Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.

United States Court of Appeals, Federal Circuit
429 F.3d 1364 (2005)

ELI5:

Rule of Law:

Subject matter disclosed in a patent specification, but not claimed, is dedicated to the public only if the patentee identifies that subject matter as an alternative to a claimed limitation; mere disclosure for a different purpose is insufficient to trigger dedication.

Facts:

Warner-Lambert owns the '450 patent for a pharmaceutical composition for ACE inhibitors, such as quinapril, which are used to treat high blood pressure.
The patented composition is stabilized against degradation (cyclization, hydrolysis, and discoloration) by using a metal carbonate and a 'saccharide.'
The patent specification lists 'Mannitol, lactose, and other sugars' as preferred examples of saccharides.
The specification also mentions 'modified cellulose derivatives' as an example of an optional excipient called a 'disintegrating agent.'
Ranbaxy developed a generic version of Warner-Lambert's drug, Accupril®, which used magnesium carbonate as a stabilizer and microcrystalline cellulose (a polysaccharide and modified cellulose derivative) as another component.
Ranbaxy entered into a Distribution and Supply Agreement with Teva Pharmaceuticals to market its generic product.
After Teva relinquished its 180-day market exclusivity period for a generic version of Accupril®, Teva began marketing Ranbaxy's product.

Procedural Posture:

Pfizer, Inc. and Warner-Lambert Company sued Teva Pharmaceuticals USA, Inc. and Ranbaxy in the U.S. District Court for the District of New Jersey for patent infringement.
The plaintiffs, Pfizer and Warner-Lambert, filed a motion for a preliminary injunction to prevent the defendants from marketing their generic drug.
The district court granted the motion for a preliminary injunction, finding that the plaintiffs were likely to succeed on the merits and that the other equitable factors favored an injunction.
Teva and Ranbaxy, as appellants, appealed the district court's order granting the preliminary injunction to the U.S. Court of Appeals for the Federal Circuit, with Pfizer and Warner-Lambert as appellees.

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Issue:

Did the district court abuse its discretion in granting a preliminary injunction by finding that the patent holder was likely to succeed on its infringement claim, based on its construction of the claim term 'saccharide' and its application of the disclosure-dedication rule?

Opinions:

Majority - Prost, Circuit Judge.

No, the district court did not abuse its discretion. The grant of the preliminary injunction is affirmed because the district court's claim construction was not erroneous and its findings on likelihood of infringement, irreparable harm, balance of hardships, and public interest were not an abuse of discretion. The court correctly construed 'saccharide' to include polysaccharides like microcrystalline cellulose by looking at the entire patent specification, including the preferred embodiments, rather than being limited by a single parenthetical phrase. This construction is supported by extrinsic evidence, such as technical dictionaries, and avoids the improper result of excluding a preferred embodiment (mannitol, a sugar derivative) from the claim's scope. Given this construction, the district court did not err in finding a likelihood of literal infringement. Furthermore, the disclosure-dedication rule does not apply here because the patent did not identify microcrystalline cellulose as an alternative to the claimed 'saccharide' for inhibiting hydrolysis; it was merely mentioned for a different function as a 'disintegrating agent.' Finally, the district court properly applied the four-factor test for a preliminary injunction, correctly presuming irreparable harm upon a strong showing of likely infringement and finding that the other factors weighed in favor of granting the injunction.

Analysis:

This decision significantly clarifies the scope of the disclosure-dedication rule in patent law. It establishes that for unclaimed subject matter to be dedicated to the public, the patent specification must identify it as an alternative to a claimed limitation, not merely mention it in another context for a different purpose. This narrows the defense for accused infringers, making it harder to argue that any disclosed but unclaimed material is automatically free for public use. The case also reinforces modern claim construction principles post-Phillips, emphasizing the importance of reading claims in the context of the entire specification and cautioning against interpretations that would exclude preferred embodiments.

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