The Cabilly Controversy
In 1989, Genentech was issued the first ‘Cabilly’ patent (named after the inventor Shmuel Cabilly and others). The Cabilly patent (US 4,816,567) claims methods for making monoclonal antibodies using recombinant DNA technology. In the same year Celltech was issued a similar ‘Boss’ patent (named after the inventor Michael Boss and others). The Cabilly patent claims also included the claims in the Boss patent ( US 4,816,397). As a result the two companies entered into a lengthly interference dispute that was resolved in 2001.
An interference is a legal proceeding unique to U.S. patent law where the Patent Trademark Office (PTO) resolves which party, if any, is entitled to priority of invention where the same subject matter is allegedly invented by the two different parties. The agreement led to the issuing of a second Cabilly patent (US 6,331,415) that is not set to expire until 2018. This meant that the total length of patent protection for Genentech was a whopping 29 years.
Genentech receives an estimated $300 million each year in patent royalties for the licencing of the Cabilly patent from companies such as Johnson & Johnson, MedImmune, and Amgen. In 2003, MedImmune filed a lawsuit against Genentech and Celltech claiming violations for antitrust, patent and unfair competition laws. MedImmune challenged the validity and the enforceability of the Cabilly II patent which contains the same claims as Celltech’s Boss patent. On October 18th 2003, the U.S. Court of Appeals in Washington D.C., ruled against MedImmune’s appeal.
Following an anonymous third party request, the Cabilly II patent is being re-examined to determine if Cabilly II covers the same inventions as Cabilly I which expired in March 2006. In a preliminary ruling, examiners rejected the Cabilly II patent. Genentech appealed and as a result a re-examination is in process which could take many years, all through which the Cabilly II patent remains valid. This means that companies developing antibody drugs have to continue to pay royalty for the licensing of the technology until the re-examination is complete.
Links
Genentech Tries to Calm Cabilly Worries – TheStreet.comIt Lives for 29 Years – Legal Times, November 2003
