This document discusses a patent infringement case between Bayer and Ajanta regarding Bayer's patent for the drug vardenafil. Some key details: - Bayer was granted a patent in India in 1997 for vardenafil and filed suits against several companies producing generic versions, including Ajanta. - Ajanta argued they should not be subject to an injunction, as Bayer had not worked the patent in India commercially as required by law, by only stating they were "evaluating the market". - The court had to determine if Bayer's non-working of the patent disentitled them to injunctive relief against infringers like Ajanta. This involved interpretation of precedence and balancing patent

1. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
SUCHITRA BAI
PATENT DEPARTMENT
BAYER VS AJANTA.NEW
JURISPRUDENCE IN PUBLIC
INTEREST FOR INJUNCTIONS

2. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
FACTS OF THE CASE
• Bayer Intellectual Property GmbH, Patent was
granted for Application No. IN225529
(3275/DEL/1998).
• Bayer filed a suit against Ajanta Pharma Ltd.
• On grounds that the patent covered vardenafil, a
drug used to treat erectile dysfunction, and that
Ajanta was manufacturing and selling the drug
under its brand Valif.

3. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
Contd…
• The Patent was filed on 12 November 1997 as priority
date.
• After the grant of Patent to Bayer Healthcare AG, the
said Patent was assigned to Bayer’s IP holding company
in 2013.
• During the Periods of 2013, 2014, 2015 and 2016 Bayer
has filed Form 27 [Statement regarding the working of
the Patented Invention on commercial scale in India] to
disclose the working of the patent, as mandated by
Section 146.
• In the Form 27, Bayer stated that the patented invention
has not been worked commercially in India because “it
is evaluating the market for the product”.

4. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
FORM 27
THE PATENTS ACT, 1970
AND
THE PATENTS RULES, 2003
STATEMENT REGARDING THE WORKING OF THE PATENTED INVENTION ON COMMERCIAL SCALE IN INDIA
In the matter of Patent No. ----- of ------, we, ------, the Patentees under Patent No. ----, hereby furnish the following statement regarding the working of the patented
referred to above on a commercial scale in India for the year 2013, 2014, 2015 and 2016.
(i) The patented invention:
[ ] Worked [x] Not Worked
Please find below the reasons for not working and steps being taken for working of the invention:
EVALUATING THE MARKET FOR THE PRODUCT.
(ii) The licences and sub-licences granted during the year.
Nil
(iii) State whether public requirement has been met partly/adequately/to the fullest extent at reasonable price.
Not Met
The facts and matters stated above are true to the best of our knowledge, information and belief.
Dated this -----day of ---- 2017.
---------
To
The Controller of Patents
The Patent office
At Chennai

5. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
Contd…
• Bayer as globally marketing the drug through
a co-promotion agreement with
GlaxoSmithKline since 2001.
• Following the drug’s failure to meet
expectations GSK sold its marketing rights
back to Bayer.
• It was clear that Bayer has exclusive rights to
manufacture and market the drug in Indian
market.

6. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
Contd…
• During the period of 2016, Bayer realised that Indian companies
were already manufacturing a drug that it was still “evaluating the
market” .
• On 11 August, Bayer obtained an ex parte injunction against Vipro
Lifescience, a company which was manufacturing vardenafil.
• Subsequently, Vipro submitted in court that it would cease
infringement, and further agreed to give Bayer information about the
foreign customers who purchased its shipments of vardenafil so as
to enable Bayer to proceed against them abroad.
• Based on this assurance, Bayer dropped proceedings against Vipro
on 22 November.
• Bayer is also proceeding against Mehta API Pvt. Ltd., Manus
Aktteva Biopharma LLP, Rakshit Pharmaceuticals Ltd., Hetero
Drugs Ltd., and Dr. Reddy’s in the Delhi High Court.

7. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
Contd…
• On 20 December an ad interim injunction was given against
Ajanta.
• On 4 January 2017, Ajanta filed an application under O39R4
to vary the terms of the injunction. Ajanta’s application
was based on multiple factors, including jurisdiction,
but primarily invoked Franz Xaver Huemer v. New Yash
Industries to plead that non-working of a patent disentitles its
holder to injunctive relief. Curiously, Ajanta appeared to
suggest that it was not infringing since Section 48 does not
explicitly cover export.
• In response, Bayer pointed out that the exclusive right under
Section 48 covered manufacture regardless, and
cited Novartis v. Cipla to argue that although non-working
could be a ground for revocation before the Controller, it’s no
defence for infringement.

8. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
MEANING OF INJUNCTION
• Injunction is as an equitable remedy in the form
of a Court Order, whereby a party is required to
do, or to refrain from doing, certain acts.
• Interim injunction is a remedy that prevents the
violation of rights pending the trial of the suit.
• The object of the interlocutory injunction is to
protect the patentee against injury by violation of
his right for which he could not be adequately
compensated in damages recoverable in the
action if the uncertainty were resolved in his
favor at the trial.

9. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
GROUNDS FOR INJUNCTION
• An Injunctive relief must establish
(1)they have a prima facie case with a
reasonable chance to succeed on merits;
(2)Denial of the injunction will result in
irreparable harm;
(3)the balance of convenience favours the
grant of an injunction; and
(4)the injunction would not oppose the
public interest.

10. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
CONCLUSION
• Justice RK Gauba found that the “self-interest of the
patentee” had to be “balanced against the larger
public interest”.
• The Indian courts have time and again opined that
“public interest” in pharma patent litigation as the
interests of the patients who need access to the
patented drug.
• This order denies injunctive relief on the ground that
it would lead to “not only loss of employment, but
revenue to the state as well”.

11. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
THANK YOU