Times of India: Mumbai: Saturday, 03 May 2014.
A huge spurt
in infringement suits (stay orders) recently against domestic drug companies
highlight that multinational firms are increasingly using the right to
information (RTI) route to enforce intellectual property and block entry of
affordable generics. Domestic companies like Glenmark, Biocon, Cadila and
Alembic are facing a fresh attack from MNCs like Novartis and Astra Zeneca, the
impact of which will be critical for development and expansion of the domestic
pharma industry, experts say.
Recently,
Novartis filed injunctions against half a dozen companies to prevent them from
launching generic versions of its block-buster anti-diabetic drug, Galvus
(vildagliptin).
Legal sources
say that there are over a dozen cases where the RTI route has been deployed by
MNCs to seek information on regulatory dossiers of generic firms on patented
drugs. Though the trend of deploying RTIs by MNCs started three-four years
back, there is a huge spurt in cases now to aggressively safeguard against
competition.
"The
impact of such actions can be critical for generic companies and will affect
the expansion of India pharma industry as also affect filings internationally.
The use of RTIs to stop the launch of the product itself will also seriously
affect the development of affordable generics as it fastens the burden of
proving non-infringement upon the generics," senior advocate Prathiba
Singh told TOI.
IP
enforcement cases where the courts are requested to blindly hand out injunctions
to keep out more affordable generic versions from the market are increasing
here.
Ranjit
Shahani VC and MD Novartis India says "Respect and protection of
intellectual property ensures that patients receive benefits of future
discoveries to conquer unmet medical needs. There are over 5,000 medicines
under development by the pharma industry. Systematic undermining of patents by
discriminatory rulings does not help the patient in the long run."
MNCs fear
that the generic companies are trying to bust patents and would launch the drug
in the market, while domestic companies say that the approvals sought may be
for exports to lucrative markets like US.
"Looking
at the recent trend, law firms representing MNCs file urgent applications
seeking ex-parte injunctions against generic producers of low-cost versions of
expensive originator medicines. The generic company is not present on the first
day and the MNCs' version is taken as true and ex-parte injunctions granted.
After ex-parte injunction, even if the generic company appears in the matter,
and files its defence, the damage is done with delayed hearings and the court
not keen to hear the patent dispute frequently. With rising litigation costs -
and no resolution in sight pressure builds on the generic company; some even
breakdown and give up the pharmaceutical product all together. Also, failure by
the courts to look at principles such as irreparable harm to patients and legal
safeguards in the patent law such as 'bolar' is leading to the violation of basic
rights of patients who are left with no low-cost versions of expensive
medicines" says Leena Menghaney India coordinator, Access Campaign,
Medecins Sans Frontieres.
In March,
Novartis had obtained 'quia-timet' injunctions from the Delhi high court against
two other drug-makers Biocon and Wockhardt, charging the domestic companies of
infringement on vildagliptin.
Domestic
companies like Glenmark have no intention to launch the drug in India till the
patent is valid and enforceable, while Biocon's plans for the product include
only R&D and regulatory filings covered under the Patent Act.
Legal experts
point out that the bolar provision in the Patent laws (Section 117A) allows the
manufacture of patented product during term of the patent by third parties, as
long as information on these is submitted to regulatory authorities in India or
elsewhere.
.JPG)
.JPG)
