This is really a dry topic so I think these slide are helpful to you to learn well, this is generally covered in III year of Pharm.D under Pharmaceutical Jurisprudence. So make use of this notes and prepare well.

1. PATENTS & DRUG
ACT-1970
By
Sri Ramya Vaddiparthy

2. Introduction
 The term of patents in the case of processes or
methods of manufacture of a substance
intended to be used or capable of being used as
food or as a medicine or drug is for a period of
seven years from the date of filing or five years
from the date of sealing the patent, whichever
is less.
 Patents filed last for 20 years from the date
of patent application filing. This is true for
“utility” patents, but the terms for certain
other, less common types of patents, are
different. The short answer to how long drug
patents last is “twenty years.” It's usually
more complex than that

3.  Under this law, patent rights are granted
for inventions covering a new and inventive
process, product or an article of
manufacture that are able to satisfy
the patent eligibility requirements of having
novelty, inventive step, and are capable of
industrial application.A patent application
and any resulting patent is owned by the
inventor(s) of the claimed invention, unless
a written assignment is made or the
inventors are under an obligation to assign
the invention, such as an employment
contract.

4.  A patent is a legally enforceable right for a
device, substance, method or process. For
application to be successful, your invention
must be new, useful and inventive or
innovative. When granted, a patent will
give exclusive commercial rights to
invention.
 A patent is considered as a transferrable
property that can be transferred from the
original patentee to any other person by
assignment or by operation of law.
A patent can be licensed or assigned only
by the owner of the patent.

5. There are several types of patent or
patent claim that are particularly
relevant to pharmaceuticals. These
are:Product patent or claim
 This claims the active chemical substance as a new chemical entity and is
generally regarded as being superior claim. If there is a product claim on
the drug then none but the patent holder or licensee can make, sell or
import the chemical for any use without infringing the product patent.
 This type of patent claim is now allowed in most commercially important
countries, although it is a fairly recent event in many others.
 The novel drug is claimed either by chemical name or by chemical
structure, or both. The drug may be claimed within a Markush structure.
This comprises a core chemical structure with several optional chemical
groups that may be attached to the core structure. This is known as a
generic claim to a compound. A drug will be covered by the generic claim
and there may be a specific claim to the chemical as well. Some Markush
structures are so general that they can cover millions of actual chemicals.
 Note that in patentees the term ‘composition of matter’ actually denotes
a product claim.

6. Product by process patent or
claim
 This type of claim ‘claims’ a chemical or
other process used to manufacture the
drug whenever the drug is made by the
patented process. It is the ‘next best’ type
of claim as it also confers protection
against importation of a product. However,
the drug can be made and sold if another
company can devise a commercially viable
process not covered in the patent.

7. Process patent
 This claims the chemical or other process used
to manufacture the drug. The chemical
product itself is not covered. Because of the
difficulty of proving that another company is
using the patented process, many countries
have a ‘burden of proof reversal’ clause where
the potential infringer has to prove that the
patented process is not being used. In the USA,
the patent law was amended to made
importation of the product of a patented
process an infringing act, although this is not
generally the case.

8. Formulation patent
 This claims the pharmaceutical dosage form on the
drug, commonly also known as a composition but not
to be confused with ‘composition of matter’ (see
previously). It may take the form of a formulation of
a particular drug or class of drugs, or a general
formulation applicable to many drugs with different
actions, such as slow release technologies,
transdermal patches, etc. There may also be
formulation process patents covering the
manufacturing processes used to make the
formulation.
 Remember that not all types of claim are allowed in
all countries and some countries do not have patent
laws.

9. Patent law in INDIA
 Patent rights were introduced in India for the first
time in 1856 and, in 1970, the Patent Act 1970
("the Patents Act") was passed, repealing all previous
legislations. India is also a signatory to the Paris
Convention for the protection of industrial property,
1883, and the Patent Cooperation Treaty, 1970.
The Patents Act provides that any invention that
satisfies the criteria of newness, non-obviousness and
usefulness can be the subject matter of a patent.
Some of the non-patentable inventions under the
Patents Act include methods of agriculture or
horticulture, processes for the medicinal, surgical,
curative, prophylactic or other treatment of human
beings, animals or plants or substances obtained by a
mere admixture, resulting only in the aggregation of
the properties of the components, etc.

10.  With regard to pharmaceuticals, in the
case of substances intended for use or
capable of being used as food, drugs or
medicines or substances produced by
chemical processes, patents are granted
only for the processes of manufacture of
such substances and not for the
substances themselves. Hence,
pharmaceutical products are currently
not granted patent protection under
Indian law.

11. Applying for Patent
 The process of filing for and being
granted a patent can take years. Filing
a patent starts with writing
a provisional application, which is like a
placeholder for the full application that
clearly states what the invention is and
its limits. Provisional patents don’t need
to include specific claims yet (those are
included in the full application).

12.  Priority date: Filing a provisional patent is very
important because it establishes the “priority date,”
or the first date that the patent was filed. This could
be crucial if a legal battle erupts between different
inventors claiming rights to the same invention or
similar inventions; the first patent filed will generally
be upheld as it defines what other patents or
documents are “prior art,” or what documents and
patents already exist prior to that date. The priority
date can be thought of as the defining line between
old information (prior art) and new information
(invention in the patent application).
 Once you’ve filed a provisional application, you can
say your invention is “patent pending,” meaning
you’ve filed an application, but the patent hasn’t
been granted yet.

13.  12 Months Later: You must file a full
“non-provisional” patent application that
includes the full set of claims within 12
months after filing your provisional
application. The claims clearly lay out the
boundaries of the invention. After filing the
full application, you can’t add any
additional subject matter (topics or
information outside of those specified in the
application). Once the full application is
filed, the administrative details are
reviewed during a formal examination
period.

14.  16 Months Later: After publication, the search and
substantive examination is conducted where the
application is examined to ensure it satisfies the
requirements for being patentable. An
authorized International Searching Authority
(ISA) begins searching for the most relevant prior art
documents and compiles them into an International
Search Report (ISR).
 The patent office also writes a non-binding written
opinion on patentability and sends the ISR and
opinion letter to the inventor, who can address any
objections made and modify the patent application
as needed. This iterative process widdles down the
scope of the claims to ensure the invention and
patent fulfills all patentable criteria.

15.  18 Months Later: During this time, you may also
submit the Patent Cooperation Treaty (PCT)
application, which allows you to seek patents in 152
countries worldwide (shown on the map) at a later
stage in the patent process. The PCT application is
published 18 months after the priority date.
 22-28 Months Later: If the authority cannot find
any prior art (the ISR is negative), the inventor can
request an optional International Preliminary
Examination to examine the chances of getting the
patents granted in the locations being pursued. This
is economical because it can give the inventor a
better idea of a patents chances before proceeding
with the trouble and costs of regional and national
examination.

16.  30 Months Later: Once the ISR and opinion letter cycle is
complete, the application enters the regional (such as the
European Patent Office, EPO) and national (such as the
USPTO and Canadian Intellectual Property Office, CIPO)
substantive examination phase. This phase is the most
expensive because it involves multiple local patent
attorneys and business in multiple languages.
 More Than 30 Months Later: After the examination phase,
the patent office decides whether a patent is granted and
published or not. This process varies widely between offices
and can take anywhere from a few months to up to five
years. If the patent is granted, the inventor must decide
which countries the patent will be published in. Each
country has its own patent office and translation costs.
 Following publication, opposition proceedings allows third
parties to voice their opinions where they may oppose the
granting of a patent if they think the invention is not new.

17. Common Pharmaceutical Patent
Extentions.
 There are many different types of
pharmaceutical patents, depending on the
drug they are protecting. The exclusivity of
each patent can be extended by various lengths
because drug discovery, validation, and
marketing can take more than 10 years.
 By extending the patent exclusivity, it
encourages companies to study and develop
new drugs by derisking the extended time and
effort expended during development. This is
especially important for drugs in understudied
areas, such as rare diseases, antibiotics, and
pediatric populations.

18.  Because a large portion (up to 80 percent) of
pharmaceutical company’s revenue comes from their
patents, they want to extend their patents for as
long as possible. Once a patent expires, other
companies can manufacture and sell the drug, which
is where generic competitors come into play.
 Patents for new chemical entities (drugs that contain
a portion that has never been FDA-approved) can be
extended for five years under the FDA and European
Medicines Agency (EMA). Sponsors may also receive
up to 11 years of exclusivity for new drugs (eight
years of data exclusivity, two years of market
exclusivity, and a one-year extension).

19.  Patents for new methods of use (a new use for a
drug or drug reformulation via extended-release
drug versions, reduced dosing, or increased ease of
use) can be extended for three years under the FDA
and ten years under the EMA.
 Patents for drugs with orphan designation (drugs to
treat rare diseases) have an extra seven years of
exclusivity on drug sales under the FDA and ten
extra years under the EMA.
 Patents for drugs with pediatric exclusivity (ones
that include pediatric data) can enjoy an additional
six months of exclusivity under the FDA and EMA.
 Patents for certain new antibiotics can have an extra
five years of exclusivity under the FDA.

20. Common Questions about Patents
& Publishing
If you’re considering applying for a patent, you should closely
examine the variety of advantages, risks, and alternatives.
 There are also a variety of other questions you should ask
yourself:
 Is there a market for the invention?
 Do the expected profits from an exclusive position in the market
justify the costs of patenting?
 What are the alternatives to your invention and how do they
compare?
 Is the invention useful for improving an existing product or
developing a new product? Does it fit with the business strategy?
 How likely are others, especially competitors, to invent and
patent what you have invented?
 Is it the right time to file an application?

21. When should you file for
Patent?
 It’s always too early until it’s too late,” said Alacrita’s
consultants. If the competition is thick, filing for a
patent early may be crucial as the first-to-file date
is dominant when deciding on patent rights – just
look at the drama unfolding in the courtroom over
CRISPR patents! However, filing a patent too early
can turn around to bite the inventor in the butt; if
the invention isn’t well fleshed out when the PCT is
filed, more subject matter can’t be added to the
application, stunting the patent coverage. If you need
to withdraw the patent application for any reason,
you can do so during the 12-month provisional
period, bearing in mind that you will lose the
priority date from the provisional patent.

22. Differences between a patent
application and a grant or scientific
paper
 If a patent isn’t the right answer for you,
maybe a scientific paper is. While a patent and
a grant or scientific paper both discuss novel
ideas or entities, they do so in opposing ways.
A grant or paper must be an evidence-based,
logical, systematic report based on preliminary
data that usually speculates about future
applications or potential. On the other hand, a
patent must be a non-obvious, non-
incremental, novel report that no one has
done before and does not speculate about
future applications or potential (speculation
would make those future applications
unpatentable!).

23. When is it safe to publish
 There is always a risk when publishing – most
novelty-destroying disclosures are made by the
inventors themselves! If you’re between provisional
application and PCT, you may need to withdraw and
re-file, which can’t be done if you’ve published your
work in a scientific paper/abstract/poster. Publishing
after the PCT can provide ammunition to the
Examiner as to why you lack an inventive step
because explaining the scientific method in the
publication is at odds with the “surprise” element
needed to be patentable. After a patent is granted,
you may be considering additional patents and don’t
want to impact future patents’ novelty. Publication is
a strategic issue that balances patent issues and the
need to establish credentials through high impact
publications.

24. References
 https://www.google.com/search?q=patent+
and+drug+act&oq=patent+and+drug+act&a
qs=chrome..69i57.8849j0j15&sourceid=ch
rome&ie=UTF-8
 https://www.mondaq.com/india/patent/8
65888/patents-and-the-indian-
pharmaceutical-industry
 https://www.alacrita.com/blog/pharmaceu
tical-patents-an-overview
 http://mpasearch.co.uk/product-process-
formulation-patents