Strong intellectual-property rights are essential to the sustainability of the pharmaceutical industry. Because of strong appropriation effects, pharma companies generally adopt an IP business model resembling a fortress monopoly with large patent portfolios, strong market barriers, and consistent action against IP infringement into their IP strategy. In recent years, companies have struggled to maintain their foothold as a result of many blockbuster drugs going off-patent, creating a boon for the generic pharma players.
Cost containment has provided a competitive advantage as manufacturing has shifted increasingly to less-developed countries. In addition, R&D pipelines have proven to be difficult and costly to replenish even for the largest entities with ample scientific talent. Research efforts have turned to biodiverse sources to help get a jumpstart on targeting candidate compounds.
Furthermore, the pharma industry has given birth to niche areas such as nutraceuticals and cosmeceuticals which have had a sizable impact in their own right on patent thresholds. Over-the-counter (OTC) drugs and functional foods have not even come close to cresting the wave that forecasters predict these markets will become. Knowing how to claim a patentable invention to maximize value during the patent-drafting process is tantamount to securing a strong position in the competitive landscape of leveraged stakeholders, especially with the escalating risks of prolonged and costly patent litigation.
The emergence of biosimilars have also created new leveraging options for intellectual property firms in developing an overarching IP strategy. Sometimes referred to as follow-on biologics, biosimilars are subsequent versions of an innovator’s biopharmaceutical products made by a different entity following patent and exclusivity expiration on the innovator’s product. As stated on Wikipedia:
Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator’s molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product. Differences in impurities and/or breakdown products can have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the product. Consequently only a few subsequent versions of biologics have been authorized in the US through the simplified procedures allowed for small molecule generics, namely Menotropins (January 1997) and Enoxaparin (July 2010), and a further eight biologics through the 505(b)(2) pathway.
It is further mentioned that the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), formally passed under the Patient Protection and Affordable Care Act (PPAC Act) by President Obama in 2010 as an amendment to the Public Health Service Act (PHS Act), was drafted to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to a Food and Drug Administration (FDA) approved biological product. The BPCI Act is similar in concept to the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly referred to as the “Hatch-Waxman Act”) which created biological drug approval through the Federal Food, Drug, and Cosmetic Act (FFD&C Act).
An important point to factor into the IP strategy during the patent-drafting process is that of data exclusivity. Data exclusivity is a key part of the amendment in the PPAC Act for biosimilars, relating to the period of time between FDA approval and an abbreviated filing for a biosimilar on the original producer’s data. Data exclusivity is designed to preserve innovation and recognize the long, costly, and risky process involved while the innovator waits to gain FDA approval. The time allowed for data exclusivity is critical for the future of biologics. The PPAC Act guarantees a 12-year time period from the time of FDA approval to compensate for perceived shortcomings in patent protection for biologics. Data exclusivity extends from the date of product approval, and this protection period runs concurrently with any remaining patent-term protection for the biologic.
Thus, data exclusivity provides additional protection to the innovator when the remaining patent length is shorter than the data exclusivity period at the time of approval (which can occur due to lengthy pre-clinical and clinical research required to obtain FDA approval), or to the extent that the patent term is circumvented by a biosimilar prior to its expiration.
FlashPoint IP, a leader among intellectual property firms, factors these wide-ranging aspects into the process of securing patent protection, whether in performing a patent search of the prior art, engaging in patent drafting of applications, selecting how and where to file, or prosecuting your claims to an invention to help you maximize value in an extensive array of practice areas. Having Ph.D. degrees and industrial experience, our patent attorneys are adept at synthesizing the many facets needed to create a winning formula for your IP. Contact us to discuss your options regarding IP strategy and positioning, and how best to secure your rights.