USPTO drops patent rules

GlaxoSmithKline

UK-based pharmaceutical giant GlaxoSmithKline experienced something of a victory in the US on Monday after moves by the United States Patent and Trademark Office (USPTO) to drop four controversial patent regulations.

Drawn up in 2007 by the Bush Administration, the regulations had sought to force pharmaceutical companies to shrink the size of their patent applications, thereby allowing the USPTO to speed up and improve its work - as well as manage its expanding backlog of unexamined applications.

Now though, the regulations have been repealed by USPTO director and Under-Secretary for Intellectual Property David Kappos, who, when signing a Final Rule on the regulations last week, commented how they had been "highly unpopular" and were "not well-received by the applicant community," not least GSK - who had been fighting the regulations in the courts.

As such, with both GSK and revered Dr Triantafyllos Tafas having begun court proceedings against the USPTO in the fourth-quarter of 2007, the regulations - which had initially been published in the Federal Register in August 2007 for implementation that November - never came into effect.

While at the time the District Court of the Eastern District of Virginia had upheld the case, an appeal later lodged by the agency had been accepted and a rehearing was now due to commence shortly. Now though, following Kappos' rescinding of the regulations, the Office and GSK have asked the court to dismiss the suit.

Its an interesting quandary, not least because of the effect the regulations would have had on innovation in the pharmaceutical industry. Two of the regulations, for instance, the Continuation Rule and the Request for Continued Examination (RCE), would have permitted an applicant to file only two continuation applications and one RCE request per application family as a matter of right.

The Claims Rule, a third regulation, would have permitted applicants to file five independent claims and 25 total claims per application. According to guidelines pertaining to the Claims Rule, in order to file more claims the applicant would have been required to supply the Office with specific information - details of which were outlined by the fourth regulation, termed the ESD Rule.

Now, in light of the repealing, GSK have backed the USPTO for its leadership in deciding to withdraw the regulations. According to Pharma Times, GSK "believes the rules would have harmed innovation across all industries, and specifically would have deprived [the firm] and other manufacturers of the patent protection necessary to promote medical research and innovation."

Reports now suggest the pharmaceutical colossus is looking forward to working closely with Kappos and the agency in the future "to ensure a patent law framework is in place that promotes the investment essential to all innovation."

GSK were further boosted by more good news today, which saw the firm announce that final results from a large, 4-year study showed that Avodart (dutasteride) and tamsulosin combination treatment reduced the risk of acute urinary retention (AUR) or Benign Prostatic Hyperplasia (BPH)-related surgery (also known as Enlarged Prostate (EP) in the US), and reduced the risk of BPH clinical progression more than tamsulosin alone.

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