Merck Sharp & Dohme filed a patent infringement suit against Glenmark Pharmaceuticals for manufacturing and selling an anti-diabetic drug containing sitagliptin, which was covered by Merck's Indian patent. Glenmark argued that sitagliptin phosphate used in its drug was not covered by the patent. The Delhi High Court ruled in favor of Merck, but the Supreme Court of India stayed the injunction. The case highlighted the tension between intellectual property rights and access to affordable medicine.

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Merck Sharp & Dohme (MSD)Vs
Glenmark Pharmaceuticals
(Anti- Diabetic Drug Case)
Er. N.Vignesh Kumaran
Associate- Patents,
Altacit Global

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3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
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WHAT IS A PATENT?
A patent is an exclusive right granted for an invention, which is a product
or a process that provides, in general, a new way of doing something, or
offers a new technical solution to a problem. To get a patent, technical
information about the invention must be disclosed to the public in a patent
application.
Among various requirements of patentability, novelty and non-
obviousness/inventive step requirements are judged based on prior art. A
claim of a patent application is considered to be novel if the claim is not
anticipated by a prior art reference.

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3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• Glenmark Pharmaceuticals is a pharmaceutical company headquartered
in Mumbai, India. It manufactures and markets generic formulation
products and active pharmaceutical ingredients (API), both in the
domestic and international markets. In the formulation business, its
business spans segments such as Dermatology, Internal Medicine,
Paediatrics, Gynaecology, ENT and Diabetes.
INTRODUCTION

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BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
Continued….
• Merck Sharp & Dohme (MSD) outside the United States and Canada, is
an American pharmaceutical company and one of the largest
pharmaceutical companies in the world.
• The company was established in 1891 as the United States subsidiary of
the German company Merck, which was founded in 1668 by the Merck
family. Merck & Co. was nationalized by the US government during
World War I and subsequently established as an independent American
company in 1917. Merck & Co. is the world's seventh largest
pharmaceutical company by market capitalization and revenue. Its
headquarters is located in Kenilworth, New Jersey.

5. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• Patent infringement is the commission of a prohibited act with respect to
a patented invention without permission from the patent holder.
Permission may typically be granted in the form of a license. The
definition of patent infringement may vary by jurisdiction, but it
typically includes using or selling the patented invention. In many
countries, a use is required to be commercial to constitute patent
infringement.
• The scope of the patented invention or the extent of protection is defined
in the claims of the granted patent. In other words, the terms of the
claims inform the public of what is not allowed without the permission
of the patent holder.
PATENT INFRINGEMENT

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COIMBATORE
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• MSD’s Indian patent numbered 209816- BETA-AMINO
HETEROCYCLIC DIPEPTIDYL PEPTIDASE INHIBITORS FOR
THE TREATMENT OR PREVENTION OF DIABETES
• MSD’s patent is directed to compounds which are inhibitors of the
dipcptidyl pcptidasc-IV enzyme ("DP-IV inhibitors") and which are
useful in the treatment or prevention of diseases in which the
dipeptidyl peptidasc-IV enzyme is involved, such as diabetes and
particularly type 2 diabetes. The patent is also directed to
pharmaceutical compositions comprising these compounds and the
use of these compounds and compositions in the prevention or
treatment of such diseases in which the dipeptidyl pcptidase-IV
enzyme is involved.
CASE HISTORY

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Chennai - 600 004.
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BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
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WEBSITE
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• The infringement suit was filed by Merck alleging Glenmark for
making anti diabetic drug known by non proprietary name
‘SITAGLIPTIN’. The molecule ‘SITAGLIPTIN’ was invented by
Merck has been patented in 102 countries including India. The patent
claims the base molecule SITAGLIPTIN in free base form and also
‘pharmaceutically accepted salts thereof’. Merck also filed for a patent
for SITAGLIPTIN phosphate which was abandoned later on in view of
certain pre grant oppositions. However, the patent for the phosphate
salt of Sitagliptin has been granted in USA. The drug was approved
for marketing in India on 28th March 2008. The plaintiff also granted a
license in India to Sun Pharmaceutical Industries Limited (plaintiff 2)
which sells the drug under the brand name Istavel & Istamet.
INFRINGEMENT SUIT WAS FILED BY
MERCK ALLEGING GLENMARK

8. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
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CONTINUED…
• Glenmark argued that, as the validity of the patent of the plaintiffs has
been challenged, therefore the question of grant of any interim relief to
the plaintiff, does not arise until the said validity is decided by the
court. Referring to the granted patent in USA for the phosphate salt and
a separate application for same in India, they argued that phosphate salt
is not a mere improvement patent but a distinct product which was also
confirmed by the fact that plaintiff applied for a separate protection for
the same in India and obtained a patent in USA.
• Further, the defendents argued that patent of the plaintiff Merck was
not on the pharmaceutical composition as described in plaintiff’s
product but only on a part thereof. Thus, similarity of pharmaceutical
composition of the products cannot be a ground for infringement. They
also alleged Plaintiffs for suppression of the facts regarding the Indian
patent application for the phosphate salt of the molecule.

9. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
CONTINUED…
• While Plaintiffs argued that SITAGLIPTIN was the invention and
SITAGLIPTIN phosphate was merely a derivative of the invention and
therefore wasn't eligible for patent protection under Section 3(d).
Referring to the package inserts information available with the
defendant’s product they argued that the pharmaceutical composition of
their product is similar to composition of Glenmark’s product Zita and
hence the infringement is obvious. Merck’s counsels also emphasized
that “there is no price difference in the product of the plaintiffs and
defendant” to allay the influence of Novartis supreme court decision.
Probably this is the first case of differential pricing in India as the drug
in India is available at a reduced price equivalent to 1/5 price of that is
being charged in USA.

10. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
JUDGEMENT
• The Delhi high court held that if the combination by the defendant in its
product, of SITAGLIPTIN on which the plaintiff Merck has a patent with
phosphate salt, have a material effect upon the way SITAGLIPTIN
works, then the product of defendant will be outside Merck’s patent , but
if it does not have any material effect then infringement will be proved.
However, no satisfactory answer was provided by the defendants.
• The Delhi high court on 20th March 2015 barred Mumbai-based
Glenmark Pharmaceuticals Ltd from selling, distributing, marketing or
exporting its anti-diabetes drugs Zita and Zita-Met, on the ground that
they infringed the patent of US-based pharmaceuticals company Merck
Sharp and Dohme Corp.

11. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
CONT…
• Hon’ble Supreme Court of India on Special Leave Petition filed by
Glenmark stayed the Delhi High Court order which passed injunction
against Glenmark for the generic drug Sitagliptin till 28th April 2015.
Merck Sharp & Dohme filed an application for an ad interim injunction
restraining the respondent/defendant Glenmark Pharmaceuticals from
using its patented product Sitagliptin [Indian Patent No. 209816] at the
Supreme Court. The Delhi high court conclusively held that all the three
ingredients (Prima facie, Irreparable injury and balance of convenience)
for passing the order of injunction were established by MSD and hence
injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

12. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• The struggle for access to medicine presents a legal and ethical
minefield for rich and poor countries alike—one that is being fought out
as humanitarians challenge corporations over intellectual property
rights.
• Hence, generic medicine for treating diabetics, blood pressure should
not be allowed to be patented anywhere in the world in view of public
interest

13. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com