Patent Law in Biology

Nations disagree on patent laws for biological products.

When it comes to patenting biological inventions, nations cannot reach agreement. This creates frustrations among manufacturers who must pursue lengthy developments to commercialize the solutions while facing the risk of copycat competitors. In this landscape of global disharmony, some countries have stepped forward with liberal patent laws to stimulate inventions in biology.

Invented Versus Discovered

Efforts to harmonize the patent laws regarding biological inventions have gathered attorneys, religious leaders and experts in ethics. The discussions center on the definition of what represents an invention in contrast to what is discovered. Specifically, the debate challenges whether the work of Mother Earth merits a patent when humans notice its ingenuity for the first time.

Morality

To further complicate the matter, patent laws in most nations exclude inventions "contrary to the public order or morality.” These laws, originally drafted to protect societies from mass destruction or to block inventions with prime purpose to be detrimental to humans, apply also to biological discoveries. Some genetic manipulations might cause moral concerns pending the religious belief or the societal values of the nation. In this regard, human embryos and stem cells receive varied levels of endorsement or exclusion, as explained by W.H. Huang and Dennis Fernandez, managing partners from Fernandez and Associates.

United States Patent Law

The U.S. Patent and Trademark Office welcomes biological concepts that present new properties as the result of the intervention of a human being. The legal definition encompasses nonobvious and new ideas that point to a composition of matter, the methods required to apply the concept, and the processes associated with the novel product. The patent protection lasts 20 years and blocks someone else from manufacturing, using or selling a product based on the same idea.

European Patent Law

The 1998 European Directive 98/44 EC accepts some biological patents if the genetic content can reproduce itself. This definition extends an umbrella over DNA and organisms and the processes required to generate them. In contrast, the European Directive excludes any plant and any form of agricultural crossbreeding, according to the European Patent Office in its regulations. The EPO also declines inventions, which include human embryos and their cells. However, the UK Intellectual Property Office welcomes novel stem cell ideas.

India's Patent Act

Shikha Chaturvedi, attorney with Surana & Surana International Attorneys, explains in her Law in Brief article, "Patents and Biotechnology," that the Indian Patent Act excludes patent rights for plants and tissue cultures. Some exceptions are made for microbiological processes, new micro-organisms, non-living plasmids and new viruses.

Strategy

Harmonization of patent laws outside of the United States will take several years to resolve. In the meantime, global manufacturers have filed biology patents with the United States to secure some protection within the United States for their invention. This allows them to block anyone else in the United States from manufacturing and selling a similar idea in the country. As clarity surfaces in Europe and biology patent laws align, manufacturers will expand their patent portfolio in Europe with enhancements to their current U.S. patents.

References

• USPTO: Plant Patent
• Sinapse: Complication in Patenting Biotech Inventions: A Peek at U.S. Law
• European Patent Office: Patent on Life?
• Jurisnotes.com: Patents & Biotechnology; Chaturvedi, S.; Jan 2003
• Biodevelopments; "Patent Prosecution Strategies for Biotechnological Inventions" (.pdf); W.H. Huang et al.; 2005

Resources

• University of Edinburgh: School of Law; “Inogen Scoping Paper” (.pdf); Graeme Laurie; 2003