Novartis AG vs.

Union of India53
Novartis AG (“Novartis”) had filed an Indian patent
application for the beta crystalline form of Imatinib
Mesylate in July 1998. Due to the impending change
in patent regime, the application was “kept in
mailbox”. The application received five pre grant
oppositions. In 2006, the application was rejected
on the basis that the application lacked novelty, was
obvious and was not an invention in view of Section
3(d) of the Act. The Controller held that the Product
was a new version of an older molecule that Novartis
first patented in 1993 and the increment in efficacy
is not substantial enough to receive the grant of a
patent. An appeal was preferred before the Madras
High Court, during the pendency of which, the case
was transferred to the Intellectual Property Appellate
Board (“IPAB”). The IPAB upheld the decision of
the Controller with respect to the finding that the
patentability of the drug was barred under Section
3(d). A Special Leave Petition was filed by Novartis in
the Indian Supreme Court (“SC”) appealing against
the decision of the Controller. The SC made an
exception and admitted the Special Leave Petition
side-stepping the jurisdiction of the Madras High
Court, in view of the importance of the case and the
number of seminal issues that were involved in the
case. The SC noted that this was an exception and
any attempt directly challenging an IPAB order.
before the SC side-stepping the High Court, was
strongly discouraged.
The invention as claimed in the patent application
was the beta-crystalline form of Imatinib Mesylate.
This was a derivative of the free base form called
Imatinib disclosed vide example 21 of a patent
application filed by Novartis in US on April 2, 1993
(“Zimmermann patent”).
Novartis’ argument was that the known substance
was Imatinib as disclosed in Zimmerman patent
from which beta-crystalline form of Imatinib
Mesylate was derived and that the substance
immediately preceding beta crystalline form of
Imatinib Mesylate was Imatinib and not Imatinib
Mesylate as the Zimmerman patent did not disclose
Imatinib Mesylate. The SC rejected this argument
after examining the evidence on record and
concluded that the known substance was Imatinib
Mesylate from which beta-crystalline form of
Imatinib Mesylate was derived.
Since the term “efficacy” is not defined in the
Act, the SC referred to the Oxford Dictionary and
observed that Efficacy means “the ability to produce
a desired or intended result”. Accordingly the SC
observed that the test of efficacy depends “upon the
function, utility or the purpose of the product under
consideration”. Therefore, the SC held that in case of
medicines, whose function is to cure disease, the test
of efficacy can only be “therapeutic efficacy”.
In relation to “enhanced efficacy”, the SC held that
the parameters for proving enhanced therapeutic
efficacy especially in case of medicines should
receive a narrow and a strict interpretation.
However, the SC pointed out that just because the
word ‘efficacy’ has to be given a strict interpretation
under Section 3 (d), that does not in any way mean
that it bars all incremental inventions of chemical
and pharmaceutical substances. Essentially Section
3 (d) provides a bar that incremental inventions of
chemical and pharmaceutical substances need to
pass in order to be patentable.
The SC had concluded that the known substance
was Imatinib Mesylate and not free base Imatinib.
However, all the evidence submitted by Novartis
compared the efficacy of the Product with that of
Imatinib, but there was no evidence provided by
Novartis which compared the efficacy of the Product
with that of Imatinib Mesylate.
However, SC went on to examine the expert
affidavits submitted by Novartis according to which
the following properties exhibited by the Product
demonstrated its enhanced efficacy over Imatinib:
i. more beneficial flow properties
ii. better thermodynamic stability
iii. lower hygroscopicity; and
iv. 30 % increase in bio-availability.
The SC held that the first three properties of the
Product related to improving processability and
storage, thus they did not in any way demonstrate
enhancement of therapeutic efficacy over Imatinib
Mesylate as required to pass the test of Section
3(d). The SC came to this conclusion even though
the affidavits submitted by Novartis compared the
Product over Imatinib.
The SC after this was left with 30 % increase in
bio-availability, with regard to this the SC held
that increase in bioavailability could lead to
 Types of patent applications
A)     PROVISIONAL APPLICATION
A provisional application is a temporary application which is filed when the invention is not finalized and is still under
experimentation.
Advantages of filing a provisional application
 Applicant gets 12 months’ time to fully develop the invention and ascertain its market potential
 Helps to establish “priority” right over the invention
 Enables the applicant to use the term "patent pending” on their product
 Less expensive to prepare and file the application
 Enables the applicant to file International applications and claim priority within 12  months.
However, in order for the patent to be granted, a provisional application must be followed by a complete specification within 12
months. Moreover, the provisional application should be sufficiently detailed and must be drafted very carefully to ensure that
the priority rights are secured for your invention.
B)     ORDINARY APPLICATION OR NON-PROVISIONAL APPLICATION
An application for patent filed in the Patent Office without claiming any priority of application made in a convention country or
without any reference to any other application under process in the office is called an ordinary application. An ordinary
application must be accompanied with a complete specification and claims.
 C)     CONVENTION APPLICATION
An application for patent filed in the Patent Office, claiming a priority date based on the same or substantially similar
application filed in one or more of the convention countries, is called a convention application. In order to get convention
status, an applicant should file the application in the Indian Patent Office within 12 months from the date of first filing of a
similar application in the convention country.
 D)     PCT INTERNATIONAL APPLICATION
A PCT Application is an international application governed by the Patent Cooperation Treaty, and can be validated in upto 142
countries.
Advantages of filing a PCT Application
 A single international patent application can be filed in order to seek protection for an invention in up to 142
countries throughout the world.
  The priority date obtained by filing a PCT application is internationally recognized, and has an effect in each of the
countries designated.
 It gives the application 30/31 months to enter into various countries from the international filing date or the priority
date, and therefore gives the applicant more time to assess the viability of the invention.
 Delays the expenses associated with applying for a patent in various countries
 Provides an International Search Report citing prior art, which gives an indication to the applicant whether the
invention is novel and innovative.
 Provides an option for requesting an International Preliminary Examination Report, the report containing an opinion
on the patentability of the invention.
 The International Search Report and International Preliminary Examination Report, allows the applicant to make
more informed choices early in the patent process, and to amend the application to deal with any conflicting material, before
the major expenses of the national phase of the patent process begin. It also gives the applicant a fair idea on the patentability of
the invention before incurring charges for filing and prosecuting the application in each country.
 E)      PCT NATIONAL PHASE APPLICATION
When an international application is made according to PCT designating India, an applicant can file the national phase
application in India within 31 months from the international filing date or the priority date (whichever is earlier).
F)      PATENT OF ADDITION
When an applicant feels that he has come across an invention which is a slight modification of the invention for which he has
already applied for or has obtained patent, the applicant can go for patent of addition if the invention does not involve a
substantial inventive step. There is no need to pay separate renewal fee for the patent of addition during the term of the main
patent and it expires along with the main patent.
G)     DIVISIONAL APPLICATION
When an application made by applicant claims more than one invention, the applicant on his own or to meet the official
objection may divide the application and file two or more applications, as applicable for each of the inventions. This type of
application, divided out of the parent one, is called a Divisional Application. The priority date for all the divisional applications
will be same as that claimed by the Parent Application (Ante-dating)
A Patent Agent is a professional entitled to draft, file and prosecute patent applications on behalf of an applicant. And also, the patent
agent name has been registered in the register of patent agents maintained by the Indian patent office. Simply put, a patent agent is one
who is registered to practice before the Indian Patent Office. He prepares all documents, transacts all business and discharges other duties
in connection with the proceeding before the Controller.
 What is the importance of a patent agent in India?
The Indian Patents Act 1970 allows an applicant by himself/herself can draft, file and prosecute the patent application. It also allows an
advocate who is not a patent agent in India to participate in any hearing before the Controller on behalf of a party in a proceeding under
the Act. However, as the process of patent drafting a patent specification, correspondence with the patent office, replying to objections
raised by the patent office by way of examination reports, participating in hearings, filing oppositions and defending the application is
complex, there is a great demand for patent agent in India who are qualified and who can ensure maintenance of a high standard of
efficiency and professional integrity. Therefore, many companies and universities engaged in research and development hire patent
agents to help them in protecting their inventions in India and other countries of interest.
 What are the qualifications required to be an Indian patent agent?
The requisite qualifications are as follows:
-He/she should be a citizen of India.
-Applicant should have completed 21 years of age.
-Candidate should have obtained a degree in science, engineering or technology from any university established under the law for the
time being in force in the territory of India or possess such other equivalent qualifications as specified.
-He/she has passed the qualifying examination prescribed for the purpose or has for a total period of not less than ten years, functioned
either as an examiner or discharged the functions of the Controller under S 73 or both, but ceased to hold any such capacity at the time of
making an application for registration.
 What is the role of a patent agent in India?
S 127 and S 129 of the Indian Patents Act elucidate the role of the patent agent in India. The patent agent India is entitled to:
-Practice before the Controller;
-Prepare all documents, transact all business and discharge any such function as may be prescribed with respect to any proceeding before
the Controller.
-Apply for or obtain patents in India or elsewhere.
-Prepare specifications or other documents.
-Give advice other than of scientific or technical nature as to the validity of patents or their infringement.
 Can a patent agent be disqualified? How?
Rule 114 of the Patent Rules enumerates the grounds for disqualification of a patent agent in India:
-If he has been adjudged to be of unsound mind by an incompetent court.
-He is an undercharged insolvent.
-He, being a discharged insolvent, he has not obtained a certificate of his insolvency from the court.
-Or if the patent agent convicted of an offence in India or outside and has not been pardoned.
-In case the agent, being a legal practitioner, has been guilty of professional misconduct.
-If he, being a chartered accountant, he has been guilty of negligence or misconduct.