{"id":376,"date":"2019-02-11T00:00:00","date_gmt":"2019-02-11T00:00:00","guid":{"rendered":"https:\/\/norrismclaughlin.com\/mtym\/2019\/02\/11\/developing-ip-strategy-for-fda-regulated-drug-products-requires-special-considerations\/"},"modified":"2019-02-11T00:00:00","modified_gmt":"2019-02-11T00:00:00","slug":"developing-ip-strategy-for-fda-regulated-drug-products-requires-special-considerations","status":"publish","type":"post","link":"https:\/\/norrismclaughlin.com\/mtym\/general\/developing-ip-strategy-for-fda-regulated-drug-products-requires-special-considerations\/","title":{"rendered":"Developing IP Strategy for FDA-Regulated Drug Products Requires Special Considerations"},"content":{"rendered":"

Despite the widely diverging needs of the different industries that make use of the US patent system, US patent law applies essentially the same rules to innovations from all technology fields. This means that drug and biotechnology-based inventions are treated no differently by the U.S. Patent and Trademark Office (USPTO) as inventions in fields such as computer science, information technology, household consumer products, financial services, and industrial chemicals, etc.<\/p>\n

This one-size-fits-all approach is problematic for pharmaceutical companies whose products are regulated by the U.S. Food & Drug Administration (FDA). \u00a0Due to the significantly greater financial and time investment required to develop a drug product, obtain regulatory approval, and ultimately bring the product to market, the development and life-cycle of drug products aligns particularly poorly with the current U.S. patent rules.<\/p>\n

Further, the TRIPS Agreement states that \u201c\u2026 patents shall be available and patent rights enjoyable without discrimination as to \u2026 the field of technology \u2026\u201d Accordingly, there are limitations of what can be done to the patent system to carve out rules and exceptions based on the needs of different industries.<\/p>\n

Nevertheless, efforts have been made by the pharmaceutical industry to lobby for legislation that might mitigate the shortcomings of the patent system in protecting pharmaceutical innovations. A result of this effort is a rather Byzantine system of interrelated and overlapping legal protections based on patent exclusivity and regulatory exclusivity.<\/p>\n

In view of the foregoing, patent practitioners with clients in the pharmaceutical industry should become familiar with FDA regulations that have ties with the US patent framework, in order to develop a comprehensive IP strategy that maximizes exclusivity for their clients\u2019 high market value assets.<\/p>\n

With the foregoing in mind, an introductory description of important terms and concepts relevant to the intersection of FDA regulations and U.S. patent system are discussed below. Dedicated blog posts focusing on one or more of these concepts will follow in the future.<\/p>\n

Patent Exclusivity<\/strong><\/h4>\n

Most innovator companies, in particular pharmaceutical companies, routinely rely on patents for a period of exclusivity to protect their high market value commercial product, in order to recoup some of the costs associated with bringing the product to market.<\/p>\n

The complex calculation to determine the term of a patent is discussed in detail in my earlier blog posts here<\/a> and here<\/a>.\u00a0One factor that contributes to patent term is Patent Term Extension (PTE) available under 35\u00a0U.S.C. \u00a7156, which was aims to compensate for commercialization delays due to premarket regulatory review, in particular delays due to time lost during clinical trials and FDA review.<\/p>\n

Regulatory Exclusivity<\/strong><\/h4>\n

It is illegal to sell drugs with advertised medical claims that are not FDA approved. FDA\u2019s New Drug Application<\/strong> (<\/strong>NDA<\/strong>) <\/strong>is the vehicle for obtaining FDA approval for a new pharmaceutical for sale and marketing. The FDA approval process is onerous and difficult to navigate without guidance from experts familiar with the relevant regulations. For competitors of innovative pharmaceutical companies, the FDA approval process is another barrier (in addition to patents) to bringing a competitive generic product to the market.<\/p>\n

FDA exclusivity is the exclusive rights granted by the FDA upon approval of a drug which can run concurrently with a patent or not and can be present even without a valid patent. FDA exclusivity prevents the submission or effective approval of an Abbreviated New Drug Application (ANDA) for a generic drug.<\/p>\n

The length of exclusivity depends on the type of exclusivity: Orphan Drug (ODE) – 7 years; New Chemical (NCE)- 5 years; “Other Significant Change” (OSC) – 3 years for a “change” if criteria are met; Pediatric Exclusivity (PED) – 6 months added to existing Patents\/Exclusivity; and Patent Challenge \u2013 (PC) \u2013 180 days (ANDAs only). Sometimes exclusivity runs concurrently with patent protection and sometimes it extends beyond.<\/p>\n

The Orange Book<\/strong><\/h4>\n

The FDA publishes the \u201cApproved Drug Products with Therapeutic Equivalence Evaluations,\u201d commonly referred to as the \u201cOrange Book,\u201d which identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act, and related patent and exclusivity information. Unlike the courts or the USPTO, the FDA makes no effort to determine whether patents listed in the Orange Book are valid and infringed, or even whether they claim the listed drug or its use.\u00a0 The FDA relies on the NDA sponsor to identify which patents are appropriate for listing in the Orange Book.<\/p>\n

The Hatch-Waxman Act<\/strong><\/h4>\n

The Drug Price Competition and Patent Term Restoration Act of 1984 is commonly referred to as the Hatch-Waxman Act. This Act aimed to provide a better balance between providing an incentive for drug innovators to spend the significant resources required to develop a new drug product and encouraging and facilitating generics to come into the market more quickly. After the Hatch-Waxman Act, the number and rate of generics coming into the market increased dramatically compared to the early 1980s. Key provisions of the Hatch-Waxman Act include:<\/p>\n