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...

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