Recent Developments Impacting Hatch-Waxman Litigation

Transcription

1 March 18, 2015 Litigation Webinar Series: INSIGHTS Our take on litigation and trial developments across the U.S. Recent Developments Impacting Hatch-Waxman Litigation Brian Coggio Of Counsel, New York Jonathan Singer Principal, Twin Cities

2 Overview Monthly 3 rd Wednesday at 1pm ET Key Developments & Trends Housekeeping CLE Contact: makarevich@fr.com INSIGHTS Litigation Webinar Series Questions Materials: fishlitigationblog.com/webinars Next webinar April 15 th #fishwebinar Next in Series Wednesday, April 15 th 1:00 p.m. EST Webinar Changes in NPE Litigation 2

3 Agenda Personal jurisdiction in Hatch-Waxman litigation Good faith belief in invalidity to negate inducement Obviousness in view of Bristol's Baraclude decision Drug labels as inducing infringement Sham litigation and the recent Tyco decision IPRs and their potential impact on Hatch-Waxman litigation 3

4 Personal Jurisdiction in Hatch-Waxman Litigation 4

5 Personal Jurisdiction in Hatch-Waxman Cases Prior Framework: Generic could generally be sued wherever it had previously done significant business under accepted doctrines of general jurisdiction. See e.g., Cephalon, et al v. Watson Labs., et al, 629 F. Supp. 2d 338 (D. Del. 2009) Consequences: 1) While Hatch-Waxman suits were concentrated in New Jersey and Delaware, relatively easy to establish jurisdiction in other jurisdictions, if brand so desired led to use of Eastern District of Texas as a potential jurisdiction 2) Personal jurisdiction challenges were largely unsuccessful 3) No need to resort to doctrines of specific personal jurisdiction 5

6 Personal Jurisdiction in Hatch-Waxman Cases Supreme Court Rulings on General Jurisdiction: 1) Goodyear Dunlop Tire, S.A. v. Brown (2011): No jurisdiction over foreign corporations based on small amount of sales of product in state for tort out of state based on same kind of tires. A court may only assert general jurisdiction over foreign corporations where their affiliations with the [forum] State are so continuous and systematic as to render them essentially at home there. 2) Daimler AG v. Bauman (2014): Extending Goodyear to all cases, not just foreign-based torts. Finding that parent company of Mercedez- Benz USA could not be sued in California based on subsidiary s California contacts, even assuming those contacts were sufficient for jurisdiction in California, and could be imputed to parent company. A corporation is typically at home in only the states of its incorporation and where it has its principal place of business. 6

7 Personal Jurisdiction in Hatch-Waxman Cases Supreme Court Rulings on Specific Jurisdiction 1) Calder v. Jones (1984). Jurisdiction over publishers of Florida-based newspaper (National Enquirer) for libel of a California resident. Widely cited for effects test of personal jurisdiction effect of libel was felt in California, thus subjecting the Florida residents to jurisdiction in California, despite no contacts with the state. 2) Walden v. Fiore (2014). No jurisdiction over Georgia police officer in Nevada for alleged harm suffered by Nevada residents in Nevada, even if Georgia officer knew they had significant contacts in Nevada. Georgia officer did not direct his conduct at Nevada. The focus of the "minimal contacts" inquiry is "the relationship among the defendant, the forum, and the litigation," not the defendant's contacts with persons who reside in the forum. 7

8 Personal Jurisdiction in Hatch-Waxman Cases District Court Applications of Goodyear/Daimler/Walden: 1) AstraZeneca v. Mylan Pharms. (D. Del.) (Sleet) (2014) Rejected general jurisdiction under Daimler based on sales (Old standby in Hatch- Waxman cases) Rejected general jurisdiction under Daimler based on consent through Delaware registration of doing business Found specific jurisdiction based on plaintiff s presence in state and paragraph IV directed to plaintiff in Delaware. Harm from ANDA filing occurred in Delaware and was directed there by defendant. 2) Acorda Therapeutics v. Mylan Pharms. (D. Del.) (Stark) (2015) Rejected general jurisdiction under Daimler based on sales Accepted general jurisdiction under Daimler based on consent through Deleware registration of doing business Found specific jurisdiction based on plaintiff s presence in state and paragraph IV directed to plaintiff in Delaware. 3) Forest Laboratories v. Mylan Pharms. (D. Del.) Burke (2015) Follows Acorda to find general jurisdiction by consent 8

9 Personal Jurisdiction in Hatch-Waxman Cases District Court Applications of Goodyear/Daimler/Walden: 3) Allergan, Inc. v. Actavis PLC (E.D.Tx.) (Dec. 23, 2014) (Gilstrap) Sidestepped general jurisdiction under Daimler based on sales Found specific jurisdiction based on plaintiff s presence in state and defendant s extensive presence in Texas. Distinguished Walden based on defendant s prior presence in Texas. Paragraph IV was NOT sent to Texas. Plaintiff had manufacturing facility and employees for product at issue in Texas. Assessed future nature of harm in a Hatch-Waxman case, and nature of future infringement that would take advantage of defendant s established presence in state. 9

10 Personal Jurisdiction in Hatch-Waxman Cases Consequences/Questions: Both Delaware cases are up on appeal at Federal Circuit (interlocutory appeal certification) Are cases consistent with Walden? Are cases consistent with Federal Circuit authority that Paragraph IV is not enough to create jurisdiction? What are due process requirements where lawsuit is inevitable and expected (Paragraph IV challenge)? o reasonableness under Int l Shoe/Helicopteros/Asahi Will generic applicant seek to change states of incorporation/ppbs? Will branded patentees seek to change their behavior? 10

11 Good Faith Belief in Invalidity to Negate Inducement 11

12 Commil USA, LLC v. Cisco Sys., Inc., 720 F.3d 1361 (Fed. Cir. 2013) A good faith belief in invalidity may negate the intent to infringe required under 271(b). Defendant can present such evidence to the court or jury. Lower court decision that defendant induced infringement was vacated and remanded because evidence of an invalidity opinion was precluded. Intent to infringe requires actual knowledge or willful blindness. The jury instruction that defendant knew or should have known that the product infringed was erroneous in light of Global-Tech Appliances Inc. v. SEB SA, 131 S.Ct (2011). The majority held that, since one cannot infringe an invalid patent, a good faith belief in invalidity negates intent, just as it does with a belief in non-infringement. Judge Newman, in dissent, argued that an invalid patent can be infringed, but there is no liability, and that the language in 271(b) does not support this new defense. Motion for rehearing en banc denied, with Judges Newman, Lourie, Wallach, Rader and Renya dissenting on the admissibility of an opinion of invalidity (not noninfringement) to negate specific intent. G.D. Searle LLC v. Lupin Pharm., Inc., 2:13-cv (E.D. Va. 2013), implies that the good-faith defense could apply in Hatch-Waxman cases. 12

13 Non-Infringement Opinions Have Been Successfully Used To Negate Intent DSU Medical Corp. v. JMS Co. Ltd., 471 F.3d 1293 (Fed. Cir. 2006) (en banc in relevant part). Section 271(b) requires actively and knowingly aid[ing] and abet[ing] another s direct infringement [K]nowledge of the acts alleged to infringe is not enough. (emphasis is original) (opinion negated intent). Opinion or executive testimony negated intent: Bettcher Indus, Inc. v. Bunzl USA, Inc., 661 F.3d 629 (Fed. Cir. 2011) (attorney testimony); Kinetic Concepts, Inc. v. Blue Sky Med. Group. Inc., 554 F.3d 1010 (Fed. Cir. 2009); Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009); Kolmes v. World Elastic Corp., 107 F.3d 1534 (Fed. Cir. 1997); Manville Sales Corp. v. Paramount Systems, Inc., 917 F.2d 544 (Fed. Cir. 1990); Gros Int l Am., Inc. v. Graphic Mgmt. Assoc., Inc., 739 F. Supp. 2d 1089 (N.D. Ill. 2010). Summary judgment of inducement denied due to opinion: Gen-Probe v. Becton Instruments and Co., 899 F. Supp. 2d 971 (S.D. Cal. 2012); VNUS Med. Tech., Inc. v. Diomed Holdings, 2007 WL (N.D. Cal. 2007). Timing and reliance are key! Opinions obtained after the suit is filed are essentially worthless, and evidence must show opinion was relied upon. 35 U.S.C. 298 (eff. 1/14/13) Lack of an opinion is not admissible regarding willfulness or inducement. Does not affect admissibility of an opinion. 13

14 Supreme Court Review Of The Commil Decision In its cert. petition, Commil limited its attack to the use of invalidity opinions (not non-infringement opinions) to negate the intent requirement of inducement. It argued that this new defense is not supported by statute or case law. Cisco argued that an invalid patent can not be infringed, so a good-faith belief of invalidity negates intent. In its cert. amicus brief, the government agreed with Commil, but also argued that Global-Tech, relied upon by the Commil Court, does not clearly resolve whether the defendant must possess actual knowledge that the induced conduct constitutes infringement. Cert. Brief for United States as Amicus Curiae, at 7. The government then implicitly questioned the DSU holding that led to the good-faith defense, but noted that neither party had challenged that holding. 14

15 Supreme Court Review Of The Commil Decision In its merits brief, Commil adopted the government s approach, highlighting the ambiguity in Global-Tech and argued that a good-faith belief in invalidity or non-infringement is irrelevant to the inducement issue. Indeed, most of the brief attacks all good-faith defenses. Only, in the last section does Commil focus on the invalidity defense and argue that an invalid patent can still be infringed and thus, the good faith invalidity defense is improper. Commil cites Aro Mfg Co. v. Convertible Top Replacement Co., 377 U.S. 476 (1964) (Aro II), arguing that the Court treated the receipt of a notice letter as satisfying the intent requirement of 271(b). Cisco argues that Global-Tech focuses not only on infringement but also whether defendant will be liable as an infringer. This, according to Cisco, implicates invalidity and thus, a good-faith belief in invalidity negates liability under 271(b). Cisco also cites non-patent tort cases where liability turned on a belief in wrong doing. 15

16 Supreme Court Review Of The Commil Decision AIPLA, IPO, BIO, PHARMA amici briefs support Commil (no good-faith invalidity defense), but do not attack the good-faith non-infringement defense. In the government s merits brief, it argues in Section 271(b) does not require knowledge of the infringing nature of the induced acts, and a good faith belief in non-infringement is not a defense to inducement liability. Merits Brief for United States as Amicus Curiae, at 9. The government argues that the Aro II approach strikes the appropriate balance between rights of patent holders and the protection of truly innocent inducers. A patentee may establish the intent required for 271(b) by proving that the inducer knew about the patent and was aware of the patentee s view that the induced conduct was infringing. At a minimum, a good faith belief in invalidity is not a viable defense to inducement. An invalid patent can be infringed. 16

17 Obviousness in View of Bristol's Baraclude Decision 17

18 BMS v. Teva: Overview Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, reh g denied 769 F3d 1339 (Fed. Cir. 2014). BMS s patent to the Hepatitis B drug Baraclude (entecavir) is obvious. Several separate opinions on denial of rehearing: Concurrence by Judge Dyk, joined by Judge Wallach Concurrence by Judge O Malley Separate dissents by Judges Newman and Taranto, both joined by Judges Lourie and Reyna 18

19 BMS v. Teva: Prior art vs. the claims Entecavir (claimed compound) Most potent Hepatitis B treatment Very few patients become resistant 2 -CDG (prior art lead compound) Researchers were using it as a lead and viewed it as promising. Post-invention in vivo studies revealed it was toxic. 19

20 BMS v. Teva: The panel s rationale Obvious to select 2 -CDG as lead compound BMS s expert admissions about its use at the time of invention Obvious to modify 2 -CDG to arrive at entecavir Substitution of carbocyclic ring yielded greatest activity changes Prior art showed adding exocyclic methylene increased efficacy Any unexpected results were insufficient Unexpected properties did not upset the motivation to combine Superior efficacy a difference in degree, not difference in kind Difference in toxicity with 2 -CDG irrelevant because that was unknown at the time of invention 20

21 BMS v. Teva: Other opinions Judge Dyk, joined by Judge Wallach: Post-invention evidence never relevant because 103 requires the inquiry to be conducted at the time of the invention (or, post-aia, at the effective filing date ) Judge O Malley: Agrees with the dissenters view of the law But ultimately, a case is won or lost on the record. Judge Newman dissent Precedent says that data developed post-invention can be used to show non-obviousness The panel s rule creates conflicting incentives regarding when to file Rejects a bright-line rule regarding differences in degree and differences in kind 21

22 BMS v. Teva: Judge Taranto s dissent Full court should analyze how to define reasonable expectation of success Serious question whether prior in vitro testing here was enough What is reasonable? o KSR and policy suggest a higher bar What is success? o Should be accomplishing what motivated the research Post-invention evidence Not prohibited by text of section 103 Seemingly allowed by precedent Can fit in depending on how you define reasonable expectation 22

23 BMS v. Teva: Consequences/Questions Is it right to restrict analysis to time of invention? Prior art is not restricted to time of invention Makes inquiry subjective as opposed to objective What if inventor doesn t know, but others do? Vice versa? Differences in degree vs. differences in kind Is there anything to this distinction? o Just a pithy way to summarize what is intuitive, that a change in functionality of something is typically more unexpected than a change in efficiency of something. Dangerous to categorize things in this fashion? o Law of unintended consequences. 23

24 Drug Labels as Inducing Infringement 24

25 Patent Claims, Drug Labels, And Inducement of Infringement In DSU Medical Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc in relevant part), the Federal Circuit held that inducement to infringe under 271(b) requires an affirmative intent to cause direct infringement. But the court provided little guidance on how the requisite specific intent may be established. Labels can play an important role in pharmaceutical cases especially since merely obtaining an AB rating for a generic drug does not establish an intent to infringe. See Organon Inc. v. Teva Pharm. Inc., 244 F. Supp. 2d 370, 379 (D.N.J. 2002). Moreover, off-label uses will not support a claim. Allergan Inc. v. Alcon Labels Inc., 384 F. 3d 1322, 1331 (Fed. Cir. 2003). Substantial non-infringing uses may also preclude a finding of inducement. See Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003); Acorda Therapeutics Inc. v. Apotex Inc., No. 07-cv-4937, 2011 WL (D.N.J. Sept. 6, 2011), aff d, 476 F. App x 746 (Fed. Cir. 2012). But see Toshiba Corp. v. Imation Corp., 681 F.3d 1358, (Fed. Cir. 2012) where the label controlled. Even though non-infringing uses existed, case was remanded to the lower court for decision on specific intent. 25

26 Patent Claims, Drug Labels, And Inducement of Infringement Abraxis Bioscience Inc. v. Navinta LLC, 640 F. Supp 553, 570 (D.N.J. 2009), rev d on other grounds, 625 F.3d 1359 (Fed. Cir. 2010) ( statements in a package insert that encourage infringing use of a drug product are alone sufficient to establish intent to encourage direct infringement. (emphasis added). See also Eli Lilly & Co. v. Actavis Elizabeth LLC, 435 F. App x 917, (Fed. Cir. 2011). In AstraZeneca LP v. Apotex Inc., 633 F.3d 1042, 1047 (Fed. Cir. 2010), the claim required a specific dosage. The label did not specify that dosage but statements in the DOSAGE AND ADMINISTRATION and PRECAUTIONS sections of the label repeatedly warn[ed] that patients should titrate down to the lowest effective dose The Federal Circuit held that physicians would titrate the dosage downward, and this would necessarily lead to the use of the claimed dosage, and thus infringement. Id. at Here, how the physician/patient actually used the drug controlled based on information specifically in the label. That the FDA required Apotex to alter the label in a manner that infringed did not shield it. Apotex should have appealed the FDA ruling or filed a paragraph III certification. 26

27 Patent Claims, Drug Labels, And Inducement of Infringement In Bayer Schering Pharma AG v. Sandoz, Inc. 676 F. 3d 1316 (Fed. Cir. 2012), the claim covered the use of a drug to treat three conditions. The patentee s drug label, which was copied by the generic, specified the use of the drug to treat only one of the three conditions, but discussed the other two conditions. The Federal Circuit affirmed the lower court s decision of no inducement because the label did not indicate that the specific three-pronged use claimed in the patent was safe and effective. Id. at Judge Newman dissented because when the drug was administered, all three conditions were treated. Id. at Thus, the actual use of the drug to treat all three conditions, although inherent, did not control. The approved uses of a drug were found in the INDICATION and USAGE section and that controls and other parts of the label (the CLINICAL PHARMACOLOGY SECTION ) were essentially irrelevant. That section indicated that the drug may have properties that treated the other two claims. The Bayer Court apparently recognized that instructions in the DOSAGE AND ADMINISTRATION are significant to the question of inducement. 27

28 Patent Claims, Drug Labels, And Inducement of Infringement In United Therapeutics Corp. v. Sandoz Inc., Nos , , 2014 U.S. Dist. LEXIS (D.N.J. Aug. 29, 2014), the patent required the use of a specific diluent, which reduced the possibility of infection, when administering the drug product. The ANDA label eliminated a specific direction to use a diluent. Numerous sections of the label, however, including the WARNINGS AND PRECAUTIONS section, stressed the possibility of infection, which United argued would induce physicians to review the literature and learn about the safety effects of dilution. In ruling for Sandoz, the court noted that there is a rather significant difference between a warning and an instruction. A warning provides information regarding a potential risk, whereas, [a]n instruction is a statement directing one to take some action, such as how to avoid a potential risk. Id. at *49. [I]nstructions must be such that a court can infer from the instruction an affirmative intent to infringe the patent. Id. at *55 (citation omitted). Original label would have infringed, but later amended to eliminate any mention of a diluent. Case is on appeal. 28

29 Sham Litigation and the Recent Tyco Decision 29

30 Tyco: New Potential Antitrust Liability Tyco Healthcare v. Mutual Pharm., 762 F.3d 1338 (Fed. Cir. 2014): Reverses SJ of no sham litigation because of fact issues on whether ANDA suit was objectively baseless Reverses SJ of no sham litigation for FDA Citizen s Petition 30

31 General Two-Part Test for Sham Litigation A litigant cannot face antitrust liability for bringing a lawsuit, unless: 1. The litigation is objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits, and 2. The litigation is motivated by a desire to interfere directly with the business relationships of a competitor. 31

32 Tyco: Sham Hatch-Waxman Litigation The patent required a drug formulation where the active ingredient had a given parameter ANDA reported non-infringing value for that parameter at one temperature The patentee relied on test data at a higher temperature The mere fact the ANDA suggested non-infringement was not itself enough for antitrust liability But the patentee s testing did not show infringement Higher temperature seemed to skew the ANDA product s composition Without decomposition, higher temperature would actually take the composition further outside the claim 32

33 Tyco: Sham FDA Citizen s Petition The same two-part test that applies to sham litigation claims applies to a sham FDA filing too Fact issues on whether CP was objectively baseless : FDA said CP provided no evidence from testing and relies entirely on uncorroborated generalities and theoretical speculation Generic s expert says patentee had no scientific basis Fact issues on whether CP was filed in bad faith: Timing of CP filed the day after district court found non-infringement Patentee s internal said it was possible to make a non-infringing but bioequivalent product 33

34 Tyco: Consequences/Questions How realistic is analysis on infringement side? Newman s dissent articulates a point of view that litigation is part of the Hatch-Waxman process. What is proper standard in light of that? o Oftentimes, there is no information available before suit; or, if available, it is highly restricted. o Perhaps a flexible standard that puts more onus on the patent-holder as the case progresses is appropriate. And on Citizen s Petition side? Undoubtedly, timing was a big factor and provided strong inference of subjective bad intent But how relevant is FDA s review? Is it really the case that FDA should effectively be arbiter on whether a petition is a sham? o FDA CP decisions are fairly one-sided 34

35 IPRs and their Potential Impact on Hatch-Waxman Litigation 35

36 IPRs And The Hatch-Waxman 30-Month Stay And 180-Day Exclusivity A. The 30-Month Stay - If a patentee files suit within 45 days after recent of notice letter, FDA cannot approve ANDA for 30 months from date of patentee s recent of notice letter, which the court can be lengthen or shorten for failure to cooperate 21 U.S.C. 355 (1)(5)(B)(iii). Stay has equitable overtones. If a district court holds the patent invalid or not infringed, the 30-month stay terminates when judgment is entered by the district court. 21 U.S.C. 355 (1)(5)(B)(iii)(I). No need to wait for appeal. If a generic loses at trial, but succeeds on appeal, the 30 month stay terminates when the court of appeals decides that the patent is invalid or not infringed. 21 U.S.C. 355 (1)(5)(B)(iii)(II) (Is entry of judgment necessary?). B. 180-Day Exclusivity (As Relevant Here) Day exclusivity ends if ANDA fails to market within 75 days after decision in an infringement or declaratory action from which no appeal can be taken (other than a petition to the Supreme Court for a writ of certiorari) holding patent invalid or not infringed in an action involving first applicant or any other applicant (which other applicant has received tentative approval). 21 U.S.C. 355 (J)(5)(D)(i)(1) (aa)-(bb). Appellate decision controls, petition for cert. does not stay effect of ruling. 36

37 IPRs And The Hatch-Waxman 30-Month Stay And 180-Day Exclusivity C. Termination of the 30-Month Stay And 180-Day Exclusivity A successful PTAB decision may form the basis for a summary judgment motion. If a district court enters summary judgment of invalidity, the 30-month stay ends, even if the patentee appeals. If judgment is entered, the appeal time regarding the forfeiture of the 180-day exclusivity begins. No forfeiture while appeal is pending. The different standards of claim interpretation and invalidity applied by the PTAB and district courts should not prevent summary judgment by the court. See generally eplus, Inc. v. Lawson Software, Inc., 760 F.3d 1350 (Fed. Cir. 2014); Fresenius USA, Inc. v. Baxter Int l, Inc., 721 F.3d 1330 (Fed. Cir. 2013). If the Federal Circuit affirms a PTAB holding of invalidity, the precise language of the provisions regarding the termination of the 30-month stay and 180-day exclusivity are not satisfied. The appeal is not from an infringement or declaratory judgment action. But if the generic seeks a ruling from a district court in an existing paragraph IV infringement action or institutes a declaratory judgment action to obtain a court judgment ruling, the patentee could argue that, since the patent is now invalid, a justifiable controversy does not exist. If the case is dismissed on those grounds, a judgment of non-infringement or invalidity can not be entered. Thus, no triggering event occurs for ending either the 30-month stay or 180-day exclusivity. 37

38 IPRs And The Hatch-Waxman 30-Month Stay And 180-Day Exclusivity In eplus, supra, the Federal Circuit affirmed a ruling holding the patent-in-suit valid and infringed and the defendant had been enjoined. The decision was not final because the case had been remanded to the district court to make a minor modification to the injunction. But in an appeal from a reexamination, the Federal Circuit held the patent invalid. In the infringement action, the Federal Circuit vacated the injunction because [i]t is well established than an injunction must be set aside when the legal basis for it has ceased to exist. Id. at Thus, after affirmance of the PTO s decision invalidating a patent, that patent no longer confers any rights that support an injunction against infringement. Since both the 30-month stay and the 180-day exclusivity are, in essence, injunctions preventing the FDA from acting to approve generic drugs, an argument that they should end when the Federal Circuit affirms invalidity is possible. A return to the district court should not be necessary. It will delay termination of 30-month stay until the district court rules, and delay forfeiture until summary judgment decision on invalidity is affirmed on appeal a decision already entered by the Federal Circuit. 38

39 IPRs And The Hatch-Waxman 30-Month Stay And 180-Day Exclusivity D. Timing: When Does A PTAB Decision Trump A District Court Decision Race to Finality Once a PTAB proceeding becomes final (after appeal) and the USPTO issues a certificate cancelling all claims, any pending infringement action must be dismissed. Can issuance of a decision affect the 30-month stay or 180-day exclusivity? Is a certificate necessary to activate Hatch-Waxman remedies? Once a district court decision becomes final, a PTAB win - even if affirmed by the Federal Circuit - cannot upset a verdict of infringement or an award of damages. What do we mean by final? Final means different things in different circumstances Appeal from district court action has been completed and nothing of significance remains to be done by the district court. In typical Hatch-Waxman cases, no damages need to be determined, and the scope and duration of an injunction are governed by statute. Fresenius USA, Inc. v. Baxter Int l, Inc., 721 F.3d 1330 (Fed. Cir. 2013) (damages were to be determined by district court) (not final). eplus, Inc. v. Lawson Software, Inc. 760 F.3d 1350 (Fed. Cir. 2014) (injunction to be slightly modified by district court) (not final). Versata Software Inc. v. SAP America Inc., 717 F.3d 1255 (Fed. Cir. 2013) (final). See also In re Baxter Int l, Inc., 698 F.3d 1349 (Fed. Cir. 2012). 39

40 Questions? 40

41 INSIGHTS Litigation Webinar Series Mark your calendar! Wednesday, April 15 th The Current Landscape for NPE Litigation: Legislative, Judicial, and Administrative Challenges for NPEs fishlitigationblog.com/webinars

42 Thank you! Brian Coggio Of Counsel, New York Jonathan Singer Principal, Twin Cities Please send your NY CLE forms or questions about the webinar to Ellen at A replay of the webinar will be available for viewing at 42

43 Copyright 2015 Fish & Richardson P.C. These materials may be considered advertising for legal services under the laws and rules of professional conduct of the jurisdictions in which we practice. The material contained in this presentation has been gathered by the lawyers at Fish & Richardson P.C. for informational purposes only, is not intended to be legal advice and does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel. Unsolicited s and information sent to Fish & Richardson P.C. will not be considered confidential and do not create an attorney-client relationship with Fish & Richardson P.C. or any of our attorneys. Furthermore, these communications and materials may be disclosed to others and may not receive a response. If you are not already a client of Fish & Richardson P.C., do not include any confidential information in this message. For more information about Fish & Richardson P.C. and our practices, please visit #1 Patent Litigation Firm (Corporate Counsel, ) 43