Just a day before they were due to come into force, GlaxoSmithKline has won a court case to block controversial changes to patent rules.
The new rules were due to come into effect today but that was before the US District Court for the Eastern District Court of Virginia issued a Preliminary Injunction preventing the US Patent and Trademark Office (PTO) from implementing them yesterday.
The last minute reprieve will undoubtedly have left GSK delighted - at least for the moment. Whether or not this will lead to a permanent scrapping of the changes is unclear.
Under the present system, companies such as GSK submit their patent applications in order to stake their intellectual property claim as soon as possible after the discovery of a potential new drug candidate. These original applications are usually very broad in scope and as more and more information about the candidate comes to light, companies then file continuations and add extra claims to the original application, all which must then be reviewed by the PTO. Currently there is no limit to the number of continuations and claims that firms such as GSK can make.
However, under a change to the Claims and Continuations Final Rule, first proposed by the PTO in August, companies may only file up to two continuation applications, with up to 25 claims. Should they wish to exceed this quota they must petition the PTO to do so, proving that "the amendment, argument or evidence sought to be entered could not have been submitted during the prosecution of the prior-filed application," as well as pay the agency additional fees.
The ruling yesterday means that the old rules will still be in play "until further notice", according to a statement from the PTO. The changes were intended to reduce the PTO's workload, as it feels it is becoming impractical to deal with the number of continuation applications it receives.
According to the PTO the review process is as a result becoming too cumbersome, taking roughly 32 months, and a backlog of 760,000 applications is mounting.
"We recognize that the PTO has a workload challenge, but these rules are not the answer to that challenge," said Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), before going on to welcome yesterday's ruling.
"This is a sound decision that reflects the concerns expressed in BIO's recent submission in the case," said BIO CEO Jim Greenwood.
"We hope this delay signals recognition of the unintended consequences of these rules and will ultimately result in a permanent stay. As we have long said, the rules will adversely impact biotechnology innovation. [They] will inhibit the ability of innovators to obtain adequate coverage on their inventions, significantly decreasing their ability to attract the financing necessary to bring a product to market."
When GSK filed the case, a spokesperson for the company told DrugResearcher.com:
"We believe the changes in place go beyond the authority of the PTO and have the potential to stifle innovation," they said.
If the rules had of come into effect, the PTO planned to apply them retrospectively to all pending patent applications. GSK said it has over 100 such filings pending and another 30 filings planned that would have been affected.