Dive Brief:
- Last March, the U.S. Patent and Trademark Office issued guidelines which limited the extent to which natural products and processes can be patented by biotech and pharmaceutical companies. After industry complaints, the agency has decided to change the rules once again, reports WSJ's Ed Silverman.
- Biotech and pharma companies were concerned that the original rules wold be too restrictive and that many patent applications would be unfairly rejected.
- Under the previous guidance, patents for recombinant industrial enzymes, pharmaceutical formulations having purified naturally-occurring substances as active ingredients, methods of treatment using medicines molecules, and diagnostic laboratory procedures and other inventions were rejected, to name just a few examples.
Dive Insight:
In light of the restrictive guidelines, many organizations, including the International Biotechnology Associations and PhRMA, wrote complaints to the USPTO. After much consideration, the USPTO issued these new ones, and they could be a big deal for biotechs and pharma companies when it comes to protecting their innovations.
For example, a combination of two or more materials with different characteristics than what exists in nature may now be eligible for a patent approval, whereas last year that may not have been the case. The new guidance is considered a step in the right direction by the industry that represents a more "integrated approach" to patents.