Second Medical Use

Claims In Europe

Second medical use claims including a novel treatment regime are attracting controversy in Europe both in terms of whether they should be granted and whether courts should enforce them. The following case sheds a little more light on the issue.

The Technical Board of Appeal (TBA) of the European Patent Office (EPO), in Decision T 1020/03, held that second medical use claims whose novelty lies in a treatment regime should be patentable.

This particular case concerned the finding that a patient with a chronic disease, such as chronic renal failure, could be treated more effectively with insulin-like growth factor-1 (IGF-1) if exposed to cycles of treatment, as opposed to continuous treatment.

The claims were drafted as second medical use claims but included a cyclical treatment regime. They were rejected by the Examining Division which considered "The prescribing and modification of drug regimes … appear to be part of the typical activities and duties of the Doctor in attendance in exercising his professional skills in curing, preventing or alleviating the symptoms of suffering and illness." They were therefore rejected as being non-industrial medical activities falling within Article 52(4) EPC.

The applicant argued that the treatment regime was novel and that it provided for long-term therapy with reduced side effects which, in turn, brought about a potential increase in the market for IGF-1.

The TBA held that the claims were allowable because:

  1. Given the claims were in a Swiss format, the patent proprietor would only have a remedy against the maker or dealer of the composition that was to be used in the relevant treatment; the use of the composition for therapies was not covered by this claim format.

  2. The Enlarged Board of Appeal Decision G5/83, which established second medical use claims, said that "if the therapeutic application was novel and inventive, then a patentee could obtain protection for the use of a composition for making a medicament for use in this therapy even though the only novel feature was the therapy which itself was a non-commercial and non-industrial medical activity".

  3. The TBA considered it appropriate to "choose a broad interpretation (of the relevant exclusion) which does not require any restriction of the area where novelty can be looked for".

  4. "The fundamental considerations moving the Board, namely that any invention in the pharmaceutical field is in essence a new method of using a composition in a therapeutic treatment, and that any ingenious chemistry is merely incidental to this use. Use of any composition at a low enough level is likely to have negligible effect for good or ill, whereas use at too high a level may lead to severe ill effects, or possibly a fatality. An invention lies in finding the use (including both level of dose and the form of application) where at least some types of patient will receive a net benefit from application of the composition."

  5. "The marketing of pharma-ceuticals is tightly controlled within the EPC Contracting States by the relevant control authorities, including for the EU, the European Medicines Agency. This means that for most pharmaceuticals it can be established for what therapeutic treatment they are marketed. This makes it practicable to grant patent rights with Swiss form claims which are enforceable against identifiable suppliers of an old substance for a specific new therapeutic use, but not against the persons ultimately responsible for this use, the physicians. The Board does not see Swiss form claims, even when they refer to steps to be taken by a physician, as interfering with the liberty of the physician to do the best for the patient, but only as restricting the purpose for which suppliers may act freely."

The case also included a discussion of national decisions within EPC Contracting States and noted a divergence of view. In the UK, the House of Lords has yet to express its views on second medical use claims that are drafted in the form of a particular treatment regime. This decision will therefore be reported in a future newsletter.

We conclude this article with Judge Jacobs’ (as he was then) comments on second medical use claims whose novelty is defined by a treatment regime. "Patents are provided to encourage research. If new and non-obvious improved methods of administration of known drugs for known diseases are not patentable in principle – even with a Swiss form claim, then there will be less of a research incentive to find such methods."

Snippet: On 1 July 2007 Alison Brimelow CBE, previous Comptroller of the UK Patent Office, took over as President of the European Patent Office. During her time at the UK Patent Office, Alison made significant improvement in terms of organisation and efficiency and was both admired and respected by her colleagues. We wish her well in her new post.

Fast Track Europe

The European Patent Office is currently piloting a fast track scheme whereby European patent applications claiming priority from searched UK patents undergo an expedited procedure. Germany, Denmark and Austria are also participating in the pilot project with a view to determining whether better use of national searches can expedite procedures for at least some applicants at the European Patent Office.

Snippet: The Norwegian Parliament will ratify and accede to the European Patent Convention. It will become a member of the EPO at the beginning of next year.

Snippet: With effect from 1 July 2007 Sweden has notified the International Bureau that the time limit for entering the National Phase before it as a designated or elected office is 31 months. This means that the only States that do not yet apply the 30 month time limit for entering the National Phase under Chapter I, as fixed in PCT Article 22, are Switzerland, Luxembourg, Tanzania and Uganda.

Referrals To The Enlarged Board Of Appeal

There have been a number of referrals to the Enlarged Board of Appeal which concern the interpretation of the European Patent Convention as it applies to our field.

The first one concerns Article 53(b) which says:

European Patents shall not be granted in respect of:

(b) plant or animal varieties are essentially biological processes for the production of plants or animals; this provision does not apply to microbial processes or the products thereof.

The referring Board found that the correct interpretation of Article 53(b) has yet to be determined and posed the following two questions for the Enlarged Board to consider.

  1. Does a non microbial process for the production of plants which contains the steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, an additional feature of a technical nature?

  2. If question 1 is answered in the negative, what other relevant criteria for distinguishing non-microbiological plant production processes, excluded from patent protection under Article 53(b) EPC, from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

The case that led to this referral concerned a method of producing broccoli having elevated levels of glucosinolates, a class of compounds with anti-cancer potential.

The second case referred the following points of law to the Enlarged Board of Appeal.

  1. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04), which comprises or encompasses a step consisting in a physical intervention practised on the human or animal body (in the present case, an injection of a contrast agent into the heart), to be excluded from patent protection as a "method for treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if such step does not per se aim at maintaining life and health?

  2. If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?

  3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) to be considered as being a constitutive step of a "treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if the data obtained by the method immediately allows a surgeon to decide on the course of action to be taken during a surgical intervention?

Referrals such as these are clearly welcomed by members of our profession, because the resultant decisions (to be reported in due course) enable us to advise clients with greater accuracy.

Snippet: With effect from 2 April 2007 the UK Patent Office changed its name to the UK Intellectual Property Office.

The Thorny Issue Of Added Matter

A recent case in the UK High Court, European Central Bank v. Document Security Systems Inc reminds us about the dangers in the UK (and EP) of amending patent claims to refer to integers that are not explicitly disclosed in the original application and thus invalidating the patent document.

The judge for this case, Kitchen J, stressed that "the (added matter) test is merely whether the alleged added matter goes beyond what was disclosed in the application. The fact that the alleged matter would be obvious based on what was disclosed is of no help to a patentee if there was no actual disclosure".

Helpfully, the Judge set out six guidance points on making an added matter analysis.

  1. The Court must construe both the original application and amended specification to determine what they disclose. For this purpose, the claims form part of the disclosure.

  2. The exercise must be carried out through the eyes of the skilled addressee, who will approach the documents with the benefit of the common general knowledge.

  3. The two disclosures must be compared to see if any relevant added matter has been added. This comparison is strict, and matter will be considered "added" if it was not clearly and unambiguously disclosed in the filed application.

  4. Both the express and implicit disclosures are relevant.

  5. Only subject matter relevant to the invention is a problem. The provision is aimed at preventing the applicant from obtaining an unwarranted advantage by extending the application as originally filed, and also to protect third parties who rely on original disclosure to judge the scope of the granted monopoly. If the feature merely excludes protection for part of the subject matter of the claimed invention as covered by the application as filed, then these principles are not offended against.

  6. Hindsight must be avoided. Therefore, it is appropriate to view the disclosure through the eyes of a skilled person who has not seen the amended disclosure and does not know what he is looking for.

Unity Of Invention

We are reporting the following TBA case on unity of invention because quite often the European Patent Office, in its capacity as International Searching Authority, raises a unity issue against a set of claims and invites an applicant to pay additional search fees.

Where the unity issue seems ill-founded, it is possible to pay additional search fees under protest and so have the issue of unity re-examined. However, there is a feeling that overturning the initial ruling is an uphill struggle. The following case demonstrates some success.

The claims at issue are second medical use claims (a popular format in this Newsletter). Claims 1-48 concerned

Use of a secretagogue compound or a pharmaceutically acceptable salt thereof for the preparation of a medicament for the stimulation of appetite, food intake and/or weight gain in an individual suffering from liver failure.

Claims 49-67 concerned

Use of a secretagogue compound or a pharmaceutically acceptable salt thereof for the preparation of a medicament for the stimulation of appetite, food intake and/or weight gain in an individual suffering from renal failure.

On first inspection the unity issue seems justified.

However, the ISA raised the unity issue on the basis that the common concept pertaining to the two claims, i.e. use of a secretagogue for the stimulation of appetite, food intake and/or weight gain in an individual suffering from liver failure or renal failure, was known having regard to D1. Since the common concept was not novel, there was a lack of unity.

Under review, D1 was said to describe secretagogue compounds and give a detailed list of their use including treating renal failure resulting in growth retardation; reducing cachexia and protein loss due to chronic illness such as cancer or AIDS.

However, it was decided that in order to assess the novelty of the claimed subject matter, it is not permissible to combine separate uses belonging to different embodiments. In particular, the described use of the secretagogue compounds, in D1, for reducing cachexia due to chronic illnesses such as cancer or AIDS may not be combined with the use of secretagogue compounds in patients with renal failure in order to arrive at the conclusion that reducing cachexia in patients with renal failure is also disclosed, thus this combination is not directly and unambiguously derivable from the documents.

Accordingly, the Board of Appeal considered that the claimed subject matter was novel over D1 and that the issue of inventive step would require a detailed discussion with the applicant. In the circumstances, the requirement of unity was said to be met and both the additional search fee and the protest fee was refunded.

This case therefore illustrates that it is possible to overturn decisions concerning unity of invention and that, as always, the devil is in the detail.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.