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...
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 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...
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
Data Exclusivity for Biologic Drugs: The TPP’s Potential Poison Pill?
Tina Cheung On October 5, 2015, after many years of secretive negotiations, the US government with 11 other countries across the Asia Pacific and Latin America reached an agreement on the largest free-trade deal in history, the Trans-Pacific Partnership (TPP). Addressing everything from wildlife conservation and tax reductions for agriculture, to the free flow of information on the Internet and intellectual-property rights for movies and pharmaceutical drugs, this far-reaching agreement has the potential to impact up to one-third of world trade. One of the most contentious parts of the agreement involves intellectual property rights of pharma companies to data exclusivity...
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...
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...