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trialpatent

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University Of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 185 Ed. Law Rep. 122, 69 U.S.P.Q.2d 1886

Facts

The University of Rochester owned a patent for a method of treating inflammation without undesirable side effects, which was allegedly infringed by Pfizer's COX-2 inhibitors, Celebrex and Bextra. The patent, issued in 2000, claimed methods for selectively inhibiting PGHS-2 activity in humans. However, the district court found that the patent did not disclose any specific compounds that could achieve this inhibition, leading to the conclusion that the patent was invalid for lack of written description and enablement.

On the day the ′850 patent issued, Rochester sued G.D. Searle & Co., Inc., Monsanto Co., Pharmacia Corp., and Pfizer Inc. (collectively, 'Pfizer'), alleging that Pfizer's sale of its COX–2 inhibitors Celebrex® and Bextra® for treatment of inflammation infringed the ′850 patent.

Issue

Did the United States Patent 6,048,850 satisfy the written description requirement under 35 U.S.C. § 112, ¶ 1?

Rule

The specification of a patent must contain a written description of the invention and the manner and process of making and using it in full, clear, concise, and exact terms to enable any person skilled in the art to make and use the same.

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Analysis

The court analyzed the claims of the ′850 patent and determined that while they required the use of a non-steroidal compound that selectively inhibits PGHS-2 activity, the patent did not disclose any such compound or provide guidance on how to create one. The court concluded that the lack of a specific compound meant that the patent failed to meet the written description requirement, as it did not allow a person skilled in the art to recognize what was claimed.

The court found that, although all of the claims require the use of a 'non-steroidal compound that selectively inhibits activity of the PGHS–2 gene,' the ′850 patent neither discloses any such compound nor provides any suggestion as to how such a compound could be made or otherwise obtained other than by trial-and-error research.

Conclusion

The Court of Appeals affirmed the district court's decision, holding that the ′850 patent was invalid for failing to comply with the written description requirement.

Accordingly, the court concluded that the patent's claims are invalid for lack of written description.

Who won?

Pfizer prevailed in the case because the court found that the patent did not meet the necessary legal requirements for validity, specifically the written description requirement.

Pfizer responds to Rochester's argument by pointing out that we have 'interpreted § 112 as requiring a “written description” of an invention separate from enablement.'

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