The Supreme Court’s Missed Opportunity to Save Genus Claims in Life Sciences Patents
Alexander Franzosa The life sciences industry is a vital sector of the American economy, and its success is reliant on the protection of patent holder rights. One common feature in life sciences patents is the genus claim, a claim type traditionally allowing the patent holder to claim a group of related species based on common functionality. A novel interpretation of “written description,” a required element for patent applications, has emerged in recent decisions by the Court of Appeals for the Federal Circuit. This new interpretation has caused concern among some members of the life sciences industry regarding the validity of...
Allergan’s Battle to Stay in Court: Does Inter Partes Review Violate the Constitution by Circumventing Courtroom Adjudication?
Ashley E. Petrarca Since its institution in 2011, inter partes review has caused considerable disruption in the intellectual property world, with some industry players questioning the process’ constitutionality. One of these players is Dublin-based pharmaceutical company Allergan, Inc., which asserts that it is unfair to force patent owners to defend their USPTO-granted patent rights before the Patent Trial and Appeal Board (“PTAB”), a non-Article III sanctioned forum. Central to this debate is the question of whether patents confer private or public rights. This article discusses both sides of the dialogue over inter partes review constitutionality, and postulates that the process...
Deference Runs Deep
Brooks Kenyon Under 35 U.S.C §101, a patent must be either a new and useful process, machine, manufacture, or composition of matter and, thus, must not lay claim to any idea that is abstract. This abstraction can be increasingly difficult to eliminate when drafting software claims because the implementation of code onto a generic computer is somewhat abstract in nature. Areas of software that are, and are not, abstract have been hotly debated and a thorn in the side of court system. Hence, when Justice Thomas opined that the Supreme Court “need not labor to delimit the precise contours of...
The CRISPR Patent Battle: Who Will be “Cut” Out of Patent Rights to One of the Greatest Scientific Discoveries of Our Generation?
Kristin Beale At the center of the United States patent system lies an intricate balance between creating monetary incentives that lead to creation, invention, and discovery, and impeding the flow of the very information that might permit invention. One such invention, that of a novel gene-editing technology called CRISPR-Cas9, has been called one of the “greatest scientific discoveries in the last century.” In simplest terms, the ability to edit genes (the basis of hereditary traits in living organisms made up of DNA) allows scientists to target a specific mutated gene sequence that leads to disease, cut that region out, and,...
A Review of the Modern IPR Process
Michael Thomas Once a patent is issued for a drug there is still a chance that the validity of the patent may be challenged. One such way a purported infringer or competitor can challenge a patent’s validity is through an inter partes review (IPR) Process allowed by the United States Patent and Trademark Office (USPTO). Until recently the use of this process by generic drug-makers to invalidate patents has had no success. However, a recent decision by the Patent Trial and Appeal Board (PTAB) gave generic drug-makers their first break when they invalidated the patent for the multiple sclerosis drug...