While the biosimilar market in the United States has gotten off to a relatively slow start compared with Europe – where biosimilars have been available since 2006 – it has recently gained momentum and will continue to grow in the coming years as more blockbuster biologics lose regulatory exclusivity and patent protection.
The Supreme Court recently held that the sale of a patented invention to a third party that is contractually obligated to keep the invention confidential can trigger the on-sale bar of the Leahy-Smith America Invents Act. The decision clarifies statutory language in the act, which has been a source of considerable confusion to patent litigants. The decision also requires that IP owners carefully ensure that public disclosure of their business dealings does not interfere with their patent rights.
A Federal Circuit panel recently held that a patent term extension (PTE) granted pursuant to 35 USC Section 156 was not invalid for obviousness-type double patenting. The decision should provide pharmaceutical patentees with some assurance that their PTEs generally will not fall foul of the obviousness-type double patenting doctrine.
The Federal Circuit recently held that the assignor estoppel is not available in inter partes review proceedings. Assignor estoppel is a common law doctrine which prevents a party that assigns a patent to another party from later challenging the validity of the assigned patent. In a decision by Chief Judge Prost (joined by Judges Schall and Chen) the Federal Circuit held that the assignor estoppel is not available in inter partes reviews.
The Federal Circuit recently affirmed the Patent Trial and Appeal Board's determination that there was no interference-in-fact between the University of California's Patent Application 13/842,859 and the 12 patents and one patent application owned by the Broad Institute, the Massachusetts Institute of Technology and Harvard University concerning CRISPR-Cas9 technology.