USA – NEW YORK Trends and Developments Contributed by: Naira Simmons, Pierson Ferdinand LLP
Skinny Labels and the Future of Induced Infringement: Understanding Why and How It Carries Particular Weight in New York Intellectual property (IP) is one of the most valuable assets for most companies. Unsurprisingly, companies consider various forms of IP, such as patents, trade marks, copyrights, and trade secrets to safeguard their IP. In life sciences in particular, certain patent portfo- lio strategies have proved to be “tried and true”. An example of such a strategy follows a typical pattern: a company develops a novel, non-obvious, core product, a drug or a biological. The company then pursues an initial patent filing (which we call a patent family in pat- ent law). This initial patent filing is designed to protect the characteristics of the core product itself – whether a drug, a biological product, or a piece of hardware. Over time, the company spends millions of dollars further developing and validating the core product. During such further developments and validation, new discoveries are frequently made. A series of improve- ments are also frequently made to the composition of that core product, such as refinements to its for- mulation. Clinical validation of the product in most countries also requires compliance with regulatory guidelines, and in most cases, millions of dollars are invested by the company to assess not only the safety of the compound but also its efficacy for the treatment of a first indication. As has been said by others, the difference between the efficacy of a drug and its inef- ficacy in treating any particular indication can be the proper dosage for the target indication. Validation of such dosages also requires significant investment and risk; after all, in many cases clinical studies can fail to prove efficacy. In the case of pharmaceuticals, the identification of new therapeutic indications is often protected through method-of-use or process patent filings tailored at the new indication. Because these patents have a later filing date, they typically extend the period of exclusivity for the original product well beyond what the initial patent alone would afford. Such strategies are tried and true, and many have considered policy questions as to whether or not such patents properly reward companies that assume the risk in pursuing validation of products for new indica- tions, or whether they unfairly extend exclusivity to a product. In the United States, Congress has consid-
ered this issue and provided a path for “skinny labels”. The future of skinny labels is one of the largest topics of interest in IP law at the moment in the United States and in New York. What are skinny labels? A skinny label is a regulatory strategy allowing generic drug manufacturers to market a product by omitting (or “carving out”) specific patented uses from the label, while retaining approved, non-patented indi- cations. It was introduced as part of a 1984 Federal Law, named the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) which established the modern US generic drug regulatory system, providing laws that apply to each American state, including New York. A skinny label enables earlier market entry for gener- ics, often before all patents on a brand-name drug expire, fostering competition. All new drugs must be approved by the Food and Drug Administration (FDA) before they can be marketed or sold in the United States. More specifically, in the United States all drugs sold in the State of New York (or in any other state) are generally approved by the FDA through a new drug application (NDA). To obtain FDA approval, NDA spon- sors typically conduct the clinical trials to demonstrate a drug’s safety and effectiveness, which is generally a part of a costly and time-consuming process. NDA sponsors must also submit proposed labelling for the drug for the FDA’s approval, including the approved indications for use of the drug (eg, the diseases or conditions that the drug is approved to treat). Although the FDA approves new drugs for specific indications, physicians may still prescribe an approved drug “off label” to treat other indications that the FDA has not reviewed for safety and effectiveness. In New York, New York’s generic substitution laws interact directly with the skinny label framework. Skinny labels and the future of induced infringement Hatch-Waxman created a separate pathway for FDA approval through abbreviated new drug applications (ANDAs). ANDA filers need only show that their prod- uct is pharmaceutically equivalent and bioequivalent to an FDA-approved drug with the same active ingredi- ent (such that the new drug can be expected to have
410 CHAMBERS.COM
Powered by FlippingBook