Newsletter presents concise summaries of important developments in U.S. patent law occurring during the month of August, 2008.

Developments include:

1) Safe harbor provision of § 271(e)(1) did not apply to research tool used in obtaining data for FDA submission where tool itself was not subject to FDA pre-market approval;

2) Evidentiary burdens for inequitable conduct must be “strictly enforced”;

3) Patentee must take some affirmative action to show case or controversy for declaratory judgment;

4) Patentee may not base irreparable harm to support an injunction on harm allegedly suffered by non-joined exclusive licensee;

5) No grace period for an accused infringer to cease accused activity before being liable for damages when given notice under § 287(a);

6) “Original application” for purposes of eligibility for inter partes reexamination includes continuing applications;

7) Federal Circuit addresses inherent anticipation of structure claimed with a functional limitation;

8) Oral opinion of counsel, obtained post-verdict, defeats willful infringement charge for post-verdict sales;

9) One district court partially lifts stay during reexamination so patentee can obtain discovery to rebut PTO’s obviousness rejection; second district court refuses to permit accused infringer’s confidential discovery materials to be released for use by patentee in reexamination proceeding; and

10) PTO will issue a new effective date for regulations governing applications with patentably indistinct claims.