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Tafas v. Doll: Drug Companies Face New Limits on Patents

By Jim Edwards | Mar 23, 2009

Drug companies will be dismayed by a federal appeals court ruling that came down on Friday which gives the U.S. Patent and Trademark Office new powers to limit the way patents are filed.

The drug business depends heavily on its ability to patent chemicals and processes for defined lengths of time that give the patent-holder exclusive use of those products, protecting them from competition.

The ruling, in Tafas v. Doll, says that the USPTO does have the power to alter its own rules and restrict the way patents are filed. (BNET Technology’s Erik Sherman has an excellent summary of the decision here.) The new ruling would limit companies to:

… five unique claims and 25 total claims per invention, versus the historic lack of limit. Among other things, [the new rules] would also have restricted the number of requests to reconsider a decision to reject a patent application as well as the number of continuations, or chances to effectively amend a patent application already in process.

Companies believe the new, restricted rules will trigger more appeals of the rules — and thus make the process even longer.

You can see which drug companies opposed the new rules here. Among the opposition are Pfizer, Amgen, Biogen, Wyeth, Novartis, Novo Nordisk, Neurocrine, Isis, Medarex, Genentech, Eli Lilly and of course PhRMA.

A good summary of the new ruling can be found here, on the Patent Docs blog.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

BNET User Analysis

Web Buzz:
  • US PTO and DOJ: no further review of patent term adjustment ruling

    Scrip News - 15 days 17 hours 4 minutes ago

    The US Patent and Trademark Office (PTO) and the Department of Justice will not be seeking further review of the recent appeals court ruling that gives companies a shot at extending a patent's life to compensate for administrative delays in the processing of patents. That decision, which is known... ...

  • Mixed Results in Tafas v. Doll Appeal Over New Patent Rules

    BNET Technology - 326 days 6 hours 44 minutes ago

    The industry has been closely monitoring the Tafas v. Doll (formerly Tafas v. Dudas) lawsuit over whether the U.S. Patent and Trademark Office would be able to make rule changes that would significantly limit patent applications. Today, the U.S. Court of Appeals for the Federal Circuit (CAFC) announced its ruling, and the net result won't leave...

  • Back to Court for Tafas v. Doll Suit and USPTO Rule Changes

    BNET Technology - 217 days 18 hours 17 minutes ago

    Back in March I wrote about the closely-watched Tafas v. Doll lawsuit challenging new patent rules put into place by the U.S. Patent and Trademark Office. At the time, a three-judge panel of the Court of Appeals for the Federal Circuit (CAFC) came down with a mixed ruling that could have significantly changed the IP landscape. Well, it’s back...

  • Pfizer gains in Alzheimer's patent term adjustment debate with US PTO

    Scrip News - 26 days 17 hours 19 minutes ago

    A much-anticipated ruling by the US Court of Appeals for the Federal Circuit has handed Wyeth (now part of Pfizer) and Elan Pharma a shot at extending a patent's life to compensate for US Patent and Trademark Office's administrative delays in processing a patent. In the case,... ...

  • Court gives partial OK to new, streamlined patent rules

    Ars Technica - 319 days 14 hours 40 minutes ago

    As Congress continues to struggle with legislative changes to the patent system, the US Patent Office last week won a partial reversal of a federal court ruling that had blocked implementation of a set of rule changes designed to streamline the patent application process. The opinion in Tafas v. Doll , handed down by the Court of Appeals...

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