The Big Pharma superpowers are on the edge of a patent cliff. The combination of patent expirations, uncertain product and patent pipelines, and expiring regulatory exclusivities will negatively impact a host of Big Pharma...more
Any new and useful process, machine, manufacture, or composition of matter may be patented in the United States. However, the Supreme Court has held that “laws of nature, natural phenomena, and abstract ideas” are not...more
Congress’s protection from patent infringement for drug developers created under the Hatch-Waxman Act of 1984 (Act) has been extensively litigated over the past three+ decades, but the scope of the so-called “safe harbor...more
On December 17, 2014, the Federal Circuit Court of Appeals found that certain claims relating to Myriad’s BRCA1 genetic test for breast and ovarian cancer were invalid under 35 U.S.C. § 101 as being ineligible for patent...more
This past week, the Food and Drug Administration (FDA) announced the creation of the “Purple Book,” which will list all biological products, including any biosimilar and interchangeable biological products, licensed by the...more
On January 15, 2014, the Federal Circuit issued in Novartis v. Lee its anticipated opinion regarding the proper interpretation of 35 U.S.C. § 154, the statute that determines how patent term adjustment (PTA) is calculated....more
Today, the U.S. Supreme Court held that human genes are not patent eligible subject matter under 35 U.S.C. §101 simply because they have been isolated from the surrounding genetic material....more
The United States Patent and Trademark Office (USPTO) has recently published increases in maintenance fees that are effective on March 19, 2013. Careful attention to your maintenance fee schedule may provide a savings for...more