EPO Enlarged Board of Appeal Decisions on Patent Eligibility of Medical Inventions
By John Richards
Two February 2010 decisions of the Enlarged Board of Appeal of the European Patent Office (EPO) have added some clarity as to what is patent eligible in the field of medical inventions where there was previously some conflict between prior decisions of the technical boards of appeal. The issues involved in the two cases were:
1) in case G2/08 (Dosage regime/Abbott Respiratory) the extent to which differences other than treatment of a totally different disease from what had been treated in the prior art justified a “second medical use” claim; and
2) in case G1/07 (Treatment by surgery/Medi-Physics), the extent of the European Patent Convention’s exclusion of methods of treatment of the human or animal body by way of surgery.
At the same time, the Enlarged Board held in G2/08 that in view of the changes in the European Patent Convention (EPC) by the amendments adopted in 2000, it is no longer necessary to adopt an artificial means for protection of second and subsequent medical uses by so-called “Swiss form claims” and that for new applications filed more than three months after the publication of the decision in the Official Journal, Swiss form claims should no longer be allowed.
The most relevant provisions of the EPC to both decisions are the following:
Article 53European patents shall not be granted in respect of: …
(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;
and
Article 54 Novelty:
(4) Paragraphs 2 and 3 (which define the state of the art for the purposes of novelty) 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.
Both of decisions G2/08 and G1/07 address the role of the Vienna Convention on the Law of Treaties on the interpretation of the European Patent Convention and the reasons for “medical” exclusions from patent eligibility in the EPC. On the first, both decisions conclude that even though the European Patent Organization is not a party to the Vienna Convention it is proper to apply its principles to interpretation of the EPC. However, contrary to what had been implied in earlier decisions by the Enlarged Board, there is no general requirement to read exclusions narrowly. The true requirement is to read the provisions in good faith and in the light of their object and purpose. It was noted that although the original version of the EPC had barred the grant of patents for methods of therapy, surgery or diagnosis applied to the human or animal body on the basis of the legal fiction that such methods were not industrially applicable, this was never the real reason and the 2000 amendments to the EPC had abandoned this pretence and accepted that the real reasons for the exclusions were of a socio-ethical nature relating to questions of public health. The 2000 amendments had also changed the way in which protection for such inventions could be claimed by expressly providing for use-limited product claims in the last part of Article 53(c).
In Case G2/08, the claim before the Enlarged Board was a Swiss-form claim relating to:
use of nicotinic acid or certain of its metabolites for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep of hyperlipidemia .…
The Examining division had rejected the claim on the basis that the claim did not specify a new disease, a new patient group or a new route or mode of administration, these being the recognized categories of invention for which Swiss form protection was permissible. The applicant appealed. The technical board of appeal took the view that there was an important issue of law to be decided (there have been conflicting decisions by various appeal boards on what types of features can be used to impart novelty to a Swiss form claim).
The Enlarged Board noted that under the transitional provisions implementing the 2000 changes to the EPC, it had to apply new Article 54(5) to the situation. This provides that novelty is not lost by prior disclosure of a substance or composition claimed for “any specific use” of the substance or composition as a treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body (which methods are themselves not patent-eligible) unless that prior disclosure is for that specific use.
This therefore provides patent protection by use-limited claims of substances or compositions already known as medicines provided that the use set out in the claim is specific and not comprised in the state of the art. The Enlarged Board noted that the EPC does not define the degree of distinctiveness the new use is required to have to qualify as a “specific” use under this provision. It also noted that “any” specific use could qualify.
Based on these observations, the Enlarged Board reformulated the main question put to it as “Is a new use, deserving of patent protection, of a per se known medicament, necessarily restricted to a disease not yet treated by said composition?”
After a review of the legislative history, the Enlarged Board concluded that the specific use referred to in Article 54(5) should not be limited to a “new disease”.
The Enlarged Board then had to decide what did qualify as a new specific use. The Enlarged Board noted that prior case law had permitted Swiss form claims in cases where novelty lay in the novelty of a group of subjects being treated, new rotes or modes of administration and different technical effects leading to a “truly new application”. The Board indicated that such uses should also provide basis for novelty for use-limited product claims. It went on to state “there is no reason to give a feature consisting of a new dosage regime of a known medicament a different treatment than the one given to any other specific use acknowledged in the case law.” Hence novel dosage regimes could in principle impart novelty to a use-limited product claim. However, since grants of patents in this form could provide a tool for ever-greening, care had to be taken that the dosage regime claimed was not only “verbally different from what was described in the state of the art but also reflect a different technical teaching”. When examining applications in which novelty was based on the dosage regime set out, the presence of a new technical effect could be a key issue in determining whether the claimed invention possessed an inventive step.
Finally, after having noted that use-limited product claims as permitted by the 2000 Amendments of the EPC could give rise to broader protection than Swiss form claims, which perhaps national legislatures might look at, the Enlarged Board held that the reason for the legal fiction of Swiss form claims no longer existed and so held that as from three months from the date of the publication of the present decision in the Official Journal, Swiss form claims should not be permitted in new applications.
In Case 1/07, the claims before the Enlarged Board were to methods of imaging pulmonary and/or cardiac vasculature which included the step of “delivering polarized xenon 129″ to the region being investigated. It was accepted that such method might involve injecting xenon 129 into the heart.
Prior case law was spilt between cases that had held that virtually any intrusion into the body was a “surgical method” (and so excluded from patentability) and other cases that had held that only methods that were directly therapeutic were so excluded.
The first question addressed by the Enlarged Board was whether the presence of any surgical step (however that was defined) rendered the claim unpatentable as a surgical method. After noting that if the claim contained multiple steps, a surgeon would not infringe if he avoided the other steps and so it was arguable that the principle of maintaining freedom of action for the physician that underlay all of the limitations on protection for medical methods was met, the Enlarged Board rejected this argument and held that the legislator had intended to provide “medical and veterinary practitioners freedom to use the best available treatments to the benefit of their patients unhindered by any worry that some treatment might be covered by a patent” and the only way to do this was to exclude all methods involving a surgical step from patent eligibility. The Enlarged Board noted that such a principle also applies to methods of therapy.
The second question was whether only therapeutic surgical methods were excluded from patent protection. The Enlarged Board concluded that this was not the case. If it were, reference to methods of surgery in Article 53(c) would be redundant. The Enlarged Board also noted that health issues and the need to maintain a medical practitioner’s freedom to operate, arose with a number of surgical methods that were not strictly therapeutic including: cosmetic treatments, termination of pregnancy, castration (e.g. for sex change), sterilization, artificial insemination, embryo transplants, experimental treatments and organ, skin and bone marrow donor operations. On the other hand, it had been noted that a hair removal method using optical radiation had previously been found not to be excluded as a surgical method and this decision seemed reasonable.
The Enlarged Board noted that the current practice of the EPO in examining applications was to refuse methods that involve irreversible damage to or destruction of living cells as being surgical treatments precluded form patent protection irrespective of the underlying mechanism of intervention. The Enlarged Board agreed with the appellant that this was an overly broad exclusion “when considering today’s technical reality”. Many such techniques were now safely carried out in non-medical commercial environments such as cosmetic salons and beauty parlors and there was no justification to exclude such methods from patentability. The Enlarged Board specifically mentioned treatments such as tattooing, piercing, hair removal by optical radiation and micro abrasion of the skin as being treatments for which there was no good reason to deny patent protection.
Based on this reasoning, the Enlarged Board held that it was not possible to provide a bright line general definition of what was or was not a method of surgery. For the purposes of the present case, however, it would treat as a method of surgery as a method “encompassing an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which involves a health risk even when carried out with the required care and expertise”. More generally, the
“exclusion from patentability should not be applied to methods in respect of which the interests of public health, of protection of patients, and as a counterpart to that of freedom of the medical profession to apply the treatment of choice to their patients does not call for their exclusion from patentability.”
The Enlarged Board went on to consider the fact that in the claims before it, the delivering step did not specifically recite any invasive step. However, it concluded that since injection into the heart was one clear embodiment that did involve such an invasion, one could not avoid a prohibition simply by defining the invention at a greater degree of generality.
On the other hand, claims that recite a pre-delivered material or a pre-implanted device do not of themselves involve a surgical step. In such a case, however, it would be necessary to consider whether such a claim “fully and completely” defines the invention in question as is required by Article 84 when read in conjunction with Rule 43. This would be a factual matter in each case. What is clear, however, is that prior case law holding that it is permissible to claim methods of operating a device without any functional link between the claimed method and the effects produced by the device on the body even if the device was implanted by a surgical method remains good law.
Finally, the Enlarged Board pointed out that what is excluded from patentability is a surgical method as such and not a method that might be of use to a surgeon in carrying out his tasks. Therefore imaging methods of use to the surgeon were not excluded from patent protection as surgical methods if the criteria set out above relating to delivery of the imaging agent were met.