The Federal Circuit Court of Appeals upheld a ruling that a patent for a method for making blood pressure drugs was unenforceable due to inequitable conduct by the founder and chairman of the company that owned the patent.
The patent at issue was granted in 2004. Dr. Bernard Charles Sherman, the founder and chairman of Apotex, wrote the application and is the sole inventor on the patent.
Dr. Sherman has written about 100 other patent applications for Apotex and directs all of its patent litigation activities.
The patent covers a process for making tablets used to treat hypertension (high blood pressure). Specifically, the process includes a method for stabilizing ACE inhibitors.
The court noted that several other methods for stabilizing ACE inhibitors were known in the prior art before Dr. Sherman filed his patent application. The application was rejected three times at the US Patent and Trademark Office for reasons of obviousness.
Dr. Sherman then submitted an expert declaration from a Dr. Michael Lipp that a person “skilled in the art” would not find the method claimed in the patent to be obvious. The challenged claim in the patent was modified and the patent was finally granted.
Apotex sued UCB for patent infringement.
The district court ruled that the patent was unenforceable due to Dr. Sherman’s inequitable conduct. The court found that he misrepresented the nature of the defendant’s drugs, that he withheld prior art references, and that he submitted “results” of experiments he never actually conducted.
Dr. Sherman admitted at trial that the experiments “were made up in his head.”
The court noted that Dr. Sherman failed to inform Dr. Lipp of the true facts and thus knowingly perpetuated his mischaracterizations of the prior art.
Apotex appealed the court’s holding that the patent was unenforceable.
The Federal Circuit upheld the lower court’s decision, finding that Dr. Sherman had “breached his duty of candor, good faith, and honesty before the PTO.”
According to Patent Attorney, Laura Lloyd:
This case illustrates how important it is to keep the Patent Office (USPTO) informed of any prior references that an inventor knows of.
Inequitable Conduct after Therasense
Invalidating a patent based on inequitable conduct before the USPTO has been relatively rare since 2011, when the Federal Circuit’s ruling in the Therasense case made such conduct more difficult to prove.
The Federal Circuit had become concerned that defendants in patent cases had overused the defense.
Under Therasense, a defendant must show that a patent holder deliberately withheld prior art from the USPTO and that the disclosure of the prior art would have led the USPTO to disallow the patent claim.
The Risks of Withholding Prior Art
Intentionally withholding information from the Patent Office is unethical, usually self-defeating, and often fruitless.
Undisclosed prior art can be uncovered by various parties and at various stages. It may be uncovered during the patent examination process or during litigation after a patent has been issued.
Some companies have even turned to crowdsourcing to detect prior art, as in contests run by Patexia.
If you are ready to prepare a patent application for your invention, contact our office to arrange a free initial consultation.
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Photo Attribution: “Digital Blood Pressure Monitor” by Solaris2006 is used under the GNU Free Documentation License.