Patent laws in many countries impose an onus on patent applicants to act in good faith in dealing with the patent office. For example, in Australia, a patent may be held to be invalid if it is shown that the patent was obtained by fraud, false suggestion, or misrepresentation. In the United States, applicants, inventors and their attorneys have a duty of candour, good faith, and honesty in dealings with the patent office and a patent may be held to be unenforceable if there was inequitable conduct on the part of any of those people in their dealings with the patent office.
In Australia, the full Federal Court revoked a patent directed to a specific form of Warner-Lambert's blockbuster cholesterol lowering drug, Lipitor (Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC (2008) 77 IPR 449). The court held that data included in the patent specification represented that Warner-Lambert had found that activity of the R form of the drug was about ten times that of the racemate (ie mixture of R and S forms of the drug). Warner-Lambert's attorneys made a similar representation in response to an Examiner's report on the application. However, it turns out that all of the data available to Warner-Lambert showed that the R form of the drug had an activity level that was only about two times greater than the racemate. The court found that the representation that the R form of the drug was ten times greater was material to the patent office's considerations in granting the patent and were false and misleading. The patent was therefore revoked.
The charge of inequitable conduct by patent applicants, inventors or their attorneys is also being increasingly used in the United States to render patents unenforceable. A recent decision of the Delaware District Court (Cancer Research Technology et al. v Barr Laboratories et al., D-Del, Civ. No. 07-457-SLR, January 26, 2010) provides an insight in to the extent of the duty of good faith that is owed to the United States Patent and Trademark Office (USPTO) by patent applicants.
Cancer Research Technology (CRT) was the assignee of a US patent covering the tetrazine compound temozolomide, which is marketed under the name Temodar® for the treatment of brain cancers. A patent application was filed in 1982 and the USPTO initially rejected the application for lack of utility on the grounds that the application did not include data showing the efficacy of the claimed compounds in humans. CRT did not file a substantive...