Strategies to protect a market entry against (provisional) injunctions

Size: px

Start display at page:

Download "Strategies to protect a market entry against (provisional) injunctions"

Silas Carson
5 years ago
Views:

1 Strategies to protect a market entry against (provisional) injunctions Dr. Clemens Tobias Steins, LL.M. German Attorney-at-Law Partner 1 Life Science IP Seminar 2017

2 Strategies to protect a market entry against (provisional) injunctions Injunction risk in Germany Counter measures Clearing the way Negative Declaratory Action (Cross-Border) Arrow declaration Protecting against PI in Germany 2 Life Science IP Seminar 2017

3 Injunction risk in Germany Counter measures Clearing the way Negative Declaratory Action (Cross-Border) Arrow declaration Protecting against PI in Germany 3 Life Science IP Seminar 2017

4 Injunction risk in Germany Provisional Injunction granted within day(s) ex parte and few months inter partes special requirement: urgency validity must have been confirmed in inter partes proceedings (in principle) Injunction in main proceedings decision within 9-15 months (depending on court and circumstances) bifurcation: stay if parallel invalidity proceedings will likely succeed Invalidity proceedings usually are started later and take longer (Federal Patent Court: ~ 2 years; EPO opposition (target): 15 months + 9 months opposition period creating window of opportunity to enforce infringement decision before validity is thoroughly tested 4 Life Science IP Seminar 2017

5 Injunction risk in Germany Counter measures Clearing the way Negative Declaratory Action (Cross-Border) Arrow declaration Protecting against PI in Germany 5 Life Science IP Seminar 2017

6 Clearing the way Proactive invalidity proceedings Can serve to invalidate patents facilitate license negotiations Disadvantages: takes time and money (nullity actions Germany ~ 2 years; revocation action UK ~ 15 months; EPO opposition months, new target 15 months) can strengthen patent if not successful can draw attention to own business plans (strawman?) Proactive license proposal Disadvantages can draw attention to own business plans often going nowhere 6 Life Science IP Seminar 2017

7 Injunction risk in Germany Counter measures Clearing the way Negative Declaratory Action (Cross-Border) Arrow declaration Protecting against PI in Germany 7 Life Science IP Seminar 2017

8 Negative Declaratory Actions (NDA) NDA at German court is not a popular instrument High admissibility hurdle: requires legal interest, i.e. actual threat e.g. prior warning letter or PI request cannot be triggered no obligation for patentee to engage No forum-shopping effect: patentee can file infringement action at other court and legal interest in NDA is lost upon first oral hearing Risk of throwing the first stone: can trigger infringement action and while burden of proof remains the same as in infringement action, plaintiff may wish to substantiate the non-infringement and thereby involuntarily educate patentee Alternative, Cross-Border NDA synergies: one court can decide for several countries forum shopping: choosing a friendly or helpful court delaying infringement action: gaining time for clearing the way 8 Life Science IP Seminar 2017

9 Cross-Border NDAs Cross-Border NDA regarding inter alia Germany Raises issues of international civil procedure law so that Regulation 1215/2012 (Brussels I Reg.) must be considered: Brussels I Regulation 1215/2012 Jurisdiction for defendants in EU Member States Art. 6(1) National law applies to defendants not domiciled in EU MS Exceptions General Jurisdiction Special Jurisdiction Jurisdiction for Provisional Measures Exclusive Jurisdiction Pending Suits Art. 4(1) Courts of defendant s state of domicile Art. 8 No.1 Co-defendants ( claims are closely connected ) Art. 35 Obtainable at courts not competent for main action Art. 24 No. 4 Concerning validity of a patent: Court of state of registration Art. 29 Stay if proceedings re same cause of action and between same parties are pending Art. 7 No.2 Courts of place where infringement occurred 9 Life Science IP Seminar 2017

10 Cross-Border NDAs Does the court have jurisdiction? Brussels I Regulation 1215/2012 General Jurisdiction Art. 4(1) Courts of defendant s state of domicile Jurisdiction for defendants in EU Member States Special Jurisdiction Art. 8 No.1 Co-defendants ( claims are closely connected ) Art. 7 No.2 Courts of place where infringement occurred Art. 6(1) National law applies to defendants not domiciled in EU MS Defendant domiciled ex-eu UK Pemetrexed Court of defendant s domicile (hitting home) Co-defendant Place of infringement Italian Supreme Court General Hospital v. Asclepion (CJEU Folien Fischer) 10 Life Science IP Seminar 2017

Cross-Border NDAs However, jurisdiction is lost if invalidity is raised Brussels I Regulation 1215/2012 Jurisdiction for defendants in EU Member States Art.

Art. 4(1) Courts of defendant s state of domicile Art. 8 No.1 Co-defendants ( claims are closely connected ) Art. 35 Obtainable at courts not competent for main action Art. 24 No.

11 Cross-Border NDAs However, jurisdiction is lost if invalidity is raised Brussels I Regulation 1215/2012 Jurisdiction for defendants in EU Member States Art. 6(1) National law applies to defendants not domiciled in EU MS Exceptions General Jurisdiction Special Jurisdiction Jurisdiction for Provisional Measures Exclusive Jurisdiction Pending Suits Art. 4(1) Courts of defendant s state of domicile Art. 8 No.1 Co-defendants ( claims are closely connected ) Art. 35 Obtainable at courts not competent for main action Art. 24 No. 4 Concerning validity of a patent: Court of state of registration Art. 29 Stay if proceedings re same cause of action and between same parties are pending Art. 7 No.2 Courts of place where infringement occurred 11 Life Science IP Seminar 2017

Cross-Border NDAs Jurisdiction may not concern plaintiff if objective is delaying an infringement action (Torpedo) Brussels I Regulation 1215/2012 Jurisdiction for defendants in EU Member States Art.

4(1) Courts of defendant s state of domicile Art. 8 No.1 Co-defendants ( claims are closely connected ) Art. 35 Obtainable at courts not competent for main action Art. 24 No.

12 Cross-Border NDAs Jurisdiction may not concern plaintiff if objective is delaying an infringement action (Torpedo) Brussels I Regulation 1215/2012 Jurisdiction for defendants in EU Member States Art. 6(1) National law applies to defendants not domiciled in EU MS Exceptions General Jurisdiction Special Jurisdiction Jurisdiction for Provisional Measures Exclusive Jurisdiction Pending Suits Art. 4(1) Courts of defendant s state of domicile Art. 8 No.1 Co-defendants ( claims are closely connected ) Art. 35 Obtainable at courts not competent for main action Art. 24 No. 4 Concerning validity of a patent: Court of state of registration Art. 29 Stay if proceedings re same cause of action and between same parties are pending Art. 7 No.2 Courts of place where infringement occurred 12 Life Science IP Seminar 2017

13 Cross-Border NDAs (Torpedo) When does lis pendens apply? The lawsuit (i) must be pending, (ii) must regard the same cause of action; and (iii) must be between the same parties. What is the effect? Second seized court must stay its proceedings until the court first seized has denied jurisdiction (finally and bindingly). Example: Actavis v. Eli Lilly RC Dusseldorf: (i) UK lawsuit not yet pending as complaint could not be served on registration address in the patent register (ii) Not the same parties; tbc under the law of the court first seized whether legal effect extends to other party (ECJ, Drouot./. CMI: same party includes party having same and inseparable interest) HRC Dusseldorf: confirmed (ii) no retroactive extension 13 Life Science IP Seminar 2017

14 Cross-Border NDAs (Torpedo) Potential counter measures against stay for lis pendens Abuse of legal procedure Only under particular circumstances, e.g. court has clearly no jurisdiction and proceedings are intentionally delayed or prior rejection of Torpedo action as inadmissible in identical case (RC Dusseldorf, 10 March 2016, 14c O 58/15). Provisional injunction Not sufficient to constitute grounds for PI, in particular urgency must still be given (RC Dusseldorf, 24 September 2001, 4a O 162/01). Assignment or exclusive license Assigning the patent or granting a license and suing as assignee/ licensee has been used to shed Torpedo action (Matryoshka-strategy). However, in Wundverband the FCJ held that if a patent in suit is assigned or licensed after a suit is pending, the decision has legal effect also against assignee/licensee (Sec. 325 GCCP), thus it is the same parties and same matter. If first action is in Italy, Italian law? 14 Life Science IP Seminar 2017

pendens Branching-off utility model Action

claiming the same priority has been held to

(HRC Dusseldorf, 20 July 2009, I-2 W 35/09).

Prior use right RC and HRC Dusseldorf: No,

15 Cross-Border NDAs (Torpedo) Potential counter measures against stay for lis pendens Branching-off utility model Action under a different IP right (e.g. divisional) is held to be not the same matter. NDA which extends to future patents claiming the same priority has been held to merely be an announcement of future action (HRC Dusseldorf, 20 July 2009, I-2 W 35/09). UM can be branched-off within the first 10 years as long as prosecution (including opposition) is pending. Same matter due to prior use right branch-off 15 Life Science IP Seminar 2017 Prior use right RC and HRC Dusseldorf: No, a defense cannot make it the same matter (CJEU Gantner, C-111/01; I-15 W 36/16 - unpublished). <-> PUR gives defendant an independent use right which is the core issue in both suits.

16 Cross-Border NDAs (Torpedo) Conclusion A Torpedo is therefore not a foolproof instrument against an infringement action in Germany but it may make it more difficult for the patentee to commence a legal action and/or provide the defendant with additional defenses. A Topedo is therefore successfully used in practice to gain time for clearing the way. 16 Life Science IP Seminar 2017

various countries or defend infringement actions File central

17 Cross-Border NDA Pemetrexed Actavis v. Eli Lilly (Pemetrexed) File negative declaratory actions in various countries or defend infringement actions File central negative declaratory action regarding also other countries 17 Life Science IP Seminar 2017

18 Negative Declaratory Actions (NDA) Pemetrexed Procedural issues for the UK court has the UK court jurisdiction to decide on non-infringement of the patent in Germany, France etc.? invalidity of the patent in suit in Germany, France etc.? what is the applicable law regarding the admissibility of the NDA? substantive requirements for a NDA? 18 Life Science IP Seminar 2017

19 Negative Declaratory Actions (NDA) Pemetrexed Has the UK court jurisdiction? non-infringement of the patent in Germany, France etc.? Yes, arguments: Lilly s counsel accepted service UK research facility is business seat; hence complaint can be served there invalidity of the patent in suit in Germany, France etc.? No: if validity had been challenged, UK court would have lost jurisdiction according to Art. 24 No. 4 BR I (ECJ, July 13, 2006 GAT v LuK) Actavis did not challenge validity 19 Life Science IP Seminar 2017

20 Negative Declaratory Actions (NDA) Pemetrexed What is the applicable law regarding admissibility of the NDA? admissibility of NDA differs country-by-country procedural law issue, hence lex fori, i.e. English law substantive requirements of the NDA? Lex loci protectionis, the laws of the respective countries for which NDA is requested (Art. 8 (1) Rome II Regulation) 20 Life Science IP Seminar 2017

21 Negative Declaratory Actions (NDA) Pemetrexed Conclusions Advantages of the central proceedings are the blocking of national proceedings (torpedo effect) and the higher likelihood of a uniform decision NDA is available under UK law which may not have been the case in the respective country Duration of the proceedings is rather long (commenced mid 2012, Supreme Court ruling still outstanding by May 2017) 21 Life Science IP Seminar 2017

22 Injunction risk in Germany Counter measures Clearing the way Negative Declaratory Action (Cross-Border) Arrow declaration Protecting against PI in Germany 22 Life Science IP Seminar 2017

23 Arrow Declarations And then there are cases where it is difficult to clear the way Case: FUJIFILM KYOWA KIRIN BIOLOGICS (FKB) v. Abbvie Antibody adalimumab, sold by Abbvie as Humira is highest selling prescription drug in the world with more than US$ 12 billion net sales p.a. FKB and others are preparing for launch of biosimilars when SPC expires in October 2018 Abbvie has a large portfolio of second generation patents which FKB probably sees as a Hydra for every head chopped off, a couple of heads regrow: 23 Life Science IP Seminar 2017

24 Arrow Declarations Basic adalimumab patent and SPC EP 578 Dosage regime patents SPC expiry 10/2018 EP 656 Text disapproved DIV 1 DIV 2 Abandoned DIV 3 DIV 4 DIV 5 EP 322 EP 491 DIV 3 De-designated GB Text disapproved Rev. Consent De-designated GB Life Science IP Seminar 2017 Application Granted Patent Opposed Patent

Arrow Declarations Basic adalimumab patent and SPC EP 578 Dosage regime patents EP 656 DIV 1 DIV 2 DIV 3 DIV 4 DIV 5 EP 322 EP 491 DIV 3 Text disapproved Abandoned SPC expiry 10/2018

25 Arrow Declarations Basic adalimumab patent and SPC EP 578 Dosage regime patents EP 656 DIV 1 DIV 2 DIV 3 DIV 4 DIV 5 EP 322 EP 491 DIV 3 Text disapproved Abandoned SPC expiry 10/2018 De-designated GB Text disapproved Rev. Consent De-designated GB HC FKB 1 EP revocation + Arrow SJ SJ J HC FKB 2 EP Life Science IP Seminar 2017 SJ CoA J

Attacked embodiment Attacked embodiment Arrow

defense : instead of asking whether a patent is valid

of the attacked embodiment is old or obvious: Scope of

26 Attacked embodiment Attacked embodiment Arrow Declarations Arrow Declarations are based on Gillette defense : instead of asking whether a patent is valid and infringed, it is considered whether the technology of the attacked embodiment is old or obvious: Scope of Protection Scope of Protection 26 Life Science IP Seminar 2017

27 Arrow Declarations Arrow is declaratory judgment regarding the product Request: products containing a biosimilar monoclonal antibody to the antibody adalimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40mg every other week by subcutaneous injection would have been anticipated or obvious at the priority dates of the two challenged patents. (emphasis added). Granted considering the following reasons: AbbVie s threat to sue for infringement huge investment costs for clinical development potential damages risk in the event of launch at risk need for commercial certainty useful purpose in the UK no preemption of decision on validity, thus no usurpation of EPO s competence 27 Life Science IP Seminar 2017

28 Arrow Declarations Cross-border effect? Not directly, the decision only regards the UK (otherwise potential issues with Art. 24 No. 4 Brussels I Regulation) However, the court weighed the aspects that declaration makes it: o o o more difficult for Abbvie to obtain injunctions in other EU countries (spin-off effect) allows FKB to build and protect supply chain in other EU countries could facilitate a pan-european settlement Decision may inspire the future UPC to grant similar remedy 28 Life Science IP Seminar 2017

29 Injunction risk in Germany Counter measures Clearing the way Negative Declaratory Action (Cross-Border) Arrow declaration Protecting against PI in Germany 29 Life Science IP Seminar 2017

30 Protecting against PI in Germany If a provisional injunction in Germany is a concern: Protective brief Preemptive response brief Cannot prevent PI with certainty arguments must be convincing, otherwise protective brief may even increase PI risk Triggering urgency A further option is trying to trigger the PI application early by informing the patentee of the intention to come to market must be sufficiently informative and express serious intent urgency clock may start anew upon market entry o (so RC Munich, GRUR-RR 2016, and RC Hamburg, GRUR- RR 2014, 137; in unfair trade cases the majority opinion regards urgency to be forfeited) Patentee may not take the risk and be interested in a decision before market entry as well 30 Life Science IP Seminar 2017

31 Thank you for your attention! Dr. Clemens Tobias Steins, LL.M. German Attorney-at-Law Partner 31 Life Science IP Seminar 2017

The Unitary Patent Plan Beta Update on National Case Law in Europe

The Unitary Patent Plan Beta Update on National Case Law in Europe Leythem Wall 28 November 2013 Declarations of Non-Infringement Article 15 of the Unified Patent Court (UPC) Agreement sets out the areas