Finnegan, Henderson, Farabow, Garrett & Dunner, LLP AIPLA BIOTECHNOLOGY COMMITTEE WEBINAR Leslie McDonell The contents of this presentation represent the views of this author and do not represent the policies or viewpoints of Finnegan or its management

2 2 Future of 2 nd Medical Use Claims A method of treating disease X comprising administering drug Y to a patient suffering from disease X. A method of treating a human having acquired immunodeficiency syndrome comprising the oral administration of an effective acquired immunodeficiency syndrome treatment amount of 3'-azido-3'-deoxythymidine [AZT] to said human. U.S. Patent No. 4,724,232

3 3 What Is a Law of Nature? “Prometheus’ patents set forth laws of nature -- namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.... While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action.”

4 4 Isn’t a 2 nd Medical Use an “entirely natural process”? A method of treating disease X comprising administering drug Y to a patient suffering from disease X. effect of drug in body = entirely natural process? law of nature = relationship between the presence of drug Y in the body and a reduction of the symptoms of disease X?

5 5 Personalized Medicine – has the bell tolled? methods involving novel dosage methods involving specific route of administration –well-understood, routine, conventional activity? methods of diagnosing/treating disease by correlating disease with the presence (or absence) of a biomarker newly discovered marker vs. newly discovered correlation between known marker and disease

6 6 Tip of the Iceberg Smartgene, Inc. v. Advanced Biological Laboratories, SA, No , 2012 U.S. Dist. LEXIS (D.D.C. March 30, 2012) methods for computer-aided guidance for the selection of a therapeutic treatment regimen

7 7 Is There a Congressional Fix? Should or can Congress fix the ambiguities caused by the Mayo decision? Is an amendment to the patent statutes necessary or will future judicial interpretation make the correct application of the Mayo decision more clear? Consider cases following: –Seagate – no negative inference on willful infringement due to failure to secure opinion of counsel –Kingsdowne  Therasense regarding definition of inequitable conduct standards –Ebay – standards for obtaining a preliminary injunction –KSR, Bilski

U.S.C. § 103(b) 35 U.S.C. 103 ( Conditions for patentability; non-obvious subject matter. (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if- (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1)- (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154. (3) For purposes of paragraph (1), the term "biotechnological process" means- (A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to- (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).

9 9 America Invents Act Section 33(a), 125 Stat. at 340 no patent may issue on a claim directed to or encompassing a human organism Section 14(a), 125 Stat. at 327 any strategy for reducing, avoiding, or deferring tax liability whether known or unknown at the time of the invention or application for patent shall be deemed insufficient to differentiate a claimed invention from the prior art

10 Congress Has Implicitly Approved Diagnostic Methods Congress affirmatively considered certain diagnostic method claims at Section § 27, (125 Stat. at ) Congress required the Director of the USPTO to “conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist” AIA § 27(a), 125 Stat. at 338 (emphasis added)

11 Is a Fix Necessary? Is an amendment to the patent statutes necessary to protect diagnostics and personalized medicine? What type of amendment would be required?