Round Two: Madras High Court
Continuing from our earlier post where we discussed
rejection of beta-crystalline imatinib mesylate application by the Madras
Patent Office under S. 3 (d), we will now focus on round two where Novartis
approached the Madras High Court challenging constitutional validity of S. 3
(d). Before we discuss the judgment, a quick reading of S. 3 (d)
–
“mere discovery of a new form of a known substance which
does not result in increased efficacy of that substance or the mere
discovery of any new property or new use for a known substance or the mere use
of a known process, machine or apparatus unless such process results in a new
product or employs at least one new reactant.
Explanation: For the purposes of this clause, salts, esters,
ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known substance shall
be considered to be the same substance, unless they differ significantly in
properties with regard to efficacy.”
The Patent Office rejection particularly involved the
underlined portion of S. 3 (d) which Novartis in its appeal argued is vague,
arbitrary and unconstitutional. Novartis also argued that S. 3 (d) is
non-complaint with the TRIPS Agreement. The appeal was filed with the Madras High Court and was dismissed in August 2007.
TRIPS Compatibility
On TRIPS issue, the Madras High Court refused to address the
question and categorically cited lack of jurisdiction to decide the validity of
S. 3 (d) being in violation of Article 27 of TRIPS Agreement and further noted
that the proper forum to bring this issue would be the WTO’s Dispute Settlement
Body (DSB).
Constitutional
Validity
On Constitutional validity issue, Novartis argued violation
of Article 14 of the Constitution of India on the ground of vagueness,
arbitrariness and conferring un-canalised powers on the Patent Office. During
hearing, Novartis counsel particularly stressed upon that:
(1) in
the absence of proper guidelines as how to establish the enhancement of known
efficacy of a known substance, the Patent Office is vested with arbitrary
discretionary power to decide the enhancement efficacy.
(2) in
the absence of proper explanation and guidelines to the expression “enhancement of the known efficacy” and
“differ significantly in properties with regard to efficacy”, these expressions
stand ambiguous.
Opposing counsels, however, defended use of general
expressions and argued that the Legislature left these expressions for the
Patent Office to apply mind and decide whether the invented drug is within or
outside S. 3 (d) and further added that any fixed formula would be unwise and
humanely impossible.
The Madras High Court found none of Novartis arguments
persuasive and hold S. 3 (d) not in violation of Article 14 of the Constitution
of India. The High Court categorically relied upon (1) Medicinal Dictionary,
and (2) Parliamentary debate to come to a decision over Novartis arguments.
While addressing Novartis argument that S. 3 (d) stands
vague and ambiguous, the Court look into Dorland’s Medical Dictionary for the
meaning of the expression “efficacy” in the field of Pharmacology which defines
it as “the ability of a drug to product
the desired therapeutic effect” where efficacy is independent of the
potency of the drug. The court further noted the dictionary meaning of
“therapeutic” which defines it “healing
of disease – having a good effect on the body.” Taking both “efficacy” and
“therapeutic” definitions into account, the Court came with the observation
that the patent applicant is expected to show “how effective the new discovery would be in healing a disease/having a
good effect on the body?”
The Court further limited applicability of the Explanation
provided under S. 3 (d) to discoveries made in the pharmacology field. The
Court particularly found that the Explanation creates a deeming fiction of
derivatives of a known substance are deemed to be the same substance unless
they differ significantly in properties with regard to efficacy.
The Court finally came with the observation that S. 3 (d)
along with the Explanation prescribes a test “to decide whether the discovery is an invention or not is that the
Patent applicant should show the discovery has resulted in the enhancement of
the known efficacy of that substance and if the discovery is nothing other than
the derivative of a known substance, then, it must be shown that the properties
in the derivatives differ significantly with regard to efficacy.”
In the course of addressing issue of vagueness and
ambiguity, the Court surprisingly pointed that Novartis, being a pharmaceutical
giant, “cannot plead that they do not
know what is meant by enhancement of a known efficacy and they cannot show that
the derivatives differ significantly in properties with regard to efficacy.”
The Court while addressing Novartis second argument that the
Patent Office is vested with arbitrary discretionary power to decide the
enhancement efficacy looked into Parliamentary debate for the Legislative
object and purpose of enacting S. 3 (d). The Court observed that S. 3 (d) was
included “to achieve namely, to prevent
evergreening; to provide easy access to the citizens of this country to life
saving drugs and to discharge their Constitutional obligation of providing good
health care to it's citizens.”
The High Court also relied upon the Supreme Court precedents
recognizing that Legislature is permissible to lay down broad policy and
delegate powers of rule making to the statutory authority to implement the
policy, particularly in areas of specialized knowledge, where the Legislature
lacks and knowledge and expertise to frame detailed rules.
In short, the Madras High Court dismissed Novartis plea
challenging constitutional validity and TRIPS compatibility of S. 3 (d). The
decision, however, lacked meticulousness that could have resolved uncertainty
and debate concerning S. 3 (d) as the Madras High Court missed important
opportunity by taking an approach which was more to defend the provision rather
acknowledging and resolving the issue. If mere theoretical use of medicinal
dictionary could have resolved such complex issue then neither Novartis
(pharmaceutical major) nor the Patent Office (specialized body) would have ever
approached the High Court just to hear dictionary meaning of “efficacy”. The
Patent Office could have easily discussed and conveyed mere dictionary meaning
to Novartis in their Office library. The expression “efficacy” needed more
scientific and technical explanation which is obviously beyond the expertise of
the Patent Office, in fact, Office of Drug Controller General of India would be
the appropriate body to decide the efficacy enhancement.
In its decision, the Madras High Court restricted efficacy
in terms of therapeutic efficacy for new discoveries made in the pharmacology
field but the decision lacked diligent insight to take into account inventions
such as polymers, liposomes, peptides, lipids, releasing agents etc. which are
therapeutically inactive but broadly falls in the area of pharmacology and are
used to deliver and facilitate absorption of therapeutic active agents. Is the
Court expecting such inventions per se to show enhancement in therapeutic
efficacy or else they altogether do not qualify for patent protection in India? In fact,
we have been prosecuting more than dozen patent applications that claim classes of
polymers and compounds used to deliver and facilitate adsorption of therapeutic
agents and surprisingly all these applications got rejection under S. 3 (d) as
the Patent Office contended that claimed subject-matter lack increased
efficacy.
Ironically contrary to the High Court theoretical
observations that S. 3 (d) is not vague and arbitrary and having hindsight to
help Patent Office adjudicate patents applications in the field of
pharmacology, the Patent Office continue to use fairly irrational discretions
in applying S. 3 (d) even where it is not required. The so-called specialized
body not only lacked insight to basics of pharmaceutical science but even
failed to differentiate therapeutic active inventions from therapeutic inactive
inventions. As of now, the Patent Office has been treating both therapeutic
active compounds and therapeutically inactive agents (such as biodegradable
polymers used as carriers for therapeutic active agents) exactly the same and
constantly been applying S. 3 (d) rejections.
Using “efficacy” yardstick for inventions that are not
therapeutically active but still falls in the area of pharmacology is correct
or erroneous, not only leave considerable ambiguity but also arbitrariness on
the Patent Office in deciding the same. As a patent practitioner, it is often
hard to process the fact that the Patent Office asked for “therapeutic efficacy”
for therapeutically inactive inventions.
Let us now summarize what the High Court observed in its
judgment.
(1) S.
3 (d) not in violation of Article 14 of the Constitution of India.
(2) Lack
jurisdiction to decide issue of TRIPS compatibility.
(3) Inclusion
of S. 3 (d) to prevent ever-greening.
(4) Expression
“efficacy” not vague and ambiguous.
(5) Explanation
under S. 3 (d) limited to discoveries in the field of pharmacology.
(6) Patent
Applicant either needs to show how effective new discovery would be in healing
a disease or how effective new discovery would be in having a good
effect on the body.
In light of facts covered so far, the expression “efficacy”
contemporarily needs to be in terms of “therapeutic efficacy” which as the High
Court observed can be gauged by showing effectiveness in healing a disease or
showing effectiveness in having a good effect on the body. Let us end this post
by putting the Court observation into analytical perspective.
(1) Whether
a toxic drug provides healing or good effect on the body? Or in other words,
does the threshold to make drug non-toxic qualify for therapeutic efficacy?
(2) Whether
an unstable drug provides good effect on the body? Or in other words, does the
threshold to make drug formulation stable/increase self-life qualify for
therapeutic efficacy?
(3) Whether
lack of bioavailability provides healing or good effect on the body? Or in
other words, does the threshold to make drug bioavailable qualify for
therapeutic efficacy?
However, one point that we found hard to digest was the
High Court observation that inclusion of S. 3 (d) was to prevent ever-greening.
Anyone with experience working in pharmaceutical industry can easily understand
that “ever-greening” is more of a business strategy for product lifecycle management to extend protection beyond
original compound/patent by protecting incremental and even possibly trivial
innovations. It would be completely wrong to acknowledge that ever-greening is
only and all about trivial innovations. Now if we consider the Legislature has intention
to prevent ever-greening then that would mean to rule out any protection beyond
original patent. In that case, S. 3 (d) not only disqualifies trivial
innovations but also genuine incremental innovations. And if incremental
innovations are not what the Legislature wanted to exclude from patent
protection then the word “ever-greening” is inappropriately used.
