Supreme Court: Merck v. Integra Amicus Briefs

NOTE: Link to the Merck v. Integra Amicus Briefs.

Cell Attachment Inhibition

Over the next month, I will be posting both party and amicus briefs for the upcoming Merck KGaA v. Integra case as they come available.  Although the hearing date is not set yet, it is expected to be scheduled for April with the opinion by mid-summer. 

The appeal to the Supreme Court questions the limits of the safe harbor statute (35 USC 271(e)(1)) that permits a drug manufacturer to perform experiments needed to obtain FDA approval of their drugs without incurring liability for patent infringement, even if their activities infringe other’s patent rights.  Although not the specific question on appeal, I expect that the Court will also delve into the common law experimental use exception that dates back at least to the Whittemore v. Cutter case from 1813 (Story).  More recently, in Madey v. Duke (cert denied) many observers saw the Federal Circuit severely limiting the defense.

Counsel writing amicus briefs are invited to send PDF copies of their briefs to me as well as any comments or interesting issues.  (crouch@mbhb.com).

In preparation for the case, Here is a fun site to check out your own biases: Supreme Court Quiz — Find out what justice you are most like.

As Professor Mueller at Pittsburgh has pointed out, there is a conception distinction between (i) the experimental use defense to infringement under 35 USC 271 that was at issue in Madey and may be an issue in Integra and (ii) the doctrine of experimental use negation of a 102(b) public use at issue in Lisle.