Teva Pharmaceutical Industries Limited -v- Mylan Teoranta t/a Mylan Institutional & anor, [2018] IEHC 324 (2018)

Docket Number:2017 9398 P
Party Name:Teva Pharmaceutical Industries Limited, Mylan Teoranta t/a Mylan Institutional & anor
 
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THE HIGH COURT

COMMERCIAL[2017 No. 9398 P.]

BETWEEN

TEVA PHARMACEUTICAL INDUSTRIES LIMITED PLAINTIFFAND

MYLAN TEORANTA T/A MYLAN INSTITUTIONAL AND BY ORDER YEDA RESEARCH AND DEVELOPMENT COMPANY LIMITED DEFENDANTS

JUDGMENT of Mr. Justice David Barniville delivered on the 5th day of June, 2018

Introduction

  1. This is my judgment on the plaintiff’s application for an interlocutory injunction restraining the first named defendant, its servant or agents, from directly or indirectly infringing Irish Patent No. EP (IE) 2 949 235 entitled “Low Frequency glatiramer acetate therapy” (“Patent” or EP (IE) 335, as appropriate). Without prejudice to the generality of that relief, the plaintiff also seeks an injunction restraining the first named defendant, its servants or agents, from making, offering, putting on the market and/or using any articles, products or other matter which directly or indirectly infringe the Patent and/or from importing or stocking any such articles, products or other matter together with various ancillary orders.

  2. The application was made by a notice of motion dated 19th October, 2017 in the context of proceedings commenced that day. In the proceedings, the plaintiff claims that a generic drug for the treatment of multiple sclerosis (“MS”) manufactured by the first named defendant at its facility in Inverin, Co. Galway infringes the Patent, of which the plaintiff is the exclusive licensee. The second named defendant is the registered owner of the Patent. It was joined as a co-defendant to the proceedings on consent of the parties at the end of the hearing of the interlocutory injunction application in order to address a technical objection to the proceedings made by the first named defendant.

    Description of the parties

  3. The following is a brief and hopefully non-controversial description of the parties based on the affidavit evidence adduced in this application.

  4. The plaintiff, Teva Pharmaceutical Industries Ltd. (“Teva”), is an international pharmaceutical company incorporated in Israel which specialises in the development, manufacturing and marketing of generic and proprietor pharmaceuticals and active pharmaceutical ingredients. Copaxone is Teva’s drug for the treatment of relapsing forms of MS, a chronic inflammatory demyelinating disease of the central nervous system. Another Teva entity, Teva Pharmaceuticals USA, Inc. (“Teva USA”) is a subsidiary and licensee of Teva and is an authorised distributor of medicines including Copaxone in the United States on its behalf. Teva USA purchases Copaxone from Teva and then resells the product to third party customers in the United States. Teva USA is the holder of a marketing authorisation in the US (known as a New Drug Application authorisation) in respect of Copaxone 40mg/ml (which is the particular Copaxone drug, the market for which in the US Teva is seeking to protect in these proceedings) (“Copaxone 40mg”). For convenience, where appropriate, I will refer to the various companies in the Teva Group collectively as “Teva”.

  5. The second named defendant, Yeda Research and Development Co. Ltd. (“Yeda”), is also an Israeli corporation and is the registered owner of the Patent. It has granted an exclusive licensee in respect of the Patent to Teva.

  6. The first named defendant, Mylan Teoranta trading as Mylan Institutional (“Mylan Teo”), is a company incorporated in Ireland. Its immediate parent company is Mylan Pharma Group Ltd., also incorporated in Ireland. The ultimate parent company in the Mylan Group is Mylan N.V.. Again, where appropriate I will refer to the various companies in the Mylan Group collectively as “Mylan”. Mylan is another leading company in the global pharmaceutical industry. It develops, licenses, manufactures, markets and distributes generic, branded generic and speciality pharmaceuticals. In Ireland, Mylan has facilities in Dublin, Meath and Galway and a work force in Ireland of in excess of 1,000 employees. Mylan Teo operates a facility at Inverin, Co. Galway. At that facility, which was acquired by Mylan in 2010, Mylan Teo develops and manufactures high quality, sterile injectable pharmaceutical products, for a range of therapeutic categories.

    The product at issue in the proceedings

  7. At issue in these proceedings is Mylan’s generic glatiramer acetate 40mg/ml drug (the “Mylan 40mg GA product”) which is manufactured by Mylan Teo at its facility in Galway and which was launched by Mylan in the United States on 4th October, 2017 to compete with Copaxone 40mg, Teva’s 40mg GA product. Teva alleges that the Mylan 40mg GA product infringes the Patent. While the Mylan 40mg GA product is manufactured in Ireland, it does not have a marketing authorisation and is not sold in Ireland. It is exported to the United States where it is supplied and prescribed to MS patients.

  8. The active drug substance in Copaxone and in Mylan’s competing products is glatiramer acetate (“GA”). Copaxone is administered as either a 20mg daily subcutaneous injection or (since 2014) as a 40mg subcutaneous injection administered three times per week with at least a day between injections (referred to as “TIW”). GA was first discovered and synthesised in the 1960s by a group of scientists at the Weizmann Institute of Science. In 1987, Yeda, an arm of the Weizmann Institute, entered into an agreement with Teva to commercially develop and seek regulatory approval for GA. In 1996, the US Food and Drug Administration (the “FDA”) approved Copaxone 20mg/ml (“Copaxone 20mg”) to be administered daily for treating relapsing forms of MS. Since approximately 2002, Copaxone 20mg has been commercially sold in the US in prefilled syringes.

  9. In January 2014, Teva received FDA approval for a new dosing regimen for Copaxone. The approval was for a 40mg dosage administered three times per week ie, TIW. This is Copaxone 40mg. When the FDA approved Copaxone 40mg, it granted Teva a three year period of marketing exclusivity. This meant that the FDA would not grant approval under the US regulatory regimen for a generic version of the drug for three years following its approval. That period of exclusivity expired on 28th January, 2017.

  10. The global revenues for Copaxone are very significant indeed. They were $4.283 billion in 2016. In the first two quarters of 2017, global revenues of Copaxone (both the 20mg and 40mg products) were almost $2 billion. At the end of the second quarter 2017, Copaxone 40mg accounted for over 85% of total Copaxone prescriptions in the US.

  11. In 2009, Mylan sought approval from the FDA for a high quality, substitutable, generic Copaxone equivalent. It did this by filing an Abbreviated New Drug Application (“ANDA”) with the FDA. In February 2014, Mylan filed an ANDA with the FDA seeking specific approval for the Mylan GA 40mg product. On the expiry of the three year period of exclusivity for Copaxone 40mg on 28th January, 2017, it was open to the FDA to grant approval in respect of Mylan’s 40mg GA product, barring any legal or regulatory impediments. As we shall see, it did so on 3rd October 2017.

    US Regulatory Regime

  12. The regulatory regime for generic drugs in the United States is governed by legislation enacted by the US Congress in 1984 called the Drug Price Competition and Patent Term Restoration Act of 1984, known informally as the Hatch-Waxman Act. Briefly explained, the holder of a New Drug Application (“NDA”) approval for a branded pharmaceutical drug product is required to inform the FDA of the patents which it asserts cover the branded drug. Those patents are then listed by the FDA in an FDA publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is commonly referred to as the “Orange Book”. When a company wishes to manufacture and sell a generic equivalent, it must file what is called an Abbreviated New Drug Application (“ANDA”) with the FDA. The ANDA filer must also include a certification stating that any unexpired Orange Book patents are invalid or will not be infringed by the manufacture, use or sale of the generic product the subject of the ANDA, (this certification is known as “Paragraph IV certification”) unless that company is not seeking FDA approval until the Orange Book patents expire. If the ANDA filer submits a Paragraph IV certification, then the patent holder/owner of the NDA, if it wishes to contest the approval, must bring an action for infringement of the patent that is the subject of the certification before the US District Court. The FDA will not generally approve the ANDA until infringement proceedings are resolved or thirty months past, whichever is the earlier. This procedure, therefore, allows the patent holder the opportunity to protect valid patents while at the same time not delaying the filing of the ANDA or its regulatory review. The idea is that the legislation allows ANDA filers to launch their competing generic products once the patents have been found invalid or not infringed or immediately upon the expiration of valid patents.

    Delaware Proceedings

  13. Mylan’s filing of an ANDA in respect of its 40mg GA product led to the commencement of proceedings by Teva in the United States District Court for the District of Delaware (the “Delaware District Court”) against Mylan and five other ANDA filers, Sandoz (in partnership with Momenta), Synthon (in partnership with Pfizer), Amnel, Dr. Reddy’s Laboratories and Apotex (in partnership with Biocom). In those proceedings (the “Delaware Proceedings”), which I consider in later detail below, Teva alleged infringement of four US patents obtained by Teva in 2012 which were intended to cover the Copaxone 40mg TIW dosing regimen. Those patents all issued from the same priority applications as the Patent the subject of these proceedings and claim the same dosing regimen as that Patent. Mylan filed Paragraph IV certifications in respect of those patents following which Teva commenced proceedings in the Delaware District Court in 2014 asserting that Mylan’s 40mg GA product would infringe four of the five relevant patents. Following a trial in September and October 2016, the Delaware District Court delivered its opinion on 30th January, 2017 holding all four of the patents invalid as obvious. Teva have appealed to the United States Court of Appeals for the Federal Circuit. Teva sought an injunction or stay preventing Mylan from launching the Mylan 40mg GA product pending the appeal but that application was refused by the Delaware District Court on 1st February, 2017. No application for an injunction or stay pending the determination of the appeal was made to the Court of Appeals.

    Commencement of Proceedings

  14. The FDA approved Mylan’s ANDAs for the Mylan 40mg GA product and Mylan’s 20mg GA product on 3rd October, 2017. Mylan issued press releases on 3rd October, 2017 and 4th October, 2017 in respect of those approvals. Teva, initially through its English solicitors, and then through Irish solicitors, corresponded with Mylan Teo and its Irish solicitors commencing on 11th October, 2017 and, ultimately issued these proceedings on 19th October, 2017. The proceedings were entered in the Commercial List on 6th November, 2017. By that stage a statement of claim had been delivered (on 3rd November, 2017) with particulars of infringement. Thereafter, particulars were sought and replies furnished.

  15. Initially Teva claimed in the proceedings that Mylan’s 40mg GA product infringed two patents, the Patent and another patent, Irish Patent No. EP (IE) 3 050 556 entitled “Process for manufacturing a pharmaceutical preparation containing glatiramer acetate” (the “556 Patent”). Interlocutory injunctive relief was initially sought in respect of both patents. However, the plaintiff withdrew its claim in respect of the 556 Patent and delivered an amended statement of claim and amended particulars of infringement on 20th December 2017 alleging infringement of the 335 Patent only. At the time of the hearing of the interlocutory injunction application in January, 2018 Mylan Teo had not yet delivered its defence and counterclaim. However, it was indicated that a defence and counterclaim would be delivered in which it would be asserted that the Patent was invalid. Mylan Teo had not sought revocation of the Patent prior to the launch of the Mylan 40mg GA product. This failure to “clear the way” by Mylan in advance of the launch of its product was relied on by Teva in the course of its application as being significant in the context of the balance of convenience.

    The Patent/EP (IE) 335

  16. Teva filed an application for a European patent, EP 2 949 335 (“EP 335”) on 19th August, 2010 with the European Patent Office (“EPO”) with Ireland as one of the designated contracting states. Priority was claimed to 20th August, 2009 from US Provisional Application US 274687 P. EP 335 was granted by the EPO on 4th January, 2017. It was subsequently validated in Ireland.

  17. Under s. 119 of the Patents Act 1992 (as amended), a European patent designating Ireland as one of the contracting states is treated as if it were an Irish patent granted by the Irish Patents Office. It has the same rights as those conferred by an Irish patent granted by the Irish Patents Office. Any alleged infringement is dealt with under Irish law.

  18. EP 335 is a divisional patent stemming from the parent patent, EP 2 405 749 (“EP 749”). EP 335 covers a method of using GA in treating patients with a relapsing form of MS or who have experienced a first clinical episode and have a high risk of developing MS in accordance with a specified dosing regimen, namely 40mg GA subcutaneous injections administered three times per week with at least one day between injections (ie TIW).

  19. As noted, EP 335 Patent is a divisional patent stemming from EP 749. EP 749 also covered the 40mg TIW dosage regimen. It was the first patent issued in Europe which claimed the use of GA in that particular dosing regimen. It was granted by the EPO on 8th May, 2013. Mylan and others commenced opposition proceedings in respect of EP 749 before the EPO. An appeal hearing was scheduled for November 2017. However, on 7th February, 2017 the opposition proceedings were terminated because Yeda, the patent owner, requested that EP 749 be withdrawn. It was withdrawn and revoked by the EPO.

    International Developments

  20. Teva claims that the Mylan 40mg GA product infringes the Patent. Mylan contends in response that the Patent is invalid and will counterclaim in the proceedings to that effect. Reliance is placed by Mylan on the fate of the equivalent to the Patent in other European states, including the United Kingdom and Germany, and on the fate of a number of US patents obtained by Teva which purportedly cover Copaxone’s 40mg TIW dosing regimen which all issued from the same priority applications as the Patent and claim the same dosing regimen. Teva disputes the significance of those developments and contends that its application must be determined by reference to an Irish patent, which is presumed to be valid notwithstanding the fate of the equivalent patent in other European states and notwithstanding the fate of the US patents in respect of the same dosing regimen. An examination of what has happened in those other jurisdictions is, in my view, essential.

  21. I commence with the position in the United States. In the period between 2009 and 2014 there was litigation in the United States in relation to the Copaxone 20mg product. Teva commenced proceedings in the United States District Court for the Southern District of New York in October 2009 (Teva Pharms US Inc. v. Mylan Pharms Inc. 09 Civ. 8824 BSJAJP) in relation to Mylan’s generic equivalent of the product alleging infringement of a series of US patents (different to the US patents referred to in these proceedings). The New York District Court found for Teva, upheld the patents in issue as valid, found that Mylan’s 20mg GA product would infringe those patents and granted an injunction restraining Mylan and others from launching competing generic products until the expiration of one of the patents in September 2015. Mylan appealed that decision to the United States Court of Appeals for the Federal Circuit. That court held some of the claims of the patents invalid but upheld the validity of certain other of the claims and reduced the duration of the injunction restraining the defendants, including Mylan, from entering the market with a 20mg GA product until May 2014. Teva appealed that decision to the United States Supreme Court. Teva requested the US Supreme Court to recall and stay the order shortening the injunction so that the generic competitors to Copaxone 20mg could not be launched while the appeal was pending. Teva alleged that it would suffer irreparable harm if the generic product could be launched while the appeal was pending. The US Supreme Court refused the stay. In a judgment delivered in April 2014, Roberts C.J., as the assigned Justice of the Supreme Court for the Federal Circuit, rejected the assertion that Teva would suffer irreparable harm if a stay were denied. He held that should Teva prevail and its patents be held valid it would be able to recover damages for past patent infringement. While not directly relevant to the substantive claims made in these proceedings, the refusal by the US Supreme Court of the stay on the grounds just summarised is relied upon by Mylan to resist the grant of interlocutory injunctive relief in respect of the Patent at issue in these proceedings.

  22. Of more direct relevance to the patents at issue here are the proceedings in the US District Court for the District of Delaware (touched upon above) (the “Delaware Proceedings”) and proceedings before the United States Patent Trial and Appeal Board (the “US PTAB”).

  23. In the period from 2012 Teva obtained a series of US Patents covering Copaxone’s 40mg TIW dosing regimen. These patents issued from the same priority applications as the Patent and claim the same dosing regimen as that patent. Three of these patents were held to be unpatentable by the US PTAB in August and September 2016. These were US Patent Nos. 8, 232, 250 (the “250 Patent”), 8, 499, 413 (the “413 Patent”), and 8, 969, 302 (the “302 Patent”). The US PTAB found that the patents were unpatentable in light of the prior art and, in particular, Teva’s US Patent application disclosing and claiming the use of Copaxone 40mg every other day. Teva requested that the US PTAB to reconsider its decisions in respect of these three patents. It did so and issued three modified final written decisions on 2nd December, 2016. In these modified decisions, the US PTAB again held that the relevant claims in the three patents were unpatentable. Teva has appealed these three decisions to the US Court of Appeals for the Federal Circuit. As of the date of the hearing of Teva’s application for interlocutory injunctive relief in respect of the Patent, the parties were awaiting a date for the oral hearing of that appeal.

  24. As noted earlier, Teva commenced the Delaware Proceedings asserting that Mylan’s 40mg GA product infringed four of the five relevant US Patents held by Teva. The four patents at issue in those proceedings were the 250 Patent, the 413 Patent, the 302 Patent and a further patent, US Patent No. 9, 155, 776 (the “776 Patent”). Those proceedings were heard by the US District Court for the District of Delaware in September and October 2016. The Delaware District Court gave judgment on 30th January, 2017 finding that all the asserted claims of the patents in suit were invalid as obvious. As I touched on earlier, the Delaware proceedings were consolidated Hatch-Waxman patent infringement actions, and were brought by various Teva entities including Teva US and Teva itself as well as Yeda against a number of entities that had filed ANDAs seeking approval to market generic versions of Copaxone 40mg. It was alleged that those generic products (including Mylan’s 40mg GA product) infringed the four US Patents referred to. The Delaware District Court held that the patents in suit were obvious over certain prior art publications including a US Patent application published by Teva which disclosed a 40mg GA every other day dosing regimen to treat MS (the “Pinchasi application”). The Delaware District Court expressed the view that the patents in suit were “nothing more than ‘life-cycle management’ – an attempt to continue to monopolise a multi-billion dollar market for blockbuster drug” (p. 47 of the judgment).

  25. Teva has appealed this decision to the US Court of Appeals for the Federal Circuit. This appeal was, at the time of the hearing of the current application, awaiting a hearing date before that court. Thus, there are two appeals pending the US Court of Appeals in relation to a number of the relevant equivalent US Patents.

  26. There have also been relevant developments in relation to equivalent patents to EP (IE) 335 in a number of European jurisdictions. Before turning to look at some of those, I should record what has occurred before the EPO. As noted earlier, EP 335 was granted by the EPO on 4th January, 2017 on the back of a parent patent EP 749. EP 749 was withdrawn by Teva in February 2017 and revoked by the EPO after opposition proceedings had been commenced against it by Mylan and others thereby obviating the need for the appeal hearing, scheduled for November 2017. Mylan and others have commenced opposition proceedings at the EPO in respect of EP 335. A preliminary assessment has not yet issued by the Opposition Division and hearings are not expected for some time.

  27. EP 335 has, however, been considered by the courts in a number of European states. The parties have referred to these proceedings in evidence and each has sought to put its own gloss on the impact of those proceedings in other European states on Teva’s present application.

  28. I first consider the position in the UK. Mylan and Synthon BV (“Synthon”) (a generic manufacturer) commenced proceedings in the High Court of England and Wales, (Chancery Division) (Patents Court) relating to EP (UK) 335 (being the UK patent granted on foot of EP 335) in February 2017 seeking revocation of that patent. Yeda, as the registered proprietor, was joined as the defendant and Teva, the exclusive licensee, was joined as a third party. They counterclaimed for infringement of the patent. Arnold J. heard the revocation proceedings in October 2017 and delivered judgment on 26th October, 2017. He held that the relevant claims of EP (UK) 335 were obvious in light of Pinchasi and, therefore, invalid. In the course of his judgment, Arnold J. observed that:-

    “The sole difference between Pinchasi and claim 1 of the patent is that Pinchasi discloses a regimen of 40mg QOD [ie every second day] while claim 1 requires a regimen of 40mg TIW [ie three times per week]. As discussed above, the difference amounts to one dose every fortnight”. (para. 175).

    Arnold J. refused permission to appeal. Yeda/Teva then sought permission to appeal from the Court of Appeal. That permission was refused in an order made on 9th January, 2018 by Lewison L.J. The order refusing permission noted that the appeal would have “no real prospect of success”.

  29. Recent developments also occurred in relation to EP 335 in the Netherlands. Synthon brought proceedings before the District Court of the Hague seeking the revocation of the Dutch version of EP 749, the parent patent from which EP 335 stemmed. However, as noted above, the EPO’s Technical Board of Appeal revoked EP 749 in February 2017. Teva did not seek to validate EP 335 for the Netherlands. In those circumstances, Synthon confined its claim to certain declaratory relief, seeking a declaration equivalent to an “Arrow declaration” under the law of England and Wales (Arrow Generics Ltd. v. Merck & Co. Inc. [2007] EWHC 1900 (Pat)). The Netherlands court refused to grant that declaration on the basis that Synthon had no legitimate interest as there were no 40mg GA patent claims in force in the Netherlands.

  30. Proceedings were also commenced by Mylan and by Synthon in Italy seeking revocation of EP (IT) 335 in March 2017. Those proceedings are ongoing. Finally, proceedings were brought by Teva against a Mylan subsidiary in Germany seeking an interim injunction restraining the infringement of EP 335 in respect of a Mylan 40mg GA product which was about to be launched and marketed in Germany. In a judgment given on 14th December, 2017, the Regional Court of Munich rejected Teva’s application. In doing so the Munich Court placed considerable reliance on the decision of Arnold J. in the UK proceedings.

    Correspondence prior to proceedings

  31. I now turn to the correspondence exchanged between the parties prior to the commencement of these proceedings. The correspondence is addressed in some detail in the affidavit sworn on behalf of the parties. The correspondence is detailed and extensive and many of the points made in the correspondence were pressed in submissions on the hearing of Teva’s application.

  32. It will be recalled that following FDA approval for Mylan’s 40mg GA product on 3rd October, 2017 and the press releases issued by Mylan on that date and on 4th October, 2017, Teva and its English and, subsequently, Irish solicitors commenced corresponding with Mylan and its Irish solicitors. The first letter was sent on 11th October, 2017 by Teva’s UK solicitors. There then followed an extensive exchange of correspondence between that date and 18th October, 2017. Many of the issues relied on by the parties on this application were ventilated in that correspondence. I will address those issues below.

    The Proceedings

  33. Proceedings were then commenced on 19th October, 2017 and the motion seeking interlocutory relief was issued on the same date. Teva’s application was grounded on an affidavit sworn on 19th October, 2017 by Alan McBride of Teva Europe’s Legal Department. It was also grounded on an affidavit sworn on 18th October, 2017 by John Hassler, the Senior Vice-President and General Manager for Teva USA’s Central Nervous System Division and an affidavit sworn by Professor Jerry A. Hausman, McDonald Professor of Economics at the Massachusetts Institute of Technology (MIT). Replying affidavits were affirmed on behalf of Mylan by Jennifer Sunderland, Senior Patent Litigation Counsel at Generics (UK) Ltd. (trading as Mylan), which is part of the Mylan group on 9th November, 2017 and sworn on behalf of Mylan by Robert Tighe (Head of Mylan Pharmaceutical Inc. (“MPI”) and Mylan Canada (and previously Chief Financial Officer of Mylan North America)) on 8th November, 2017 and by Professor Joel Hay, Professor and founding chair of Pharmaceutical Economics and Policy in the School of Pharmacy at the University of Southern California. Further affidavits were sworn on behalf of Teva on 20th November, 2017 by Dr. McBride, Mr. Hassler and Professor Hausman. Additional replying affidavits were affirmed by Ms. Sunderland on 4th December, 2017 and sworn by Mr. Tighe on 30th November, 2017 and by Professor Hay on 1st December, 2017.

  34. In its notice of motion issued on 19th October, 2017 (as amended by an amended notice of motion dated 20th December, 2017), Mylan now seeks the following interlocutory injunctive relief:-

    “4. An injunction restraining the defendant, its servants or agents, for directly or indirectly infringing Irish Patent No. EP (IE) 2 949 335 entitled ‘low frequency glatimer acetate therapy’ (the ‘335 Patent’) pending the final determination of these proceedings or until further order of the court.

  35. Strictly without prejudice to the generality of the foregoing, an injunction restraining the defendant, its servants or agents, from making, offering, putting on the market and/or using any articles, products or other matter which directly or indirectly infringe the 335 Patent, and/or importing or stocking any such articles, products or other matter for those purposes, pending the final determination of these proceedings or further order of the court.

  36. An order requiring the defendant to deliver up, or at the plaintiff’s election, destroy all articles, products, or other matter in their possession or control which infringed the 335 Patent.

  37. An order for disclosure on oath of any and all persons to whom the defendant may have supplied or offered to supply any article, product or matter which infringed the 335 Patent.

  38. All appropriate relief pursuant to the European Communities (Enforcement of Intellectual Property) Regulations 2006.”

  39. Teva’s claim is appended in the amended statement of claim delivered on 20th December, 2017. The original statement of claim was delivered on 3rd November, 2017 but included claims in relation not only to EP (IE) 335 but also in relation to the EP (IE) 556. Teva subsequently dropped its claims in relation to the EP (IE) 556 Patent and now confines its claim to EP (IE) 335. Teva maintains its claim as the exclusive licensee from Yeda of the Patent. Yeda has since been joined as a co-defendant in the proceedings by agreement of the parties.

  40. Teva’s claim is that Mylan Teo and/or its servants or agents had done the acts specified in the particulars of infringement and have infringed the exclusive rights granted to Teva under s. 40 of the Patents Act 1992 (as amended). Teva further pleads that Mylan Teo threatens and intends to continue to infringe the Patent in the manner set out in those particulars. It further pleads that, without prejudice to the generality of the forgoing and from a date unknown pending discovery, Mylan Teo and/or its servants or agents have been making in the State products the subject matter of the Patent and/or have been importing and stocking such products for the purposes of shipping them to MPI for disposal on the US market in breach of Teva’s rights under s. 40(1) of the 1992 Act.

  41. In the amended particulars of infringement delivered on 20th December, 2017, Teva provided further particulars in respect of its claim. It asserts that MPI is authorised to market and sell the Mylan 40mg GA product in the United States and that it received its marketing authorisation from the FDA on 3rd October, 2017. It is further asserted that it recently came to Teva’s attention that Mylan Teo had been manufacturing that product in the State for the purpose of shipping it to MPI for disposal on the US market. It is pleaded that in so doing Mylan Teo is acting in breach of Teva’s exclusive rights in the Patent. It is then alleged that Mylan Teo has infringed and is continuing to infringe the Patent by doing in the State without the consent of Teva certain acts namely:-

    “Making the Mylan GA 40mg/ml generic product, which is a GA product in accordance with Claims 1 and 3 of the 335 Patent, and/or a medicament comprising GA in accordance with Claims 2 and 4 of the 335 Patent, or importing or stocking the product for those purposes.” (para. 7 of the amended particulars of infringement)

    The particulars then refer to the press releases issued by Mylan on 3rd and 4th October, 2017 and to the link to the Patient Information Leaflet (“PIL”) in respect of the Mylan 40mg GA product which confirms that the marketing authorisation holder for the product is MPI and that the product in question is manufactured by “Mylan Institutional, Galway, Ireland”. Teva pleads that the name “Mylan Institutional” is a registered business name of Mylan Teo. The particulars then refer to certain publicly available shipping documentation concerning the importation into the US from Ireland of the Mylan 40mg GA product confirming a shipment of the product by Mylan Teo to MPI in the United States. The particulars then assert that the records show that the Mylan 40mg GA product is being manufactured in Ireland “in part at least” and shipped by Mylan Teo to the US to MPI for disposal on that market. The particulars refer to the correspondence between the parties’ respective solicitors prior to the commencement of proceedings and to the confirmation in a letter from Whitney Moore (on behalf of Mylan) to Philip Lee (on behalf of Teva) dated 17th October, 2017 that Mylan Teo is manufacturing the Mylan 40mg GA product at its manufacturing site in Inverin, Galway for the US market and that the product “has been made widely available to patients in the US” since the FDA approval for the product was obtained on 3rd October, 2017. It is then pleaded (at para. 15 of the amended particulars) as follows:-

    “This information, coupled with the information outlined at paras. 8 to 14 above, shows that the Mylan GA 40mg/ml generic product being manufactured by [Mylan Teo] is a fully-finished product, that is, that it is contained in its FDA-authorised packaging with the relevant PIL inserted into the packaging. From a US drugs-regulatory perspective, the concept of manufacture of a product includes the processes of packaging the product for final sale; and given that ‘Mylan Teo’ is the only listed manufacturer for the Mylan GA 40mg/ml generic product for the US market, this shows that the product is fully finished (vis-à-vis being packaged) in [Mylan Teo’s] Irish facility ready for sale in the US market.” (para. 15 of the amended particulars)

  42. The amended particulars then plead as follows:-

    “The activities of [Mylan Teo] insofar as they relate to the importation, stocking and/or manufacturing of the [Mylan 40mg GA product] for use in treating patients with a relapsing form of MS or who have experienced a first clinical episode and have a high risk of developing MS and covers 40mg GA subcutaneous injection administered three times per week, with at least a day between injections amounts to infringement of the 335 Patent.” (para. 16)

  43. The amended statement of claim pleads that Teva has sustained loss and damage by reason of the alleged wrongful acts of Mylan Teo as pleaded in the amended particulars of infringement. Among the particulars of loss and damage pleaded are allegations that Mylan Teo has deprived and continues to deprive Teva and/or its servants or agents of the benefit of the proceeds of sale of the inventions the subject matter of the Patent and has damaged Teva’s ability commercially to exploit the monopoly rights conferred on it by the Patent in respect of its inventions. It is further pleaded that the activities of Mylan Teo constitute an interference with Teva’s constitutionally protected property rights in the Patent and that the activities of Mylan Teo are likely to result in a significant reduction in Teva’s market share in the US market as well as causing “significant price erosion” in respect of Teva’s Copaxone 40mg product which it is alleged may be permanent and irreversible. Teva further pleads that as a result of the reduction in market share and significant price erosion in respect of Copaxone 40mg Teva is likely to have to reduce or withdraw certain patient support services which relate to and are funded from sales of that product in the US (namely, its “Shared Solutions” services) as a result of which it is said Teva is likely to suffer damage to its “Teva” and “Copaxone” brands and reputations. It is further pleaded that if Teva loses a significant percentage of its revenues from the Copaxone 40mg product, Teva would be likely to be forced to delay or eliminate Copaxone-related research as well as research and development into other new products currently in development and that this would in turn lead to significant lost opportunities in the future. It is in those circumstances that Teva seeks declarations in relation to the alleged infringement of EP (IE) 335, injunctions and other orders and damages or an account of profits as well as all necessary accounts and enquiries and other reliefs.

  44. While, as noted earlier, no defence and counterclaim had been delivered at the time of the hearing of this application and was due to be delivered shortly thereafter, it is clear from the evidence adduced on behalf of Mylan on the interlocutory injunction application and from the submissions made on its behalf that Mylan intends defending the proceedings on various different grounds but principally on the grounds that the Patent is invalid and that even if it were not invalid the Mylan 40mg GA product does not infringe the Patent. Those two issues go to the first issue which I have to consider as part of the test to be applied in adjudicating on the application for interlocutory injunctive relief. It is also clear from the evidence and submissions adduced on behalf of Mylan on the hearing of the interlocutory injunction application that Mylan will also deny the loss and damage being alleged by Teva.

    The test to be applied

  45. Teva’s application is required to be considered in accordance with the test identified by the Supreme Court in Campus Oil Ltd. v. Minister for Industry and Energy (No. 2) [1983] I.R. 88 (“Campus Oil”). As is well known, the Supreme Court in that case in turn accepted the test contained in the speech of Lord Diplock in American Cyanamid & Co. v. Ethicon [1975] AC 396 (a case involving an application for interlocutory injunctive relief in a patent infringement case). The test has been discussed and elaborated upon in various respects by the Irish courts in the years since Campus Oil, including by the High Court (McCracken J.) in B&S Ltd. v. Irish Auto Trader Ltd. [1995] 2 I.R. 142 (“B&S”) (a passing off case) and was summarised by Clarke J. (as he then was) in his judgment for the Supreme Court in Okunade v. Minister for Justice [2012] 3 I.R. 152 (“Okunade”) (an immigration case). In a passage approved of by McGovern J. in Gilead Sciences Inc. & another v. Mylan S.A.S. Generics (UK) Ltd. & others [2017] IEHC 666 (“Gilead”) (the most recent judgment of the High Court on an application for interlocutory injunctive relief in a patent infringement case), Clarke J. summarised the test as follows:-

    “• The party seeking the injunction must show that there is a fair or bona fide or serious question to be tried.

    • If that be established, the court must then consider two aspects of the adequacy of damages. First, the court must consider whether, if it does not grant an injunction at the interlocutory stage, a plaintiff who succeeds at the trial of the substantive action will be adequately compensated by an award of damages for any loss suffered between the hearing of the interlocutory injunction and the trial of the action. If the plaintiff would be adequately compensated by damages the interlocutory injunction should be refused subject to the proviso that it appears likely that the relevant defendant would be able to discharge any damages likely to arise.

    • If damages would not be an adequate remedy for the plaintiff, then the court must consider whether, if it does grant an injunction at the interlocutory stage, a plaintiff's undertaking as to damages will adequately compensate the defendant, should the latter be successful at the trial of the action, in respect of any loss suffered by him due to the injunction being enforced pending the trial. If the defendant would be adequately compensated by damages, then the injunction will normally be granted. This last matter is also subject to the proviso that the plaintiff would be in a position to meet the undertaking as to damages in the event that it is called on.

    • If damages would not adequately compensate either party, then the court must consider where the balance of convenience lies.

    • If all other matters are equally balanced the court should attempt to preserve the status quo.” (per Clarke J. at para. 70, [2012] 3 I.R. 152 at 180-181).

  46. The test in Campus Oil, has been approved of and applied by the High Court in a number of cases in which interlocutory injunctions had been sought in patent infringement cases. The leading cases in this respect are the judgments of the Kelly J. (as he then was) in Smithkline Beecham plc. & others v. Genthon B.V. and (by order) Synthon B.V. [2003] IEHC 623 (“Genthon”), and, most recently, of McGovern J. in Gilead.

  47. In summary, it is first necessary to consider whether the plaintiff seeking the interlocutory injunction has established a serious issue to be tried (there being no difference in substance between this formulation and the “fair or bona fide or serious question to be tried” referred to in some of cases). In the event that the plaintiff does establish a serious issue or issues to be tried, the plaintiff must then demonstrate that damages would not adequately compensate it in the event that the interlocutory injunction were ultimately to be refused but the plaintiff were to succeed at trial. If the plaintiff cannot establish this, then the application for the interlocutory injunction must be refused. If the plaintiff can establish that damages would not be an adequate remedy for it, the court moves to consider whether damages would adequately compensate the defendant in the event that the interlocutory injunction were granted but the defendant were ultimately to succeed at trial. If damages would adequately compensate the defendant, then the interlocutory injunction would normally be granted subject to the plaintiff being in a position to demonstrate that it could meet any liability on foot of its undertaking as to damages. It is normally only when damages would not adequately compensate the plaintiff or the defendant that it is necessary to go on to consider the question of the balance of convenience.

  48. Some further legal principles do arise for consideration in the context of the application of each element of the Campus Oil test and I consider those as they arise in my application of the test later in this judgment. For present purposes, however, it may be helpful to refer to the following observations of Clarke J. in relation to the application of this test. In Okunade, Clarke J. described the test as follows:-

    “It can be seen that the analysis of McCracken J. [in B&S] involves an application of the basic principle, under which the court is required to minimise the risk of injustice, to the sort of facts which normally arise in the context of commercial or property litigation. If a plaintiff does not establish a fair case or serious issue to be tried then interfering with the position of the defendant by means of imposing an interlocutory injunction on that defendant would create a serious and disproportionate risk of injustice. Where damages are adequate on either side and likely to be capable of being recovered in practice then there is no great risk of injustice for the plaintiff or defendant, as the case may be, will, if they win the case, be either awarded damages (in the case of a plaintiff) or be able to recover damages on the undertaking (in the case of a defendant). There is, of course, no real risk of injustice if such recovery would adequately compensate the relevant party.” (per Clarke J. at para. 71)

  49. Clarke J. also observed in relation to the balance of convenience as follows:-

    “The test of the balance of convenience is, of course, itself expressly directed to deciding where the least harm would be done by comparing the consequences for the plaintiff in the event that an interlocutory injunction is refused but the plaintiff succeeds at trial with the consequences for the defendant in the event that an interlocutory injunction is granted but the plaintiff fails at trial”. (per Clarke J. at para. 72).

    Preliminary points raised by Mylan

  50. Before considering Teva’s application in light of this test, I should first deal with a number of preliminary points which have been raised on behalf of Mylan which it contends should lead to a refusal of Teva’s application without even embarking upon a consideration of the Campus Oil test.

  51. Mylan makes two such preliminary points. The first is that Teva’s application is tainted by delay. The second is that I should decline to entertain Teva’s application on the grounds that courts in the United States have already declined similar applications made by Teva.

  52. I can deal very briefly with both of these points. On the issue of delay, Mylan contends that Teva has been guilty of very considerable delay in seeking the interlocutory injunction. Teva disputes that assertion. It seems to me that while the question of delay is very much live in this case, the appropriate stage at which to consider that issue is in the context of the balance of convenience when a whole range of factors will fall to be considered including the question of delay and the not unrelated contention by Teva that Mylan had failed to “clear the way” prior to embarking upon the manufacture and launch of the Mylan 40mg GA product. In my view, the appropriate stage at which to discuss these various issues is in the context of the balance of convenience in the event that it becomes necessary to consider that question as part of the Campus Oil test. I do not believe that I should refuse Teva’s application on the grounds of alleged delay without considering that question in the context of the Campus Oil test.

  53. I have reached a similar conclusion in relation to the second of the preliminary grounds of objection raised by Mylan. Mylan asserts that the US Supreme Court refused to grant a stay on an order of the Court of Appeals for the Federal Circuit (on appeal from the United States District Court for the Southern District of New York) which had shortened the duration of an injunction preventing Mylan from launching its generic 20mg GA product. Mylan contends that much of the evidence on which Teva relies on support of its application of these proceedings was raised in support of its request for that stay and makes particular reference to the evidence of Mr. Hassler adduced by Teva in the course of that application. Mylan relies on the order of Roberts C.J. dated 18th April, 2014 refusing the stay, where he stated:-

    “I am not convinced, however, that it [i.e. Teva] has shown likelihood of irreparable harm from denial of a stay. Respondents [including Mylan] acknowledge that, should Teva prevail in this Court and its patent be held valid, Teva will be able to recover damages from respondents for past patent infringement … Given the availability of that remedy, the extraordinary relief that Teva seeks is unwarranted.”

  54. In addition to relying on these observations of Roberts C.J. in those proceedings, Mylan also relies on the refusal by the Delaware District Court on 1st February, 2017 to grant an injunction to Teva pending appeal from the judgment delivered on 30th January, 2017 in the Delaware proceedings brought by Teva against Mylan and others for infringement of the relevant US Patents. The Delaware District Court agreed with the position adopted by the defendants (including Mylan) that an injunction pending appeal was “unwarranted” and it denied Teva’s request for such relief. Mylan relies on the fact that Teva did not make any application for a stay or injunction to the United States Court of Appeals for the Federal Circuit.

  55. Mylan prays in aid these developments in the United States in support of its contention that as a matter of comity of courts, and having regard to the fact that a consideration of Teva’s application involves an extensive analysis and consideration of the US market for pharmaceutical products, I should, as a matter of legal principle and in the exercise of my equitable jurisdiction, decline to entertain Teva’s application.

  56. Teva rejects those assertions, relies on the fact that its claim is one brought by an extensive licensee in respect of an Irish patent against an Irish defendant to prevent the manufacture in Ireland of a product which infringes an Irish patent. It does not accept that principles of comity of courts or otherwise should preclude me from considering its application in accordance with the well-established test for such applications in this jurisdiction.

  57. I am satisfied that it would not be appropriate to decline to entertain Teva’s application on this ground. I accept that the observations of Roberts C.J. in the US Supreme Court arose in the context of different litigation arising out of a different product (Copaxone 20mg) and in respect of different patents. While the arguments made by Mylan in relation to developments on the US market have considerable merit, and while principles of comity of courts undoubtedly arise for consideration, in my view, these are all factors to be considered in the context of the balance of convenience, in the event that the application of the earlier stages of the Campus Oil test leads me to a consideration of the balance of convenience. I do not believe that it would be appropriate for me to decline to entertain Teva’s application on any of these grounds. In those circumstances, I will proceed to consider the application in the context of the Campus Oil test.

    Application of

    Campus Oil

    test

    (1) Serious Issue to be Tried

  58. Mylan originally submitted that no serious issue to be tried could arise as the proceedings were not properly constituted. The basis for that submission was that Teva brought the proceedings in its capacity as exclusive licensee of the Patent from Yeda. Mylan contended that while s. 51(1) of the Patents Act 1992 entitled Teva to bring proceedings in its capacity as exclusive licensee, s. 51(2) requires that the proprietor of the relevant patent be a party to the proceedings either as plaintiff or defendant. Mylan submitted that as Yeda was neither a plaintiff nor a defendant to the proceedings, the proceedings were commenced and were being maintained in breach of the provisions of section 51(2).

  59. It is not necessary for me to resolve this issue as it was agreed during the course of the hearing of this application that Teva would apply to join Yeda as a co-defendant to the proceedings. An order was made on consent on the third day of the application (16th January, 2018) joining Yeda as a co-defendant to the proceedings. This point, therefore, fell away and does not require to be further considered.

  60. The next question which arises for consideration in the context of whether there is a serious issue to be tried is the issue of the alleged invalidity of the Patent, EP (IE) 335. Mylan initially contended that there was no serious issue to be tried on the question of the validity of the Patent. It contended that the Patent was clearly invalid. It relied in that regard on:-

    (1) The judgment of Arnold J. in the High Court of England and Wales delivered on 26th October, 2017 which found that Claims 1 and 3 of EP (UK) 335 were obvious having regarding to Pinchasi;

    (2) The decision of the Delaware District Court of 30th January, 2017 finding the 250, 413, 302 and 776 Patents invalid;

    (3) The decisions of the US PTAB of August, September and December 2016 finding the 250, 413 and 302 Patents to be unpatentable.

  61. Teva maintained that it had established a serious issue to be tried on the question of validity and pointed to the fact that the Patent had not been revoked or even the subject of any counterclaim for revocation and that Mylan had not sought to “clear the way” before commencing the manufacture and supply of its generic product.

  62. At the outset of the hearing of this application, however, it was confirmed on behalf of Mylan that while it would be asserting the invalidity of EP (IE) 335 in its counterclaim and that the validity of the Patent would very much be in issue in the proceedings, it did not propose to advance a submission that there was not a serious issue to be tried on this point. This was not withstanding that, some two days before the hearing commenced, the Court of Appeal of England and Wales had refused Teva/Yeda permission to appeal from the decision of Arnold J. on the ground inter alia that the appeal would have no reasonable prospect of success. Mylan’s decision not to advance a submission that no serious issue to be tried on the question of validity arose was no doubt driven by a realistic acknowledgment of the relatively low threshold which has to be surmounted in order to satisfy this part of the Campus Oil test.

  63. While Teva will undoubtedly have an uphill task on this issue at the trial, in light of developments elsewhere, and particularly in England and Wales, I am prepared to accept for the purpose of this application that a serious issue to be tried does arise in respect of the validity of EP (IE) 335.

  64. The next question which requires to be considered at this first stage of the Campus Oil test under this heading is the question of infringement. Teva submits that it has established a serious issue to be tried on the question of infringement by Mylan Teo of EP (IE) 335. As noted earlier, in its amended statement of claim and amended particulars of infringement, Teva claims that the manufacture by Mylan Teo of the Mylan 40mg GA product at its manufacturing site in Inverin, Galway for the US market amounts to an infringement of EP (IE) 335. Teva seeks injunctive relief restraining Mylan Teo, its servants or agents from directly or indirectly infringing that patent. Although Teva relies on both alleged direct infringement under s. 40 of the 1992 Act and indirect infringement under s. 41 of that Act, it is fair to say that Teva relies principally and emphasises to a greater extent its claim for direct infringement under s. 40.

  65. Teva submits that under s. 40, the proprietor of a patent (and its exclusive licensee) has a right to prevent third parties without their consent:-

    “from doing in the State all or any of the things following:-

    (a) making, offering, putting on the market or using a product which is the subject-matter of the patent, or importing or stocking the product for those purposes ….”

  66. Teva asserts that Mylan Teo is “making” a product which is the subject matter of the patent and reserves its position on whether Mylan Teo is also “offering” such a product. Teva also relies on the fact that the Mylan product is manufactured, packaged and labelled in Ireland with the PIL being inserted here also. It submits that at that point, the Mylan 40mg GA product is complete and is not subject to any other process before its ultimate supply to the patient (in the United States). In those circumstances, Teva contends that an infringement occurs in Ireland and should be restrained. It cites a number of authorities in support of its contention that infringement occurs in Ireland. These include Smithkline Corporation v. DDSA Pharmaceuticals Ltd. [1978] FSR 109 (an English case arising under the pre-existing legislative regime) and An Bord Trachtala v. Waterford Foods plc. (Unreported, High Court, Keane J., 25th November, 1992) (a passing off case). It also relies on the judgment of Arnold J. in Virgin Atlantic Airways Ltd. v. Delta Airways Inc [2010] EWHC 3094 (Pat) (“Virgin Atlantic”) (a case concerning “kits of parts”) and on the discussion of that case in Terrell on the Law of Patents (18th ed., Sweet and Maxwell, 2016) (paras. 14-47 to 14-53, pp. 425 to 427). While noting that this is not a “kit of parts” case, Teva relies on the conclusion of Arnold J. that it is arguable that dealing in a complete “kit of parts” in the UK for assembly outside the UK constituted infringement. Teva submits that even without the Virgin Atlantic case, it is plain that it has established a serious issue to be tried on the question of infringement. It submits that the word “making” in s. 40 of the 1992 Act must mean something.

  67. In response, Mylan contends that Teva has failed to establish even a stateable case on the question of infringement and that consequently there is no serious issue to be tried on that question. It points to the fact that there is no “use” of the Mylan 40mg GA product in Ireland. Its only “use” is in the United States. Mylan refers to Claims 1 to 4 of EP (IE) 335 and submits that the Patent does not cover GA or a GA 40mg product per se but rather it is a use specific product. It contends that this is clear from Claim 1 which refers to GA “for use in a regimen of three subcutaneous injections of a 40mg dose of [GA] every seven days … for use in treating a patient …”, with a similar reference in Claim 2 to “(a) medicament comprising [GA] for use in treating a patient …”, with Claim 3 being dependent on Claim 1 and Claim 4 being dependent on Claim 2. It submits that the only new and inventive technical contribution made by EP (IE) 335 was the manner of administration of the drug three times per week and that this was accepted by Teva in the proceedings before Arnold J. in relation to EP (UK) 335.

  68. Mylan submits that s. 40 requires that the subject matter of the patent to be made in Ireland and that the subject matter of EP (IE) 335 and the invention contained therein is the “use” of GA in accordance with the regimen referred to in Claim 1 and that such use is not taking place in Ireland. Mylan notes that Teva accepts that GA and the administration of 40mg/ml of that substance every second day are part of the state of the art (and referred to in Pinchasi), and that the claims in the Patent are confined to use in a regimen of 40mg three times per week since GA is a long known and unpatented substance. It submits that as an Irish patent covering “use” as the sole inventive contribution, EP (IE) 335 is a patent claiming a monopoly in respect of use in Ireland rather than use somewhere else. Mylan submits that the patent is not extraterritorial and does not, therefore, cover use outside Ireland. It too relies on Virgin Atlantic.

  69. Mylan further relies on Warner-Lambert Co., LLC v. Actavis Group PTC EHF & Ors [2015] EWCA Civ 556, [2015] RPC 25 (Court of Appeal of England and Wales) (“Warner-Lambert”). It submits that that case makes it clear that any liability on the part of a manufacturer can only arise if the manufacturer knows or foresees that the patented use will take place as a consequence of its manufacture. Mylan submits that the manufacturer here (Mylan Teo) anticipates or foresees use of the Mylan generic product in the US which is not the subject matter of the Irish patent. It submits that it is a novel proposition to suggest that manufacture for the purpose of deploying a patented use in a foreign country, where the patent is inapplicable, is an infringement of an Irish patent.

  70. In response Teva reiterated its reliance on Virgin Atlantic, disputed the relevance of Warner-Lambert and stressed that the product is being manufactured in Ireland.

  71. I have set out the respective contentions of the parties on the question as to whether a serious issue to be tried exists in respect of Teva’s case on infringement in order to demonstrate the gulf between the parties on this issue. The question of infringement is going to be a very significant question in the case should it go to trial. In contesting the existence of a serious issue to be tried on the question of infringement, Mylan in effect asks me to conclude at this stage in the proceedings that Teva’s claim for infringement must fail on the ground that the patent in suit protects use and nothing else and that such use takes place exclusively in the United States with no use taking place in Ireland. There may be force to that submission but it seems to me that it would not be appropriate for me to resolve that issue on this interlocutory application. I must bear in mind the relatively low threshold which has to be met by a plaintiff seeking to establish a serious issue to be tried. I consider that both Teva and Mylan have raised arguable points on the question of infringement and that it would not be appropriate for me to resolve this question against Teva at this stage in the proceedings. I also bear in mind the approach taken by...

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