The Patent Utility Requirement and Its Impact on Alternative Medical Treatments for Lyme Disease
Sarah Murphy Alternative medicine has made its way to the forefront of medical innovation, changing the way both doctors and patients approach complex health issues. Patenting medical inventions promotes advancement by increasing the exchange of vital information. This crucial benefit to society is particularly important for patients suffering from chronic illnesses who are dissatisfied with conventional medicine. Though the patent system requires that patented inventions are “useful,” there is no guarantee that the product is effective or even safe to use. The medical field must grapple with this trade-off between the benefit of new treatments made easily available to people...
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...
Antitrust Issues in Reverse Payment Settlements: Federal Trade Commission v. Actavis, Inc. et al., a Case Study
Amanda Creedon In Federal Trade Commission v. Actavis, Inc., the Federal Trade Commission (FTC) filed a complaint alleging that reverse settlement payments were unfair restraints of trade and therefore violated federal antitrust laws. The Supreme Court held that reverse payment settlements in patent infringement litigation are not presumptively unlawful but can sometimes violate antitrust laws, to be determined on a case-by-case basis. The settlements are not immune from antitrust attack even if the agreement’s anticompetitive effects fell within the scope of the exclusionary potential of the patent. Read Full Text Here
Awarding Enhanced Damages in Patent Infringement Cases
Michael Thomas This term the Supreme Court will take up the issue of awarding enhanced damages in patent infringement cases. Two separate cases petitioned the court to take up the issue after defendants were spared enhanced damages following some questionable activity. The current test used in awarding enhanced damages is a two-part test implemented by the Federal Circuit that incorporates an objective and subjective component. Read Full Text Here
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,...
Intersection of American Law and Technology: The Innovation Act’s Fight Against Patent Trolls
Mohamed Elfarra The economic and social burdens of frivolous litigation have led “academics, policymakers, and even judges to suggest that patent law[s] may have overleaped its proper bounds, or at least become too likely to frustrate, rather than to fulfill, its constitutional purpose of ‘promot[ing] the progress of science and useful arts’. The primary causes of this problem are the overly litigious entities pejoratively known as patent trolls, who are collectively responsible for the majority of today’s patent infringement cases. Although solutions to this complex problem are evasive, the need for reform is readily apparent. One of the most important...
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...
Intellectual Property Indemnity Clauses
Thomas Hemnes, M.S. The practices associated with intellectual property indemnity can be traced in part to Article 2 of the Uniform Commercial Code. At the dawn of the computer age, practitioners searched for legal models that they could use for transactions in intangible rights and products such as computer software. Although computer software did not fit easily into the “sale of goods” paradigm, analogies to the familiar rules governing sales of goods were inevitable. Lurking in the lower reaches of Article 2 of the UCC, one finds an implied warranty of non-infringement in Section 2-312(2): Unless otherwise agreed, a seller...
Dosage Patenting in Personalized Medicine
Jerry I-H Hsiao, PhD; Wei-Lin Wang, JSD Inventions for dosage regimens often arise after the pharmaceutical product has been dosed in patients and more information is known about the in vivo and pharmacokinetic properties of the medical agent. However, securing patent protection for this type of invention has been difficult because dosage inventions are considered to be simple medical methods whose protection is believed to limit doctors’ choices in clinical practice. Moreover, novel dosage inventions are also considered to involve a process that does not enjoy the same scope of patent protection as new chemical entities despite their superior therapeutic...