[Ip-health] After a decade: why we need to protect Section 3(d) of the patent law

Lorraine Misquith lorrainemisquith at gmail.com
Tue Apr 7 03:58:50 PDT 2015

   - [image: Anand Grover]
   Anand Grover

For affordable medicines; to ensure only true innovations are rewarded with
patent protection

Before the 1970s, the Indian Patent Law was on the lines of the British
law, allowing foreign companies to make huge profits. Thus, we had among
the highest medicines prices.

In the 1970s, after detailed reports of Bakshi Tek Chand and Justice
Ayyangar to reform the Indian Patent Law in the interest of its citizens,
the Law was amended to protect only process patents, not product patents on
medicines and food.

Product patents give an absolute monopoly to the owner, permitting them to
charge monopolist exorbitant prices for medicines.

But process patents allow competition, as persons develop better processes
to make a product and compete with each other, thereby resulting in
lowering of prices for the people.

This happened in India. Several Indian generic companies came up with
effective processes and began to compete with the foreign companies.

>From a relatively low presence, the Indian generic drugs industry became a
dominant player in India and the developing world. By the 1990s, it became
the largest supplier of safe and effective anti-retrovirals [to treat HIV]
in the developing world. Indian generic pharmaceutical companies were
“making in India” not only for Indians but for the rest of the world.
*Section 3(d)*

In 1995, after years of negotiations, when India became a signatory to the
TRIPS agreement, it was mandated to honour process and product patents on
medicines and food from January 1, 2005.

The challenge was to comply with TRIPS and make sure that Indian generics
could enter the market and compete, to keep drugs affordable.

We realised by early 2001 that a large number of patents in the US, Europe
and Japan (about 76%) were granted for new forms of known substances
without any real improvement in therapeutic benefit.

The new forms (a salt or crystal etc.) did not change the active ingredient
and its efficacy, but was perhaps better at say, handling of the drug.
Despite this, new forms were granted patents in the developed world, and
the resultant medicines were exorbitantly priced.

Therefore in 2005, Parliament unanimously passed, cutting across party
lines, section 3(d) – so a new form of a known substance could not be
patented unless it showed significant enhanced efficacy. Parliament did not
define “enhanced efficacy”, but left it to the courts.

This was the bone of contention in the Novartis case. The Supreme Court
held that efficacy in section 3 (d) was therapeutic efficacy. Novartis
argued that the â-crystalline form of the salt of imatinib, imanitib
mesylate (gleevec) had better flow properties, was less hygroscopic,
thermodynamically more stable.

The Supreme Court rightly held that these were not elements for determining
therapeutic efficacy. Novartis also argued that gleevec was 30% more
bioavailable which implied significantly enhanced efficacy. The court held
that by itself bioavailability cannot imply higher therapeutic efficacy,
which has to be shown by separate experiments.
*The verdict*

The Supreme Court in Novartis not only saw the significance of section 3(d)
but gave a fuller meaning to it. Had it not been for section 3(d), gleevec
and a large number of other new forms of existing medicines would be
granted patents. In fact a recent study shows that section 3(d) has been
effective in preventing non deserving patents on new forms from being

As we mark a decade of 3(d) and pressure from multinational companies
increases on India to change its IP (Intellectual Property) laws, there is
reason enough to protect and celebrate section 3(d) and not allow it to be

Not just to keep medicines affordable for people in India and overseas, but
to ensure only true innovations are rewarded with patent protection.

*Anand Grover is a Senior Advocate who argued the Novartis case for the
Cancer Patients Aid Association*
(This article was published on April 3, 2015)


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