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The norms of medical profession as articulated in
Hippocratic Oath and medical codes of ethics precepts that physician share medical knowledge for benefit of their patients and not for personal gain. Medical profession finds itself in a unique situation because it forms part of the scientific community where innovation is encouraged but it also specifically imposes a code of ethics on its members restricting them from patenting medical procedures. Patenting of medical treatment method is a burning issue in both the medical and legal communities. It has been remained argumentive issue in both communities too.
The main reason of prohibition of medical method
patent is based on ethical obligation and public health grounds. Approximately 80 countries around the globe prohibit methods of medical treatment from patent granted.
NEED FOR MEDICAL METHOD PATENTS
Inventing new methods of treating a disease is as vital as inventing new drugs and medical devices therefore, allowing the patents for drugs and medical devices and not allowing for medical methods is not justice. New medical methods are as valuable as drugs & other patentable subject matter. Following points depicts the need of medical method patent:
• New medical methods such as surrogate
embryo transfer, retinal implants and other
technology with medical treatment can be
developed only under a patent regime.
• New medical methods that integrate
technology require huge investment in
research which can be accomplished only
through protection provided by the patent
• The speed of invention of medical methods
which has been very slow compared to the
invention of drugs and medical devices which
are patentable can be boost only by allowing
them to be patented.
• Furthermore, incentive to promote the
development of alternative healing methods
such as acupuncture, ayurveda, and
homeopathy and so on whose development
has been kept from growing due to deficiency
of sufficient economic incentives can be
accelerated by allowing them to be patented.
American Medical Association Council on Ethical and Judicial Affairs is very concerned about the effects of patenting a medical method with regard to ethics inherent in the practice of medicine. (Ethical issues in the Patenting of Medical Procedures at page 341, Food and Drug Law Journal, 1998). AMA is bothered If medical methods are to be patented then following
consequences may be emerges:
• Responsibility of a doctor to make known
information about a medical method which
has been laid down under Principal V of the
Principles of Medical Ethics of AMA will be
restricted by the patent system.
• It will restrict clinical and academic access to
• Patenting a medical method will increase the
financial burden on the patient
• Patient confidentiality and privacy may be
hampered during the enforcement of patent
• Health care of the patient, which should be
the basic concern of the doctor, will be driven
by an economic motive if medical methods
All the concern articulated by AMA has other options that can be chosen to balance the dissent as mentioned below:
• By fixing royalty an economic motive of
doctor while treating a patient can be handled
by fixing royalty rate on licenses based on cost
of medical method used. For example, a
method of treating cancer can have a lower
royalty when compared to a method of plastic
• A compulsory licensing scheme can be
planned in force to ensure wide practice of the
• Patent system order to disclose the
information to obtain a patent therefore
duty of a doctor to disclose information will
not be affected .Because the AMA’s concern
that patenting a medical method hinders
clinical and educational access is not true
because patent system does not restrict
access; it makes it conditional on obtaining a
license. This condition is also only temporary,
as the method will fall into the public domain
after the patent term expires at that time
access is available to all.
• Subsidized treatments for patients who
cannot afford- Government by providing
subsidized treatment to poor’s can neutralize
the effect of the medical method patents. It is
also not completely true, as claimed by the
AMA, that new method reduces the overall
cost of the treatment.
• Legal sanctions or disciplinary actions can be
helpful in controlling doctors who violates
ethical norms by practicing methods for
OBSTRUCTIONS IN PROVING INFRINGEMENT
OF A MEDICAL METHOD PATENT
Generally, it is easier to confirm infringement for a drug or device patent because patentee can follow the sale or manufacturer of exacting drug or device. However with respect to medical method/treatment patent making it more difficult to prove that the patented medical treatment/method is being infringed.
One approach to prove infringement is to ask patients directly. This may not seem very supportive, especially if a patient is unwilling to speak or does not know exactly what surgical method was used. An alternative would be to get information from a patient’s operative report, which provides an in depth surgical report
indicating the procedure that was used on the patient.
However, a patient’s operative report is generally
confidential and not available to third parties. Hence only teaching of such medical methods through colleges or books can be checked or compensated and in individual cases it is not possible.
Alternatively, the patent holder can refer to insurance companies, clinics or health maintenance organizations, which maintain extensive patient records and statistics
on computer, to determine the method a physician used in a given surgical procedure.
ARE COSMETIC TREATMENTS COME UNDER
Purely cosmetic treatments of the skin and hair are patentable in UK. These may include cosmetic methods of strengthening hair and nails (following Joos v. Commissioner of Patents),3 and cosmetic methods to prevent hair loss. Methods of protecting the skin by simply blocking UV radiation are not considered to be therapy, but where a method includes a physiological effect then it is considered to be therapeutic (T1077/935). In this case the Technical Board decided that
the cosmetic and therapeutic aspects of the claimed method of protecting skin were “inevitably linked, such that each one necessarily develops together with the other and such that it is impossible to separate them”.
The argument that the treatment was effectively
directed towards natural ageing of the skin, and was therefore not therapeutic, was rejected on the grounds that “a natural process of cell degeneration loses its physiological normality when it develops in an abnormal manner, and in particular faster than its normal Process”. A similar view was taken by the Board of Appeal in T 67/02236 wherein “non therapeutic method of prevention of skin ageing was held (on the
facts of the case) to be inseparable from therapeutic effects acting on the skin. In the same case however, the use of the same agent to protect the lips (e.g. from sunburn) was held to be a purely cosmetic application with no therapeutic benefit. The use of a composition for the local treatment of comedones (blackheads) was
regarded as a cosmetic method of non-medical body hygiene, although when applied for the treatment of acne this would be regarded as therapeutic.
All skin treatment are not purely cosmetics. Some
people suffer from diseases like vitiligo or leukoderma, they get their skin grafted from one region to another region, and such treatments can be of both therapeutic as well as cosmetic importance.
Moreover in some countries fairness creams are popular and physician may develop some medical methods for fairness too. Now the question arises whether fairness treatment would be considered as patentable or not.
ALTERNATIVES TO BANNING THE PATENTING
OF MEDICAL METHODS
After all, without a patent option, the only alternatives left for a physician are to pursue disclosure through publication in academic journals, lecture at medical symposiums or keep the invention a trade secret. The preferential alternative is to improve the current patent law to include mandatory licensing of medical method patents.
Mandatory licensing system would enable a physician who patents a medical method invention to receive reasonable monetary benefits, while ensuring that other physicians who want to use the patented method are not barred from doing so. This royalty may reflect the fair market value of invention’s utility i.e. a price that the market will bear. Prohibiting unreasonably high royalties will force a physician to market the patented invention aggressively and a desire to profit will motivate the physician to do so on.
Number of granted patents is relatively rare, even in countries where patentability of medical method is allowed. One suitable reason for this may be difficulty in enforcement of such patents. Patentee would need to monitor the activities by a more or less large number of doctors and surgeons, who generally provide their services subject to strict privacy rules. Enforcement may be workable when new and complex methods are applied by a small group of easily identifiable professionals.
Legal system around the world permits granting of
patents for drugs and medical devices, at the same time, patentability for a method of treatment of the same body is denied in some countries on various public policy grounds. In order to make legal system more crystal clear, it is required to spotlight more on the public policy considerations and the impact of the patents of medical treatment on medical profession
and the public as a whole. It is up to the respective government and society to award incentive and appreciation to the Inventors. A legal committee should be established to consider such matters and give the necessary remuneration and recognition to one who deserves.