Judge Andrews Finds One Patent Not Invalid, Another Patent Obvious in ANDA Case

November 3, 2016

Publication| Intellectual Property

In Merck Sharp & Dohme Corp. v. Hospira Inc., C.A. No. 14-915-RGA (D. Del. October 7, 2016), an ANDA case, Judge Andrews found one of two patents-in-suit invalid as obvious after trial. The plaintiff, Merck Sharp & Dohme Corp. (“Merck”), had alleged that the defendant, Hospira Inc. (“Hospira”), infringed two patents-in-suit related to an antibiotic. The Court held a four-day bench trial to address the validity of one patent-in-suit (Hospira had earlier stipulated to infringement of this patent) and infringement and invalidity of the other.

The Court found that Hospira had not shown that the teachings of the prior art necessarily resulted in the method disclosed in the first patent, thus rejecting Hospira’s anticipation argument. As to obviousness, Judge Andrews concluded that Hospira’s five prior art references did not teach the claimed invention, and that prior art references cited by Merck taught away from the invention. On secondary considerations, the Court found that although the reference drug enjoyed commercial success, this consideration was weak overall because another patent covering the drug blocked others who may have attempted to market their own products. But Hospira’s decision to copy inactive ingredients and manufacturing methods (as opposed to just the active ingredient of the reference drug) indicated non-obviousness, as did unexpected properties of the claimed formulation.

The Court rejected Hospira’s written description challenge, finding that the patentee had no obligation to incorporate subject matter described elsewhere in the patent into certain claims as a limitation.

Andrews found that Hospira infringed the other patent-in-suit, but held that that patent was obvious. Merck argued, and Judge Andrews agreed, that the first patent-in-suit and an international patent application filed by a Hospira employee each rendered the second patent-in-suit obvious. The Court further found that evidence of commercial success and copying, though present, did not overcome Merck’s obviousness case.

Key Points:  Judge Andrews memorably summarized his non-obviousness analysis as follows: “If, at the moment before invention, a voice whispered to the inventors, ‘Do you think it’ll work?’ the answer would most likely have been, ‘I don’t know.’” The practical nature of this question should be considered when litigating before Judge Andrews.

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