Establishing a winning biotechnology patent portfolio.

• Author: McCarthy, Robert E.
• Position: Brief Article

The 20th century has been hailed as the century of physics and chemistry. Many predict the 21st century will be characterized by great achievements in biological sciences. Advances in diverse areas ranging from medicine to agriculture will tremendously change our world. Researchers are poised to develop cures for cancer and AIDS. The human-genome project has provided information that will revolutionize clinical therapies. More than ever before, these research-and-development activities are occurring in the biotechnology industrial sector.

Critical to the success of any start-up biotech company is establishing an intellectual-property portfolio that will generate the interest and financial support necessary to sustain and develop the company into a dominant player in the marketplace and to stifle competition.

In their early development, biotech companies should adopt an approach to procuring intellectual-property rights that will foster their growth and protect the technical advancements that are their core. Some generalized guidelines will aid that process and guarantee long-term commercial success. However, there are also some pitfalls with potential deleterious effects for a company in its embryonic stage.

Initial technology development

In a company's initial stages of development, it is prudent to identify technologies that merit patent protection. This requires sound investigative research of the scientific literature, published U.S. patents and published international and European patent applications. The Internet is a valuable tool in making this initial assessment. It is important to determine what is out there before embarking on product development and commercialization, particularly in competitive markets.

The scope of patent claims being allowed in a given technology should be examined closely. Claims of narrow scope are common in technical areas where an abundance of prior art exists. However, it is important not to assume that a large number of issued patents in a given technical area leaves no room for future patents. Important intellectual-property rights can still be obtained, and a defensive patent can have significant value through licensing agreements. In some fields, narrow patents have value and can be used as good bargaining tools.

Business plans that consider IP rights

The establishment of a business plan that does not lead to loss of crucial patent rights is invaluable to the success of a start-up biotech company...