No claim, no gain; Swiss claim, now lame

Here are a couple of patent decisions from England and Wales last week, both of which were first picked up by the subscription-only LexisNexis Butterworths service but have since been posted on BAILII.

R (on the application of Knight) v Comptroller-General of Patents, Trade Marks and Designs [2007] EWHC 2264 (Admin) was a decision of Mr Justice Kitchin sitting in the Queen’s Bench Division (Administrative Court) last Tuesday, 9 October 2007. Knight filed with the UK Patent Office (as receiving office) a patent application under the Patent Co-operation Treaty (PCT), via his patent attorneys whose cover letter stated that they were filing a total of 14 sheets of paper, including two pages of claims. The Patent Office only received 12 sheets, on receipt of which it concluded that the two sheets of claims had been omitted and that the application had not therefore contained a part which, on the face of it, appeared to be a claim or claims, contrary to art 11(1)(iii)(e) of the PCT. Knight was told about this apparent defect and was invited to respond. What he did was to request that either (i) a section of text headed ‘Abstract’ be considered as a claim or (ii) that a numbered list concluding the section of the text headed ‘Description’ be treated as a set of claims. The Patent Office refused both these requests. At a subsequent hearing, Knight's requests were refused, so he sought judicial review of that decision.

In his application for judicial review Knight said that either (i) the Office had erred in law in determining that the application contained no claim or claims or (ii) the hearing officer's decision was irrational. Article 11 of the PCT imposed upon the receiving officer an obligation to determine whether an application contained a part which, as a matter of substance, was or could be a claim and then to ask itself whether that part could be identified without undue burden. For the record, what Article 11 says is this:

"(1) The receiving Office shall accord as the international filing date the date of receipt of the international application, provided that that Office has found that, at the time of receipt …

(i) the applicant does not obviously lack, for reasons of residence or nationality, the right to file an international application with the receiving Office …

(ii) the international application is in the prescribed language …

(iii) the international application contains at least the following elements …(e) a part which on the face of it appears to be a claim or claims".

Kitchin J dismissed the application for judicial review. In his view it was clear that the role of any PCT receiving office was to check that the application was in order: it had to be in an appropriate language and it had to contain the various essential elements of an application. This was not a duty of search or examination but merely clerical function that ensured the various formal requirements had been met before the examination went to the search and examination stages. In this case the receiving office had properly carried out its Article 11 functions and the Office was right to refuse Knight's request that passages under the headings ‘Abstract’ and ‘Description’ be treated as a claim. There was therefore no error of law or act of irrationality for the court to rectify.

The IPKat sympathises with the applicant in this case: if something can be identified as a "claim", then there is at least a PCT application and the claims can be amended later, but if there are no claims there is no application at all. It's also harsh on an inventor whose ability to secure legal protection and thus a basis upon which he can secure working capital or the cooperative interest of others depends on apparently arbitrary rules over which he has little control. It's even tougher where, as in this case, the description of the invention in the abstract does give a fairly good idea of what's being claimed. However, the judge's decision - like that of the Patent Office itself - appears correct as a matter of law and must be taken as a reminder to applicants and their advisers that they can never be too careful when complying with bureaucratic requirements. Merpel adds: given that the Patent Office is only acting as a sort of post office for the PCT application, rules such as Article 11, as applied in this case, are there as much for the Office's own convenience and protection as a way of putting stumbling-blocks before patent applicants.

Teva Pharmaceutical Industries Ltd and another v Merrell Pharmaceuticals Inc, Aventis and Sepracor [2007] EWHC 2276 (Ch) was a Patents Court decision of Mr Justice Warren last Friday, 12 October 2007.

Merrell held a patent for terfenadine (right), an anti-histaminic drug with the generic name fexofenadine which, when taken, produced an acid metabolite inside the human body. Aventis and Sepracor owned two other patents which related to the use of the acid metabolite itself, rather than terfenadine, to make a medicament for use as an anti-histamine and to treat allergic rhinitis and urticaria. Teva, a generic pharmaceutical manufacturer which wanted to sell generic fexofenadine hyrdochloride in the UK, sought declarations that the patents were invalid for lack of novelty over, inter alia, a US patent and also for lack of inventive step.

According to Teva, in 1992, when Merrell's patent had been about to expire, it was plain that the acid metabolite was sufficiently effective and safe to be used as an anti-histamine. Merrell however argued that it was inventive to administer the acid metabolite rather than terfenadine, since this avoided observed side effects of terfenadine which included cardiac arrhythmia in patients with impaired liver metabolism or who had taken excessive doses of terfenadine.

Warren J granted Teva the declarations it sought, the patents being neither novel nor possessed of inventive step. The vast bulk of the judgment is comprised of the close analysis and evaluation of technical evidence, but the IPKat notes that Warren J has helpfully summarised the current, somewhat parlous state of Swiss claims as follows (at paragraphs 23 to 33:
"Swiss form claims

It will be seen that most of the Claims are in "Swiss form" ...

Sections 4(2) and 4(3) of the Patents Act 1977, which are derived from Article 52(4) of the Convention on the Grant of European Patents (the European Patent Convention) ("EPC"), state:

"(2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application.

(3) Subsection 2 above shall not prevent a product consisting of a substance or composition being treated as capable of industrial application merely because it is invented for use in any such method."

Section 2(6) of the 1977 Act, which is derived from Article 54(5) of the EPC, states:

"(6) In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art."

The result is that it is possible to obtain a patent for the first medical use of a known substance or composition, where this substance or composition was not previously known to have any medical application: see Sopharma SA's Application [1983] RPC 195.

Owing to the prohibition on method of treatment claims in Article 52(4) of the EPC (which corresponds to sections 4(2) and 4(3) of the 1977 Act), the Enlarged Board of the European Patent Office has held that a European patent may not be granted for the use of a substance or composition for the treatment of the human or animal body by therapy.

However, it has also accepted, on policy grounds, and following the practice of the Swiss Federal Intellectual Property Office, that a European patent may be granted with claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application. This gave rise to the now widely used form of the second medical use, or so-called "Swiss form" claim: see Eisai/Second Medical Indication (1985) OJEPO, 64 ("Eisai").

Accordingly, a claim in the form: "Use of [X] for treatment of [Y]" would not be accepted, whereas a claim "Use of [X] for the manufacture of a medicament for treatment of [Y]" would be accepted. It might be noted that the feature supporting novelty and inventive step is the new treatment; nonetheless the Swiss form claim itself covers the use in preparation of the medicament in question, not the use of the medicament for the novel therapy.

The leading case under English law in relation to claims in the Swiss form is the decision of the Court of Appeal in Bristol-Myers Squibb v Baker Norman [sic] [2001] RPC 1. This case concerned a novel dosing regime rather than a new therapeutic application. ...

In summary, the Court of Appeal held that, in so far as Swiss-type claims were permissible at all, they must be limited to a therapeutic application which was not only inventive but new; novelty must reside in the new second, or subsequent, therapeutic use. In other words, the novelty must lie in a new application (ie the known compound is to treat an additional disorder or prevent a disease rather than cure) not in an improved use in the method of administering an existing treatment.

Mr Waugh points out, however, that the Technical Board of Appeal in the EPO has recently interpreted the Eisai decision differently to the Court of Appeal in Bristol-Myers and expressly declined to follow it. He says that the law in this country is now out of step with the EPO. In the light of the observations of the House of Lords to the effect that even decisions of the EPO, and a fortiori of the Technical Board of Appeals, are to be regarded as of great persuasive authority, it is said that I should not follow Bristol-Myers.

I do not consider that it is open to me to depart from the decision in Bristol-Myers which is a carefully considered and argued decision of the Court of Appeal. It is for that Court to consider whether its earlier decision should be departed from in the light of developing case-law in the EPO".
No claim, no gain; Swiss claim, now lame No claim, no gain; Swiss claim, now lame Reviewed by Jeremy on Monday, October 15, 2007 Rating: 5

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