Unique issues involved in patenting biotechnology inventions

On behalf of Jon Spiers at JP Spiers PLLC

Learn about the complexity of obtaining intellectual property rights in products and processes from living organisms.

Biotechnological advances have contributed significantly to health care improvements, including new vaccines, medicines and treatments. Biotechnology research on new health care products is often performed by private companies that must protect their inventions against competitors.

The main way to preserve intellectual property rights in biotechnology is through the patent process. Because biotechnology deals with living organisms, granting legal protection to a biotech product raises complex issues.

The World Intellectual Property Organization, called WIPO, defines biotechnology as the "application of cellular and molecular biology to make or modify products or processes," including the following:

  • Scientific attempts to understand and manipulate living material "at the molecular level"
  • Research involving DNA and "genetic information"

Biotechnology can be viewed more broadly. The University of Nebraska notes that in its broadest sense, biotechnology is the "use of living organisms to make a product or run a process," including:

  • Modification of the "genetic material of living cells" to make them do different things or produce new substances
  • Genetic engineering, or transferring DNA between organisms

Biotechnological research can be costly, but lucrative in the medical marketplace, so biotech firms must carefully protect their property rights in their inventions. Patent eligibility requires that the invention be novel, useful and nonobvious.

When the federal government grants patent rights in an invention, others may not produce, use, market, sell or import the product for 20 years. A biotech patent owner may license its rights to another party to produce, market or sell the protected product.

With the globalization of health care processes and products, a biotech inventor may also want to seek international patent protections.

WIPO notes that patenting products and processes developed from living organisms has raised some inherently challenging intellectual property issues:

  • The fine line between discovering something already in the natural world and developing something from living material that can be called a true invention
  • The requirement that an invention be useful is complicated when the invention is in "an early and fundamental state of innovation or a new gene with its future application still not determined"

WIPO's observations are relevant to U.S. patent applicants because U.S. patents are not allowed for naturally occurring processes or things, or abstract ideas. However, if a natural phenomenon is used to create something else that is not naturally occurring, the invention may be patentable.

Complicated U.S. Supreme Court case law on these particular issues has greatly impacted legal issues of biotech patentability.

In addition, the speed of scientific discovery complicates the patent process in swiftly advancing areas of biotechnology. Because the first to file for a patent for a particular invention has the right to it, companies in the same fields of biotech research are under pressure to get their patent applications filed quickly before the other guys can, yet such applications - which can be extremely complex - must still be properly prepared and filed.

The bottom line is that anyone involved in medical biotechnology research and development should develop a close working relationship with legal counsel who not only understands the complicated laws and procedures in the patent process, but also has a firm grasp of biotech science.

Legal counsel can advise the inventor throughout the inventive process, perform necessary worldwide research on similar inventions, and prepare and prosecute U.S. and international patent applications.

From Houston, the law firm of JP Spiers PLLC, with a lawyer on staff who is also a doctor, serves biotech clients in intellectual property matters and other clients in a wide variety of health care issues.



Keywords: intellectual property, product, process, patent, biotechnology, biotech, invention, genetic, DNA, right