[Ip-health] Novartis: do Indian patent laws stifle research?

[Prabhu Ram]

Novartis: do Indian patent laws stifle research?

FEROZ ALI K


The story of Novartis' challenge to a particular provision of the
Indian Patents Act 1970 goes much beyond its interest in the patent
application for its life-saving cancer drug 'Gleevec' (imatinib
mesylate). It is a story involving many powerful players each trying
to wrest the initiative and many conflicting interests each trying to
influence the development of patent law in this country.

India's unique pharmaceutical past and the growth of a vibrant generic
pharmaceutical industry can be attributed to the privileges enjoyed by
the industry. Many decades ago, India took the conscious decision of
confining monopoly rights in the field of pharmaceuticals by granting
'process patents'.

Under the Patents Act 1970, pharmaceutical companies were free to
devise a non-infringing process to manufacture a drug even if the same
was protected by a process patent in India.

This situation changed when India agreed to switch over to the product
patent regime. By being a founding member of the WTO, India had to
bring into effect the obligations under the TRIPS Agreement which
required every member country to provide product patent protection for
pharmaceuticals. Though India became a member of the WTO in 1995, it
was given a 10-year transition period to bring into effect the change
in regime from granting process patents to product patents for drugs.

At the heart of the matter is the issue of the standard of
patentability under the Indian Patents Act. The TRIPS Agreement being
a minimum standard agreement requires its members to grant patents for
inventions in all fields of technology for a period of 20 years if it
satisfies the universally accepted criterion of patentability.

The first notable external interference into the Indian patent law
came in when U.S. and EU filed a complaint against India before the
WTO dispute settlement panel alleging that it had not complied with
its obligation under the TRIPS.

That case was decided against India and the Patents Act had to be
amended to introduce provisions for accepting patent applications
through a 'mail-box' and for granting a patent-like right known as the
Exclusive Marketing Rights (EMR) pending consideration of the patent
application in certain cases.
Caught in transition

The time that Novartis chose to enter India was the one in which
rampant changes were made to the Indian law. It filed its application
in 1998 before three critical amendments were made in 1999, 2002 and
2005.

The Novartis case (the patent application for its anti-cancer drug
Gleevec) had many firsts to its credit. It signified the first
instance of grant of a patent-like right known as the Exclusive
Marketing Right (EMR), which led to the world's first contentious case
of EMR. It was also the first time a foreign multinational questioned
the constitutional validity of a provision of the Indian Patents Act.

As soon as the law changed in India, Novartis preferred an application
for beta crystalline form of imatinib mesylate (Gleevec) in 1998.
Gleevec offers cure to life threatening form of cancer, chronic
myeloid leukaemia. Imatinib as a free base molecule was invented by
Novartis in 1992 and patented in the U.S. and other countries in 1993.
Novartis however chose not to apply for a patent for the imatinib free
base in India as India did not offer product patent protection in
1993. It is pertinent to note that the 1993 U.S. patent of imatinib
disclosed the salt imatinib mesylate.

But in 1998, Novartis came up with an application for a beta
crystalline form of imatinib mesylate which was, in the terms of
section 3(d) of the Patents Act 1970, a new form of a known substance.
Section 3(d) of the Act states that "the mere discovery of a new form
of a known substance which does not result in the enhancement of the
known efficacy of that substance" shall not be treated as an invention
within the meaning of the Act.

Phrased differently, it meant that the new form of a known substance
will be entitled for a patent if it results in the enhancement of the
known efficacy of that substance. Knowing full well about this
requirement of the Indian law, Novartis tried to demonstrate before
the Controller how there was an enhancement of efficacy and submitted
that there was an enhanced bioavailability of 30 per cent in studies
conducted on rats. Bioavailability is one of the indicators of
efficacy of a drug.

The Controller rejected this submission and held that Novartis had
failed to demonstrate the enhancement in efficacy as required under
the Act.

Efficacy enhancement

The case failed as Novartis failed to discharge the burden of showing
the enhancement of efficacy. Section 3(d) has an in-built guideline
for determining the enhancement of efficacy. It states that with
'known efficacy' as the benchmark, the person seeking patent has to
show the enhancement of efficacy. The explanation to section 3(d)
requires such enhancement to be significant. Novartis' case suffered
as they had produced a bioavailability study conducted on rats while
the drug was admittedly in the market for many years and was consumed
by humans. Then again, it was not shown how the 30 per cent increase
was critical in the performance of the drug and how the increase in
enhancement of efficacy made a difference when compared to known
efficacy.

Aggrieved by the order of the Controller, Novartis approached the
Madras High Court with two batches of writ petitions: one challenging
the constitutional validity of section 3(d) and the other challenging
the order of the Controller with the request for quashing the same as
the appeal mechanism (appeal from a Controller's order to the
Intellectual Property Appellate Board =97 IPAB) under the Patents Act
has not come into force by then.

In the writ petition challenging the constitutional propriety of
section 3(d), Novartis took a contradicting plea that the provisions
section 3(d) was vague and arbitrary despite trying its best to plead
its case on the lines of section 3(d) before the Controller.

Though the Madras High Court had dismissed the writ petitions filed by
Novartis challenging section 3(d), the High Court had directed the
transfer of the other batch to the IPAB questioning the order of the
Controller after converting the same into a statutory appeal.
Impact of decision

Though the prophets of doom had signalled the end of research
activities and innovation in this country, the judgment of the Madras
High Court and the impact of section 3(d) must be understood better by
knowing what it permits and what it prohibits.

Patents for pharmaceutical substances today fall into two broad
categories: Original inventions and incremental innovation.

Incremental innovation is a grey area; what actually amounts to
incremental innovation and the extent to which such innovations should
be protected is debatable. In any case, the language of section 3(d)
permits incremental innovation. But it is for the applicant to
demonstrate why a fresh patent should be granted to a known substance.
For this the applicant has to demonstrate an increase in efficacy of
the substance over the known efficacy. It would be misleading to state
that section 3(d) stifles innovation.

What section 3(d) actually does is to allow genuine improvements and
at the same time bar frivolous 'tweaking' which are passed under the
garb of incremental innovation.

In this regard, section 3(d) is trendsetting provision as it is the
first legal provision in the world not to be found in the patent
legislation of any country, which provides a check on frivolous
patenting.

Any country whose laws are in the state of transition will see
casualties who run the risk of testing it for the first time.

But then, Novartis took a calculated risk of not applying for an
Indian patent in 1993 and did so when the laws did change to permit
the grant of product patents.

Having taken this route, which is without doubt a risky one, it will
not be proper to denigrate the laws of this country merely because it
could not achieve what it wanted.

(The author is a Chennai-based advocate and the author of the recent
book "The Law of Patents =96 With a Special Focus on Pharmaceuticals in
India")


Source: http://www.hinduonnet.com/thehindu/thscrip/print.pl?file=3D20070809=
50161500.htm&date=3D2007/08/09/&prd=3Dseta&