Abstract

It takes 10-15 years to bring a new chemical entity (NCE) or medicinal product in the market. While research and development for a new chemical entity or a medicinal product is in progress, pharmaceutical companies usually protect their intellectual property or trade secrets by applying for a patent grant. Patent grants only applies to a novel or new innovation. In the US, the patent grant application is administered through the United State Patent and Trade Mark Office (USPTO) (Schacht, & Thomas, 2005). In addition, pharmaceutical company’s ability to protect it’s intellectual property and market exclusivity through the FDA may also depend on whether the drug in question falls under the Hatch-Waxman Act of 1984. In some cases, the ability to protect a company’s intellectual property may also depend on the kind of project in question. For instance, the Orphan drug Act and FDA modernization Act (FDAMA)’s “pediatric exclusivity”, may also provide protection of intellectual property and market exclusivity.

IPPS

Protection of intellectual property is an economic status allowing industries in a free market society to protect their investment, innovations and trade secrets for a limited time. This statutory provision will also allow them to recoup profits from research and development costs and other substantial investments associated with the product. Although inventions falls under four categories; processes, machines, manufactures and compositions; there are critical factors that affect the ability of drug developers to protect their intellectual properties which include but not limited to scope of novelty, area of research (rare disease) and the scope of intended patient for the investigational product (Schacht, & Thomas, 2005).
Novelty is one of the desired criterion for protecting intellectual property. The ability for an industry to protect its intellectual property may rely on it’s ability to be innovative and the ability to be the first to come up with a novel idea within a subject matter (new chemical entity, disease remedy, clinical pathways, mechanism of action e.t.c). Innovation by itself produces new knowledge and yet, innovation is knowledge driven. Innovation is costly and resource intensive. Thus, patent grant permits novel concept or discovery to become “property” (Schacht, & Thomas, 2005). When this property is reduced to practice or application and allows control over it’s use, it becomes a “utility”. Hence, utility is used in a patent to either grant or disapprove a patent application. In addition, the utility aspect of a patent may have appropriability factors which may facilitate the exclusion of others from marketing the patented product in question. Therefore, appropriability is the environmental factors such as a patent that governs inventor’s ability to capture profit generated by an innovation under a patent law (Schacht, & Thomas, 2005). Thus, patent law, is a statute that allows investors to obtain monopoly on processes, machines manufactures and compositions of matter that are useful, new and nonobvious (Schacht, & Thomas, 2005).
The ability for a company to invest in some area of research such as rare diseases may increase their likelihood to obtain intellectual property protection. Most rare diseases are deserted, but thanks to the Orphan Act which has created additional incentives for industries that invest and conduct research on this area of scientific need. This Act allows for extended market exclusivity for a patented product under this umbrella to encourage research and development in this field. In addition, it protects the intellectual property and allow the pioneer (inventor) to recoup substantial amount of profits in their inventions before a generic version can be allowed/approved in the market by the regulatory agency (FDA) (Ashbrook, & Whitmore, 2013).
The Hatch-Waxman Act also had provisions to enhance a company’s ability to protect its intellectual property. The Hatch-Waxman Act was introduced to encourage drug price competition in 1984. This Act modified the 1952 patent Act. The 1984 Act focuses on the introduction of a generic version of a branded product in the market. This Act allows the introduction of generic drugs in the market at the expiration of the granted brand patent. In an exchange for this patent modification-the 1952 Act, or the application of the 1984 Act, the original inventor of a branded product is provided with the opportunity to extend their market exclusivity through the FDA. This opportunity allows the extension of the market exclusivity of the product in question for part of the drug’s test period and the whole time period of the FDA approval process. The total restoration to be given may not exceed five years, and the remaining patent term of the restored patent following FDA approval of the NDA may not exceed 14 years (Schacht, & Thomas, 2005). Furthermore, the Hatch-Waxman Act also awards 180 days market exclusivity to the first generic company that wins a paragraph 4 certification on a granted patent. Another area through which an intellectual property could be protected is through the FDAMA. The FDAMA uses the “pediatric exclusivity” to extend market exclusivity in drug research and development for children.
Finally, freedom to operate (FTO) with commercial intent is not currently allowed in concurrent with the patent life span. Hence, to avoid intellectual property right infringement, the FDA uses “Orange Book” to list all the contents covered in a patent that must not be infringed by other competitors or generic companies. However, if a company feels that a patent is invalid they may file a paragraph 4 certification to dispute the validity of the patent in question. Once a company files a paragraph 4 certification, the pioneer company has 45 days to file a lawsuit against the company in question for infringement. Once a lawsuit is issued, the FDA will suspend the approval process of the ANDA or any other application to allow for proper legal review of the situation at hand. This concept also act as an incentive by allowing the brand company to continue with the market exclusivity right and any other possible drug improvement and modification in the area without competition. Finally, it is important to note that no drug is foolproof or guaranteed to be safe. Nonetheless, many products can be made safer and more efficacious through extensive design changes and optimal drug modifications (Whitmore, 2004).

References

Ashbrook, C & Whitmore, E.(2013). Intellectual property and patent. Retrieved from https://class.waldenu.edu/webapps/portal/frameset.jsp?tab_tab_group_id=_2_1&url= %2Fwebapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DCourse%26id %3D_2099284_1%26url%3D.

Schacht, W., & Thomas, J. (2005). Patent law and its application to the pharmaceutical industry: An examination of the drug price competition and patent term

restoration Act of 1984 (“The Hatch-Waxman Act”). Retrieved from http://www .law.umaryland.edu/marshall/crsreports/crsdocuments/r l3075601102005.pdf.

Whitmore, E. (2004). Development of FDA-regulated medical products: Prescription drugs, biologics, and medical devices. Milwaukee, WI: ASQ Quality Press.