SUCCESSFULLY LITIGATING METHOD OF USE PATENTS IN THE U.S.

SUCCESSFULLY LITIGATING METHOD OF USE PATENTS IN THE U.S. The 10 th Annual Generics, Supergenerics, and Patent Strategies Conference London, England May 16, 2007 Provided by: Charles R. Wolfe, Jr. H. Keeto Sabharwal Blank Rome LLP 202.772.5841 wolfe@blankrome.com sabharwal@blankrome.com Copyright 2007, by Charles R. Wolfe, Jr. and Brian Wm. Higgins

Today s s Presentation Introduction Overview Legal Framework Pre-Litigation Strategy Proving Infringement: Method of Use Patents Remedies: Infringement of Method of Use Patents Questions? 2

Introduction 3

Overview Legal Framework New Drug Application Patent Information Drug Products (API, polymorphs, formulations) Method of Use (NDA use, non-nda use) Excluded subject matter Timing 4

Overview Legal Framework (con( con t) NDA Patent Information: The applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. 21 U.S.C. 355(b)(1) 5

Overview Legal Framework (con( con t) NDA Patent Information for API (drug substance): For patents that claim the drug substance, the applicant shall submit information only on those patents that claim the drug substance that is the subject of the pending or approved application or that claim a drug substance that is the same as the active ingredient that is the subject of the approved or pending application. 21 C.F.R. 314.53(b) 6

Overview Legal Framework (con( con t) NDA Patent Information for polymorph: For patents that claim a polymorph that is the same as the active ingredient described in the approved or pending application, the applicant shall certify in the declaration forms that the applicant has test data, as set forth in paragraph (b)(2) of this section, demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the new drug application. 21 CFR 314.53(b) 7

Overview Legal Framework (con( con t) NDA Patent Information for formulation (drug product): For patents that claim a drug product, the applicant shall submit information only on those patents that claim a drug product, as is defined in 314.3, that is described in the pending or approved application. 21 CFR 314.53(b) 8

Overview Legal Framework (con( con t) NDA Patent information for method of use: For patents that claim a method of use, the applicant shall submit information only on those patents that claim indications or other conditions of use that are described in the pending or approved application. 21 CFR 314.53(b) 9

Overview Legal Framework (con( con t) Excluded Subject Matter Methods of manufacturing Packaging Metabolites Intermediates Process patents, patents claiming packaging, patents claiming metabolites, and patents claiming intermediates are not covered by this section, and information on these patents must not be submitted to FDA. 21 CFR 314.53(b) 10

Overview Legal Framework (con( con t) Timing: existing patents The applicant shall file with the application 21 U.S.C. 355(b) 11

Overview Legal Framework (con( con t) Timing: newly issued patents...after the filing date but before approval of the application, the applicant shall amend the application to include the information... 21 U.S.C. 355(b)... after an application is approved... within 30 days of the date of issuance of the patent. 21 CFR 314.53 12

Overview Legal Framework (con( con t) ANDA Patent Certification Paragraph I Paragraph II Paragraph III Paragraph IV Section VIII Statement (non-approved use) Timing 13

Overview Legal Framework (con( con t) ANDA Patent Certification An abbreviated application for a new drug shall contain (vii) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug referred to in clause (i) or which claims a use for such listed drug for which the applicant is seeking approval under this subsection. 21 U.S.C. 355(j)(2)(A)(vii) 14

Overview Legal Framework (con( con t) ANDA Paragraph I Patent Certification that such patent information has not been filed. 21 U.S.C. 355(j)(2)(A)(vii)(I) 15

Overview Legal Framework (con( con t) ANDA Paragraph II Patent Certification that such patent has expired. 21 U.S.C. 355(j)(2)(A)(vii)(II) 16

Overview Legal Framework (con( con t) ANDA Paragraph III Patent Certification of the date on which such patent will expire. 21 U.S.C. 355(j)(2)(A)(vii)(III) 17

Overview Legal Framework (con( con t) ANDA Paragraph IV Patent Certification that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted. 21 U.S.C. 355(j)(2)(A)(vii)(IV) 18

Overview Legal Framework (con( con t) ANDA Section viii Statement Patent Certification... a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. 21 U.S.C. 355(j)(2)(A)(viii) 19

Overview Legal Framework (con( con t) ANDA Patent Certification: Paragraph IV Notice An applicant that makes a certification described in [Paragraph IV]... will give notice as required by this subparagraph. 21 U.S.C. 355(j)(2)(B)(i) 20

Overview Legal Framework (con( con t) ANDA Patent Certification: Paragraph IV Notice To whom given? (I) each owner of the patent... (II) the holder of the approved application... 21 U.S.C. 355(j)(2)(B)(iii) 21

Overview Legal Framework (con( con t) ANDA Patent Certification: Paragraph IV Notice When given? (I)...not later than 20 days after date of the postmark on the notice [form FDA]...that the application has been filed... (II)...at the time at which the applicant submits the amendment or supplement 21 U.S.C. 355(j)(2)(B)(ii) 22

Overview Legal Framework (con( con t) Consequences 30 month stay Drug Product Method of Use 23

Overview Legal Framework (con( con t) Paragraph IV litigation brought by patent owner before the expiration of 45 days after... notice... is received... an action is brought for infringement... the approval shall be made effective upon the expiration of the thirty month period beginning on the date of the receipt of the notice... 21 U.S.C. 355(j)(5)(B)(iii) 24

Overview Legal Framework (con( con t) Paragraph IV litigation brought by ANDA applicant i.e., Civil action to obtain patent certainty No action may be brought...for declaratory judgment with respect to a patent which is the subject of the certification...unless 25

Overview Legal Framework (con( con t) (aa) the 45-day period...has expired (bb) neither the owner of such patent nor the holder of the approved application...brought a civil action...for infringement (cc) in any case in which the notice...relates to non-infringement, the notice was accompanied by [an offer of confidential access] 21 U.S.C. 355(j)(5)(C)(i) 26

Pre-Litigation Strategy Guarding against willful infringement A finding of willful infringement is made after considering the totality of the circumstances. Knorr-Bremse Systeme Fuer Nutzfahrzeuge GmbH v. Dana Corp., 383 F.3d 1337, 1342-43 (Fed. Cir. 2004) (en banc). 27

Pre-Litigation Strategy Guarding against willful infringement (cont.) [W]here, as here, a potential infringer has actual notice of another's patent rights, he has an affirmative duty to exercise due care to determine whether or not he is infringing, including the duty to seek and obtain competent legal advice from counsel before the initiation of any possible infringing activity. Underwater Devices, Inc. v. Morrison- Knudsen Co., 717 F.2d 1380, 1389-90 (Fed. Cir. 1983) 28

Pre-Litigation Strategy Adverse inference (old rule): [A] court must be free to infer that either no opinion was obtained or, if an opinion were obtained, it was contrary to the infringer's desire to initiate or continue its use of the patentee's invention. Fromson v. Western Litho Plate & Supply Co., 853 F.2d 1568, 1572-73 (Fed. Cir. 1988) 29

Pre-Litigation Strategy Adverse inference (new rule): [T]he assertion of attorney-client and/or work-product privilege and the withholding of the advice of counsel shall no longer entail an adverse inference as to the nature of the advice. See Knorr-Bremse Systeme Fuer Nutzfahrzeuge GmbH v. Dana Corp., 383 F.3d 1337 (Fed. Cir. 2004) (en banc). 30

Pre-Litigation Strategy Waiver of Attorney Client Privilege The attorney-client privilege protects disclosure of communications between a client and his attorney. United States v. Zolin, 491 U.S. 554, 562 (1989) 31

Pre-Litigation Strategy Waiver of Attorney Client Privilege (cont.) [W]hen [defendant] chose to rely on the advice of in-house counsel, it waived the attorney-client privilege with regard to any attorney-client communications relating to the same subject matter, including communications with counsel other than in-house counsel, which would include communications with [outside counsel]. In re EchoStar Communications Corp., 78 USPQ2d 1676 (Fed. Cir. 2006) 32

Pre-Litigation Strategy Waiver of Attorney Work Product Unlike the attorney-client privilege, which protects all communication whether written or oral, work-product immunity protects documents and tangible things, such as memorandums, letters, and e-mails. Judicial Watch, Inc. v. Dep't of Justice, 432 F.3d 366 (D.C. Cir. 2005) 33

Pre-Litigation Strategy Waiver of Attorney Work Product (cont.) Three categories of work product that are potentially relevant to the advice-ofcounsel defense: (1) documents that embody a communication between the attorney and client concerning the subject matter of the case, such as a traditional opinion letter - WAIVED 34

Pre-Litigation Strategy Waiver of Attorney Work Product (cont.) (2) documents analyzing the law, facts, trial strategy, and so forth that reflect the attorney's mental impressions but were not given to the client NOT WAIVED 35

Pre-Litigation Strategy Waiver of Attorney Work Product (cont.) (3) documents that discuss a communication between attorney and client concerning the subject matter of the case but are not themselves communications to or from the client WAIVED In re EchoStar Communications Corp., 78 U.S.P.Q.2d 1676 (Fed. Cir. 2006) 36

Pre-Litigation Strategy Declaratory Judgment Actions Applies to Paragraph IV certification If patentee/nda holder does not bring an infringement suit within 45 days after receiving notice, ANDA applicant may bring declaratory judgment civil action that the patent at issue is invalid or will not be infringed by the drug for which the ANDA was submitted. 21 U.S.C. 355(j)(5)(C) 37

Pre-Litigation Strategy Declaratory Judgment Actions (cont.) The [Federal Circuit s] reasonableapprehension-of-suit test [] conflicts with our [Supreme Court] decisions MedImmune, Inc. v. Genentech, Inc., 127 S. Ct. 764, 774 & n11 (2007) 38

Pre-Litigation Strategy Declaratory Judgment Actions (cont.) Actual controversy? Look at all the circumstances, but at least 3 needed: (1) Listing patents in OB (not enough by itself); (2) Submitting ANDA with P-IV; (3) Being sued by NDA/patent holder; Teva Pharmaceuticals USA Inc. v. Novartis Pharmaceuticals Corp., 82 U.S.P.Q.2d 1225 (Fed. Cir. 2007) 39

Pre-Litigation Strategy Declaratory Judgment Actions (cont.) Not available where seeking to have patent de-listed from OB Mylan Pharmaceuticals Inc. v. Thompson, 60 U.S.P.Q.2d 1576 (Fed. Cir. 2001) 40

Proving Infringement: Method of Use Patents Inducing infringement Whoever actively induces infringement of a patent shall be liable as an infringer. 35 U.S.C. 271(b) 41

Proving Infringement: Method of Use Patents (cont.) Inducing infringement (cont.) [D]ependent upon the existence of direct infringement Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 774 (Fed. Cir. 1993) Must establish intent (circumstantial evidence is allowed) Metabolite Labs. Inc. v. Labs. Corp. Am., 370 F.3d 1354, 1365 (Fed. Cir. 2004) 42

Proving Infringement: Method of Use Patents (cont.) Inducing infringement (cont.) For method or process patents, must shown that the direct infringer performed all process steps in the U.S. See NTP Inc. v. Research In Motion Ltd., 75 USPQ2d 1763 (Fed. Cir. 2005) 43

Proving Infringement: Method of Use Patents (cont.) Inducing infringement of pharma method of use patents A method of use patent holder may not sue an ANDA applicant for induced infringement of its patent, if the ANDA applicant is not seeking FDA approval for the use claimed in the patent and if the use claimed in the patent is not FDA-approved. Warner-Lambert Co. v. Apotex Corp., 65 U.S.P.Q.2d 1481 (Fed. Cir. 2003) 44

Proving Infringement: Method of Use Patents (cont.) Inducing infringement of pharma method of use patents (cont.) The mere filing of an ANDA is not itself evidence of direct infringement needed to satisfy an inducement claim; the patentee must still prove all elements of direct infringement Allergan Inc. v. Alcon Laboratories Inc., 66 U.S.P.Q.2d 1225 (Fed. Cir. 2003) 45

Proving Infringement: Method of Use Patents (cont.) Sources of proof inducement Direct infringement Testimony from doctors and patients Surveys Active inducement Labeling Promotional material 46

Proving Infringement: Method of Use Patents (cont.) Sources of proof inducement (cont.) Intent Admissions (emails) Marketing studies Financial projections 47

Remedies: Infringement of Method of Use Patents Preliminary Injunction Other than likelihood of success on the merits, the other factors relevant to decision to grant or deny a preliminary injunction are (1) irreparable harm if the injunction is not granted; (2) the balance of hardships between the parties; and (3) the public interest. Abbott Labs. v. Andrx Pharma. Inc., 81 U.S.P.Q.2d 1289 (Fed. Cir. 2007) 48

Remedies: Infringement of Method of Use Patents Permanent Injunction A patentee seeking a permanent injunction must satisfy a four-factor test before a court may grant such relief. (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; 49

Remedies: Infringement of Method of Use Patents Permanent Injunction (cont.) (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction See ebay Inc. v. MercExchange LLC, 78 U.S.P.Q.2d 1577 (U.S. 2006) 50

Remedies: Infringement of Method of Use Patents Monetary damages (lost profits) The Panduit test requires that a patentee establish: (1) demand for the patented product; (2) absence of acceptable non-infringing substitutes; (3) manufacturing and marketing capacity to exploit the demand; and (4) the amount of profit it would have made. Rite-Hite Corp. v. Kelley Co., Inc., 56 F.3d 1538, 1545 (Fed. Cir. 1995) (en banc) (citing Panduit) 51

Remedies: Infringement of Method of Use Patents Monetary damages (reasonable royalty) A jury may award a patentee damages adequate to compensate for the infringement, but in no event less than a reasonable royalty for the use made of the invention by the infringer. 35 U.S.C. 284 52

Remedies: Infringement of Method of Use Patents Exceptional cases Exceptional cases usually feature some material, inappropriate conduct related to the matter in litigation, such as willful infringement, fraud or inequitable conduct in procuring the patent, misconduct during litigation, vexatious or unjustified litigation, conduct that violates [FRCP] 11, or like infractions. Serio-US Indus. Inc. v. Plastic Recovery Tech. Corp., 80 U.S.P.Q.2d 1065 (Fed. Cir. 2006) 53

Questions? Contact Information Name: Charles R. Wolfe, Jr. Phone: +1 202-772-5800 Email: wolfe@blankrome.com Name: H. Keeto Sabharwal Phone: +1 202-772-5932 Email: sabharwal@blankrome.com 54

Presenter Bios Charles Wolfe, Intellectual Property and Technology Practice Group Leader for Blank Rome, is a registered U.S. patent attorney with over thirty years of experience in U.S. patent law beginning as a patent examiner with the U.S. Patent and Trademark Office ( USPTO ). He has extensive experience representing clients before the USPTO and U.S. courts, including defending generic drug companies in Hatch-Waxman Paragraph IV litigations, which involved formulation and method of use patents. Keeto Sabharwal is a partner in the Intellectual Property and Technology Group for Blank Rome. For over 12 years, he has litigated patent cases in forums throughout the United States and abroad involving a variety of pharmaceutical, chemical and biotechnological products. In addition to Mr. Sabharwal s extensive litigation experience, he has advised pharmaceutical companies throughout the world as to licensing, due diligence and antitrust issues. 55