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  • Trinity Term

    [2017] UKSC 48

    On appeals from: [2015] EWCA Civ 555 and 556

    JUDGMENT

    Actavis UK Limited and others (Appellants) v Eli

    Lilly and Company (Respondent)

    Eli Lilly and Company (Appellant) v Actavis UK

    Limited and others (Respondents)

    Eli Lilly and Company (Appellant) v Actavis UK

    Limited and others (Respondents)

    before

    Lord Neuberger, President

    Lord Mance

    Lord Clarke

    Lord Sumption

    Lord Hodge

    JUDGMENT GIVEN ON

    12 July 2017

    Heard on 4, 5 and 6 April 2017

  • Actavis and others Eli Lilly and Company

    Daniel Alexander QC Thomas Mitcheson QC

    Thomas Raphael QC Andrew Waugh QC

    Isabel Jamal Stuart Baran

    (Instructed by Bird & Bird

    LLP)

    (Instructed by Hogan

    Lovells International LLP)

  • Page 2

    LORD NEUBERGER: (with whom Lord Mance, Lord Clarke, Lord

    Sumption and Lord Hodge agree)

    1. The issue raised on this appeal and cross-appeal is whether three products manufactured by the Actavis group of companies (Actavis) would infringe a

    patent whose proprietor is Eli Lilly & Company (Lilly), namely European Patent

    (UK) No 1 313 508 (the Patent), and its corresponding designations in France,

    Italy and Spain.

    2. This judgment was circulated in draft to the parties legal representatives in the normal way on 5 July 2017, on the basis that it would be handed down a week

    later. On the following day, just after midday, Actaviss solicitors emailed the Court

    expressing concern about the potential prejudice which their clients could suffer if

    they did not know of the outcome of this appeal until 12 July. Not least because

    publication of our decision could have an effect on the share prices of Actavis or

    Lilly or both of them, the Court proposed to the parties respective solicitors that we

    should announce our decision at once, while maintaining the intention, in

    accordance with this Courts usual practice, to hand down the judgment a week after

    circulation of the draft. This was agreed by both solicitors, and accordingly on 7 July

    at 11.30 am, the following announcement appeared on the Courts website:

    The Supreme Court allows Eli Lillys appeal and holds that

    Actaviss products directly infringe Eli Lillys patent in the

    United Kingdom, France, Italy and Spain. The Court dismisses

    Actaviss cross-appeal on the basis that if its products did not

    directly infringe, they would indirectly infringe to the extent

    held by the Court of Appeal.

    Accordingly, these are technically the reasons for those conclusions.

    The factual and technical background

    The factual background

    3. Pemetrexed is a chemical which has been known for some time to have therapeutic effects on cancerous tumours. However, when used for that purpose on

    its own, pemetrexed can often have seriously damaging, sometimes even fatal, side-

    effects. Accordingly, its use as an anti-cancer drug was effectively precluded in

  • Page 3

    practice. The essential disclosure of the Patent was that the damaging side-effects

    could largely be avoided if a compound called pemetrexed disodium was

    administered together with vitamin B12. This has enabled pemetrexed disodium to

    be used for treatment in the form of a medicament which includes the vitamin. Such

    a medicament has been successfully marketed, under the brand name Alimta, by

    Lilly since 2004.

    4. The Patent primarily claims the use of pemetrexed disodium in the manufacture of a medicament for use in combination with vitamin B12 (and,

    optionally, folic acid) for the treatment of cancer.

    5. Pemetrexed itself is a member of a class of chemicals known as antifolates, and its molecular structure is shown below, with C, N, O and H being respectively

    the chemical symbols for carbon, nitrogen, oxygen and hydrogen; and the

    unallocated points on the chains and the rings being carbon.

    6. The presence of the two -CO2H units results in pemetrexed being an acid (hence it is also known as pemetrexed diacid), or as it is sometimes called, a free

    acid. When pemetrexed is dissolved in water, the hydrogens in those two units

    separate from the rest of the molecule as positively charged entities, protons, and

    the rest of the molecule becomes a negatively charged entity called an anion. The

    structure of pemetrexed disodium is similar except that, instead of the two -CO2H

    units, it has two -CO2Na units (Na being the symbol for sodium). Pemetrexed

    disodium dissolves in water, where the two sodiums separate from the rest of the

    molecule as positively charged entities called cations, and the rest of the molecule

    becomes an anion. Because it is the pemetrexed anion which is of interest, the

    sodium cation is often referred to as a counter-ion. A substance such as pemetrexed

    disodium, where the acidic hydrogens have been replaced, is known chemically as

    a salt.

    7. Although one might have thought that the actual invention should have been characterised as a disclosure that pemetrexed could be administered safely if it was

    combined in a medicament with vitamin B12, the claimed invention in the Patent is,

    https://en.wikipedia.org/wiki/File:Pemetrexed.svg

  • Page 4

    as mentioned in para 4 above, the manufacture of such a medicament. This

    formulation was required by the then-prevailing law contained in article 52(4) of the

    European Patent Convention 1973 (EPC 1973), which prohibited from

    patentability any method of treatment of humans or animals. This led to inventions

    which otherwise might have been expected to be expressed as being new therapeutic

    treatments being cast as manufacturing claims. Such claims are known as Swiss

    form claims, and they were illuminatingly discussed by Kitchin J in Ranbaxy (UK)

    Ltd v Astrazeneca AB [2011] FSR 45, paras 42 to 60. As he explained, the

    prohibition was substantially modified in article 53 in the European Patent

    Convention 2000 (EPC 2000), but that modification had not come into force when

    Lilly applied for the Patent.

    8. Actaviss proposed products involve pemetrexed compounds being used together with vitamin B12 for cancer treatment. However, rather than pemetrexed

    disodium, the active ingredient in those products (the Actavis products) is (a)

    pemetrexed diacid, (b) pemetrexed ditromethamine, or (c) pemetrexed dipotassium.

    In other words, rather than including the disodium salt referred to in claim 1 of the

    Patent, the Actavis products include as the active ingredient (a) pemetrexed itself (ie

    the free acid), or pemetrexed with the hydrogens on the two -CO2H units replaced

    by (b) tromethamine, or (c) potassium. Actavis contend that, because they intend to

    use the Actavis products which do not include pemetrexed disodium, the claims of

    the Patent, which are expressed as involving the use of pemetrexed disodium, would

    not be infringed. By contrast, Lilly contends that there would be either direct or

    indirect infringement of the Patent if Actavis launch any of the Actavis products on

    the market in the UK or in France, Italy, or Spain. The allegation of direct

    infringement is based simply on the proposition that marketing or use of the Actavis

    products would infringe the Patent; indirect infringement is said to arise because

    pemetrexed disodium is claimed to be involved in the preparation of the Actavis

    products before they are administered.

    9. After a four-day trial, Arnold J decided that none of the Actavis products would directly or indirectly infringe the Patent in the UK or in France, Italy or Spain

    - [2015] Bus LR 154; [2015] RPC 6. The Court of Appeal allowed Lillys appeal to

    the limited extent of holding that there would be indirect infringement in the four

    jurisdictions, but they agreed with the Judge that there would be no direct

    infringement - [2015] Bus LR 1068. Lilly appeals against the rejection of its case

    that there would be direct infringement, and Actavis cross-appeal against the

    rejection of their case that there would be no indirect infringement.

    10. As Floyd LJ explained in the Court of Appeal, the appeal raises the issue of the correct approach under UK law (and the law of the three other states) to the

    interpretation of patent claims, and in particular the requirement of EPC 2000 to take

    account of equivalents, and also the extent to which it is permissible to make use

    of the prosecution history of a patent when determining its scope. The issue on the

  • Page 5

    cross-appeal is rather more fact-specific, namely whether the application of the law

    of contributory infringement justifies a finding of indirect infringement in this case.

    11. It is appropriate to start by setting out the relevant provisions of the Patent and the knowledge of its assumed addressee, topics on which my account is largely

    taken from the clear judgment of Floyd LJ in the Court of Appeal. I will then turn

    to the issue of direct infringement, which involves considering the proper approach

    to that issue generally, and also the relevance of the prosecution history. I will then

    consider the position in the three other states and finally I will address the issue of

    indirect infringement.

    The specification and claims in the Patent

    12. The Patent is entitled Combination containing an a

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