US generics body GPhA finds fault with Patent Reform Bill, labeling it an incentive for deception

The USA’s Patent Reform Bill (S 23), as announced last week, was broadly welcomed by the research-based pharmaceutical and biotechnology industries (The Pharma Letter February 4), but it received a very different response from makers of generic medicines.

The Generic Pharmaceutical Association (GPhA) said that the bill would weaken current inequitable conduct standards in U.S. patent laws. “While we appreciate the efforts of Senators Leahy and Grassley to pass meaningful patent reform legislation, we are deeply concerned with language in the bill that would severely weaken the current inequitable conduct standard. This provision not only harms consumers needing affordable medicines, but at the same time, it incentivizes innovators to be less than honest when seeking patents,” the trade group stated.

“Currently, patent applicants are subject to a strong penalty for misleading or deceiving the US Patent and Trademark Office (PTO). Under the doctrine of inequitable conduct, a court can render a patent unenforceable if the patent applicant knowingly withholds information or makes material misrepresentations with the intent to deceive during the patent application process,” it said.