Construction of second medical use claims The Hon. Mr Justice Richard Arnold The problem Claim 1 of European Patent (UK) No. 0 934 061 reads: Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain. What does the word for in the phrase for treating pain mean? How can this be interpreted so as to provide fair protection for the patent proprietor and reasonable certainty for third parties? Background to the problem: Swiss-form claims Claim 1 set out above is a claim in so-called Swiss-form. Claims in this form were devised in response to the provisions of the European Patents Convention 1973, and in particular the following provisions: Article 52 EPC 1973: Patentable inventions (1) European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step. (4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods. Article 54 EPC 1973: Novelty (1) An invention shall be considered to be new if it does not form part of the state of the art. (5) The provisions of paragraphs 1 to 4 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52, paragraph 4, provided that its use for any method referred to in that paragraph is not comprised in the state of the art. G5/83 EISAI/Second medical indication [1984] OJEPO 64 In G5/83 a question of law was referred to the Enlarged Board of Appeal of the European Patent Office as to whether it was possible to circumvent the prohibition on patenting methods of treatment by therapy in Article 52(4) EPC 1973 by means of a claim directed to the use of a substance or composition for the treatment of the human or animal body by therapy. The Enlarged Board answered that question in the negative, holding that a claim to use of a substance or composition for treatment was no different in content to a claim directed 1
to a method of treatment, the difference between the two claims being one of form only. Of its own motion, the Enlarged Board then considered whether claims in Swiss-form were patentable, and held that they were. The core of its reasoning was as follows: 19. the Enlarged Board has also given careful consideration to the possibility of protecting second (and subsequent) medical indications by means of a claim directed to the use of a substance or composition for the manufacture of a medicament for a specified (new) therapeutic application. Such claims do not conflict with Article 52(4) EPC or Article 57 EPC but there may be a problem concerning the novelty of the invention. 21. it is clear that in all fields of industrial activity other than those of making products for use in surgery, therapy and diagnostic methods, a new use for a known product can be fully protected as such by claims directed to that use. Article 54(5) EPC provides an exception to this general rule, however, so far as the first use of medicaments is concerned, in respect of which the normal type of use claim is prohibited by Article 52(4) EPC. In effect, in this case the required novelty for the medicament which forms the subject-matter of the claim is derived from the new pharmaceutical use. It seems justifiable by analogy to derive the novelty for the process which forms the subject-matter of the type of use claim now being considered from the new therapeutic use of the medicament and this irrespective of the fact whether a pharmaceutical use of the medicament was already known or not. G2/88 MOBIL/Friction reducing additive [1990] OJEPO 93 G2/88 was not a case about a second medical use, but rather a case about a new use of old product outside the medical field. Nevertheless, it is relevant to the issue of novelty which arose in G5/83. The Enlarged Board of Appeal held at [10.3] with respect to a claim to a new use of a known compound, such new use may reflect a newly discovered technical effect described in the patent. The attaining of such a technical effect should then be considered as a functional technical feature of the claim (e.g. the achievement in a particular context of that technical effect). If that technical feature has not been previously made available to the public by any of the means as set out in Article 54(2) EPC, then the claimed invention is novel, even though such technical effect may have inherently taken place in the course of carrying out what has previously been made available to the public. The impact of the European Patent Convention 2000 The provisions which had given rise to Swiss-form claims were revised in the European Patent Convention 2000. This provides: Article 53 EPC 2000: Exceptions to patentability European patents shall not be granted in respect of: 2
(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods Article 54 EPC 2000: Novelty (4) Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art. (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art. G2/08 ABBOTT RESPIRATORY/Dosage regime [2010] EPOR 26 In G2/08 questions were referred to the Enlarged Board of Appeal as to whether Articles 53(c) and 54(5) EPC 2000 precluded the patenting of a medicament, the use of which to treat a particular illness was already known, for use in a new and inventive treatment of the same illness, and in a particular a new and inventive dosage regime. In addition to considering these questions, the Enlarged Board considered the justification of continuing to permit the grant of claims in Swiss-form. In this regard it held: 6.5 In respect of second and further medical indications the EPC now allows use-related product claims directed to the substance itself whereas under EPC 1973 decision G 5/83 allowed claims directed to the use of a substance for the manufacture of the drug for a therapeutic indication ( Swiss-type claims ). It appears that the rights conferred on the patentee by the claim category under Article 54(5) EPC are likely broader, and could, in particular, lead to possible restrictions on the freedom of medical practitioners to prescribe or administer generics. However, in view of the clear provisions of Articles 53(c), second sentence, and 54(5) EPC and the intention of the legislator, the Enlarged Board has no power to broaden or reduce in a praetorian way the scope of these provisions.. 7.1.3 Swiss-type claims could be (and have been) considered objectionable as regards the question as to whether they fulfill the patentability requirements, due to the absence of any functional relationship of the features (belonging to therapy) conferring novelty and inventiveness, if any, and the claimed manufacturing process. Therefore, where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83. 3
Case T1780/12 UNIVERSITY OF TEXAS BOARD OF REGENTS/Cancer treatment [2014] EPOR 28 In T1780/12 the Board of Appeal held that the inclusion of both claims in Swiss-form and purpose-limited use claims as permitted by EPC 2000 did not give to a double-patenting objection. In this regard it held at [22]: It follows from the above analysis (see points 16 and 17) that the claims under consideration belong to different categories, i.e. purpose-limited process claim vs. purpose-limited product claim. It is generally accepted as a principle underlying the EPC that a claim to a particular physical activity (e.g. method, process, use) confers less protection than a claim to the physical entity per se, see decision G 2/88 (supra, reasons, point 5). It follows that a purpose-limited process claim also confers less protection than a purpose-limited product claim. The context of the problem: skinny labels for pharmaceuticals Pregabalin is marketed by Pfizer under the trade mark Lyrica for epilepsy, generalised anxiety disorder ( GAD ) and neuropathic pain. It is also prescribed off-label for other types of pain. Patent protection for pregabalin itself expired on 17 May 2013 and Pfizer s data exclusivity expired on 8 July 2014. In 2014 at least 90% of prescriptions for pregabalin in the UK were written generically, about 95% of prescriptions did not state the indication for which pregabalin had been prescribed and about 70% of prescriptions were in fact for the treatment of pain. On 16 February 2015 Actavis obtained a marketing authorisation for generic pregabalin limited to epilepsy and GAD (a so-called skinny label ) which it marketed under the trade mark Lecaent from the following day. Even though Actavis only marketed Lecaent for epilepsy and GAD, Pfizer alleged that Actavis infringed Pfizer s second medical use patent for treating pain because it was likely that pharmacists would dispense the generic product against prescriptions which were in fact for the treatment of pain even if the prescription did not identify the indication. Pfizer applied for a preliminary injunction, which was refused by the Patents Court ([2015] EWHC 72 (Pat) and by the Court of Appeal ([2015] EWCA Civ 556). At trial the Patents Court dismissed the claim for infringement ([2015] EWHC 2548 (Pat)), but granted Pfizer permission to appeal to the Court of Appeal. The appeal is pending. 4
The rival contentions It was common ground that for did not merely mean suitable for (as it normally does in patent claims) since the claim would then lack novelty. Actavis contended that for meant intended for. Pfizer contended in essence that for meant which it is foreseeable will be used for. The Court of Appeal s interpretation on the first appeal The essence of the Court of Appeal s reasoning was as follows: 121. the skilled person would understand that the technical subject matter of the claim was concerned with the ultimate end use of the medicament, from which it derived its novelty. The therapeutic treatment is of course new because, and only because, it is carried out with the intention of producing the new therapeutic effect. The prior use of the compound may have in fact produced the effect, for example if a patient taking it for GAD or epilepsy was at the time experiencing pain as well. This demonstrates, to my mind, that it is the intention for which the compound is administered which is at the heart of the invention. 122. Against that background the skilled person would understand the word for in the claim to be providing a link between the act of manufacture using pregabalin and the ultimate intentional use of the drug by the end user to treat pain. The critical issue. is what is sufficient to constitute that link. 124. If a product is for a particular therapeutic indication if it is reasonably foreseeable that it will be used intentionally for the treatment of pain, then it will not be rendered lacking in novelty by showing that products in the prior art had been manufactured in circumstances when it was not possible to foresee such a result. 127. I can therefore see no reason why the skilled person would conclude that the word for implied subjective intent. He would understand that the manufacturer who knows (and for this purpose constructive knowledge is enough) or could reasonably foresee that some of his drug will intentionally be used for pain is making use of the patentee's inventive contribution, in the same way as a manufacturer who actively desires that result. In my judgment, therefore, the skilled person would understand that the patentee was using the word for in the claim to require that the manufacturer knows (in the above sense) or can reasonably foresee the ultimate intentional use for pain, not that he have that specific intention or desire himself. 5
Difficulties with the Court of Appeal s interpretation Certain difficulties with the Court of Appeal s interpretation were identified in the judgment of the Patents Court after trial. In particular: 625. The claim is to a method of manufacture of a pharmaceutical composition which derives its novelty from the mental state of the manufacturer, namely that the manufacturer prepares the pharmaceutical composition for treating pain. Counsel argued that this clearly directs attention to the manufacturer s purpose, i.e. intention, rather than mere foreseeability as to the prescriber s intention. As counsel for Actavis put it, on Floyd LJ s construction, there is no technical nexus between the manufacturer s acts and the intention to achieve the new therapeutic effect which gives the claim novelty 627. As [counsel] pointed out, Floyd LJ expressly accepted at [118] that [m]aking pregablin for patients to whom it is to be administered for the non-patented indications is not within the technical subject matter of the claim. Accordingly, this cannot be an infringing act. Counsel submitted that Floyd LJ s construction apparently had the consequence that, if it was foreseeable to an unlicensed manufacturer of pregabalin that some of his drug (as Floyd LJ put it at [127], emphasis added) would be intentionally administered for the treatment of pain, then all of that manufacturer s acts of manufacture of pregabalin would be infringing acts even though it was foreseeable that the remainder of its pregabalin would be administered for the treatment of non-patented indications. Furthermore, this would be so even if it was foreseeable that the majority (possibly even the vast majority, depending on what was meant by some ) of the pregabalin made by that manufacturer would be administered for the treatment of the non-patented indications and even if the majority (possibly the vast majority) was in fact administered for the treatment of those indications. Still further, all of the pregabalin would be infringing product, and thus anyone who subsequently dealt in it would also infringe on a strict liability basis. Application of the Court of Appeal s interpretation Despite the difficulties identified above, the Patents Court followed the Court of Appeal s interpretation. Difficulties were also identified in applying the Court of Appeal s interpretation to the facts of case. As to this, the Patents Court reasoned as follows: 636. Counsel for Actavis submitted that the relevant intention was that of the prescribing doctor. I agree that the intention of the doctor is highly relevant, if not exclusively so. Floyd LJ expressly referred to the doctor at [119], and at [121] he made the point that the novelty of the claim derives from the intention of producing the new therapeutic effect. It is the prescribing doctor who intends to produce the new therapeutic effect (here treating pain) because it is the doctor who has the requisite medical knowledge. 6
638. What about the pharmacist? After considerable hesitation, I have concluded that, on Floyd LJ s reasoning, the intention of the pharmacist is also relevant. In general, of course, the pharmacist will simply intend to dispense the drug which the doctor has prescribed for the purpose of treating whatever indication the doctor has prescribed that drug for. Moreover, in general, the pharmacist will not know what that indication is. In those circumstances the pharmacist s intention adds nothing to that of the doctor. Even if the doctor prescribes generic pregabalin for treating pain and the pharmacist dispenses the generic manufacturer s product, neither the doctor nor the pharmacist nor the two in combination will have intended that that product be administered for the treatment of pain. But what if the pharmacist knows that the doctor has prescribed generic pregabalin for treating pain and the pharmacist dispenses the generic manufacturer s product? In those circumstances it seems to me that it can be said that the result is intentional administration of the generic manufacturer s product to treat pain. Solutions to the problem As the case discussed above shows, it is very difficult to interpret Swiss-form claims in a manner which provides fair protection for the patentee and reasonable certainty for third parties. Accordingly, the following solutions to the problem are proposed: 1. The best solution is to separate the patented market from the non-patented market by ensuring that the active ingredient is prescribed by the patent proprietor s brand name for indications covered by the second medical use patent and by the generic name for other indications. This is particularly important while second medical use patents with claims in Swiss form continue to subsist. 2. In the case of second medical use patents with claims in EPC 2000 form, the patent proprietor can bring a claim for indirect infringement under Article 26 of the Community Patent Convention. Whereas Swiss-form claims are purpose-limited process claims, and there is no step of preparation after the pharmaceutical composition has been put on the market together with instructions for administration, EPC 2000 claims are purpose-limited product claims. The proprietor will still have to show that the requirements of Article 26 CPC are satisfied, but some difficulties will be avoided. 3. In the long term Article 53(c) EPC 2000 should be repealed and replaced by an exception to infringement in favour of healthcare professionals. 7