Subject Matter Jurisdiction Remains in Hatch-Waxman Patent Infringement Action after ANDA Filer Changes from Paragraph IV to Paragraph III Certification

In a recent final written decision, the PTAB determined that a reference patent was not prior art, despite the petitioner’s post‑filing attempt to correct its petition. While the petitioner argued that it intended to rely on the patent application’s earlier date of publication, both the corrected petition and the expert declaration continued to reference the issued patent rather than the published application.

The USPTO Director recently granted a petitioner’s request for rehearing of the decision discretionarily denying institution of inter partes review, ultimately vacating the original decision, and referring the petition to the board for an institution decision.

In considering claims to a method of reducing cardiovascular events, the Federal Circuit held that the term a “clinically proven effective” amount did not render the claims patentable over the prior art. Specifically, the Federal Circuit held that the “clinically proven effective” amount, whether limiting or not, could not be used to distinguish the prior art because the claims also specified the exact amount of the drugs to be administered in the method. The Federal Circuit also rejected patentee’s evidence of unexpected results because that evidence was tied solely to the “clinically proven effective” limitation.

The Federal Circuit reversed a district court’s denial of judgment as a matter of law on non-infringement, thereby setting aside a $106 million jury verdict, after holding that prosecution history estoppel barred the patentee from asserting infringement under the doctrine of equivalents.

A magistrate judge in the District of Delaware issued a Report and Recommendation, that found the sole asserted claim was a “single means” claim and therefore invalid for lack of enablement. In reaching that conclusion, the magistrate judge rejected the patentee’s argument that the preamble of the claim disclosed a second element that satisfied the combination requirement of Section 112, paragraph 6 because the preamble simply recited a descriptor of the very apparatus that was the subject of the means-plus-function limitation in the body of the claim. The district court judge presiding over this case has scheduled a hearing to review the magistrate’s ruling.

The Federal Circuit has affirmed the PTAB’s determination that a patent challenger did not show the challenged claims were unpatentable for obviousness. The Federal Circuit concluded that substantial evidence, which included expert testimony, showed there was no motivation to combine the references.

In a recent order addressing four IPR proceedings, the PTAB exercised its inherent authority under 37 C.F.R. § 42.5(a) to sua sponte authorize post-hearing discovery on a potentially dispositive privity issue. The order followed a Director review decision that vacated and remanded earlier IPRs involving the same parties, patent family, and privity issue. 

The Patent Trial and Appeal Board denied institution of an inter partes review petition in part because it determined that a patent reference was not prior art under the common ownership exception of pre-AIA 35 U.S.C. § 103(c)(1).