Primer on patenting methods of medical treatment in the United States and abroad

Paul S. Mazzola

People without expertise in intellectual property law often consider patentable inventions to be a feature of a product or the product itself; ie, the iPhone or self-driving cars. However, one of the principal categories of things that may be patented is a process or method. A method is a series of acts or steps, and a patent covering the method protects how the series of steps are carried out. Often, for example, patents with computer-implemented aspects protect the novel steps performed by the computer for the associated system to accomplish a result.

Of particular relevance to the medical community is the patentability of methods of medical treatment. In the United States, provided the method meets the other requirements of patentability (eg, novelty and non-obviousness), methods of medical treatment are patentable subject matter. For example, in the most recent posting of Intellectual Property Update, it was noted that the jury’s finding of patent infringement against Medtronic involved the methods of using a tool to de-rotate multiple vertebrae of an affected spinal segment (and not necessarily the features of the tool itself).

Internationally, however, the patentability of methods of medical treatment in several key jurisdictions is not permissible or less certain. In Europe, “patents shall not be granted in respect of methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body.” The patent laws make clear that the products, substances and compositions used in a method remain patentable, and it is less clear whether diagnostic imaging methods are patentable. Likewise, in Japan, patent claims directed to methods of medical treatment of humans are not allowable, and the patent laws of China state that no patent right shall be granted for a method of diagnosis or for the treatment of diseases.

Canada also prohibits obtaining a patent for a method that provides a practical therapeutic effect, such as curing, preventing or ameliorating an ailment or pathological condition, or treating a physical abnormality or deformity, such as by physiotherapy or surgery. Unlike Europe, in which efforts to draft the method using non-medical nomenclature are likely to be unsuccessful, Canadian law notes that “removal of the medical aspect of a [patent] claim may render the claim acceptable (ie, inclusion of terms such as “cosmetic,” “diagnostic,” or “non-medical”) so long as the result of the non-medical method cannot reasonably be said to produce a practical therapeutic effect.”

Lastly, in Australia, the Patents Act does not specifically exclude methods of medical treatment from patentability, and case law from the Australian High Court addressing the issue provided clear support for the practice of granting such patents. It is noteworthy that a distinction was contemplated between surgical methods of dosing pharmaceutical drugs.

The policy behind the prohibition of patenting methods of medical treatment are based, at least in part, on the public interest in physicians having unbridled access to advanced surgical and other medical techniques in a timely manner. Opponents argue that the physician should not fear patent infringement when caring for patents, and the practitioner should also be free from any conflicts of interest that may be associated with licensing a patent directed to one of several potential treatment modalities.

When developing new techniques for medical treatment, physicians should be mindful of the international landscape for protecting the methods of medical treatment through patents. At least in the United States, obtaining the right to exclude others from making, using, offering for sale or selling the patented method of medical treatment remains a powerful incentive for physicians to continue to innovate.

References:

35 U.S.C. § 101.

European Patent Convention, Article 53(c).

Chinese Patent Laws, Article 25, cl. 3.

Canadian Manual of Patent Office Protection (MOPOP), Section 17.02.03a.

Id.

See In re Kollar, 286 F.3d 1326, 1332 (Fed. Cir. 2002).

For more information:

Paul S. Mazzola, JD, an intellectual property associate with Howard & Howard Attorneys PLLC, can be reached at pmazzola@howardandhoward.com.

Disclosure: Mazzola reports no relevant financial disclosures. This article is for informational purposes, and is not intended to constitute legal advice.