying the statute, consistent with precedent. An alternative inference one might draw is that this recent spate of invalidations is the result of a fundamental change in the application of the law such that it is much easier for a challenger to invalidate an issued patent. For example, it may reflect a change in the makeup of the court. Or it may be that it is public policy-driven, based on ever-rising prescription drug costs and the political pressure on the government to control them. What better way to control costs than to invalidate commercially significant pharmaceutical patents, thereby paving the way for lower-cost generic alternatives to enter the market more rapidly? This is the question this article addresses-whether the recent increase in pharmaceutical patent invalidations by the Federal Circuit is no more than a proper policing of a particularly weak crop of patents or, alternatively, whether there has been a change in the legal landscape which would, in turn, require adjustments by the pharmaceutical industry to reflect the new realities. A parade of invalidations The raw statistics do not lie. Since December 2004, all but one pharmaceutical patent has been completely or partially invalidated after Federal Circuit review in a published decision. The parade of invalidations started on Jan. 28, 2005, when the Federal Circuit reversed the district court’s finding of validity and invalidated Merck’s patent directed to once-weekly administration of Fosomax for treatment of bone loss. Merck & Co. v. Teva Pharmaceuticals USA Inc. , 395 F.3d 1364 (Fed. Cir. 2005). In April 2005, the Federal Circuit invalidated SmithKline Beecham’s patent directed to a hemihydrate form of the antidepressant Paxil, again reversing a finding of validity. SmithKline Beecham Corp. v. Apotex Corp. , 403 F.3d 1331 (Fed. Cir. 2005). The next patent to come under the Federal Circuit’s knife belonged to Syntex, which, in May 2005, had its patent directed to Acular, an ophthalmic formulation, invalidated, again after the district court upheld the patent’s validity. Syntex (U.S.A.) LLC v. Apotex Inc ., 407 F.3d 1371 (Fed. Cir. 2005). In June 2005, the Federal Circuit affirmed the invalidation of Upsher-Smith’s Folgard patent directed to folic acid/vitamin B combinations as vitamin supplements. Upsher-Smith Laboratories, Inc. v. Pamlab LLC , 412 F.3d 1319 (Fed. Cir. 2005).
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