Bayer AG and Bayer Corporation v. Schein Pharmaceuticals, Inc. et al.
Decided August 9, 2002  pdf copy
Judge Clevenger with Judges Rader and Dyk, Rader separately concurring

*             The best mode requirement does not compel disclosure of an unclaimed method for making a novel material needed to practice an invention

Bayer's earliest filed application for the drug "Cipro" did not include a description for how to make a novel intermediate in the synthesis pathway of the Cipro active ingredient. A later application matured into a patent and Bayer sued Schein and other generic drug makers at the District Court for the District of New Jersey when the makers filed abbreviated new drug applications at the Food and Drug Administration. Schein unsuccessfully argued that Bayer's patent did not receive priority from the earliest filed application because that application failed to disclose Bayer's method for making a key and novel intermediate, and thus violated the best mode requirement. Schein argued that Bayer's patent was therefore invalid under 102(d) because Bayer had obtained a foreign patent from an application filed more than one year before its earliest priority date. Judge Garrett Brown Jr. granted summary judgment that Bayer's patent satisfied the best mode requirement, however, because Bayer's inventor did not claim the key intermediate. Schein appealed to the Federal Circuit.

The Federal Circuit affirmed because the preferred method of making the novel intermediate did not materially affect the claimed product. That is, only "[p]references that are reflected in a preferred embodiment or that relate to making or using the invention and have a material effect on the properties of the claimed invention must be disclosed." Bayer successfully relied on general knowledge of skilled workers for making the novel intermediate needed to produce its claimed compound. This general knowledge of a less optimum method sufficed because Bayer did not claim the intermediate or the method of making it.

 

ELI LILLY AND COMPANY v. BARR LABORATORIES ET AL.
Decided August 9, 2000  text copy
222 F.3d 973   55 U.S.P.Q. 2d 1609

  • Production details that are not novel and essential to carry out the best mode of an invention need not be disclosed in a patent specification
     

  • A later genus claim is not patentable over an earlier species claim.

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    Barr Laboratories (and others) filed an Abbreviated New Drug Application ("ANDA") seeking approval from the FDA to market its own version of Lilly’s Prozac antidepressant drug. Lilly sued for infringing a patent claim to compounds and a claim to methods of their use as pharmaceuticals. A district court on summary judgment held that neither claim violates the best mode requirement and that no double patenting exists over a previous expired Lilly patent.

    The CAFC affirmed no best mode violation but reversed the double patenting decision. The best mode argument concerned Lilly’s not disclosure of (a) its preferred method to synthesize a commercially available starting material for the claimed compound, and (b) a preferred solvent for purifying the claimed compound. The CAFC pointed out that the non-disclosed method and solvent were not "novel and essential for carrying out the best mode" and that "routine details….implicate the quality and nature of the invention, but their disclosure is unnecessary because they are readily apparent to one of ordinary skill in the art." In this instance, the undisclosed method pertained to a commercially available product and both experts admitted that selection of the solvent involved routine experimentation.

    Lilly lost its double patenting argument that selection of a specific compound claimed in a later patent "would not have been obvious to one of ordinary skill in the art because that (earlier patent) claim covers thousands of possible compounds." The CAFC, in construing and overlaying the claims in the first prong of the double patenting analysis distinguished cited cases "in which the prior art merely discloses a genus and a later patent claims a species" as non relevant where "the same party claims a genus in an earlier patent and claims a species in a later patent." Furthermore, in studying the claim differences for the second prong of the double patenting analysis the CAFC deemed the later claim ("treatment of serotonin uptake in animals") to be a genus of the former claim ("treatment of depression in humans") because humans are a subclass of animals.

    The non-included subject matter pertained to production details that relate to lowering the cost of the final product. Those details were not needed in the patent specification because lower cost or higher purity were not claimed.