BLOG POST: The Weak “Non-obvious” Patenting Requirement is Impeding Americans from Obtaining Affordable Pharmaceuticals*
*This writing is a blog post. It is not a published IPTF Journal Article. Sydney Closs A patent grants an inventor the right to exclude others from “making, using, importing, and selling” a patented invention for a specified period of time. 35 U.S.C. § 271. This right allows an innovator to enjoy a limited monopoly over an invention, providing important incentives for innovation. See 35 U.S.C. § 103. Under current patent law, there are five principal requirements for a new innovation to be eligible to receive a patent: (1) patentable subject matter, (2) utility, (3) novelty, (4) non-obviousness, and (5)...
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...
Square Peg in a Round Hole: Manipulating Patent Law to Reduce the Prices of Pharmaceutical Products
Jasmine Daniel Pharmaceutical companies are commonly criticized for charging exorbitantly high prices for their products which can make it difficult for many patients to access life-saving drugs. Competitors, such as generic manufacturers, often cannot manufacture cheaper alternatives to these drugs due to strong patents which protect against product copying. Both the Bayh-Dole Act and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) include provisions which allow competitors to circumvent pharmaceutical patent protection under limited circumstances. Although there are instances in which such circumvention is necessary, ambiguities in these statutes allow countries to bypass pharmaceutical patents and encourage production...
Expanding the Patent Eligibility of Diagnostic Tests and Their Methods
Jo-an Chen There is ongoing debate over whether diagnostic tests and their methods should be patent eligible. As it stands today, these tests are largely unpatentable given the restrictive interpretation of patent eligibility laws in the United States. Some argue that patent claims directed to observing a law of nature, such as diagnostic tests, should remain patent ineligible to prevent an inventor from monopolizing basic tools of science. Others argue that diagnostic tests should be patent eligible to incentivize and encourage similar types of socially beneficial discoveries and inventions. This Essay agrees with the policy rationale for expanding the patent...
The Case for Prohibiting the Sale of Individual Genetic Testing Data to Third Parties
Nathaniel Jaffe Genetic technology is getting cheaper, and millions of individuals are using direct-to-consumer genetic testing (DTC-GT) services. At the same time, the scientific understanding of genetics is improving, making sequencing information more valuable for predictive medicine, research, forensics, and many other fields. In turn, genetic information has become more valuable for third parties like insurers, researchers, and pharmaceutical companies. DTC-GT providers are in a position to provide increasingly low-cost services to a growing consumer base, while stockpiling data of increasing commercial value. The sale of genetic data threatens the privacy of the individuals who provided it and opens them...
Potential Impact of Section 106 of the Stronger Patents Act on the Biotechnology Industry
Jeffrey Buckman A permanent injunction is the strongest remedy available to a patent holder in a patent infringement case. Throughout much of U.S. patent litigation history, plaintiffs were presumptively entitled to a permanent injunction when a defendant infringed the plaintiff’s valid patent. In 2006, however, in eBay Inc. v. MercExchange, the Supreme Court of the United States altered the standard for awarding permanent injunctions in patent infringement cases. In eBay, the Court held that patent holders are not presumptively entitled to permanent injunctions and instead must satisfy the traditional four-factor permanent injunction test. In June 2019, the House of Representatives...
The Cancer Immunotherapy Pilot Program and Chimeric Antigen Receptor-T Cell Treatments
Ellen Shamansky The Cancer Immunotherapy Pilot Program (also known as Patents 4 Patients) provides fast-track review to patent applications describing methods of treating cancer with immunotherapy, such as chimeric antigen receptor (“CAR”)- T cell treatments. This article explores considerations for claiming CAR-T cell treatments, including court rulings and examiner guidelines on patentable subject matter in the life sciences, the Federal Circuit’s decision in NantKwest, Inc. v. Lee in 2017, and pending applications and current litigation over CAR-T cell treatments. Read Full Text Here
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,...
The Daraprim and the Pharmaceutical Pricing Paradox: A Broken System?
Franklin Liu In a recent study by the American Association of Retired Persons (AARP), the average prices for brand-name prescription drugs were found to have increased by an average of 13 percent in 2013, compared to the inflation rate the year of just 1.5 percent. The Daraprim and Cycloserine cases, while extreme illustrations, depict a broader trend of increasing U.S. drug and health care costs to patients. The two manufacturers’ pricing decisions illustrate a longstanding tension in the pharmaceutical industry between the need for firms to recoup the high costs associated with bringing drugs to market and keeping drugs affordable...
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...