Submitting A Declaration To The PTO That Contradicts The Author's Prior Publications Constitutes Inequitable Conduct

Case: Pharmacia Corporation et al. v. PAR Pharmaceutical, Inc., Fed Cir. 04-1478 & 1496 (decided August 10, 2005)

The Two Sentence Summary: The Federal Circuit affirmed a district court's finding that Pharmacia committed inequitable conduct when it submitted a declaration by a scientist that (1) implied he had performed experiments which he had not; and (2) had a conclusion directly contrary to the conclusion in an article he had previously published and which Pharmacia did not disclose to the examiner. The Federal Circuit also held that inequitable conduct in the prosecution of a patent did not automatically invalidate a later-issued related patent.

What they were fighting about: PAR filed an application with the Food and Drug Administration to market a generic version of Xalatan, a drug that threats glaucoma by topical application. The drug works by reducing the pressure of the fluid in the eye, known as intraocular pressure. Pharmacia is the owner of two patents covering Xalatan (the '368 patent and the '504 patent). The two patents are siblings, filed simultaneously on December 8, 1992 as continuations of a prior patent application. Pharmacia filed suit against PAR, alleging infringement of the two patents. PAR admitted infringing both patents, but asserted that inequitable conduct rendered the patents unenforceable. After a bench trial, the district court found the '368 patent unenforceable due to inequitable conduct, but not the '504 patent. The district court entered judgment for Pharmacia on the '504 patent and for PAR on the '368 patent.

Federal Circuit Holdings:

• The district court properly found that Pharmacia committed inequitable conduct when it submitted a declaration containing false statements in support of its application for the '368 patent. Pharmacia submitted the declaration in order to overcome the patent examiner's rejection under 35 U.S.C. § 103(a) of various claims directed at several of the compounds as being obvious in light of a patent which disclosed a group of compounds including the compound at issue in the '368 patent. Pharmacia argued that the prior patent failed to appreciate the benefits of the claimed compound, and supported its argument with a declaration comparing the properties of the two compounds. Paragraph 9 of the declaration asserted that at a certain dosage, the '368 patent's compound showed a statistically significant decrease in intraocular pressure while the compound disclosed in the prior patent did not. Paragraph 10 of the declaration asserted that, even at higher dosages, the prior patent's compound did not cause a statistically significant decrease in intraocular pressure. Paragraph 10 conflicted with a previous article written by the declarant in which the scientist reported that the compound disclosed in the prior patent caused a statistically significant decrease in intraocular pressure at the higher dose. Paragraph 9 was misleading because it implied the scientist had tested the compound at the dosage, when in fact, he had not. Since the declaration was crucial in overcoming the patent examiner's obviousness rejection, it was material.
  
• The inequitable conduct in Pharmacia's prosecution of the '368 patent did not taint the '504 patent, even though Pharmacia had filed a terminal disclaimer to overcome a double-patenting rejection. Although inequitable conduct occurring in relation to one or more claims during prosecution of a patent application renders the entire patent unenforceable, the case law applies only to claims in one patent. The Federal Circuit agreed with Pharmacia's argument that a terminal disclaimer cannot bind two related patents together so that inequitable conduct in procuring the later prosecuted patent will automatically infect an earlier issued patent.