US patent rules will help generic biotech copies

Proposed federal rules for patent protection will make it difficult and more expensive for biotechnology companies to secure long-term patent protection for their novel products and thus fight off generic competition.

The US Patent and Trademark Office (PTO) has said that the rules would improve patent quality, reduce pending applications and help patent examiners. The changes would shift the focus to claims that contain more than one independent and distinct invention.

The PTO added that the new patent rules would also reduce the practice of listing multiple inventions in a single claim (multi-invention alternative claims) and increase competition. The new rules would require more specificity in identifying the invention to be examined, as currently companies can file an unlimited number of continuation requests with new evidence to support their claims.

Commissioner for Patents, John J Doll, declared: "We believe such a rule change will lead to a more focused examination process that will effectively promote innovation.î

In an interview with Scientist magazine, Ronald Eisenstein, a partner in the biotech and intellectual-property group at the law firm Nixon Peabody, said: "It's going to have a big effect on biotechs, universities and non-profit organizations, because it limits their ability to fight with the PTO. If all that the patent examiner has to say is no, it's going to get much harder to negotiate, and will lead to applicants having to file costly appeals."