The Use Of The Hatch-Waxman Safe Harbor In Patent Infringement Cases | Caldwell Intellectual Property Law

The usefulness of patents and infringement

Patent protection in the pharmaceutical industry is a very valuable tool that is used not only to protect the property rights of a potential new drug, but also to protect a potential source of income large enough to cover the costs associated with developing a drug to enable. This recovery can fund new drug development efforts that will help maintain a healthy development pipeline for a company. Therefore, pharmaceutical, biotechnology and biosimilar companies involved in the development of new treatments to cure many diseases take patent protection very seriously and vigorously defend any attempts by a company around the world to encroach on these rights. In the United States, patent infringement is codified in 35 USC § 271 (a), which states that “whoever makes, uses, offers or sells a patented invention in the United States without authority, imports it within the United States or into the United States” patented it Invention during the term of the patent therefore infringes the patent. “

The Hatch-Waxman “Act” and Incentives

A generic drug manufacturer can take advantage of the provisions of the Drug Price Competition and Patent Term Restoration Act (colloquially known as the Hatch-Waxman Act) (“the Act”). This 1984 law provides a legal framework to streamline the process for generic drug manufacturers to gain Food and Drug Administration (FDA) approval. For example, the law created an abbreviated application for new drugs (ANDA) that accelerates the approval of generics and ensures that generic copies of previously approved branded drugs can be marketed immediately after the expiry of applicable patent protection for the originally approved drug.[1] In order to promote innovation, the law grants the first applicant for an ANDA 180 days of market exclusivity to all subsequent ANDA applicants.

The law also gives these companies an incentive to challenge patents of other pharmaceutical companies that allow them to develop generic drugs while patents on branded drugs are still in effect. Branded pharmaceutical companies are required by law to list the patents that apply to their drugs in the “Approved Drug Products with Therapeutic Equivalence Evaluations” or, as it is usually called, in the “Orange Book”. The Orange Book “identifies drugs approved by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act on the basis of safety and efficacy, and related patent and exclusivity information.”[2] More importantly, and as a time-saving measure in the regulatory schedule, generic manufacturers can rely on the clinical test results of the branded drug to prove the safety and efficacy of the generic drug candidate.

One of the provisions of the law provides a safe haven for activities that would otherwise constitute patent infringement. Section 271 (e) (1) states

It does not constitute a violation of a patented invention (with the exception of a new veterinary medicinal product or biological veterinary medicinal product (such as these terms in the Federal Food, Drugs and Cosmetics Act and the Act of March 4, 1913), which is made primarily using recombinant DNA, recombinant RNA, hybridoma technology or other processes that involve site-specific genetic manipulation techniques) exclusively for uses that are reasonably related to the development and transmission of information in accordance with a federal law that regulates the manufacture, use or sale of pharmaceuticals or biological animal products.[3]

Safe Harbor Patent Terms

Usually, the use of patented products or processes during the R&D phases of a drug could constitute patent infringement under 271 (a). However, the use of such products and processes is sometimes required in order to obtain FDA approval to market a product that contains a small molecule, biological, or medical device. This safe harbor allows a generic drug company to conduct experiments necessary to obtain regulatory approval before the patents on the drug expire. Because generic drug manufacturers can conduct certain types of experiments, this essentially maximizes their patent life since they don’t have to wait for the drugs’ patents to expire to begin experiments.

During the COVID-19 pandemic, there are current cases in court in which defendants have used the safe harbor exception to defend patent infringement suits. Recently, Regeneron Pharmaceuticals, which is developing an experimental treatment for COVID-19, asked a federal judge to dismiss a lawsuit by San Diego-based Allele Biotechnology and Pharmaceuticals using the law’s safe harbor provision in its reasoning.[4][5] Allele claims Regeneron used its mNeonGreen (US Patent No. 10,221,221) protein technology and is demanding royalties for that use.

In response, Regeneron argues that peptides as used in this case also fit the definition of research tools, as Alleles relies on the National Institutes of Health’s definition of “research tools”.[6] As defined, “research tools” include “tools that scientists use in the laboratory, including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines. “[7] Note that “Research Tools” as defined above are not specifically listed as a category that falls under the safe haven of the law. The question has been dealt with implicitly by the courts, but there is still no clear line.[8]

Regeneron’s refutation

Regeneron argued that the use of such research tools was limited to developing and submitting information to the FDA. [9] Regeneron claims that the use of mNeonGreen was “related to neutralization assays to test the potency or efficacy of candidate antibodies, including those selected for REGEN-COV – uses directly related to Regeneron’s FDA filing and under Section 271 (e) (1) are immune. . “[10]

Even if the use of peptides may fall under the Safe Harbor provisions of the law,[11] There are no explicit or unambiguous court opinions. Whether the Safe Harbor applies is a fact-intensive investigation in which each use is assessed on a case-by-case basis. This approach can lead to conflicting opinions. Therefore, clearer guidance from the courts is needed

[1] Hatch change would maintain a balanced incentive for pharmaceutical innovation and affordability of drugs,

https://www.healthaffairs.org/do/10.1377/hblog20181106.217086/full/

[2] https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

[3] 35 USC § 271 (e) (1)

[4] Allele Biotechnology v Regeneron Pharmaceuticals, Case No. 7: 20-cv-08255 (SDNY 2020).

[5] Regeneron antibody cocktail used by Trump’s patent lawsuit, https://www.bloomberg.com/news/articles/2020-10-05/regeneron-antibody-cocktail-used-by-trump-faces-patent-suit

[6] [6] Response from Regeneron in support of his motion to dismiss, page 7, Allele Biotechnology and Pharmaceuticals v Regeneron Pharmaceuticals, Inc., Case 7: 20-cv-08255.

[7] ID card.

[8] See Eli Lilly & Co. v Medtronic, Inc., 496 US 661 (1990); Proveris Scientific Corp. v Innovasystem, Inc., 536 F.3d 1256 (Fed.Cir. 2008); Integra Lifesciences I, Ltd., Merck KGaA, 331 F. 3d 860 (Fed Cir. 2003).

[9] Answer from Regeneron in support of his application for rejection, p.8.

[10] ID card.

[11] Merck KGaA v Integra Lifesciences I, Ltd., 545 US 193 (2005)