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MedImmune and Quanta FRANKLIN PIERCE LAW CENTER 1 7 th ANNUAL ADVANCED LICENSING INSTITUTE Concord, New Hampshire Thursday, January 8, 2009 By Jeff Hawley.

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Presentation on theme: "MedImmune and Quanta FRANKLIN PIERCE LAW CENTER 1 7 th ANNUAL ADVANCED LICENSING INSTITUTE Concord, New Hampshire Thursday, January 8, 2009 By Jeff Hawley."— Presentation transcript:

1 MedImmune and Quanta FRANKLIN PIERCE LAW CENTER 1 7 th ANNUAL ADVANCED LICENSING INSTITUTE Concord, New Hampshire Thursday, January 8, 2009 By Jeff Hawley Of counsel Nixon Peabody LLP Patent Law Professor FPLC

2 Sup Ct Changes the Landscape MedImmune: Declaratory Judgment Jurisdiction SanDisk v. ST Microelectronics Teva v. Novartis Cat Tech v. Tubemaster Caraco v. Forest Quanta: Patent Exhaustion of a Method

3 Prior to Medimune Gen-Probe Inc. v. Vysis Inc. 259 F.3d 1376 (CAFC 2004) DJ Jurisdiction appropriate only if: reasonable apprehension of imminent suit A patentee in good standing cannot establish an Article III case or controversy with regard to validity, enforceability, or scope of the patent because the license agreement obliterates any reasonable apprehension A material breach can result in a reasonable apprehension of suit Bard v. Schwartz 716 F. 2d 874

4 Prior to Medimune..prior to MedImmune, this court articulated a two-part test that first considers whether conduct by the patentee creates a reasonable apprehension on the part of the declaratory judgment plaintiff that it will face an infringement suit, and second examines whether conduct by the declaratory judgment plaintiff amounts to infringing activity or demonstrates concrete steps taken with the intent to conduct such activity.

5 MedImmune v. Genentech Sup Ct 2007 Justice Scalia chimeric antibodies: DJ available Can a non-repudiating licensee bring a DJ action? Article III Case or Controversy? Licensee should not have to bet the farm

6 MedImmune v. Genentech The agreement defined Licensed Products as a specified antibody, the manufacture, use or sale of which... would, if not licensed under th[e] Agreement, infringe one or more claims of either or both of [the covered patents,] which have neither expired nor been held invalid by a court or other body of competent jurisdiction from which no appeal has been or may be taken.

7 MedImmune v. Genentech If respondents were to prevail in a patent infringement action, petitioner [MedImmune] could be ordered to pay treble damages and attorneys fees, and could be enjoined from selling Synagis, a product that has accounted for more than 80% of its revenue from sales since Unwilling to risk such serious consequences, petitioner paid the demanded royalties under protest and with reservation of all of [its] rights.

8 MedImmune v. Genentech Treble damages after Seagate? Injunction after eBay?

9 MedImmune v. Genentech The Declaratory Judgment Act provides that, [i]n a case of actual controversy within its jurisdiction... any court of the United States... may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought.28 U. S. C. §2201(a).

10 MedImmune v. Genentech Even if Altvater could be distinguished as an injunction case, it would still contradict the Federal Circuit's reasonable apprehension of suit test (or, in its evolved form, the reasonable apprehension of imminent suit test,.. A licensee who pays royalties under compulsion of an injunction has no more apprehension of imminent harm than a licensee who pays royalties for fear of treble damages and an injunction fatal to his business. [Footnote 11] Altvater

11 MedImmune v. Genentech (FN 11 Cont.) The reasonable-apprehension-of- suit test also conflicts with our decisions in Maryland Casualty Co.. where jurisdiction obtained even though the collision-victim defendant could not have sued the declaratory- judgment plaintiff-insurer without first obtaining a judgment against the insured; and Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, where jurisdiction obtained even though the very reason the insurer sought declaratory relief was that the insured had given no indication that he would file suit. Maryland Casualty Co Aetna Life Ins. Co. v. Haworth,

12 MedImmune v. Genentech (FN 11 Cont.) It is also in tension with Cardinal Chemical Co. v. Morton Int'l, Inc.,.., which held that appellate affirmance of a judgment of noninfringement, eliminating any apprehension of suit, does not moot a declaratory judgment counterclaim of patent invalidity. Cardinal Chemical Co. v. Morton Int'l, Inc.,

13 MedImmune v. Genentech Aetna and the cases following it do not draw the brightest of lines between those declaratory-judgment actions that satisfy the case-or-controversy requirement and those that do not. Aetna

14 MedImmune v. Genentech Our decisions have required that the dispute be definite and concrete, touching the legal relations of parties having adverse legal interests; and that it be real and substantial and admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts.

15 MedImmune v. Genentech Basically, the question in each case is whether 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.

16 MedImmune v. Genentech The rule that a plaintiff must destroy a large building, bet the farm, or (as here) risk treble damages and the loss of 80 percent of its business, before seeking a declaration of its actively contested legal rights finds no support in Article III. Terrace v. Thompson, 263 U. S. 197 (1923) Willing v. Chicago Auditorium Association, 277 U. S. 274

17 SanDisk v. STMicroelectronics CAFC 2007 Judge Linn flash memory storage: DJ Available At the end of the meeting, Jorgenson [ST] handed Thompson [SD] a packet of materials containing, for each of ST's fourteen patents under discussion, a copy of the patent, reverse engineering reports for certain of SanDisk's products, and diagrams showing how elements of ST's patent claims cover SanDisk's products.

18 SanDisk v. STMicroelectronics But: Jorgenson further told Thompson that ST has absolutely no plan whatsoever to sue SanDisk. CAFC applies MedImmune, particularly FN 11 Promise not to sue did not save ST Under the CAFC ruling, District Court does not have discretion: we discern little basis for the district court's refusal to hear the case..

19 SanDisk v. STMicroelectronics Footnote 2: In this case, we address only the first prong of this courts two-part test. There is no dispute that the second prong is met. We therefore leave to another day the effect of MedImmune, if any, on the second prong.

20 SanDisk v. STMicroelectronics..declaratory judgment jurisdiction generally will not arise merely on the basis that a party learns of the existence of a patent owned by another or even perceives such a patent to pose a risk of infringement, without some affirmative act by the patentee. We need not define the outer boundaries of declaratory judgment jurisdiction..

21 SanDisk v. STMicroelectronics We hold only that where a patentee asserts rights under a patent based on certain identified ongoing or planned activity of another party, and where that party contends that it has the right to engage in the accused activity without license, an Article III case or controversy will arise and the party need not risk a suit for infringement by engaging in the identified activity before seeking a declaration of its legal rights.

22 SanDisk v. STMicroelectronics Bryson concurs: In sum, the rule adopted by the court in this case will effect a sweeping change in our law regarding declaratory judgment jurisdiction. Despite the references in the courts opinion to the particular facts of this case, I see no practical stopping point short of allowing declaratory judgment actions in virtually any case in which the recipient of an invitation to take a patent license elects to dispute the need for a license and then to sue the patentee.

23 Teva v. Novartis CAFC 2007 Judge Gajarsa Famvir®: DJ Allowed Novartis has an NDA including five patents Teva filed an ANDA: Novartis filed an infringement suit on only one of the 5 patents Teva seeks a DJ on the other four

24 Teva v. Novartis In the ANDA context, Congress explicitly extended federal court declaratory judgment jurisdiction under 28 U.S.C. § 2201 to ANDA paragraph IV disputes such as Teva's and did so to the extent consistent with the Constitution.28 U.S.C. § 2201 A controversy is ripe if the question presented is fit for judicial review, meaning it is entirely or substantially a question of law and postponing a decision would work a substantial hardship on the challenging party.

25 Teva v. Novartis Circumstances giving rise to the controversy: Novartis listed its Famvir® patents in the Orange BookFamvir Teva's submission of its ANDA certifying that it did not infringe Novartis' Famvir® Orange Book patentsFamvir combination of three statutory provisions Novartis' pending infringement litigation the possibility of future litigation

26 Cat Tech LLC v. TubeMaster, Inc. CAFC 2008 Judge Mayer catalyst loading: DJ appropriate There is, however, no facile, all-purpose standard to police the line between declaratory judgment actions which satisfy the case or controversy requirement and those that do not.

27 Cat Tech LLC v. TubeMaster, Inc...the issue of whether there has been meaningful preparation to conduct potentially infringing activity remains an important element in the totality of circumstances which must be considered in determining whether a declaratory judgment is appropriate.

28 Cat Tech LLC v. TubeMaster, Inc. Tubmaster has: Developed two basic loading device designs Developed four loading device configurations Generated AutoCAD® drawings Already successfully manufactured and delivered a loading device Technology is substantially fixed

29 Caraco Pharm. Labs v. Forest Labs CAFC 2008 Judge Friedman Lexapro®: DJ allowed to proceed Forest unilaterally granted Caraco a covenant not to sue for infringement of the patent-in-suit in the context of the Hatch-Waxman framework, Forest's covenant not to sue did not eliminate the controversy between the parties

30 Quanta v. LG Supreme Ct 2008 Justice Thomas Method patent exhausted LG purchased patents from WANG; licensed to Intel Two Agreements oLicensing agreement oMaster Agreement

31 Quanta v. LG Licensing Agreement: Authorizes Intel to manufacture and sell microprocessors and chipsets using the LGE Patents (Intel Products); does not purport to alter patent exhaustion rules Master Agreement Required Intel to give its customers written notice that the license does not extend to a product made by combining an Intel Product with a non-Intel product

32 Quanta v. LG The doctrine of patent exhaustion applies to method patents License Agreement authorizes the sale of components that substantially embody the patents in suit The authorized sale of an article that substantially embodies a patent exhausts the patent holders rights and prevents the patent holder from invoking patent law to control post sale use of the article.

33 Quanta v. LG Court concluded that the traditional bar on patent restrictions following the sale of an item applies when the item sufficiently embodies the patent even if it does not completely practice the patentsuch that its only and intended use is to be finished under the terms of the patent. (United States v. Univis Lens Co., 316 U. S. 241 (1942)

34 Quanta v. LG Eliminating exhaustion for method patents would seriously undermine the exhaustion doctrine. Patentees seeking to avoid patent exhaustion could simply draft their patent claims to de­scribe a method rather than an apparatus. What does substantially embodies mean??

35 Quanta v. LG..the only apparent object of Intels sales to Quanta was to permit Quanta to incorporate the Intel Products intocomputers that would practice the patents...the Intel Products constitute a material part of the patented invention and all but completely practice the patent. Here, as in Univis, the incomplete article substantially embodies the patent because the only step necessary to practice the patent is the application of common processes or the addition of standard parts.

36 Quanta v. LG Quanta was not required to make any creative or inventive decision when it added those parts. Intel all but practiced the patent itself by designing its products to practice the patents, lacking only the addition of standard parts.

37 Quanta v. LG What does authorized mean?? Nothing in the License Agreement restricts Intels right to sell its microprocessors and chip-sets to purchasers who intend to combine them with non- Intel parts.

38 Quanta v. LG Footnote 7: We note that the authorized nature of the sale to Quanta does not necessarily limit LGEs other contract rights. LGEs complaint does not include a breach-of-contract claim, and we express no opinion on whether contract damages might be available even though exhaustion operates to eliminate patent damages. See Keeler v. Standard Folding Bed Co., 157 U. S. 659, 666 (1895)

39 Quanta v. LG Footnote 7 (continued): (Whether a patentee may protect himself and his assignees by special contracts brought home to the purchasers is not a question before us, and upon which we express no opinion. It is, however, obvious that such a question would arise as a question of contract, and not as one under the inherent meaning and effect of the patent laws).

40 Compare Implied License An implied license is created when: No noninfringing uses..the circumstances of the sale... 'plainly indicate that the grant of a license should be inferred' (Met-Coil Sys. Corp v. Komers Unlimited, 803 F. 2d 684 (CAFC 1986)

41 What to do next? After MedImmune and SanDisk?? If you are the patentee: Be even more careful with language when attempting to put someone on notice – good luck! Try to get a confidentiality agreement – good luck! Mark more often File first, negotiate second If you are the target – get the patentee to use the I word What happens to Non-Practicing Entity tactics??

42 What to do next? Licensing provisions After MedImmune?? Prohibit validity challenge (What about Lear v. Adkins?)? Royalty rate increases upon challenge? Predetermined forum for DJ action? Agree that licensee will pay licensor's litigation costs for DJ action?

43 What to do next? After Quanta: If the patentee wants to control down-stream infringement, MAKE THE LICENSE AGREEMENT EXPLICITE!! Some have suggested patent grouping into different categories (method, apparatus and systems) and license separately Separately license down-stream users? How?

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