1. Korean Intellectual Property Office October 19, 2011 Sunhee Lee, SUGHRUE MION PLLC RECENT CASES IN BIOTECH/PHARM/CHEM & 2011 AMERICA INVENTS ACT

2. Agenda  Recent Cases in Biotech/Pharm/Chem  Ariad Pharm v. Eli Lilly – written description  Prometheus v. Mayo – statutory subject matter  America Invents Act of 2011 2 October 2011

3. 3 Written Description Requirement Under 35 USC 112, ¶ 1 Written Description - Requires the invention to be described in sufficient detail that one skilled in the art can conclude that the inventor had possession of the claimed invention Enablement – Requires the specification to teach one skilled in the art how to make and use the invention, without undue experimentation

4. 4 October 2011 Written Description Requirement Under 35 USC 112, ¶ 1 Breadth of Claims Representative Examples commensurate in scope with claims At the time of invention (earliest effective filing date)

5. 5 October 2011 Ariad Pharmaceuticals, Inc. v. Eli Lilly 13 inventors, including David Baltimore, Philip Sharp, and Thomas Maniatis Identification and characterization of the transcription factor NF-kB Implicated in diseases and conditions ranging from sepsis, cancer, and AIDS Patent at issue – US 6,410,516 – assigned on the face of the patent to M.I.T., the Whitehead Institute, and Harvard University Licensed to Ariad Pharmaceuticals

6. 6 October 2011 Ariad v. Lilly Claim 80. A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-κB-mediated intracellular signaling, the method comprising altering NF-κB activity in the cells such that NF-κB-mediated effects of external influences are modified, wherein NF-κB activity in the cell is reduced, wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.

7. 7 October 2011 Ariad v. Lilly Claim 144. A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF- κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells, wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.

8. 8 October 2011 Ariad v. Lilly Written description must be determined as of earliest effective filing date (here, April 12, 1989) Much of Ariad's evidence, however, was what one of ordinary skill in the art knew in 1990 and 1991, and was thus legally irrelevant

9. 9 October 2011 Ariad v. Lilly

10. 10 October 2011 Ariad v. Lilly The specification states: classes of molecules that can reduce binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB : 1. Specific Inhibitors 2. Dominantly Interfering Molecules 3. Decoy molecules Specific Inhibitors: Only one inhibitor provided, the naturally occurring IkB Figure 43 provided sequence of IkB However, Figure 43 not added until the 1991 application

11. 11 October 2011 Ariad v. Lilly Decoy molecules: Designed to mimic the NF-kB binding site Court found that actual decoy molecules were adequately described However, no description of a method of using these molecules to reduce NF-kB activity Therefore, nothing more than a desired outcome

12. 12 October 2011 Ariad v. Lilly Dominantly Interfering Molecules: No examples provided Specification only states that they are theoretically possible Irrelevant that others were practicing dominantly interfering molecules after the 1989 application

13. 13 October 2011 Ariad v. Lilly Even with the November 1991 effective filing date, the outcome would likely have been the same No working examples or even prophetic examples of methods that reduce NF-kB activity No completed synthesis of any of the molecules Even with decoy molecules, there was no accompanying description that they could be used to reduce NF-kB activity

14. 14 October 2011 Ariad v. Lilly (En banc, Fed. Cir. 2010) En banc decision to confirm that written description requirement is a separate requirement from enabling disclosure requirement Claim – method for modifying effects of external influences on a eukaryotic cell, … comprising altering NF-kB activity, …, wherein reducing NF-kB activity comprises reducing binding of NF-kB to NF- kB recognition sites on genes. No embodiments of a compound which reduces the binding Scare information in the art at the time of invention Broad scope of claim

15. 15 Statutory Subject Matter & Prometheus v. Mayo October 2011 15

16. Before Bilski Anything under the sun that is made by man A useful, concrete, and tangible result was persuasive, and little need to excuse data gathering A price for a financial product, for example, is considered to be a concrete useful and tangible result (see State Street Bank v. Signature Financial Group).State Street Bank v. Signature Financial Group Certainly no need to recite or assert a machine or transformation Who could possibly think that detecting, assaying, etc. could be done without a machine or transformation? October 2011 16 Sughrue Mion PLLC

17. The Bilski Test by CAFC: Machine or Transformation Test 2008, en banc A claimed process is patentable under 35 U.S.C. § 101 if (a) the process is tied to a particular machine or apparatus, or (b) the process transforms a particular article into a different state or thing §§ October 2011 17 Sughrue Mion PLLC

18. Supreme Court: The Bilski Test (2010) Involvement of the machine or transformation must not be insignificant, extra-solution activity, such as gathering data. A claim simply to natural phenomena, mental processes, and/or abstract ideas is not patentable. In Bilski, Curt affirmed affirmed the rejection of an application for a patent on a method of hedging losses in one segment of the energy industry by making investments in other segments of that industry, on the basis that the abstract investment strategy set forth in the application was simply not patentable subject matter Although the machine-or-transformation test is a “useful and important clue,” it was not the sole test for determining the patent eligibility of process claims. Limited its holding to the invention at issue. October 2011 18 Sughrue Mion PLLC

19. 19 Prometheus v. Mayo October 2011 19 Patents 6,355,623 &6,680,302 A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. Sughrue Mion PLLC

20. Prometheus v. Mayo 2004 Prometheus sued Mayo for infringement 2008 District Court granted Mayo SJ motion of Invalidity under 35 USC 101 - “ the patents only claimed the correlations between certain thiopurine drug metabolite levels and therapeutic efficacy and toxicity.” - “’administering’ and ‘determining’ steps are merely neces-sary data-gathering steps for any use of the correlations” and that “as construed, the the ‘warning’ step (i.e., the ‘wherein’ clause) is only a mental step.” October 2011 20 Sughrue Mion PLLC

21. Prometheus v. Mayo 2009 CAFC reversed the DC decision and held that the claims are valid (581 F.3d 1336) "administering" and "determining" steps were transformative and not merely data-gathering steps.” 2010 Supreme Court vacated CAFC decision and remanded for further consideration in view of Bilski (2010) 2010, Dec. CAFC re-affirmed validity of claims under section 101 (628 F.3d 1347) CAFC. October 2011 21 Sughrue Mion PLLC

22. Prometheus v. Mayo 2010, Dec. CAFC (628 F.3d 1347) decision: Both “administering” and “determining” steps The method claims recited a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy, i.e., the treatment of a specific disease by administering specific drugs and measuring specific metabolites. The method did not wholly preempt all uses of the recited correlations. The methods were not "merely" data-gathering steps or "insignificant extra-solution activity," but rather were part of treatment regimes, and therefore involved "a significant transformative element." October 2011 22 Sughrue Mion PLLC

23. Prometheus v. Mayo – question presented for SC Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well- known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry. Hearing scheduled on Dec. 7, 2011 October 2011 23 Sughrue Mion PLLC

24. 24 Prometheus v. Mayo: Compare to Classen October 2011 24 A method of immunizing a mammal, including the following steps: 1) screening information on immunization schedules and the occurrence of chronic immune-mediated disease, 2) comparing the results from different schedules and identifying the lower risk schedule, and [3) administering the vaccine on that lower risk schedule.]

25. THANK YOU Sunhee (Sunny) Lee, partner SUGHRUE MION PLCC sxlee@sughrue.com Sughrue Mion PLLC