A Virginia court struck down today (April 1) new patent rules which pharma and biotech companies argued would have limited their ability to protect their intellectual property.

The new rules, which were finalized by the US Patent and Trademark Organization (USPTO) last August, limit inventors to two continuing applications, which add claims to an existing patent, and cap the total number of claims in a patent at 25. "Specifically in life sciences that has a huge effect," Lisa Haile, a patent attorney and co-chair of the Global Life Sciences Sector at the law firm DLA Piper, told The Scientist, because the timeframe of life science discoveries is so long.

Previously, inventors were allowed to file unlimited continuing applications. University-based inventors and biotech companies could file continuances as the scope of their discoveries became clearer with further research, and, for example, could extend patent coverage from one or two new molecules to an entire class of compounds.

The agency, however, argued that the new rules would streamline the patent process and help reduce its backlog of cases. The rules were set to go into effect on November 1, 2007, but in response to a lawsuit filed against the USPTO by GlaxoSmithKline the court issued an 11th hour temporary injunction against them on October 31 while the case was in process.

According to today's court ruling, the patent agency did not have the authority to make such substantive regulatory changes.

Haile noted, however, that the ruling can be appealed.