DALLAS A patent is a government grant for a "monopoly" of limited duration conferring the right
to exclude others from making, using or selling an invention within a national territory.
While patent laws vary from country to country, an invention is generally patentable if it is novel,
useful, not obvious, and if it fits within statutes defining subject matter categories of protectable
inventions. A considerable amount of controversy in international patent law involves variations,
from country to country, in the definition of patentable subject matter. One such controversial
patentable subject matter area is medical procedures.
Some countries permit patenting of a medical device, but not a procedure involved in using the
medical device. In the Agreement on Trade-Related Aspects of Intellectual Property rights (TRIPS),
Section 5, Article 27 defines Patentable Subject Matter. Members of the TRIPS Agreement "may
. . . exclude from patentability . . . diagnostic, therapeutic and surgical methods for the treatment of
humans or animals."
Both medical devices and procedures are considered patentable subject matter in the United States.
The American Medical Association (AMA) recently lobbied to have medical professionals declared
immune from liability for patent infringement of medical method patents.
In response, the Patent Act was amended via the Omnibus Budget Reconciliation Act of 1996, in
September of 1996. The 1996 amendment specifies the scope and application of enforceability of
medical procedure patents, and is still subject to varying interpretations.
The amendment to the Patent Act provides a limited exemption to a medical practitioner for liability
stemming from performing a patented medical activity.
Thus, while a doctor may infringe a patent for a medical activity (procedure),
the medical practitioner is exempt from liability. However, a manufacturer of
the medical device used in the infringing use may still be held liable for contributory
infringement for actively inducing a doctor's infringement of a medical procedure
patent.
This limited exemption of liability for patent infringement of a medical activity has a few caveats, and an interpretation of the Act's terms is required. The term "medical activity" includes the performance of a medical or surgical procedure on a body; however, the term "medical activity" is expressly defined to not include "the use of a patented machine, manufacture, or composition of matter in violation of such patent." This means that if the medical machine or article of manufacture itself is patented, the medical activity does not fall under the exemption, and the doctor is liable for infringement.
Moreover, the term "medical activity" is defined to not include, "the
practice of a patented use of a composition of matter in violation of such patent."
In this section of the Code, the practice of a patented use of a patented machine, manufacture or
composition of matter is not explicitly set forth.
Therefore, it might be assumed that a doctor remains exempt from infringement of a patented medical
activity, depending on the definition of "composition of matter." An analysis of what constitutes a
"composition of matter" is therefore required.
The term "patented use of a composition of matter" is defined to not include "a claim for a method
of performing a medical or surgical procedure on a body that recites the use of a composition of
matter where the use of that composition of matter does not directly contribute to achievement of the
objective of the claimed method."
This definition implies that if the use of the composition of matter
directly contributes to achievement of the claimed method, then the method is
not considered to be entirely a medical activity use.
In this case, practicing the method constitutes combining a procedure and a composition of matter,
and the doctor would not be shielded from liability under the 1996 amendment.
Some case law has adopted the usual definition of a "composition of matter" to be the resultant
composite material from the mixture of two or more ingredients.
However, the Supreme Court has defined a composition of matter to include "all composite articles,
whether they be the results of chemical union, or of mechanical mixture, or whether they be gases,
fluids, powder or solids."
This definition may be viewed as expanding the definition of "composition of matter" to include any
pharmaceutical or medical device. If this interpretation prevails, from a patent practitioner's
standpoint, to ensure enforceability of method claims, structure that meets this definition of a
composition of matter should be included in method claims. Even a more narrow interpretation of
what constitutes a "composition of matter" does not prevent patent owners from obtaining damages
from medical device manufactures for contributory infringement.
With emphasis, manufacturers of medical devices are not immunized from
liability for infringement based on the limited exemption of liability afforded
to medical practitioners and health care entities. The Code states "whoever
actively induces infringement of a patent shall be liable as an infringer,"
and "whoever offers to sell or sells within the United States or imports into
the United States a component of a patented machine, manufacture, combination
or composition, or a material or apparatus for use in practicing a patented
process, constituting a material part of the invention, knowing the same to
be especially made or especially adapted for use in an infringement of such
patent shall be liable as a contributory infringer."
To be successful, an action for either inducement of infringement or contributory infringement, direct
infringement must still first be shown, such as a doctor's infringement, even if the doctor is exempt
from liability.
In conclusion, the 1996 amendment to the Patent Act provides only a limited shield to liability for
medical practitioners and a few related entities who may infringe on a medical procedure patent.
However, there is no liability exemption for manufacturers of medical devices, particularly those
manufacturing and inducing the use of medical devices in an infringing method of use.
Manufacturers of medical devices may still be sued for contributory infringement
in the United States if direct infringement is shown. Also, patent holders still
profit from patents having claim language that protects novel uses of medical
products, including method claims that do not fall within the definition of
"medical activity."
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.