Analysis Of The Case Of Second Medical Use Patent: Actavis Uk Ltd V Merck & Co Inc.

Second (Further) Medical Use patents is an essential component of the potential second-line patent protection. It is among many issues faced in the pharmaceutical industry. Apart from the loss of income, the originators face difficulties in relation to securing secondary patents. These patents would facilitate new therapeutic uses for known active ingredients. The hardship was seemingly diminished as the legal and historical background for the patentability of Second Medical Use was discussed in Actavis UK Ltd v Merck & Co Inc. It was deemed as a landmark case in pharmaceutical patent law pending the Court of Appeals decision. The patentability of ‘dosage regimes’ both non-obvious and new was permitted. In effect, patent litigators in all industries was obliged to recognize the new exception as settled case law in regards to the European Patent Office (EPO) Boards of Appeal, bound by its previous decision.

In the first instance, the lower court’s perspective depicted the traditional view on second medical use and dosage based on the decision of Warren J. Initially, the rule in this case mirrored that held by Parker J. in Adhesive Dry Mounting v Trapp. Merck’s patent ‘Finasteride’ was deemed invalid for second medical use. The pharmaceutical drug was originally created in 1973, a time period where the use of an “old thing to create a new thing” did not equate to novelty. The drug was to treat Androgenic alopecia (aa), baldness in men and women. The oral dosage was between 0. 05 to 1. 0 mg daily; however, by 1993 the use of the drug had expanded as well as the dosage and was used for benign prostatic hyperplasia “(BPH)”. It was to be administered orally but in tablet form at a dosage of 5mg daily. Justice Warren held that Finasteride was invalid pursuant to the provisions of the European Patent Convention (EPC) regarding novelty and inventiveness. The invention was also not thought of as being new by Peter Prescott QC who challenged the patentability of the product. The invalidation was based on EPC Art 54(2) which provides that the invasion, therapy, diagnostic methods or surgery practiced on human or animals is not regarded as an invention but may not exclude patentability of substances comprised in state of the art with the exception of those that are not. Therefore, Finasteride (claim 1) in aid of treating bald spots on humans was not comprised in the state of the art (novelty and inventiveness). In essence, the issue presented was based on the novelty and patentability of the dosage being 5mg in the new product as opposed to 1mg in the known product. In relation to the above mentioned, Activis cross-appealed the finding of non-obviousness. The product was unpatentable based on the fact that it was obvious to a skilled person in the art. The same was suggested by Antony Watson QC regarding the ‘obviousness’ challenge outlined in Biogen, pursuant to EPC Art.

It is essential to note that traditionally EPC Art 54(5), now Art 54(4) was used as a limitation of patentability to the first medical use in 1973. It was expanded by the Enlarged Board to protect second medical uses and eliminate legal uncertainty in that regard. It furthers new medical use of already known medicines via the protection of purpose related products. However, it did not provide for medical appliances; exceptions are to be narrowly construed as the general principle suggests. Nevertheless, second medical usage would be drafted as a purpose related “product” claim as opposed to the “Swiss Type Claims”, a purpose related “process” claim resulting in different claim categories. Previously, under the European Patents Convention (EPC) 1973, a patent for further medical application for swiss type claims was permitted. Swiss type claims entail the use of a substance or product for the manufacturing of a medicament for the purpose of therapeutic application.

Under EPC Art. 53(c), the swiss type claims must be novel and inventive pursuant to a line of case law which was first set out in Eisai, G 5/83. It was here where there was a special approach to gaining novelty which resulted in a narrow exception to the general novelty requirement. Novelty could be gained from the substance, method of manufacture and new therapeutic application. Thus, in order for a second medical use claim to be patentable in relation to novelty residing in the dosing regime, a swiss type formula had to be used. An example of a swiss type claim is “Use of X for the manufacture of a product for treating disease Y”. Therefore, an old substance can be used for the manufacturing of a ‘new treatment’ which was arguably novelty as agreed upon in G2/08. This was also displayed in T0051/93 where a different method of treatment created novelty. However, the claim was based on the manufacturing of the compound and not a method of treatment which also posed initial disputes in the latter. This formed the basis of a dispute in terms of method claims being less effective then product claims. A Swiss Type claim confers less protection to a physical entity than that under EPC Art 54(5), a claim to a particular physical activity. Therefore, there can be no switch made from a swiss type claim to one drafted in accordance with Art 54(5) because it cannot be amended beyond the protection that it incurs. The whole purpose of protection regarding product claims under Art 54(5) in terms of further medical use is to limit the substance or composition. The intention was to negate non-obviousness. Nevertheless, therapeutic treatment was a limiting agent and would only be recognized in second medical usages. For the sake of distinction between the relevant case law, apart from the inclusion in G2/08, a pure dosage regimen was first recognized in T 1020/03 and was not to be excluded from patentability. The case entails the use of insulin-like growth factor-I in the preparation of a medicament to be administered to a mammal in a discontinuous pattern.

The Board held that any use to which Art. 52(4) EPC applies in circumstances where the composition has already been suggested for some therapeutic use, allows a second medical use claim to the preparation of the composition for that second medical use, irrespective of in what detail that use was specified, subject to the use being novel and inventive. For the purposes of novelty also under EPC Art. 54(5) this depends on whether use for therapy is novel, irrespective of the detail with which the therapy is stated in the claim. Regarding the aforementioned, in G2/08, Mr. Thorley sought to draw an analogy with what this Court did in the trade mark case of Boehringer Ingelheim v Swingward. The analogy made was in reference to Art. 54(5) as a limitation, the same logic used in regards to novelty in the first medical use applies to second medical use This is simply saying that the new therapeutic use proves the novelty of the process. The substance must be used in order to create the therapeutic medicament to be used for an essential purpose. Therefore, in this case another question is raised in terms of whether this means different methods of compound usage to treat the same illness or the same method in treating different illness. Mr. Thorley argued the latter in response to public policy.

As a result, in G 2/08, the Enlarged Board of Appeal considered the consequences of the revised EPC for claims in the Swiss-type format. The revised European Patent Convention (EPC 2000) should be used instead which states: "Product X for use in the treatment of Y". This was due to the absence of any functional relationship of the feature in the product conferring novelty and inventiveness claimed in the manufacturing process. Thus, if the subject matter of a claim is only novel by way of new therapeutic use of a medicament, originating in the EPO case law, it would not be classified as a swiss-type claim as settled in G 5/83. However, the necessary guidelines and invalidity of a swiss type claim was outlined in the case of BMS as follows:(a) Finasteride as a substance is not novel; (b) Nor is its use as a medicine (for treating BPH); (c) So its use for the manufacture of a medicament for use as a medicine lacks novelty; (d) Moreover, finasteride had been proposed for treating aa, but with a daily dosage of 5mg or more; (e) So its use for the manufacture of a medicament for treating aa also lacks novelty. (f) Novelty cannot be saved by specifying a particular dosage regime even if that dosage was not proposed in the prior art. (g) Even if that is wrong, this court is bound under the English rules as to precedent by its prior decision in BMS to hold that the patent lacks novelty and/or is in substance one for a method of treatment of the human and thus, by virtue of Art. 52(4) is not to be regarded as susceptible of industrial application. The above-mentioned, in accordance with Art. 52(4) EPC 1973 and relevant case laws such as T 584/97 set out that a claim for the patentability for the direct administration of nicotine in increasing dosage was denied.

The issue was discussed in T 317/95, T 56/97and T 4/98 (OJ 2002, 139) but was left undecided and would have been negatived by other factors such as lack of novelty and inventive steps. It was held that novelty and inventiveness of a product is protected where there is a “use” or “process” claim. However, the method of treatment a use claim is forbidden. Therefore, the outcome would have been immaterial. In response to the question that arose in G2/08 regarding the patentability of medicaments for use in methods of treatment by therapy, where the only novel feature was a dosage regime under Art. 53(c) and 54(5) EPC the same was addressed in T 1319/04 Kos Life Sciences. The Enlarged Board in G2/08 gave the following response:

1. Treatment by therapy or medicament once classified within in their own domain is patentable and not excluded by Art. 53(c) EPC. Although different methods are used to treat the same illness, it is not to be excluded by Art. 54(5) EPC which states 'methods for treatment of the human body. . . by therapy'. Therefore, both allowable methods claim for therapeutic treatment or product claims for use in such methods is clear and unambiguous. In respect to both Art. 54(5) and Art. 53(c) EPC, method claims are not to overlap therapy claims. However, if due to novelty and inventiveness of the subject-matter, product claims may be admissible. However, the Enlarged Board made reference to the dosage regime in their second point.
2. It was held that where the dosage regime (in a swiss form claim) is the only feature claimed not comprised in the state of the art, patenting is not excluded (Eisai). Therefore, due to the points made in the first response and EPC 54(5) being used in cases for treatment of the same illness, the “specific use” outlined in that provision may reside in something other than the treatment of a different illness. The Board stated that there was no reason to treat a known medicament that was acknowledged in case law different than the others just because of the new dosing regimen. In particular, Mr. Thorley’s argument was based on the very same notion in connection with public policy. Nevertheless, novelty and inventiveness jurisprudence regarding the non-obvious dosage regime is still applicable in this sense. Based on the reasoning listed above Genentech/method of administration of IFG-I, T1020/03 upheld the relevant law set out in Eisai in relation to the novelty being based on the dosage regime in a swiss type claim. It was further reasoned that novelty and inventiveness would most likely be found in method of claims regarding a new illness as opposed to modification of the treatment in treating the same illness based on a new purpose. Therefore, a new dosage regime conferred novelty.

However, in relation to inventiveness, there was a transition from Genentech Inc. 's Patent to Biogen Inc. v. Medeva Plc. In the former case, Gentech sought monopoly rights over a protein originating in the human body/tissue called ”t-Pa” to treat bloodclots. Mustill LJ found it hard to decipher whether the unknown property of a known substance was inventive via the production of the ”product” or the ”use/process” of production of the product. However, he stated that, “a properly framed claim for a process for synthesizing, refining or transforming the substance should be capable of founding a patent". This was because the human protein could not be produced in useful quantities and needed to be synthesized to produce the necessary results. Therefore, the use of the naturally occurring product could not be patented as a new inventive step. However, once synthesized, this would amount to an invention which was patentable. In the latter case, it was a landmark case in patents of this sort where patentability for genetically engineered products were permitted. The case entailed the cloning of the Hepatitis B Virus which produced diagnostic kits for the detection of the virus. Medeva argued that the process of synthesizing the Virus was not inventive at all.

The Court of Appeals followed the same notion in Genentech in addition to obviousness and insufficiency. Lord Hoffman discarded the argument while dealing with the issue of whether the claims by Biogen constituted an invention as per section 1(1). There was undue complexity; Lord Hoffman, acknowledged that the four requirements of patentability in section 1(1) restricted the possible patentable class of inventions. Consideration should have been given to the conditions for patentability such as novelty, inventiveness, industrial application, plus the excluded categories, before undertaking the issue of whether the claims satisfy the meaning of invention. Therefore, the stance in Genentech was overturned based on other provisions of section 1(1) of the 1977 Act. As per section 3 of the 1977 Act, ‘an invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art’. Article 52 of the EPC states that European patents shall be granted for any inventions which are new and which involve an inventive step. Article 56 of the EPC states that an invention will involve an inventive step if it is not obvious to a skilled addressee. Thus, in applying this logic to both cases including the novelty and inventiveness of the dosage regime in G2/08, The Court in Genentech observed that the goal of the research, the sufficiency of the theory and practice of what Genentech was doing was known to it. It was also stated that it was obvious to the person skilled in the art to set out to produce human t-PA by recombinant DNA technology.

Therefore, all the steps taken by Genentech in finding out the composition of the sequences and applying that knowledge to produce human t-PA were applications of known technology without any original step. The Court of Appeal in Genentech decided that the invention was mere discovery which did not involve the use of which lacked an inventive step. Thus, it was non-patentable and obvious which was not challenged by the House of Lords in relation to Biogen. However, the Court of Appeals approach in defining inventive steps was criticized. Lord Hoffman in regards to commercial purposes is the basis for innovation and invention in any circumstance. The rewards anticipated justified the necessary expenditure; thus, it was concluded that commercial reasoning in itself could not justify lack of inventive step. In affirmation of the above mentioned, the inventive requirement would have been met for the patentability of medicaments for use in methods of treatment by therapy, where the only novel feature was a dosage regime in G2/08.

In an overall conclusion, the loophole in EPC 1973 was closed and amended by EPC 2000. “Cessante ratione legis, cessat et ipsa lex” is a Latin maxim meaning, “the reason for a law ceasing, the law itself ceases”. This simply means that no law can survive on the reason on which it was founded; the law itself ceases if the reason for the law ceases. It needs no statute to change it, it abrogates itself. At the time of the law in 1973, it was much needed, however, in changing times, certain traditional laws have no relevance in modern society.