Methods of Medical Treatment
Methods of medical treatment of humans have long been considered patentable in Australia and the United States; however most other jurisdictions, including Europe, do not allow such claims. This general prohibition against patenting methods of medical treatment of humans poses a challenge for Medtech companies in building an effective international patent portfolio where protection is sought for a known compound where novelty lies in its new use. Unlike novel compounds which may simply be protected by claims to the compound itself, claims must be directed to the new use. In this article, we explore the law with regard to patentability of methods of medical treatment of humans in a few key jurisdictions.
The Australian Patent Office has accepted the patentability of methods of medical treatment of humans since the early 1970s. Previously, such methods had been regarded as being "generally inconvenient" and "non economic".
The relaxation of judicial attitudes to methods of medical treatment in the 1970s is reflected in the High Court decision in Joos v Commissioner of Patents (‘Joos’), a case concerning a method of improving the elasticity of human nails and hair through the application of a chemical compound. It was held that a method of cosmetic treatment was inherently patentable by reason of its commercial significance.
The patentability of methods of medical treatment was again considered in 1994 by the Full Bench of the Federal Court in Anaesthetic Supplies Pty Ltd v Rescare Ltd. (“Rescare”), a case concerning a method for the treatment of sleep apnoea. While the method of treatment of the human body was found to be invalid on other grounds, the Court held that there was "no justification in law or logic" to distinguish a process of curative treatment of the human body from that of cosmetic treatment, and that both of these forms of treatment constitute patentable subject matter provided they have commercial application.
In 2000, the Full Bench of the Federal Court in Bristol-Myers Squibb Company v FH Faulding & Co. Ltd reconsidered Rescare and affirmed that methods of medical treatment of humans are patentable in Australia.
The European Patent Convention (EPC) excludes "methods for the treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body" from patentability. The reason for this exclusion is the belief that public health would be at risk if patent rights could be used to impede physicians in the normal course of practicing medicine. However, this exclusion does not extend to known compounds or compositions for use in the treatment methods.
The inventor of the first use of a known compound for a therapeutic treatment can obtain claims covering all therapeutic uses, in other words protection for a generic medical use. This type of claim is referred to as the "first medical use claim" and takes the form:
[Known compound or composition] for use as a medicament or as a therapeutic substance
The situation is more complex when the invention lies in the finding that a known compound which has already been used for a therapeutic purpose (first medical use) can be used to treat a different disease or disorder. An example of this is Aspirin. First, Aspirin was used to treat pain, then it was discovered that it could also be used in the treatment of cardiovascular disease. Until recently, European patent law enabled protection of such a "second medical use" invention by way of a "Swiss-type" claim which takes the form:
[Known compound or composition] for use in the manufacture of a medicament for the treatment of [new disease]
A recent European decision (G 2/08) provides that where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of the Swiss-type claim. This is due to the absence of any functional relationship of the features conferring novelty and inventiveness (i.e., the new therapeutic use) and the claimed manufacturing process. Instead, the "first medical use" form of claim must now be used, allowing claiming of second or further medical uses in a less convoluted manner. Such a claim would take the form:
[Known compound or composition] for use in [new therapeutic use]
Importantly, this decision confirmed that second and further medical uses are not restricted to the treatment of a different disease or disorder but are directed to "any specific use" including a new dosage regime of a known therapeutic compound, a novel group of subjects to be treated, or a new route or mode of administration.
The United States Patents Act does not exclude methods of medical treatment of humans from patentability.
The United States Patent Office allows medical use claims as long as the steps are recited. For example, a claim for use of a known compound in the manufacture of a medicament will be rejected unless the steps involved are recited.
Since July 1996, medical process patents have not been enforceable against medical professionals who infringe while performing a medical or surgical procedure but this exemption does not extend to methods of treatment using pharmaceutical compounds or compositions.
In New Zealand, the Philippines, China, Japan, Israel and Canada, methods of medical treatment of humans are not patentable either. However Swiss-type claims may be allowed.
This article highlights that while methods of medical treatment of humans are excluded from patentability in many jurisdictions, claims may be devised to capture novel uses of known compounds.