This Newsletter was originally posted to the articles section of the Harness IP website in November 2014. To receive the most up-to-date BioPharma news and tips, please visit www.harnessip.com and subscribe to our BioPharma emails.

Quick News & Practice Tips

1. Revised USPTO Examination Guidance on Natural Products/Principles to publish any day now! We will report once published.
2. U.S. Biosimilar Update: First lawsuit was filed over the application process for biosimilars (Amgen Inc. v. Sandoz Inc., No. 14-cv-04741 (N.D. Cal. filed Oct. 24, 2014)).Amgen filed a lawsuit and a citizen’s petition against Sandoz (a unit of Novartis). Sandoz is seeking regulatory approval to market a biosimilar version of Neupogen®. Sandoz is the first drug maker to seek FDA permission to sell a biosimilar in the U.S. At issue is the Biologics Price Competition and Innovation Act — that governs the procedures a company must follow when seeking to win regulatory approval of a biosimilar medicine. Amongst others, a key issue is whether Sandoz was required to provide Amgen with a complete copy of its biosimilar application. Amgen wants a copy to determine the extent to which there may be instances of patent infringement. The outcome of this case could have an effect on how brand-name and generic drug makers are required to resolve disputes over patent rights when biosimilar applications are filed with the FDA.
3. Patent Term Adjustment (PTA) Update: The law governing PTA calculation has been constantly shifting in recent years. Throughout all of these changes, however, the PTO has maintained that if a challenge to PTA adjustment is not filed within 180 days of the notice of issue, the challenge is jurisdictionally barred under 35 U.S.C. §154(b)(4)(A). The U.S. Federal District Court for the District of Columbia has just ruled the 180 day limit is subject to equitable tolling, so when the law changes, one may still have a chance to challenge PTA determinations, even if the challenge is not filed until long after the 180 day window has closed. (Merck Sharp & Dohme v. Lee, No. 10-1110).

ALERT:  If you have PTA challenges that you wanted to bring based on the Novartis case, but did not be you thought they were untimely, you may wish to consider filing them now.

1. Inequitable Conduct Update: Since Therasense v. Becton Dickinson, 649 F.3d 1276 (Fed. Cir. 2011), there have been few affirmances of inequitable conduct findings. However, two recent Federal Circuit cases have upheld rulings that patents were unenforceable due to inequitable conduct.

Therasense standard: To prevail on the defense of inequitable conduct, a defendant must prove that the patentee:

1. Withheld or misrepresented so-called “material” information meaning that if the USPTO had been aware of the withheld or misrepresented information, it would not have issued the patent (i.e., “but-for materiality”) and did so with intent to deceive the USPTO; or
2. Engaged in “affirmative egregious misconduct.” In such instances, it is not necessary to prove “but-for materiality” of the information.

• In Apotex, Inc. v. UCB, Inc., 112 U.S.P.Q.2d 1081 (Fed. Cir. 2014), Dr. Sherman — the founder and CEO of Apotex, sole inventor of the asserted patent, and drafter of the application — was aware that the prior art was made according to his claimed process, concealed this knowledge from the PTO, and misrepresented the nature of the prior art through his arguments and expert testimony via a declaration. Furthermore, Dr. Sherman withheld relevant prior art and wrote prophetic examples in the application as if they had been conducted. The Federal Circuit affirmed but-for materiality of Dr. Sherman’s misconduct as well as intent to deceive, thus, establishing inequitable conduct. The Federal Circuit also indicated that Dr. Sherman’s actions “come close to the type of affirmative misconduct that … justify finding inequitable conduct without showing but-for materiality.”
• In Calcar, Inc. v. Am. Honda Motor Co., Inc., 112 U.S.P.Q.2d 1353 (Fed. Cir. 2014), Calcar sued Honda alleging that navigation systems in Honda’s vehicles infringe Calcar’s patents. Honda moved for a finding of inequitable conduct based on the failure of Calcar’s founder — Mr. Obradovich — to disclose an owner’s manual and photographs of a 1996 Acura RL (“96RL”) navigation system to the USPTO during prosecution. The priority patent application only partially disclosed the 96RL system by referring to it as prior art, and it was acknowledged that the system was used as the basis of Calcar’s inventions. However, the withheld prior art was eventually submitted to the PTO in a reexamination proceeding of one of the asserted patents, and the PTO confirmed patentability. Nonetheless, the Federal Circuit affirmed the district court’s finding that the undisclosed details of the prior art were material to patentability, and there was intent to deceive.

Avoid Inequitable Conduct:

• Disclose often and disclose all material information completely—partial disclosure can be insufficient;
• Disclosure during reexamination will not necessarily cure failure to disclose during prosecution;
• Confirm whether examples in application have been performed or are prophetic.