1. #ACIPIV ACI’s 9 th Annual Paragraph IV Disputes Neal K. Dahiya Senior Counsel – Patent Litigation Bristol-Myers Squibb (Princeton, NJ) Limelight v. Akamai: Assessing Its Impact on Method of Treatment Patents and Section viii Label Carve Outs Steven E. Feldman Partner Husch Blackwell LLP (Chicago, IL) David A. Manspeizer Partner Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY) April 27-28, 2015 Mark H. Remus Partner Katten Muchin Rosenman LLP (Chicago, IL) Mark E. Waddell Chair, Patent Litigation and Counseling Loeb & Loeb LLP (New York, NY) Andrew M. Alul Partner Taft Stettinius & Hollister LLP (Chicago, IL) Tweeting about this conference?

2. #ACIPIV Pharmaceutical Method of Use Claims – Examples “A method for treating neurodegenerative diseases which comprises administering a therapeutically effective amount of a compound [selected from a genus that includes gabapentin (Neurontin®)].” – Claim 1 of U.S. Patent No. 4,663, 318. Held not infringed in Warner Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003).

3. #ACIPIV Pharmaceutical Method of Use Claims – Examples (Cont’d) “A method of treating attention- deficit/hyperactivity disorder (ADHD) comprising administering to a patient in need of such treatment an effective amount of tomoxetine [(Strattera®)].” – Claim 1 of U.S. Patent No. 5,658,590. Held not invalid in Eli Lilly & Co. v. Actavis Elizabeth LLC, 435 Fed. App’x 917 (Fed. Cir. July 29, 2011).

4. #ACIPIV Pharmaceutical Method of Use Claims – Examples (Cont’d) “A method of treating Alzheimer's disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of galanthamine or a pharmaceutically-acceptable acid addition salt thereof.” – Claim 1 of U.S. Patent No. 4,663, 318. Held invalid in In re ‘318 Patent Litigation, 583 F.3d 1317 (Fed. Cir. 2009).

5. #ACIPIV Pharmaceutical Method of Use Claims – Examples (Cont’d) “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.” Claim 1 of U.S. Patent No. 6,355,623 B2. Held invalid in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).

6. #ACIPIV Proof of Infringement As the Federal Circuit recognized in Warner Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1363 n.7 (Fed. Cir. 2003): “Pharmaceutical companies do not generally treat diseases; rather, they sell drugs to wholesalers or pharmacists, who in turn sell the drugs to patients possessing prescriptions from physicians. Pharmaceutical companies also occasionally give samples of drugs to doctors and hospitals. In none of these cases, however, does the company itself treat the disease.”

7. #ACIPIV 35 U.S.C. § 271(b) Thus, brand drug companies traditionally pursue claims of inducement against generic manufacturers: “Whoever actively induces infringement of a patent shall be liable as an infringer.” 35 U.S.C. § 271(b).

8. #ACIPIV Standard for Inducement Proof of inducement requires two elements: (1) Defendant’s actions induced direct infringement; and (2) Defendant “knew or should have known [its] actions would induce actual infringement[].” Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 553 (Fed. Cir. 1990).

9. #ACIPIV Inducement Prong (1): Direct Infringement, Divided Infringement, and Limelight. What happens when you have a situation of divided infringement in the ANDA context (not one actor performs all method steps)? Limelight Networks, Inc. v. Akamai Techs., Inc., 134 S. Ct. 2111 (2014): A defendant is not liable for inducement where there is no direct infringement because all the steps of a method claim are not performed by a single actor.

10. #ACIPIV Inducement Prong (2): Intent and Commil. In the ANDA context, what happens when the ANDA-filer has an opinion of counsel that the method of use patent is invalid? Commil USA, LLC v. Cisco Sys., Inc., 720 F3d 1361, 1368 (Fed. Cir. 2013), cert. granted, 135 S. Ct. 752 (2014): “[A] good-faith belief of invalidity is evidence that may negate the specific intent to encourage another’s infringement, which is required for induced infringement.”

11. #ACIPIV “Carve Outs” Induced infringement claims in the ANDA context, whether brought as 35 U.S.C. § 271(e)(2) claims (pursuant to 28 U.S.C. § 1338(a)) or 35 U.S.C. § 271(b) claims (pursuant to the DJ Act), are often attempted to be proven with recourse to the generic’s proposed labeling (because no actual marketing or use of the drug has occurred).

12. #ACIPIV “Carve Outs” (Cont’d) “The infringement case is therefore limited to an analysis of whether what the generic drug maker is requesting authorization for in the ANDA would be an act of infringement if performed.” Warner- Lambert, 315 F.3d at 1364. Hence, the focus on the generic’s proposed labeling.

13. #ACIPIV “Carve Outs” (Cont’d) When an Orange Book method patent is listed for an RLD, an ANDA-filer seeking approval before the patent’s expiration has two options: (1) Paragraph IV certification; or (2) Submit a “little viii” statement (21 U.S.C. § 355(j)(2)(A)(viii)) stating that the patent does not claim a use the filer is seeking FDA approval for, along with proposed labeling that “carves out” the use claimed in the patent.