ASSIGNMENT

SUBMITTED BY:- SUBMITTED TO:-

GYANVI LL.M DR. RAM RATAN V. DHUMAL
(IP)
E.NO. A03104419031
 REGISTER OF PATENT

INTRODUCTION:-
Patent act lays down a procedure for grant of patent to an inventor to
exploit his invention for 20 years subject to fulfillment of certain conditions.
the first step is to make an application in prescribed form along with
provisional a complete specific. the application is thereafter publish and
examine ( if requested ) and search for anticipation is made. oppositions are
invited from the public to grant of patent and where there is no oppositions
or the oppositions is decide in favour of inventor, patent is granted and sealed
which confers certain rights on the patentee.
 DEFINITION :-
 A patent is the granting of a property right by a soverign authority to an
inventor. this grant provides the inventor exclusive rights to the patented
process, design, or invention for a designated period in exchange for a
comprehensive disclosure of the invention.
 File a Patent in India - An Overview :-
 A patent is a right granted to an individual or enterprise by the government that excludes others
from making, using, selling or importing the patented product or process without prior approval.
A patent, like any other intellectual property like Copyright or Trademarks, can be transferred
or sold by the inventor. Every Indian inventor who wants to protect his/her intellectual property,
irrespective of their sector, looks through ways on how to file a patent in India. Patent filing in
India requires proper documents and is a fairly complicated ordeal, however, with the right legal
guidance it can be done easily. Vakil search helps you with the simplest way to file a patent.
 Why filing a Patent in India? - Benefits:-

Granting of a patent is a form of encouragement for innovations and inventions, and once a patent
applicant files for it he or she becomes the exclusive owner of the invention if the patent is
granted. Filing a patent in India is important as it restricts the contenders from copying, selling or
importing the inventors’ creation without their permission, and it is valid for a period of 20 years
from the date of application of the patent. A patent, like any other intellectual property, can be
transferred or sold by the inventor.
 ADVANTAGES OF OWNING A PATENT:-
 A patented product is likely to improve brand perception and potentially enable your business to
charge a premium.
 Additionally,
 i) Patents can increase your business revenues while slowing down rivals for years to come.
 ii) With exclusive rights, the owner of the patent controls the use of the invention for a full
twenty years.
 iii) Patents can be sold and licensed like other forms of property.
filing provisions :-
Patents can be secured by following the below-mentioned
steps:
The procedure for the grant of the patent begins with the
 Step 1: Filing a patent application:
 Ideation: Here, you need to clearly pen down the idea or concept, clearly mentioning the key
details about the invention and the desired patent.
 Visualization: Visualise your idea and elements like diagrams that explain more about the invention.
 Verification: Verify whether your invention is patentable as defined in the Indian Patent Act. Some
inventions may not be patentable, and it is necessary they meet the patentability requirements such
as:
 - Novelty
 - Non-obviousness
 - Usefulness
 - Patentable subject matter
 Drafting a patent application is an art in itself. Seeking the help of a patent professional will be a
wise choice here. If you are in the initial stages of research and development process, then it is best
to file an optional preliminary application called provisional patent application.
Step 2: Preparation of patentability
report:
 Authorized patent professionals or patent agents will then do an extensive research and prepare the
patentability report, which includes analyses based on the above-mentioned criteria.
 WHY PROVISIONAL PATENT APPLICATION IS A GOOD IDEA BEFORE FILING THE PATENT APPLICATION
 A provisional patent application secures your date and work. This means that none of your
competitors can file for a similar invention once an provisional patent application is filed.
 As India follows the first-to-file system, this ensures that the holder of the provisional patent would
also be granted the permanent patent
 There is a buffer time of 12 months to further develop your invention and to specify the its
complete details. The application gets abandoned upon expiry of 12 months of the application
 The cost and resource involved for provisional patent application are less when compared to the
permanent patent
 The provisional specification helps you assess the market potential of your invention before taking
the final plunge and filing a complete specification.
 Once you are ready with your R&D and your invention’s detailed specifications, you can go in for a
complete patent application.
PLEASE NOTE:

 A. Patent Examination: would be a formal submission of request for patent

examination that must be filed within 48 months from first filing the patent (provisional
patent or complete patent). If failed to file within the time frame, per the Patent Act the
application will be treated as withdrawn by the patent office. The examiner then
conducts a comprehensive investigation and releases the first examination report
called patent prosecution.
 B. Patent objections: It is common that patent applicants receive objections,
like “inconsistent or unclear claims”, “invention lacking novelty”, etc. Hence, it is
mandatory to analyse the patent examination report and draft a proper response to the
objections.
 Grant of patent: Once all the patentability requirements are met, the patent
grant notification will be published in the Patent Journal.
CONDITIONS TO GRANT A PATENT IN INDIA :-

 A licensed patent agent in India is an individual registered for practicing before

the Indian Patent Office. Patent agents will help in filling out the necessary forms,
contacting the patent office, prosecuting patent applications, and in following up
with any issues that arise during the filing of patent. To become a patent agent, the
individual should be a citizen of India above 21 years of age and must have
cleared the patent agent examination.
 A patent examiner is the person who sends the list of rejections and at times
when there arises the need to modify the patent application, patent agent can
intervene and address the issue or argue against the rejection.
PATENT AT LAWYER AND AGENT :-

 Often the terms “patent lawyer” or “patent agent” are interchangeable but still
there are some differences between both at some instances. Patent lawyers
are legally qualified to provide advice on intellectual property, infringement and
represent others in a court of law. They are also registered with the bar council
whereas a patent agent generally holds a degree in engineering, science, and
technology.
* Types of patent applications in India :-

 The most common types of patent applications in India are

 1.Ordinary application: An ordinary application is filed without claiming priority from any
application or any reference to any other application under process in the Indian patent
office. It is important to note that the filing date and the priority date are the same. An
ordinary application is filed along with a complete specification and claims.
 already been filed in other country and when the patent is filed for the same invention in
India, then this type of application is called conventional application. It is mandatory for the
applicant to file the application in Indian patent office within 12 months from first filing it.
 3. PCT National phase application: A PCT National Phase application can be filed within 31
months from the international filing date.
 4. PCT International application: If you want to claim your priority in multiple countries,
then filing a PCT application is important and it allows up to 142 countries. The time period is
between 30-31 months from the international filing date to enter and claim protection in
each country.
CASE LAWS RELATED TO PATENT :-

 1. Bayer Corporation v. Union of India:-

 In a very significant development, the Delhi High Court held that ‘export’ of a
patented invention for experimental purposes is also covered under Section 107A of the
Patents Act, 1970 (India’s Bolar exemption) and thus does not amount to patent
infringement. It accordingly allowed Natco to export Bayer’s patented drug ‘Sorafenib
Tosylate’ (for which it was granted a compulsory license in 2012) to China for the purpose
of conducting development/ clinical studies and trials. However, two months later, the
order was stayed by a Division Bench which asked Natco to file a separate application
seeking permission for exporting the drug for experimental purposes and observed that it
would be permitted to export only a limited quantity of the drug.
2. Kent RO Systems Ltd. & Anr. v. Amit
Kotak & Ors :-

 In a welcome development, the Delhi Court ruled that there is no obligation on the
intermediaries to screen content alleged to be violative of intellectual property laws
before publishing the same (i.e. on an ex-ante basis). It, therefore, refused to direct E-bay
to remove listings of water purifiers that allegedly infringed Kent RO’s registered design
from its website or to issue a prohibitory injunction preventing E-bay from publishing the
same in the future.
3. Neetu Singh v. Rajiv Saumitra :-

 The judgment shed light into the relatively unchartered territory of Section 17 (c) of
the Copyright Act and clarified that when the ownership of copyright is disputed
between an employer and an employee, it is the terms of employment that have to be
looked into. The Court went on to even clarify what is to be looked into to determine
the terms of employment. For instance, in the case of a Director, it is any subsisting
agreement, or the Articles of Association or the Memorandum of Association of the
company. Relying on this principle, the Court held that in the instant case although the
Plaintiff was working as a Director of the Defendant No. 2 company from 2012 to 2014,
it noted that the Defendants had failed to prove that the literary work was authored as
part of her duties and obligations as a Director and granted an injunction in favour of
the Plaintiff.
4.India: A Study On: Novartis AG v. Union Of
India

 Introduction:
 Intellectual property is an intangible form of property while a 'Patent' is a subset
of intellectual property. Granting of a patent provides a statutory right by the
state to the inventor of the invention to exclude others from making, using, or
selling their invention for the limited duration of 20 years. The judgment given by
the two judge bench of the Hon'ble Supreme Court of India in the case of Novartis
AG V. Union of India is one the landmark judgments in India. In this case Novartis
challenged the rejection of its patent application by IPAB for Beta crystalline form
of "Imatinib mesylate" wherein such challenge was rejected by the Supreme Court
of India on the ground that the said drug did not produce an enhanced or superior
therapeutic efficacy as compared to the known substance i.e., "Imatinib mesylate"
means that the said drug did not involve an inventive step. One of the major
reasons for rejecting the patent application of Novartis was to avoid ever-greening
of already patented products by introducing minor changes.
Facts:

 In 1998, one of the largest international pharmaceutical companies i.e. Novartis International AG filed an application as per the
TRIPS agreement before the Chennai Indian patent office for the grant of a patent for an anticancer drug 'Glivec' which is used
to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST) invented from Beta crystalline form of
"Imatinib mesylate". This drug is famously used in the treatment of cancer and the same is patented in more than 35 countries.
 When Novartis filed its patent application, the grant used to be restricted to methods or processes and not for products in
India, as defined under section-5 of Patent Act, 1970. After the Patent (Amendment) Act, 2005 section-5 was repealed and
patents came to be granted for methods or processes but also for products.
 In 2005 patent application of Novartis for the drug Glivec was taken into consideration and the same was rejected by Madras
Patent Office on the ground that the drug was anticipated by prior publication and failed to satisfy the requirement of novelty
and non-obviousness, further stating the alleged invention as un-patentable under the provision of section-3(d) of Patent Act,
1970 as the said drug did not exhibit any major changes in therapeutic efficacy over its pre-existing form i.e. Zimmermann
patent.
 After that Novartis filed two writ petitions in Madras High Court in the year 2006 under Article-226 of Constitution of India. The
appeals subsequently stated that the section-3(d) of Patent Act, 1970 is unconstitutional because it is not in compliance with
TRIPS agreement and also violates Article-14 of Constitution of India and the other against the order passed by Madras Patent
Office. Madras High Court transferred the case to IPAB (Intellectual Property Appellant Tribunal) in 2007. This appeal was
finally heard and dismissed by IPAB stating that the invention satisfied the tests of novelty and non-obviousness but the
patentability of the product was hit by section-3(d) of the Patent Act, 1970. The judgment given by IPAB is to prevent ever-
greening of already patented product by introducing minor changes and to provide easy access to the citizens of India to life
saving drugs.
 After that Novartis filed SLP (Special Leave Petition) in 2009 before the Supreme Court of India against the order passed by
IPAB under Article-136 of Constitution of India.
Issue

 1. According to the provision of section-3(d) of Patent Act, 1970 what is a

known substance?
 2. According to section-3(d) of Patent Act, 1970 what is the meaning of
Efficacy?
 3. According to section-3(d) of Patent Act, 1970 whether increase in
bioavailability qualify as increase in therapeutic efficacy?
 4. Whether the invention "Beta crystalline form of imatinib mesylate" claimed
by Novartis is more efficacious than the substance that it was derived from
i.e. "Imatinib mesylate"?
Judgment:

 In April 2013, the two judge bench of Supreme Court of India rejected the appeal
filed by Novartis and upheld that the beta crystalline form of Imatinib Mesylate is
a new form of the known substance i.e., Imatinib Mesylate, wherein the efficacy
was well known. Supreme Court made it crystal clear that in the case of medicine
"Efficacy" in section-3(d) only means "Therapeutic Efficacy" and states that all
properties of drug are not relevant, the properties which directly relate to
efficacy in case of medicine is its therapeutic efficacy. Supreme Court in third
issue ruled that about 30% increase in bioavailability qualifies as increase in
therapeutic efficacy under section-3(d) of Patent Act, 1970 if evidence is provided
for the same. Supreme Court compared the efficacy of "Beta Crystalline form of
Imatinib Mesylate" with "Imatinib Mesylate" with reference to its flow properties,
better thermodynamic stability and lower hygroscopicity, and held that none of
these properties contribute to increase in therapeutic efficacy according to
section-3(d) of Patent Act, 1970 and Novartis not provided any document that
shows that the efficacy of "Beta Crystalline form of Imatinib Mesylate" is more as
compared to the efficacy of "Imatinib Mesylate".
Conclusion:

 The judgment given by the Hon'ble Supreme Court is to prevent the ever-
greening of patented products and gives relief to those who can't afford the
lifesaving drug as these pharmaceutical companies sell such lifesaving drugs
at a very high price hence unaffordable for the common man. Supreme Court
in its judgement made clear that India is a developing country and the
availability of medicines at a cheaper rate is necessary for the lives of 1
billion people. Section-3(d) of Patent Act, 1970 prevents by obtaining
secondary patent by introducing minor changes in existing technology from
these big pharmaceutical companies. Novartis failed to prove that the
therapeutic efficacy of "Beta Crystalline form of Imatinib Mesylate" is more as
compared to the therapeutic efficacy of "Imatinib Mesylate". So that the
application of Novartis for patent rejected by Supreme Court.
CONCLUSION :-

 The best source of materials for the practitioner is the Manual of Patent Examining
and Procedure (MPEP). It is organized with a table of contents with 27 chapters
and seven appendixes. It has a subject matter index and it is searchable online. It
is also revised and updated on a regular basis by the USPTO. Many of the key
decisions are outlined so that their applicability to patent law is clear.For
beginners, the treatises under the secondary sources above are good places to
start. The treatise, An Anatomy of a Patent Case, is probably the best place for
beginners. After that, Chisum on Patents is a well respected treatise and is a great
reference source.Finally, of the practice materials listed, the most useful for the
seasoned patent attorney will probably be Donner’s Patent Prosecution: Law,
Practice, and Procedure. Also, included in the practice materials section is a
number of forms, which are useful for practitioners and agents communicating
with the patent office. The sources where these forms are found are good
examples of available sources for patent forms, which should give patent agents
and attorneys an idea of where other necessary forms can be found.
THANK YOU