The importance of having valid, enforceable patent protection was a key theme discussed at the recent Life Sciences Summit held in Long Island, NY, from September 22-23, 2010. With over 400 attendees at the summit, primarily from the pharmaceutical and biotechnology industries, there was extensive discussion of having solid Intellectual Property (IP) protection which is critical especially for commercializing new therapeutics. By “solid” IP protection, and in the case of patent protection, this is intended to refer to patents that are ultimately deemed both valid and enforceable. With representatives from large, midsize and emerging biopharmaceutical companies present at the summit, there was particular interest in the importance of IP in the commercialization of new therapeutics, including new pharmaceutical products or “Active Pharmaceutical Ingredients” (APIs). The importance of solid IP protection can’t be emphasized enough, especially in today’s challenging economic climate. In the case of emerging biopharmaceutical companies seeking investor funding, a solid IP portfolio is essential. Also, as discussed at the recent Life Sciences Summit, there are many instances where a major innovator pharmaceutical company seeks to in-license or acquire the IP of a target company, in order to expand its product portfolio.
Having a solid IP portfolio is critical for companies in the highly competitive pharmaceutical industry. With interested parties, e.g., investors and/or potential corporate partners, seeking a sound investment, partnership, or potential acquisition, it’s all but guaranteed that the interested party conducting their due diligence will evaluate not only the target company’s proof-of-concept regarding their technology, as well as their marketability assessment, business plan, financials, and of course the leadership team, but most certainly there will be a thorough evaluation of the scope, validity and thus the enforceability of the target company’s patent portfolio.
With the pharmaceutical industry facing increasing challenges both within the U.S. and globally, and given that an ideal and often elusive target for pharmaceutical companies is to acquire patent protection for a novel composition or matter (or, in other words, a chemical compound deemed a new chemical entity or NCE), this article will discuss some key factors that should be considered when developing, acquiring and leveraging an IP portfolio, in particular, a portfolio that seeks to cover a new composition of matter.
Regarding the development of solid patent protection for a composition of matter, as an initial point, has a thorough patentability search and analysis been performed? An initial determination of patentability is critical. For instance, the importance of established caselaw holding anticipation by enabling prior art that discloses a single chemical species cannot be overstated. Having good IP counsel that really understands the nuances of the caselaw is essential. It’s also better to know the IP landscape before seeking patent protection on a purportedly new composition of matter that may (potentially unknown to the applicant) already have been disclosed in the prior art. Moreover, once an innovator company has identified a core structure, and the medicinal chemists have contemplated all the conceivable rational substitutions on the core structure, has the entire genus and all potential permutations been adequately disclosed in the patent specification? Even though the structure and structural modifications are themselves adequately described in a patent specification, does the specification actually enable one to make and use the preferred compositions of matter, which may also be the lead compounds? Have all material references been disclosed during the course of prosecution? What is the scope of protection in the claims?
What is the full scope of the disclosure? For instance, for APIs, have all rational and conceivable salt forms been disclosed? If there is evidence that a particular salt form of the compound has preferred properties, are there enabling examples that teach a person of ordinary skill in the art how to make and use that specific salt form? For instance, for an API that may ultimately be developed as a hydrobromide salt, succinate salt, tosylate salt, or other specific salt form, having an enabling disclosure which clearly teaches how to make and use that specific salt form is essential to a solid patent disclosure. What has been disclosed about formulations? Have all various types of pharmaceutical formulations been contemplated and disclosed?
Also, what has been disclosed about routes of administration? Specific dosage forms, and dose ranges? What is known and what has been disclosed in the patent specification, regarding pharmacokinetic (PK) properties? These are all potentially extremely valuable aspects of IP protection that broadly cover a pharmaceutical product.
One preferred strategy is to disclose these features (such as specific dosages, routes of administration, salt forms of the API, PK properties, etc.) as early as possible, keeping in mind that it’s all but guaranteed that competitors – especially in the very highly competitive pharmaceutical industry – will, once a commercially valuable patent issues, make every effort to challenge the patent and/or design around the innovator’s patent(s). Thus, contemplating in advance some of these important features relating to a pharmaceutical innovation, and thinking strategically about how to build the most comprehensive and solid patent disclosure possible, after conducting thorough landscape and due diligence investigations, will be tremendously advantageous in building a solid IP portfolio. Moreover, having a solid IP position, and being able to rely on thorough and comprehensive due diligence and landscape analyses, and ensuring that the prosecution is carried out effectively, with full disclosure of all material references, will greatly enhance the chances of retaining a patent that is ultimately deemed valid and enforceable when it is challenged in litigation under Hatch-Waxman.
In summary, with regard to building solid patent protection for pharmaceutical APIs, strategic IP planning and conducting thorough and comprehensive due diligence in advance are essential to building the IP portfolio, and before approaching an investor or potential corporate partner. Under current U.S. law, the rewards for innovator companies are significant; for instance, with FDA approval of an NCE, the innovator is granted a highly sought-after five-year marketing exclusivity in the U.S., in which generics are foreclosed from marketing imitation or generic versions during that period of exclusivity. Moreover, while the FDA rewards innovator companies with this sought-after marketing exclusivity, innovator pharmaceutical companies also benefit from patent protection for their discoveries. Having taken all the steps possible in advance to ensure solid patent protection, an innovator will be in a much better position to withstand challenges to their valuable Orange Book-listed patents from generic companies, especially in an increasingly competitive global marketplace.
 John K. Weatherspoon, PhD, is Of Counsel at Stein McEwen, LLP. The opinions in this article do not represent the official positions of Stein McEwen, LLP. This paper is based upon a presentation given at Life Sciences Summit held in Long Island, NY, from September 22-23, 2010.