Federal Circuit Upholds Lyrica Patents

In a non-precedential decision issued February 6, 2014, the Federal Circuit affirmed a district court decision that upheld the four Orange Book listed patents for Pfizer's Lyrica® product. According to the court's rules, the non-precedential designation of Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. means that the panel determined that it did not add signif‌icantly to the body of law, but future panels may still look to it for "guidance or persuasive reasoning." As such, this decision upholding the Lyrica® patents illustrates the strength and breadth of patent protection that can be obtained for a new molecular entity.

The Patents at Issue

The patents at issue in the district court were U.S. Patent 6,197,819, U.S. Patent 5,563,175, U.S. Patent 6,001,876, and U.S. Reissue Patent 41,920 (a reissue of the '876 patent.). These patents are listed in the Orange Book for Pfizer's Lyrica® product, and this litigation was brought under 35 USC 271(e)(2)(A) after the defendants filed Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Lyrica®.

According to the Federal Circuit decision, only two Lyrica® patents were in play for the appeal, the '819 patent and the RE '920 patent. From these, the court focused on claim 2 of the '819 patent:

2. 4-amino-3-(2-methylpropyl) butanoic acid, or a pharmaceutically acceptable salt thereof.

The prescribing information for Lyrica® identifies the active ingredient as Pregabalin and provides the chemical name

(S)-3-(aminomethyl)-5-methylhexanoic acid

which uses different nomenclature to identify the S-enantiomer of the compound recited in claim 2. The Federal Circuit also refers to the compound as "3-isobutylGABA."

The district court upheld the claims against enablement, written description, and obviousness challenges. As summarized by the Federal Circuit, because the defendants had stipulated to infringement, the district court issued an injunction that enjoined the defendants "from commercially manufacturing, using, offering for sale, or selling their proposed products" prior to the December 30, 2018 expiration date of the '819 patent.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Prost, and joined by Chief Judge Rader and Judge Moore.

The Federal Circuit first addressed the district court's construction of claim 2 as generically reciting 3-isobutylGABA rather than specifying a racemic mixture of enantiomers, as argued by the defendants.

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