September 8, 2016

BioPharma Patents Quick Tips & News – November/December 2013 – Throwback Edition

By Leanne M. Rakers, Principal


  1. Three tips for overcoming U.S. obviousness rejections
    1. Argue no PFO first: Always argue down  existence of  an  Examiner-asserted presumption of  prima facie  obviousness (PFO), before going  on  to  second-step providing PFO-presumption rebuttal- evidence, e.g., “secondary considerations.”
    2. Use a selection argument: Map out each step an artisan would have to make to arrive at the claimed invention amongst all  the choices available  in the cited art with no guidance to make all  of the selections to arrive at the claim as a whole.
    3. Teaching  away  is  still most  persuasive. Invest a couple of hours searching the art or ask inventors to find (1) teaching away statements or (2) statements to rebut the Examiner’s assertions.
  2. Restriction practice in Art Unit 1600 (Biotechnology and Organic Chemistry)
    1. Tip: Try petitioning to have restriction requirements withdrawn.
    2. Harness Dickey recently successfully petitioned to have improper restriction requirements withdrawn, and to have others converted into requirements for election of species. Also, currently Art Unit 1600 is discouraging Examiners from imposing restrictions between products and methods of using the product. Therefore, if you are facing a restriction requirement between a product and a method of using the product, consider filing a petition to have the requirement
      withdrawn, unless a divisional application is desired.


  1. Pharmaceutical combinations – Recent case law:
    1. There have been four post-KSR Federal Circuit decisions on obviousness of claims to combinations of old drugs useful for related indications.
    2. Take Away: Claims that specify a new benefit appear to have a better chance of surviving a challenge for obviousness than claims that do not specify a benefit.
    3. Examples: longer room-temp shelf life in Leo Pharma. Prods. v. Rea, 726 F.3d 346 (Fed. Cir. 2013), longer lasting efficacy in Allergan v. Sandoz, 726 F.3d 1286, 1294 (Fed Cir. 2013) and Pozen v. Par, 696 F.3d 1151, 1164 (Fed. Cir. 2012). But see, Novo-Nordisk v. Caraco, 719 F.3d 1346 (Fed. Cir. 2013).
  2. New reporting requirements for transfers of pharmaceutical patent rights:
    1. The U.S. Federal Trade Commission (FTC) has announced final changes to the premerger notification rules for pharmaceutical companies. This is especially noteworthy as it applies to exclusive patent licensing between pharmaceutical companies even without a corporate merger, and even if the patent holder retains some manufacturing rights or co-rights for the joint development, marketing or commercialization of the patented drug. This means that certain exclusive patent licenses may require notification to the FTC and the Antitrust Division of the Department of Justice (“DOJ”).
    2. Take Away:  Patent holders should be aware of potential antitrust issues prior to entering into an exclusive patent licensing arrangement, which may be a reportable transaction.


This Newsletter was originally posted to the articles section of the Harness Dickey website in November 2013. To receive the most up-to-date BioPharma news and tips, please visit and subscribe to the BioPharma emails.