Like a bad penny, the Bayer AG And Bayer Corporation v. Housey Pharmaceuticals, Inc. case just keeps turning up. This time, the Court of Appeals for the Federal Circuit (06-1083) upheld a finding of inequitable conduct after vacating the earlier finding and remanding the case to give the district court an opportunity to provide additional support for its decision.

The District Court found U.S. Patent Nos. 4,980,281 (the ’281 patent), 5,266,464 (the ’464 patent), 5,688,655 (the ’655 patent), and 5,877,007 (the ’007 patent) unenforceable due to the inequitable conduct of Dr. Gerard M. Housey, the named inventor on all four patents.

This appeal is the second time Housey Pharmaceuticals has asked this court to reverse the district court’s inequitable conduct determination. After the district court’s earlier decision, Bayer AG v. Housey Pharm., Inc. (Bayer I), the Fed Circuit felt that the reasons given by the district court for finding Dr. Housey’s testimony not credible were insufficient to support the court’s conclusion. On remand, the district court provided further support regarding the lack of data for Dr. Housey’s “soft agar” experiment (the Table 3 experiment).

The district court said that while the lack of data itself is not evidence of inequitable conduct, Dr. Housey was not forthcoming about that data. The district court explained the contradictions between Dr. Housey’s testimony at trial and his pretrial deposition testimony. Regarding the number of incubators used in the laboratory, the district court emphasized that whatever that number may be, several experiments shared “incubator space,” yet none of Dr. Housey’s colleagues seemed to be able to remember any experiment conducted in that shared space.

The district court concluded: “I continue to believe that the clear and convincing evidence of record supports my conclusion that Dr. Housey is not credible and that he committed inequitable conduct before the PTO by presenting fabricated experimental results that were material to the issuance of the patents in suit.”

In review, the Federal Circuit stated that:

“[I]nequitable conduct includes affirmative misrepresentation of a material fact, failure to disclose material information, or submission of false material information, coupled with an intent to deceive.” Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed. Cir. 1995). These elements must be shown with clear and convincing evidence. Id. This court reviews a determination of inequitable conduct for abuse of discretion and reviews the underlying factual issues of materiality and intent for clear error. Bristol- Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234 (Fed. Cir. 2003).

Housey suffered a death by a thousand cuts as one witness testified that he believed that Dr. Housey had invented numbers. Also, the declaration that Dr. Housey submitted purporting to confirm the validity of the data in Table 3 provided now raw data or detail – only Dr. Housey’s statement that he performed the experiment and obtained the claimed results.

The Federal Circuit was not moved this time and held:

While this court has identified deficiencies in Housey’s individual arguments, Housey faces a more serious challenge: in order to prevail, it must establish that the district court lacked a sufficient basis for finding that Dr. Housey lacked credibility. Thus, even if, for example, the district court erred regarding the existence of 24-well plates, that error alone would not require reversal. When this court vacated Bayer I, it did so because all the bases for the district court’s determination were erroneous. See Bayer II, 128 Fed. Appx. at 767. Before this court for the second time, Housey has fallen well short of establishing that the district court’s credibility determination amounted to clear error.

The district court gave a nod to the testimony of Dr. Housey’s former lab colleagues, who testified that they did not see Dr. Housey perform the “soft agar” experiment and that they did not believe he could have done so without their knowledge. The district court was thus entitled to credit this evidence which, taken with the court’s other reasons for disbelieving Dr. Housey’s contrary testimony, supports the court’s finding of inequitable conduct.

No word yet on what this means to still pending U.S. Pat. Appl. Ser. No. 11/170,465, a continuation-in-part of U.S. Ser. No. 07/154,206, which is now U.S. Pat. No. 4,980,281.

  Print This Post Print This Post  

Comments are closed.