ALL PATENT FORM AND REGULATION

1. Patents
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Mr:Roshan G Bodhe.
M Pharm Pharmaceutics.
R. C. Patel Institute of Pharmaceutical
Education and Research Shirpur.

2. Defining a Patent
A patent application, for a utility patent in the United
States (as opposed to a design patent), must explain
how to work (i.e., make and/or use) the invention (s) (
Here invention is a drug) and must also include claims
that particularly point out the invention (s) and define the
scope of the subject matter for which exclusive rights
are sought by the patent applicant. The exclusive rights
are limited to the subject matter encompassed by the
patent's claims.

3. Patents & the Pharmaceutical
Industry
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Patent protection is granted for 20 Years to a
pharmaceutical drug product.
Reason for patent protection: Cost of research,
development & clinical trials is high & FDA takes time to
approve the drug.
Patent Protection can be extended beyond the
stipulated period----Hatch-Waxman Act.
Various tactics are employed pharmaceutical companies
in extending their patents through legislative loopholes ,
lobbying, initiating litigation to prevent patent
infringement, etc
Source: www.okjolt.com

4. Introduction to US Drug Approval
Process

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The Food and Drug Administration (FDA), established in
1930, a part of the US Department of Health and Human
Services (HHS), It has more than 9,000 employees
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Device and Radiological Health
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
National Center for Toxicological Research
Office of Regulatory Affairs
The Patent Approval Agency: FDA

6. The Orange Book
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•Therapeutic equivalence codes
“A” = Substitutable
“B” =In equivalent, NOT Substitutable
Expiration dates: patent and exclusivity
Reference Listed Drugs: brand drugs identified by the
FDA for generic companies to compare with their
proposed products
Electronic Orange Book –http://www.fda.gov/cder/ob/

7. Terms & Conditions of a
Patent
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Patents grant a legal monopoly on an invention for
twenty years, which begins on the date the patent
application is filed with The United States Patent and
Trademark Office.
A three-year extension changed the law prior to 1995; the
law prior to 1995 initially granted a period of exclusivity
for only seventeen years from the time a patent had
been granted. This change in the law was promulgated
through The Uruguay Round Agreement Act as a piece
on The General Agreement on Tariffs and Trade.
Essentially, it synchronized U.S. patent terms with other
nations.
The different durations for patent protection are still

8. FDA Approval
 Any new drug must go through an
extensive governmental approval process
before it can be marketed to the public.
The Food and Drug Administration (“FDA”)
may take many years to approve a new
pharmaceutical.

9. Patent Life
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Accordingly, drug companies are granted the
right to apply for a patent extension for up to
five years so that they can have a maximum
effective patent life of fourteen years.
However, since clinical trials and FDA
approval takes about eight and a half years to
complete, the viable patent term may be even
shorter than the fourteen years specified.

10. New Drug
Development—FDA
Time

11. Hatch-Waxman Act
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The Hatch-Waxman Act of 1984 limits developers of
new drugs.
The current law in the area of patents is The Hatch-
Waxman Act, which proposes to balance the competing
interests of brand name companies, generic companies,
insurance companies, and the public by promoting
competition and decreasing drug costs.

12. The Act
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The Act has two provisions of great interest in the dispute
between brand name companies and other interested parties.
The first is the automatic 30-month stay granted to the patent
holder when the patent holder brings an infringement suit
against a new generic manufacturer. This stay prevents the
approval of a generic version of the name brand drug regardless
of whether the original patent has expired.
The second provision of interest allows a 180-day period of
exclusivity granted to the first generic company to enter the
market after the patent expires. In both instances, brand name
manufacturers are able to manipulate the Act in order to extend
the life of their patent.

13. Patent Extension
Tactics
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There are at least four ways brand name drug companies
effectively extend the life of their patents.
These include the following: (1) extending patents
through legislative loopholes and lobbying; (2) initiating
litigation alleging patent infringement; (3) layering of
patents and the combination of drugs to create new
patents; and (4) advertising and developing brand names
to increase barriers for generic entry.

14. Patent Extension
Tactics
 Brand name drug companies continue to
abuse the two major provisions of The
Hatch-Waxman Act. By initiating litigation,
whether legitimate or not, pharmaceutical
companies are able to keep generics out
of the market for at least thirty months
after the original patent expires.

15. Patent Extension
Tactics
 Drug companies facing the expiration of a patent
will develop a new use or different version of
their old drug. This practice is referred to as
layering. Eli Lilly’s Prozac demonstrates one
example of a drug company obtaining a new
patent on an additional aspect of an old drug.

16. Current Patent Filings
& Trends
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The number of patents filed in the US in
2004 stood at 165,485. In comparison, the
Indian tally stood at only 1,216 patents in
2004.
During 1997-2001, India produced only 77,
200 patents as compared to the US, which
produced 1.2 million patents.
Source: India Economic Summit November 28

17. Patenting Over Time in
the Antidepressant
Patent Industry

18. Patent Scenario In India

19. Patents and India
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1856 - Protection for inventions formally started
Based on the British Patent Law of 1852
1911 - The Indian Patents & Designs Act
Product patents / composition of matter patents
available
1972 - The Patents Act came into force on April 20,
1972
Only process patents in pharmaceuticals,
agrochemicals and food
Term – 5 years from date of grant or 7 years from
date of application, whichever was earlier

20. Patents & India
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1994 – Indian signs GATT agreement
1997 – India becomes a PCT member-state
Amendments to the 1970 Act
1999 - (effective Jan 1, 1995) – introduced EMRs,
mail-box applications and 20-year term
2002 (effective Jan , 2005)

21. Indian Patent Office
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http://patentoffice.nic.in/
Locations
Four metro cities
East – Kolkata (Calcutta)
– Headquarters
Current CG is based
in Mumbai
West – Mumbai
North – Delhi
South – Chennai
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Number of examiners
Two years ago – less than 100
Now – more than 300
Examiner qualifications
Masters degree holders,
doctorates being hired
Training examiners
Intellectual Property Training
Institute, Nagpur
Hands on training at USPTO,
EPO, JPO, etc.

22. Indian Patent Office
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Online search facilities have been established
and the patent offices have been provided with
ISDN facility to ensure uninterrupted
connectivity. Similar facilities has also been
provided to Trade Marks offices and Designs
offices.
Improved novelty search in patents is being ensured
through connectivity to international databases.
Further, CD-ROMs were also acquired for this
purpose and library facilities strengthened.

23. Patent Office
Publications
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Official Journal of the Indian Patent Office
http://patentoffice.nic.in/ipr/patent/
journal_archieve/patent_journal_2005.htm
Commenced weekly publication effective Jan 21,
2005
Mail-box applications filed between Jan 1, 1995
and Dec 31, 2004 have also been published (to
enable request for examination)

24. Examination Process
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Approximate time taken for a grant
Was 5-6 years, now 2-3 years
Examination reports,normally start arriving 6-12
months after filing the complete specification
Quality of examination reports
Under process patent regime, just one
independent claim was allowed in a patent
Examiners generally insisted on including all
limitations in that independent claim.

25. Interviews
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Personal interviews
Arguing on highly complex technical
issues was virtually impossible
“Educating the examiner”

26. Implications on the Industry
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India faces a deadline of January 1, 2005 to comply with WTO
requirements, set out in TRIPS (the Agreement on Trade-Related
Aspects of Intellectual Property Rights) that it protect product patents
on medicines (TRIPS Art. 65.4). India has not protected product patents
on medicines for the last 35 years. Competitive domestic manufacturers
have kept medicine prices low in India, for domestic and export markets.
According to the WHO, India ranks 4th in the world in production of
pharmaceuticals by volume and is the world’s leading supplier of generic
medicines, with 66.7% of its exports going to developing countries.

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Two categories of drugs will be affected
First, those discovered after January 1, 2005. If a medicine
is patentable, the patent holder will be granted a 20-year
monopoly from the date of filing as a result of the new
rules.
The second category of medicines that will be affected by
the change in India’s Patents Act are those that have been
patent protected outside of India since January 1, 1995.
According to WTO rules (TRIPS Art. 70.8), India was
required to establish a “mailbox” where patent applications
could be filed between 1995 and 2005.
Implications on the
Pharmaceutical Industry

28. Ranbaxy Patent Filings

29. Indian Patent Law: Critical
Provisions
Sec 3 : What are Not Inventions
Sec 11A : Publication of Applications
Sec 25 : Opposition to Grant of Patent
Sec 39 : Prohibition to Apply for Patents Outside India
Sec 92A : Compulsory License for Export
Sec 159 : Power of Central Government to Make Rules

30. Source: WHO-CIPIH: Commission on Intellectual
Property Rights, Innovation and Public Health
Number of Patent Filings
by MNCs-1995-2004