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AIPLA IP Practice in Japan Committee Pre-Meeting Ranga Sourirajan January 27, 2009 2008 Federal Circuit The opinions expressed herein are not to be attributed.

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Presentation on theme: "AIPLA IP Practice in Japan Committee Pre-Meeting Ranga Sourirajan January 27, 2009 2008 Federal Circuit The opinions expressed herein are not to be attributed."— Presentation transcript:

1 AIPLA IP Practice in Japan Committee Pre-Meeting Ranga Sourirajan January 27, 2009 2008 Federal Circuit The opinions expressed herein are not to be attributed to the Firm’s clients

2 In re BilskiEgyptian Goddess v. Swisa En Banc Opinions

3 Declaratory Judgment Personal jurisdiction (Avocent Huntsville) Subject matter jurisdiction (Caraco; Cat Tech; Janssen; Micron; Prasco) Jurisdiction In Personam Jurisdiction (Campbell Pet; Medical Solutions) Subject Matter Jurisdiction (Excelstor Tech.) Standing (Lucent; Mars) Writ of Mandamus (In re TS Tech) Multidistrict Litigation (In re Omeprazole Pat. Litig.) Settlement Agreement and Antitrust (In re Ciprofloxacin Hydrochloride) Open Source License (Jacobsen) Standards Setting (Qualcomm) ITC’s Exclusion Order (Kyocera Wireless) Panel Opinions and Order

4 Claim Construction (800 Adept) Means-Plus-Function (Welker Bearing; Net Moneyin) Reverse Doctrine of Equivalents (Roche) Invalidity Indefiniteness (Star Scientific) Obviousness (In re DBC; Asyst Tech.) Lack of Written Description (In re Alonso; Carnegie Mellon Univ.) Anticipation (Net Moneyin; Cohesive Techs.) Obviousness-Type Double Patenting (In re Basell Poliolefine) Inequitable Conduct (Star Scientific) Joint Infringement (Muniauction) Damages Subsidiary (Mars) Exceptional Case (Takeda Chemical; Nilssen) Panel Opinions and Order

5 Preliminary Injunction Procedural (Procter & Gamble) Substantive (Abbott Labs.) Reexamination (In re Swanson; Cooper Techs.) Maintenance Fee (Burandt) Panel Opinions and Order

6 Declaratory Judgment Act The judicial Power shall extend to all Cases... to Controversies... U.S. Const., art. III, § 2

7 Facts MedImmune manufactures Synagis, a drug to treat respiratory tract disease Genentech granted MedImmune a license to make, use and sell subject matter covered by a patent and a pending application After pending application issued as patent, Genentech sent a letter to MedImmune alleging that Synagis infringed its patent and demanded royalty MedImmune believed patent to be invalid and unenforceable, and the letter a clear threat to enforce patent; MedImmune filed DJ action Procedure C.D. Cal. dismissed the DJ action for lack of subject matter jurisdiction under the “reasonable apprehension of suit” test Fed. Cir. affirmed the DCT decision; MedImmune filed cert Holding A justiciable declaratory judgment action exists when “the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment” MedImmune v. Genentech

8 Facts Avocent Huntsville and Avocent Redmond (Avocent), and Aten, a Taiwanese Co., compete in keyboard-video-mouse switches market Aten owns U.S. Pat. Nos. 6,957,287 and 7,035,112 re: KVM switches Aten sent a letter to Avocent Corp. (parent), a letter to; a letter to Avocent Redmond during ongoing litigation in W.D. Wash. Avocent filed DJ in N.D. Ala. Procedure DCT grants Aten’s FRCP 12(b)(2) MTD for lack of personal jurisdiction No “systematic and continuous contact” by Aten with Alabama Arguments Avocent: general jurisdiction under “stream of commerce” theory Aten: no specific jurisdiction based on letters asserting infringement Holding (1) Mere acts of making, using, offering to sell, selling, or importing products to a forum do not satisfy the “other activities” requirement for specific personal jurisdiction over patentee; (2) no specific jurisdiction over patentee based only on letters asserting infringement Avocent Huntsville v. Aten Int’l

9 Reasoning “General” jurisdiction: Def. have “continuous and systematic” contacts with forum “Specific” jurisdiction: (1) Def. purposefully directed activities at forum (2) claim arises out of or relates to the activities (3) jurisdiction assertion is reasonable and fair Letters threatening suit by themselves are insufficient to create personal jurisdiction because it would not comport with “fair play and substantial justice” “other activities” in addition to cease and desist letters to meet “relate to” requirement: judicial or extra-judicial patent enforcement within forum; entering into exclusive license agreement imposing obligations on forum resident Dissent (Newman, J.) Personal jurisdiction exists because (1) infringement letter sent to Avocent Corp.’s President in Ala.; (2) sale of Aten’s products through distributors and retail stores in Ala.; (3) Aten’s contacts with Avocent’s customers; (4) Avocent’s manufacture of accused infringing products; (5) no clear alternative forum; (6) due process and fairness Avocent Huntsville v. Aten Int’l

10 Facts Janssen holds NDA for Risperdal® Oral Solution, drug to treat schizophrenia Janssen owns U.S. Pat. Nos. 4,804,663, 5,453,425, and 5,616,587 Apotex stipulated to infringement, validity and enforceability of ‘663 patent Teva first ANDA applicant on ‘425 and ‘587 patents; Apotex second filed ANDA on ‘425 and ‘587 patents and later amended to add ‘663 patent Janssen sued Apotex for infringement of ‘663 patent Apotex counterclaimed DJ of noninfringement of ‘425 and ‘587 patents Janssen gave Apotex a covenant-not-to-sue with respect to ‘425 and ‘587 patents Procedure D. N.J. dismisses Apotex’s DJ action for noninfringement against Janssen Janssen Pharmaceutica v. Apotex

11 Holding (1) second ANDA applicant’s exclusion from the market because of first ANDA applicant’s entitlement to statutory exclusionary period; (2) possible delay in the future of a first ANDA applicant’s launch of generic product; or (3) covenant-not-to-sue which protects ANDA applicant’s affiliates, suppliers and downstream customers do not give rise to “actual controversy” Reasoning If Apotex had not stipulated to validity of ‘663 patent, Caraco would be controlling At the time when DCT entered final judgment, Apotex’s harm was speculative “having manufactured” language of covenant-not-to-sue expressly covers suppliers and affiliates Janssen Pharmaceutica v. Apotex

12 Facts Prasco makes generic benzoyl peroxide cleansing product Prasco brought DJ of noninfringement; at the time, Prasco had not marketed its product and defendants did not know of its existence Defendants filed MTD; later, Prasco sent a sample and requested covenant-not- to-sue, which defs. declined; Prasco filed amended complaint Procedure DCT granted MTD finding no case or controversy under the “reasonable apprehension” test DCT noted that result would be the same since there was “no definite and concrete dispute that touches legal relations of parties” Holding Patentee’s marking of its products, prior suit involving other patents, and patentee’s refusal to sign covenant-not-to-sue do not create immediate and real controversy Reasoning No jurisdiction without patentee’s affirmative act; mere knowledge of patent or perceived risk of infringement insufficient Laundry list: creates reasonable apprehension of suit, demands royalty, creates barrier to regulatory approval Prasco v. Medicis Pharm.

13 Facts Cat Tech owns U.S. Pat. No. 6,905,660 directed to method for using loading devices to place catalyst particles into multi-tube chemical reactors TubeMaster designs 4 different configurations of loading devices used to put catalyst into reactor tubes Cat Tech sued TubeMaster for infringement; TubeMaster counterclaimed for declaration of noninfringement; Cat Tech amended complaint seeking DJ of infringement Procedure DCT grants TubeMaster’s motion for declaration of noninfringement because a “live controversy” existed as to certain design configurations Cat Tech v. TubeMaster

14 Holding DCT may issue a declaratory judgment when the declaratory judgment plaintiff has taken significant, concrete steps to conduct infringing activity and the dispute meets the “immediacy” and “reality” requirements Reasoning Meaningful preparation to conduct infringing activity an important element in totality of circumstances “immediacy” and “reality” requirements must be met for justiciability “immediacy” requirement is satisfied because TubeMaster can “expeditiously solicit and fill orders for loading devices” “reality” requirement is satisfied because TubeMaster’s technology is “substantially fixed” Cat Tech v. TubeMaster

15 Facts Forest holds NDA for Lexapro®, used to treat depression; U.S. Pat. No. Re. 34, 712 covers pure forms of escitalopram, U.S. Pat. No. 6,916,941 covers crystalline particles of escitalopram oxate Ivax Pharm. filed ANDA application for ‘712 and ‘941 patents; Forest sued Ivax for infringement of ‘712 patent and won Caraco later filed ANDA for both patents; Forest sued for infringement of ‘712 patent; Caraco filed DJ of noninfringement of ‘941 patent; Forest unilaterally granted an irrevocable covenant-not-to-sue for ‘941 patent infringement Procedure E.D. Mich. dismissed Caraco’s DJ action because covenant-not-to-sue eliminates controversy between parties Holding In the context of Hatch-Waxman framework, Art. III controversy exists even when the patentee grants a covenant-not-to-sue because patentee’s actions effectively prevent FDA from approving ANDA Caraco Pharm. Labs. v. Forest Labs.

16 Reasoning Action is justiciable only if (1) plaintiff has standing; (2) issues are ripe; and (3) case is not moot Caraco satisfies standing requirements because (1) “restraint on free exploitation of non-infringing goods” is injury-in-fact; (2) injury is traceable to patentee due to listing of patents in the Orange-book; and (3) injury-in-fact is redressible by a favorable judgment Issue is ripe because (1) Caraco submitted its generic drug product for FDA approval; and (2) withholding court consideration would have “immediate and substantial impact” on Caraco Covenant-not-to-sue does not render action moot because Caraco can trigger exclusivity period only by court judgment Dissent (Friedman, J.) First ANDA filers may delay other generic drug manufacturers is speculative Congress may amend the statute so as not to defeat the purpose of legislation Caraco Pharm. Labs. v. Forest Labs.

17 Facts Mosaid owns several DRAM patents; Mosaid sent warning letter and follow-up letters to DRAM manufacturers (Samsung, Hynix, Infineon, Micron) Mosaid sued Samsung, Hynix, and Infineon; later settled Micron filed DJ in N.D. Cal. of noninfringement of 14 Mosaid patents; next day, Mosaid filed infringement action in E.D. Tex. Procedure N.D. Cal. grants Mosaid’s MTD finding lack of subject matter jurisdiction under reasonable apprehension of suit test Alternatively, N.D. Cal. held that it would exercise discretion and decline to hear the case because Micron’s DJ action is “tenuous at best” and E.D. Tex. action is broader Micron Tech. v. Mosaid Techs.

18 Holding Issuance of declaratory judgment is warranted when all the circumstances (threatening letters, behavioral observations, public statements and annual reports) show a substantial controversy between parties of adverse legal interests of sufficient immediacy and reality. In cases with competing forum interests, “convenience factors” must be considered Reasoning Four-year elapse period between last letter and suit unavailing due to negotiations with other DRAM manufacturers Recent public statements and annual reports confirm intent to pursue aggressive litigation strategy Objectives of Declaratory Judgment Act would be met if case is heard by N.D. Cal. than by forum of later-filed suit Micron Tech. v. Mosaid Techs.

19 Adenta GmbH v. OrthoArm, Inc., 501 F.3d 1364 (Fed. Cir. 2007) (Fed. Cir. affirms grant of DJ) Avocent Huntsville Corp. v. Aten Int’l Co., Ltd., 2008 U.S. App. LEXIS 25477 (Fed. Cir. Dec. 16, 2008) (Fed. Cir. affirms dismissal for lack of personal jurisdiction) Benitec Austl., Ltd. v. Nucleonics, Inc., 495 F.3d 1340 (Fed. Cir. 2007) (Fed. Cir. affirms dismissal of DJ action) Cat Tech LLC v. TubeMaster, Inc., 528 F.3d 871 (Fed. Cir. 2008) (Fed. Cir. affirms grant of DJ) Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278 (Fed. Cir. 2008) (Fed. Cir. reverses dismissal of DJ action) Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008) (Fed. Cir. affirms dismissal of DJ action) Micron Tech., Inc. v. Mosaid Techs. Inc., 518 F.3d 897 (Fed. Cir. 2008) (Fed. Cir. reverses dismissal of DJ action) Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329 (Fed. Cir. 2008) (Fed. Cir. affirms dismissal of DJ action) SanDisk Corp. v. STMicroelectonics, Inc., 480 F.3d 1372, 1380 (Fed. Cir. 2007) (Fed. Cir. vacates dismissal of DJ action) Sony Elecs., Inc. v. Guardian Media Techs., Ltd., 497 F.3d 1271 (Fed. Cir. 2007) (Fed. Cir. reverses dismissal of action for lack of subject matter jurisdiction) Teva Pharms. USA, Inc. v. Novartis Pharms. Corp., 482 F.3d 1330 (Fed. Cir. 2007) (Fed. Cir. reverses dismissal of DJ action) Post-MedImmune DJ Actions - Summary

20 Promise not to sue (SanDisk) Covenant-not-to-sue − − Stipulation of validity (Janssen) − − Unilateral grant (Caraco) − − Appeal brief (Benitec) Infringement analysis (SanDisk) Royalty demands Barriers to regulatory approval Effect of public statements and annual reports (Micron) Elapse period − − Parties to litigation (Micron) − − Different parties (Sony) Letter − − Breach of K, no mention of infringement (Adenta) Final Thoughts on DJ Actions

21 MedImmune Inc. v. Genentech Inc., 127 S. Ct. 764 (2007) 800 Adept, Inc. v. Murex Sec., Ltd., 539 F.3d 1354 (Fed. Cir. 2008) Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341 (Fed. Cir. 2008) Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. 2008) Avocent Huntsville Corp. v. Aten Int’l Co., Ltd., 2008 U.S. App. LEXIS 25477 (Fed. Cir. Dec. 16, 2008) Burandt v. Dudas, 528 F.3d 1329 (Fed. Cir. 2008) Campbell Pet Co. v. Miale, 542 F.3d 879 (Fed. Cir. 2008) Carnegie Mellon Univ. v. Hoffmann La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008) Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278 (Fed. Cir. 2008) Cat Tech LLC v. TubeMaster, Inc., 528 F.3d 871 (Fed. Cir. 2008) Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351 (Fed. Cir. 2008) Cooper Techs. Co. v. Dudas, 536 F.3d 1330 (Fed. Cir. 2008) Egyptian Goddess v. Swisa Inc., 543 F.3d 665 (Fed. Cir. 2008) (en banc) Excelstor Tech., Inc. v. Papst Licensing GmbH & Co. KG, 541 F.3d 1373 (Fed. Cir. 2008) In re Alonso, 2008 U.S. App. LEXIS 24320 (Fed. Cir. Oct. 30, 2008) In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371 (Fed. Cir. 2008) In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc) List of Cases

22 In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323 (Fed. Cir. 2008) In re DBC, 545 F.3d 1373 (Fed. Cir. 2008) In re Omeprazole Pat. Litig. v. Apotex Corp., 536 F.3d 1361 (Fed. Cir. 2008) In re Swanson, 540 F.3d 1368 (Fed. Cir. 2008) In re TS Tech USA, 2008 U.S. App. LEXIS 26409 (Fed. Cir. Dec. 29, 2008) Jacobsen v. Katzer, 535 F.3d 1373 (Fed. Cir. 2008) Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008) Kyocera Wireless Corp. v. ITC, 545 F.3d 1340 (Fed. Cir. 2008) Lucent Techs., Inc. v. Gateway, Inc., 543 F.3d 710 (Fed. Cir. 2008) Mars, Inc. v. Coin Acceptors, Inc., 527 F.3d 1359 (Fed. Cir. 2008) Med. Solutions, Inc. v. C Change Surgical LLC, 541 F.3d 1136 (Fed. Cir. 2008) Micron Tech., Inc. v. Mosaid Techs. Inc., 518 F.3d 897 (Fed. Cir. 2008) Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008) Net Moneyin, Inc. v. Verisign, Inc., 545 F.3d 1359 (Fed. Cir. 2008) Nilssen v. Osram Sylvania, Inc., 528 F.3d 1352 (Fed. Cir. 2008) Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329 (Fed. Cir. 2008) Procter & Gamble Co. v. Kraft Foods Global, Inc., 549 F.3d 842 (Fed. Cir. 2008) Qualcomm Inc. v. Broadcom Corp., 548 F.3d 1004 (Fed. Cir. 2008) List of Cases

23 Roche Palo Alto LLC v. Apotex, Inc., 531 F.3d 1372 (Fed. Cir. 2008) Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008) Takeda Chem. Indus. v. Mylan Labs., 2008 U.S. App. LEXIS 24743 (Fed. Cir. Dec. 8, 2008) Welker Bearing Co. v. PHD, Inc., 2008 U.S. App. LEXIS 25069 (Fed. Cir. Dec. 15, 2008) List of Cases

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