Attorneys practicing in the medical-patent field routinely submit method-of-treatment claims for prosecution before the U.S. Patent and Trademark Office, as such are considered patentable subject matter under U.S. law. When drafting and enforcing such claims, however, patent practitioners should be aware of the "physician's immunity" statute in force in the U.S. since 1996, as the statute may prevent the enforcement of remedies for infringement of certain method-of-treatment claims against physicians and hospitals.
Under 35 U.S.C. 287(c), a medical practitioner who infringes a patent by performing a medical or surgical procedure on a human body (the Section also provides immunity for procedures performed on a nonhuman animal used in medical research or instruction directly relating to the treatment of humans) is immune from liability for that infringement, including freedom from injunctions, damages and attorneys fees. The immunity does not apply if the performance included the use of a patented product (machine, manufacture, composition of matter) in violation of patented claims to the product. While nicknamed to indicate physician's immunity, this statute provides immunity to non-physician medical treatment providers as well as health care entities related to the performance (e.g. hospitals). Section 287(c) also provides that immunity does not apply to certain device manufacturers, pharmacy or clinical lab services, or to US patents having effective filing dates prior to September 30, 1996.
U.S. law provides little guidance as to the metes and bounds of 35 U.S.C. 287(c). The legislative history of the statute provides some examples of intended application of the statute, for instance stating that a physician that transplanted a healthy heart into a cardiac patient using a conventional anesthetic would likely enjoy Section 287(c) immunity and not be liable for infringing a method claim covering the transplant procedure. The legislative history also states that if the method claim were directed to the use of a novel and non-obvious anesthetic, immunity under 35 U.S.C. 287(c) may not apply, and patent holders could receive traditional remedies for infringement.
The Supreme Court was given the opportunity to comment on subject matter that might fall under Section 287(c) in Laboratory Corporation of America Holdings v. Metabolite Laboratories, Inc., et al., 548 U.S. 124, 126 S.Ct. 2921 (US S.Ct. 2006). At issue was the validity of claim 13 of U.S. Patent No. 4,940,658, which reads as follows:
A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
Commentators hoped the Supreme Court would consider whether this diagnostic method claim would be considered protected medical activity under 35 U.S.C. 287(c), and whether physicians and hospitals may enjoy immunity from liability after infringing this claim. However, the Supreme Court dismissed the case on procedural grounds and did not consider 35 U.S.C. 287(c). Dissenting Supreme Court Justices commented that this claim should have been considered by the Court to make the public aware whether such a claim falls under 35 U.S.C. 287(c).
In Emtel, Inc. v. Lipidlabs, Inc., 2008 U.S. Dist. LEXIS 77597 (S. Dist. Tex. 2008), a district court discussed 35 U.S.C. 287(c) in some detail. In Emtel, the holder of U.S. Patent No. 7,129,970 alleged infringement of claims including a method claim self-categorized as a business method, directed in part to delivering medical services by having a physician diagnose medical problems from a distance. The alleged infringer filed a motion for summary judgment, requesting dismissal of the suit in part due to immunity as a provider of health services under 35 U.S.C. 287(c). The district court denied the motion for summary judgment under 35 U.S.C. 287(c), stating that the claims at issue were not infringed and therefore section 287(c) immunity did not apply.
Also, in response to the patent holder's assertion that the physician's immunity statute does not apply because "a Diagnosis is not a 'medical or surgical procedure,'" the Emtel Court noted that a procedure can refer to diagnosis in the medical field, citing medical dictionary definitions and reviewing legislative history records to rebut the patent holder's arguments. The Court also construed the phrase "the performance of a medical or surgical procedure on a body," suggesting that a diagnosing physician need not physically interact with a patient to deliver medical or surgical treatment under 287(c), and that a company providing communication links between physician and patient may qualify for 287(c) immunity.
General Recommendations
When drafting medical method claims for filing in the United States, we recommend considering whether the claims may fall under Section 287(c) (for instance, if they are directed to a medical or surgical method, or even a diagnostic method), and whether a potential infringer might be a physician or a hospital. Where Section 287(c) may be a later issue, we recommend that a claim set include claims having patented products and non-treatment steps where possible. Also, claims should be included in the application that will be geared toward manufacturers and others in the medical industry that do not qualify for 287(c) immunity.
We also recommend that patent litigators seeking immunity under Section 287(c) remember that the immunity likely only applies if infringement has been found. The statute does not prevent patent hol¬ders from alleging infringement or allow alleged infringers to avoid suit altogether. Rather, the statute provides immunity from the enforcement of remedies for infringement against medical practitioners and related health care entities.
Multiple forms of patent protection should be considered, including utility, design and plant patents. It may be that a design patent provides the only means of patenting the product, in contrast to patenting the use of the product during a medical or surgical procedure.
Further, global marketing of a new invention should be considered during the initial claim drafting of the US utility application. In particular, patent protection and enforcement of such claims are treated differently in various countries. For example, most foreign patent offices do not allow method-of-treatment claims, but rather require "use" style claims instead. Therefore, certain claims may be composed in the US application in anticipation of the subsequent examination in specific foreign patent offices.
Vol. 53, June 2010