Dear Sirs,

I have a question regarding patents of medical/chemical use and especially the claims stated in them. If one seeks to obtain a patent about the production or use of a chemical compound for which he states in the "claims" section that it has some pharmaceutical action (e.g. it reduces tumors, fights cancer, it is immunostimulative etc), do you verify these claims by searching for published clinical trials, double-blind randomized control studies etc. that support these claims and grand the patent? In other words, does owning a patent for something mean that it actually works?

Sincerely
George Moustris

Dear Mr Moustris

Thank you for your e-mails of 31 January and 5 February 2007 concerning pharmaceutical patents. Your correspondence has been passed on to me for a more detailed response, as I am a patent examiner working in the biotechnology and pharmaceuticals area, and author of our Examination Guidelines for Patent Application for Patent Applications relating to Medical Inventions, available online here: http://www.patent.gov.uk/medicalguidelines.pdf

You asked whether a patent which contains claims which indicate a medical activity for a drug or composition are an indication of scientific or clinical validity. I should first explain that the claims of a patent define the scope of the monopoly that the applicant seeks to protect; they are not assertions as to the effectiveness of the invention. It may help to give some background about medical and pharmaceutical patents, and the types of claims that may be granted. If the applicant has invented a wholly new substance, then the claim may simply be of the form:

“A compound of the formula X”.

Alternatively, the invention may relate to the use of a known substance in medicine, where that substance has not previously been used in medicine. The patent application may then include what are known as “first medical use” claims, of the form:

“Compound A, for use in therapy” or

“Compound A, for use in the treatment of cancer”.

Finally, the invention may relate to the use of a known drug, to treat a different disease. An example of this would be the case of aspirin, which was known for many years to be a painkiller, but was more recently discovered to be useful in treating heart disease. Claims of this type are known as “second medical use” claims, and have a rather convoluted wording, of the form:

“The use of compound A in the manufacture of a medicament for the treatment of cancer”.

These categories are not mutually exclusive, and patents will often include all of these types of claim.

As stated in the response from the Central Enquiry Unit, all patents must be new, inventive and capable of industrial application. In addition, all patent claims must be supported by the description; that is there must be sufficient description to enable the skilled person to perform the invention. In the case of medical inventions with first or second medical use claims, it is our practice (endorsed by UK court decisions) that the patent application must include evidence that the substance in question is (or at least is likely to be) effective for the specified use. If there is no such evidence, then it is considered that the claims are not supported by the description. However, there is no requirement for full clinical trials; the evidence may include, for example, lab-based evidence on cultured cells or other tests carried out in vitro or in vivo. Moreover, although the patent examiner will examine the application to ensure that this requirement is met, this is not the equivalent of the peer-review process of academic journals. The purpose of this requirement is to prevent speculative patents, with no basis in evidence, which might inhibit research and development in this field. It is not intended to restrict the granting of patents to substances and treatments which have been clinically proven to be effective. Indeed, pharmaceutical companies typically apply for patent protection for a large number of promising potential new drugs, of which only a small proportion successfully go through all the stages of development and trials to go on to commercial production.

A granted patent gives the inventor a short term monopoly in return for allowing the invention to be made public, as explained in the earlier e-mail from the Central Enquiry Unit. The award of a patent has no bearing on whether a drug may be used by doctors or sold to the public, or whether it can be advertised or marketed as being effective for the treatment of a particular disease. The purpose of a patent is to enable the inventor to protect his or her invention; it is a property right of commercial value if the product is a success. It does not provide proof of clinical effectiveness or safety. To prove the efficacy and safety of a medicine, it must meet stringent EMEA/MHRA (European Agency for the Evaluation of Medical Products/Medical and Healthcare products Regulatory Agency) tests and approval before it can be marketed. This process generally takes place after filing of a patent application, and is entirely independent of the patent examination process. I hope this is helpful; please do not hesitate to contact me if you have any further questions.

Yours sincerely

Richard Sewards
Patent Examiner
Tel 01633 813536