23 September 2021 Volume :9 Issue :41

Webinar Examines the Protection and Patenting of the Drug Discovery Process

Webinar Examines the Protection and Patenting of the Drug Discovery Process
Mr Philip Hoekstra.

UKZN’s technology transfer office, UKZN InQubate, in partnership with the University of Cape Town’s (UCT) Department of Research Contracts and Innovation (RC&I) hosted a webinar on the protection and patenting of the drug discovery process.

Mr Philip Hoekstra, Intellectual Property Manager at RC&I set the scene by recognising existing tensions in the pharmaceutical world between those that support patent protection for pharmaceutical products and those that seek affordable access for developing nations. He explained that both objectives can be met and acknowledged the role that patents play in providing affordable access to these products in developing countries.

Hoekstra highlighted that the process from drug discovery to market entry can take anything from 12 to 15 years and cost between $150 million and $1 billion, thus making it important to provide market protection for commercial investment. He identified patents that are valid for 20 years as a form of market protection that enables investors to recover costs and potentially make a profit. He added that when a patent expires, companies that manufacture generic products can enter the market and offer lower prices.

Turning to how universities can partner with commercial investors for funding to bring their drug or product to the market Hoekstra said: ‘A patent can give a university the ability to control the terms of the licensing agreement, negotiate a fair royalty deal and provide the tools to negotiate an affordable price for the South African public health sector.’

He noted that the pharmaceutical industry depends on universities to conduct early, experimental research that is high risk and often grant funded; add value by de-risking technology which has to be aligned with industry timelines; and to establish a biotech spin-off company by getting a drug closer to the market and creating potential for a big company to buy into it.

Hoekstra reviewed a few cases where UCT patented too early and explained that this shortens the lifespan of a patent and reduces the value of the intellectual property by reducing the time available to pharmaceutical companies to conduct clinical trials, apply for regulatory approval, and enjoy market protection in order to recuperate costs.

He advised institutions to file patents as late as possible, typically at the end of the lead optimisation stage when they have achieved a sound in-vivo disease model, ADMET (absorption, distribution, metabolism, elimination and toxicity) testing and Pharmacokinetics profile.

Hoekstra also highlighted some of the basic requirements for patents, such as being able to prove that the drug or product is novel, inventive and useful, and added that discoveries and scientific theories are not patentable. The three steps in the patenting process are the provisional, patent cooperation treaty (PCT) and national phases and patents can take two to seven years to be granted.

In closing, Hoekstra urged universities to never file patents too early and to outsource key activities; obtain external input; set aggressive timelines for their projects; partner early with the industry or other universities to obtain valuable information; and to review patents and patent strategy on a regular basis.

To watch the recording of the webinar click here.

Words: Hlengiwe Khwela

Photograph: Supplied

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