Home > Topics > Patents and Patenting: Balancing Protection with the Public Domain > The Interface of Patents with the Regulatory Drug Approval Process and How Resulting Interplay Can Affect Market Entry > Editor's Summary, Implications and Best Practices

Obtaining patent protection and regulatory approval for biotechnology and pharmaceutical products is an extremely time consuming and expensive process. For nonprofit organizations working with limited resources, it is especially crucial to manage the process efficiently and make the most of patent protections while they last. This chapter suggests that public sector entities can use some techniques from the private sector to maximize revenue and, in turn, provide drugs to the public at the lowest possible price. The authors suggest that organizations 1) carefully time patent and Food and Drug Administration (FDA) applications to maximize the effective life of a patent and avoid unnecessary disclosures, 2) seek opportunities to extend the patent term, and 3) take steps to delay entry of generic drugs into the market.

The average application time for a biotechnology patent in the U.S. is 4.4 years. Getting FDA approval takes, on average, ten to twelve years and can cost U.S. $500 million. With such large amounts of time and money involved when R&D is included, it is crucially important to expedite the application process. One possibility for innovating companies is to conduct preclinical trials before filing patent applications. The results of these trials can help establish the drug’s utility, which is necessary to obtain a patent. However, it is crucial that companies file patent applications before proceeding with the next three phases of clinical trials. Since the FDA process requires public disclosure of the invention through publication, seeking FDA approval before filing a patent could allow other companies to jump in and patent related material. In addition, FDA approval is accelerated for patented compounds and public disclosure of the invention might attract investors that can fund FDA trials.

Nonprofits especially should note that the U.S. Patent and Trademark Office (PTO) gives special priority to certain biotechnology patent applications from small entities and nonprofits. The FDA likewise expedites approval if there are indications that the product will provide significant therapeutic benefit over existing therapies. As far as the other end of the patent lifecycle, after having gone through the steps of obtaining FDA approval it is in the best interests of innovating companies to extend the patent term for as long as possible. While the normal patent period is 20 years, extensions are possible under certain circumstances. If the patent approval process is delayed for more than three years, for example, the term can be extended. Two pieces of legislation also allow the patent term to be extended for up to five years for some human and animal drug products.

Finally, after having invested so much time and money developing and patenting products, innovating companies face the unwelcome prospect of generic drugs flooding the market at the end of the product’s patent term. While it is impossible to avoid indefinitely market competition from generic alternatives, companies can slow the entry of generic drugs into the market.

It should be noted that neither the publishers nor editors of this Handbook encourage the effective extension of patent duration nor the delay of entry of generics into the market.

Nonprofit organizations have an important role to play in distributing newly developed biotechnology and pharmaceutical products to those who need them at the lowest possible price. These organizations can usefully apply strategies used in the private sector to more efficiently obtain patent protection and FDA approval, and thus partly mitigate the time and cost that are inherent to pharmaceutical innovation.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Support and create government policies that will allow inventors to control the rights to their inventions. This way, government legislation can effectively promote the commercialization of drug research, ensuring investment recovery and increases in research productivity.
• Promote patent and drug approval process education. Taking steps to ensure that inventors know how to deal with both patent and drug processes ensures that they will take well-informed, aggressive steps to remain competitive in the industry. This competition will nurture a rapid rate of industry innovation.
• Instead of making the patent and drug organizations completely separate entities like the PTO and the FDA, consider taking steps toward communication between the two parties so that the processes will work more smoothly.

For Senior Management (university president, R&D manager, etc)

• Support and make readily available IP/drug approval education. Attempt to integrate this with the academic curriculum.
• Encourage good laboratory practices, excellent notebook keeping and so forth to ensure that your research can later be used in possible regulatory filings. This could avoid costs and reduce the time to market by several years.

For Scientists

• Scientists should be constantly thinking about patent and drug approval processes for their inventions. They should be familiar with both and devise a plan to minimize the time the invention is in these approval processes.
• Because a patent’s life is not infinite, the quicker the patent can be finished with the processes, the longer the invention will be exclusive to the patent holder. This is extremely desirable to inventors because a longer patent life means larger licensing deals and a longer period of market exclusivity.
• Ensure good laboratory practices, excellent notebook keeping and so forth to ensure that your research can later be used in possible regulatory filings. This could avoid costs and reduce the time to market by several years.

For Technology Transfer Officers

• Teaching inventors about equivalencies the Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA) processes is in a licensing officer’s best interest. The better the management of both processes, the longer a respective patent is available for licensing. The added time means that licensing deals have the potential to be more lucrative.