Author- Yashika Soni
INTRODUCTION
“Patenting methods of medical treatment of human beings is, however, a complicated issue for it
is not only based on patent law but also on medical law. Medical law has its origins in the
Hippocratic Oath, and the goal is the preservation of human life. Since the goal of patent law is
to encourage innovation by rewarding inventors, it is quite distinct from the goal of medical
law. Thus, there is a public policy concern that in order to ensure the best possible health
treatment, physicians must always be free in their choice of treatment.”1
In a time of rapidly evolving technology, innovation appears to be moving forward quickly.
Therefore, developing countries must create an administrative and legal policy framework that
effectively provides incentives to encourage innovation if they want to upgrade their logical and
mechanical foundations.2
SECTION 3 OF PATENT ACT, 1970 OF INDIA:
All non-patentable subject matter is listed in the Section 3 of Patent Act, 1970.3
Section 3(i) excludes from patentability “any process for the medicinal, surgical, curative,
prophylactic or other treatment of human beings or any process for a similar treatment of animals
or plants to render them free of disease or to increase their economic value or that of their
products”.
This clause prohibits methods used to treat not only humans but also animals and plants from being
patented. The terms used like “treatment”, including medical, surgical, prophylactic, curative, and
“other treatment” are too wide to interpret. Thus, it makes the extent of this exclusion very vast.
1 O Mitnovetski & D Nicol, ‘Are patents for methods of medical treatment contrary to order public and morality or
“generally inconvenient”?’, 30 J. Med. Ethics 470(2004), 471.
2 Aanchal Jain and Sheetal Singh Tomar, Crippling Effect of the Inadequacy of Patent Law on the Rise of the Internet
of Things, SCC Online.
3 Sec. 3, The Patent Act No. 39 Of 1970, INDIA CODE (2022).
Indian courts have not yet provided an interpretation on it. However, the Act has interpreted it on
numerous occasions.
The claim was relating to a method of repressing, delaying or otherwise reducing the expression
of a target gene in a
vertebrate cell by introducing one or more dispersed nucleic acid molecules. The Examine
r of Patent in the case of Benitec Australia
Ltd.4 held that “…for Section 3(i) to apply, all three criteria listed therein must be present and
satisfied. Therefore, the following must be satisfied:
(a)Any process for the medicinal, surgical, curative, prophylactic [diagnostic therapeutic] or o
ther treatment;
(b)The process or the treatment should be directed to either live human being or live animals; and
(c)The process or the treatment should such as to render either the human beings or animal
s free of disease or possessed of increased economic value for themselves or their products.
Even if one of the criteria were absent, Section 3(i) cannot apply.”5
In another application, it was disputed whether Section 3(i) applied to “a device for detection of
antibodies to HIV and p24 antigen of HIV in human serum or plasma”. The defendants claimed
that the applicant had camouflaged the device’s diagnostic function. The Examiner noted that the
invention in question was a device and not a technique or method for diagnosis or treatment.
Because of this, Section 3(i) was deemed to not be applicable and the rivalry argument was not
supported.6
4Patent Application No. IN/PCT/2000/00169/DEL decided on 31st March 2010.
5Ibid
6Patent Application No. 693/KOL/2007 decided on 11.01.2010
There have been other instances of interpreting the wide terms as mentioned above but as a result
of such an interpretation, a greater number of such inventions have been disqualified from
patentability.
A LOOK AT EUROPE’S DISTINCTION OF MEDICINE BETWEEN BEING A NOBLE
PROFESSION AND INDUSTRY:
According to Article 52(4) of the European Patent Convention, “methods of medical treatment”
are categorically excluded because they are not “susceptible of industrial application.”7
Some academics have questioned the validity of a justification that medicine is largely practised
under a “commercial” and possibly “industrial” context in a lot of countries.8
Meanwhile, others
have insisted that a separation still exists between the practise of a noble “profession” like medicine
and a “industry.”9
Chris Wadlow10 has provided the justifications for distinguishing features of the terms:
“…One of the distinguishing features of an organized profession is that its members are
subject themselves to a higher code of practice and honour than mere tradesmen, exemplified in
the case of medical practitioners by the so-called Hippocratic oath… The proposition that
medicine cannot simultaneously be a profession and an industry is consistent with the
treatment of patentability of methods of diagnosis, surgery and therapy… In historical as
opposed to functional terms the original European prohibition on patenting: “Methods of
treatment of the human or animal body by surgery or therapy and diagnostic methods practiced
on the human or animal body”, may plausibly be understood as turning on the status of
the professional practice of medicine (by both surgeons and physicians) rather than purely
7 Rudolf Kraβer,‘Purpose
and Limits of the Exclusion from Patentability of Medical Methods, Especially Diagnostic Methods’, cited in Pa
tents and Technological Progress in a Globalized World, (Springer Heidelberg, 2009), 275‐88.
8 O Mitnovetski & D Nicol, ‘Are patents for methods of medical treatment contrary to ordre public
and morality or “generally inconvenient”?’, 30 J. Med. Ethics 470 (2004), 471.
9 Chris Wadlow, ‘Regulatory Data Protection under TRIPS Article 39(3) and Article 10 bis of the
Paris Convention: is there a doctor in the house?’, 4 IPQ 355 (2008) 378.
10 Ibid.
on utilitarian consideration that the day to day practice of medicine should be kept free from
patent monopolies.”11
COMPARATIVE ANALYSIS – INDIA AND EUROPE:
The exclusion solely applies to medical and veterinary treatment procedures, as was mentioned in the earlier section. Consequently , it does not prevent any items employed in the performance of such procedures from being patented. Examples include drugs and medical devices, if other conditions for patentability are met, medical devices can be patented in Europe.12
CONCLUSION:
Contrary to Europe, where diagnostic methods as patentable subject matter have been the subject
of litigation in a significant number of cases, the scope of the patentability of diagnostic procedures
in India is still not well established due to a lack of judicial interpretation and the usage of wide
terms for exclusion. The capacity of the applicant to assert unique procedures and useful applications as opposed to results observation of biological or other physical effects using well-known techniques is crucial to the viability of patent claims on diagnostic methods. Given the diagnostic patents that have been issued in India, this suggests that not all patent applications for diagnostic methods will run into the Section 3(i) of Patent Act.13
11Chris Wadlow, ‘Regulatory Data Protection under TRIPS Article 39(3) and Article 10 bis of the
Paris Convention: is there a doctor in the house?’, 4 IPQ 355 (2008) 378.
12 Visx v. Nidek [1999] FSR 405, 465.
13 DPS Parmar, ‘The patent eligibility of diagnostic methods under an Indian spotlight’, at
