Smithkline Beecham v. Apotex

This is a second installment the SKB v. Apotex case brief

Experimental use was a major issue in the case. According to the court, experimental use may only be used to negate a 102(b) public use if the purpose of the experimental use was to assist in designing or testing of a claimed feature. Thus, in SKB, the “clinical trials tested only the safety and efficacy of PHC hemihydrate as an antidepressant” and were not an experimental use of the chemical compound as claimed in claim 1.

One striking idea from the case is that experimental use is now analyzed on a claim-by-claim basis. Thus, the court found that the clinical trials “may serve to negate a public use bar with regard to the inventions claimed in the more specific claims of the ’723 patent.”

Rather than determining whether the invention was undergoing experimental use, courts must now determine whether an alleged experimental use negates a 102(b) public use for each claim individually.

Read Part I, Part II, Part III, and part IV.

One thought on “Smithkline Beecham v. Apotex

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    SmithKline Beecham v. Apotex
    (Part IV)

    In an updated concurrence, J. Gajarsa adds firepower to his disagreement with the newly defined experimental use exception: According to the majority, SKB’s testing of PHC’s performance as a human antidepressant was not necessary to reduce PHC to pra…

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