Boring: Biological Product Protections Before the Patent Period

Merck KGaA v. Integra Lifesciences I, Ltd.

The following is the question in this case. Its about a rule specifically regarding biological patents before the patent period, and is not interesting. The issue below illustrates that fact:

"“To prevail on this defense, [petitioner] must prove by a preponderance of the evidence that it would be objectively reasonable for a party in [petitioner'’s] and Scripps'’ situation to believe that there was a decent prospect that the accused activities would contribute, relatively directly, to the generation of the kinds of information that are likely to be relevant in the processes by which the FDA would decide whether to approve the product in question.

Each of the accused activities must be evaluated separately to determine whether the exemption applies.

[Petitioner] does not need to show that the information gathered from a particular activity was actually submitted to the FDA."”

yeah, I'm skipping this one.