Intellectual Property in the Drug Development

Introduction of Intellectual Property in the Drug Development

Intellectual property (IP) refers to the "creations of the mind", which range from technical inventions to literary and artistic works. In the current drug development landscape, it has become impossible to bring new drug candidates to the market without proper IP protection. In addition, society is increasingly expecting a return on investment in academic research. For instance, for life sciences research, one is not only expecting that scientists provide novel insights, but more and more people expect that they maximally engage in the translation of novel findings into new therapies for patients. In this changing landscape, academics start to better understand that proper IP management is crucial to ultimately bring a product on the market. In this respect, adequate IP management should be a natural reflex to justify the use of taxpayers' money for academic research. Although this awareness is growing, there is certainly a role for Tech Transfer Office and for Innovation Managers to continue the education of academics about IP management and their moral duty.

Introduction of Patent

Patents, copyrights, trademarks, trade secrets, and designs are the different types of IP, all of which are protected by law. Among these patents are by far the most important IP in the pharmaceutical industry. The World Intellectual Property Organization (WIPO) defines a patent as "an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem.

As a general rule, any invention that is novel, unobvious, and has practical utility in real-life settings can be patented. A pharmaceutical company can seek different types of patents as follows:

Fig. 1 Sequence of events in patenting of a new compound. (Raj, 2015)

• Composition of matter patent

This is a patent for any compound, drug, biological, or diagnostic. This is the strongest of all patents as it also includes all uses of a particular product, e.g., metformin.

• Use patent

Patents for a specific use of a compound, drug, or biological, to treat or prevent disease are called "use patents", e.g., use of metformin in PCOD (newer indication).

• Process or manufacturing patent

Patents for a method of manufacture of a compound, drug, or biological are called "process patents", e.g., synthesis of metformin through a novel method.

• Formulation patent

Formulation patents are given to newer formulations of a known drug, such as sustained-release formulations or new salts of the drug with unexpected properties, e.g., a sustained-release preparation of metformin.

Importance of IP in Drug Discovery

IP protection may not be the top priority of traditional academics. Therefore, one should offer strong incentives to inventors. In this respect, the financial compensation of inventors is only one aspect. IP management and entrepreneurship could also be stimulated by putting more emphasis on these factors for developing an integrated academic career. More funding should be earmarked to support the career development of young inventors and projects should move faster toward an incubator strategy. The status and progress of projects must be tightly monitored by scientific and business experts.

The importance of intellectual property in drug discovery and development needs no further elaboration. Creative Biolabs helps our customers safeguard their rights and interests. Our drug discovery-relevant services will also accelerate the research of our customers. If you are interested in our services or you have any other questions, please feel free to contact us for more information.

Reference

1. Raj, G. M.; et al. Drug patents and intellectual property rights. Eur J Clin Pharmacol. 2015, 71(4): 403-9.