This document discusses various types of non-patent market exclusivities that provide legal protection from generic competition for pharmaceutical companies. It describes five types of exclusivities in the US including orphan drug exclusivity which provides 7 years of protection, new chemical entity exclusivity with 5 years, new clinical study exclusivity for 3 years, pediatric exclusivity which extends existing protections by 6 months, and 180 days of exclusivity for being the first generic applicant to challenge a patent. The document also discusses exclusivity regimes in Europe including supplementary protection certificates and India's framework which does not guarantee data exclusivity.

1. NON-PATENT
EXCLUSIVITIES
Dr. Bhaswat S. Chakraborty
Sr. VP & Chair, R&D Core Committee
Cadila Pharmaceuticals Ltd.
Presented at the ASSOCHAM Conference on “IPR in
Pharmaceuticals: Balancing Innovation & Access”
Pride Hotel, Ahmedabad, October 7, 2015
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2. DISCOVERY AND
DEVELOPMENT OF NEW
PHARMACEUTICALS
 Entail enormous intellectual and financial resources
 Thus, incentives and protections are required
 Motivation
 Fair ROI
 Term of market exclusivity
 NCE, NBE api/galenic products
 Internationally, 20 yr patent term from the date of filing
 Translates to ~8-12 years of exclusive sales rights
 This exclusivity is balanced with a legitimate competition
from the low cost generic drugs
 For development of generic drugs
 Other competitive aspects, e.g., para IV, compulsory licensing
2
Chakraborty BS (2014). Pharma Bio World, June, 31-34

3. PATENT & NON-PATENT
EXCLUSIVITIES
 FDA,EMA, CDSCO
 Provide legal opportunities to extend the period free of competition
 Called non-patent exclusivity provisions
 Both patents and exclusivity are similar concepts and both work
in a similar fashion
 Differences:
 Patents are granted by the patent office anywhere along the drug
development lifetime and can encompass a wide range of claims
 Exclusivity is exclusive marketing rights granted by the
regulatory agency upon approval of a drug and can run
concurrently with a patent or not
 Exclusivity is a statutory provision and is granted to an NDA
applicant if statutory requirements are met
 Designed to promote a balance between new drug innovation and
generic competition
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4. DATA EXCLUSIVITY
 Data exclusivity guarantees additional market
protection for originator
 Health authorities cannot accept applications for
generics during the period of exclusivity
 Patents can expire before or after drug approval, or
anywhere in between
 Exclusivity, however, is granted only upon approval
 Some drugs have both patent and exclusivity protections
while others have just one or none
 Patents and exclusivity may or may not run concurrently
and may or may not encompass the same claims
 Exclusivity is not added to the patent life except
paediatric exclusivity, which extends patent life for 6 mo.
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5. FIVE TYPES OF NON-PATENT
EXCLUSIVITIES IN THE USA
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S. No. Exclusivity Term
1 Orphan Drug Entity (ODE) 7 years
2 New Chemical Entity (NCE) 5 years
3 "Other" Exclusivity (Mainly new clinical study
exclusivity)
3 years
4 Pediatric Exclusivity (PED) – added to existing
Patents/Exclusivity
6 months
5 Patent Challenge (PC ) – this exclusivity is for
ANDAs only
180 days

6. ORPHAN DRUG ENTITY
(ODE)
 Drugs for rare or unusual diseases (affecting 200,000
or fewer patients) are often treated as orphan drugs
 As drug companies are very reluctant to use resources for
such small, often obscure markets
 The US orphan drug act of 1983 was passed to address this
genuine but often neglected area of drug treatment
 Provides 7 yrs of market exclusivity period after its regulatory
approval
 ODE approved by FDA will not allow a generic or
another innovator product with same API labeled for
same orphan indications
 However, a clinically superior or safer same orphan drug
for the same indications may be granted by the FDA 6

7. 7

8. NEW CHEMICAL ENTITY
(NCE)
 An NCE is an active moiety for which no NDA was
previously filed to FDA
 The emphasis of exclusivity here is on the new active moiety
that is directly or indirectly responsible for the drug’s
pharmacological action
 The NCE exclusivity granted by the FDA is valid for 5 yrs
 During this period the FDA cannot approve a competitor’s
generic [505(J)] or follow on [505(b)(2)] application which is
based on the same NCE
 Like the case for ODE, the FDA can, however, accept or
approve another NDA with evidence of adequate efficacy,
safety, and quality based on the same NCE
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9. NEW CLINICAL STUDY
EXCLUSIVITY
 New clinical study exclusivity
 Granted for reports of new clinical investigations (other than
BA/BE studies) essential to the approval
 E.g., formulations; salts; indications; dosing regimens; patient
populations; OTC switches; or other label changes
 Requirements include
 a) studies may not be BA/BE; b) studies must be conducted or
sponsored by applicant; c) the new results not rely on FDA
reference files of previously submitted data; and d) studies must be
essential to approval
 This type of exclusivity is granted for 3 years and during
this period a competitor’s ANDA will not be approved by
the FDA
 However, FDA can review an ANDA with the same drug during
this exclusivity period
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10. PEDIATRIC EXCLUSIVITY (PED)
 Pediatric CTs
 Children as patients may not metabolize/respond to a drug like
the adults
 Thus, appropriate & adequate CTs of the same drug on pediatric
population to develop useful information of safety and efficacy
 Generated pediatric efficacy and safety data need not be
successful in statistical and conventional sense
 Applicants receive an exclusivity of 6 months by FDA
modernization act of 1997
 When 6-mo pediatric exclusivity is granted
 Applies to all existing patents and exclusivity on all applications
held by the sponsor for that active moiety
 It does not stand alone
 PED is annotated in the exclusivity column and is linked to
exclusivity formerly granted. 10

11. ANDA FILINGS TO US FDA
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12. PATENT CHALLENGE (PC)
 Patent challenge or generic drug exclusivity came into
existence by virtue of Hatch-Waxman Act of 1984
 This act provides for an exclusivity to the first ANDA
applicant containing a paragraph IV certification
 A para IV certification means that the applicant shall
provide the patent number and
 Certify, in its opinion and to the best of its knowledge, that
the patent is invalid, unenforceable, is not infringed
 by the manufacture, use, or sale of the drug product for which
the abbreviated application is submitted
 A substantially complete ANDA contains data that is sufficient
to permit a full review
 The length of patent challenge exclusivity is 180 days from the
day of marketing of the product 12

13. PATENT CHALLENGE (PC)..
 For approval process of paragraph IV, the generic
applicant must:
1. Certify in its ANDA that the patent in question is invalid
or is not infringed by the generic product
2. Notify the patent holder of the submission of the NDA
 If an infringement suit is filed against generic
applicant
 Within 45 days of ANDA notification
 Then, FDA approval to market the generic drug is
automatically postponed for 30 months
 unless, before that time, the patent expires or is judged to be
invalid or not infringed
 This 30-month postponement allows the patent holder
time to assert its patent rights in court
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14. PARAGRAPH IV PATENT
CHALLENGES
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15. EUROPE: SUPPLEMENTARY
PROTECTION CERTIFICATES
(SPCS)
 The process of obtaining a patent may reduce the period to
exclude others from practicing the patent
 The European patent law offers SPCs to compensate patent
holders for the regulatory delays of medicinal/plant products
approval
 An SPC extends the statutory 20-yr max by up to five years
 Note that SPCs can be obtained only for products that have
been authorized for the first time as medicinal products in
the EU
 In Lithuania, however, an SPC may be obtained for any approved
patented product, provided the basic patent was filed after
February 1st, 1994 15

16. OTHER EXCLUSIVITIES IN
EUROPE
 Under the data exclusivity directive, pharmaceutical
companies may receive up to 11 years to market their
product without risk of competition
 11 years of exclusivity are comprised of an “8+2+1” regime
 A drug company introducing its product to market in the EU
can enjoy 8 yrs of data exclusivity, 2 yrs of marketing
exclusivity & 1 yr extension
 During 8 yr period of data exclusivity, competitors cannot
submit generic applications for MA
 During this time, the innovator’s data is treated as a trade
secret until the expiration of the 8 yr data exclusivity period
 Within the data exclusivity period a new applicant must
perform its own safety and tox studies & CTs, without
dependence on innovator’s data
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17. OTHER EXCLUSIVITIES IN
EUROPE..
 EU also has exclusivity for orphan drug medicines
 Rarity of condition (< 5 in 10,000) or insufficient return on investment
 Seriousness of condition (life threatening/chronically debilitating)
 Methods of diagnosis, prevention, or treatment exist in EU
 If a method does not exist, significant benefit should be assured
 Once an orphan MA in centralized procedure or by all
member states
 The community/member states will not accept another application for
MA for the same drug and indication for 10 yrs
 6 months of PE patent extension plus
 1 yr patent extension for products that have demonstrated a significant
clinical pediatric benefit for an approved indication
 2 yr of additional exclusivity for studies in PIP
 PUMA may provide 8 yrs of data exclusivity and 10 years marketing
exclusivity
 for products developed exclusively for use in the pediatric population
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18. EUROPEAN EXCLUSIVITIES
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19. THE INDIAN SCENARIO
 Until 1994, India had relatively weak patent laws so that all life-
saving drugs could be provided to Indian citizens at low cost
 However, under TRIPs & GATT of 1994
 Patent Amendment Act of 2005 is seeing Indian industry is in full compliance
with TRIPs in all aspects
 Both products and processes of all APIs and finished dosage forms are supposed
to be non-infringing of existing relevant patents
 In practice, no guaranteed data exclusivity in India
 Such non-exclusivity allows generic companies sometimes to
introduce competing products without doing their own safety and
efficacy tests
 Also, Indian Patents Amendment Act of 2005 excludes
patentability for derivatives of known substances
 Unless efficacy is significantly greater than the original substance
 Also, DPCO has >350 essential drugs under price control thus not encouraging
non-patent exclusivity to the extent described above for US or EU.
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21. CONCLUDING REMARKS
 It is fitting that pharmaceutical innovators would like
to enjoy a favorable return on their R&D investments
since the investments often exceed the billion dollar
mark these days
 The non-patent market exclusivities along with the
remaining patent term after approval provide for an
optimal benefit to these stakeholders
 When properly informed about these exclusivities, an
innovator, NDDS sponsor or a generic manufacturer
can develop their strategies for an appropriate short
or long term, whatever is applicable in its case
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22. REFERENCES
 US Food and Drug Administration. (2011). How can I better
understand Patents and Exclusivity?
http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm23
8582.htm
 Hathaway C., Manthei J., Scherer C. (2009) Exclusivity
Strategies in the United States and European Union. FDLI
Update, May/June issue, 34-39.
 European Medicines Agency. (2013). Orphan designation.
http://www.ema.europa.eu/ema/index.jsp?
curl=pages/regulation/general/general_content_000029.jsp&mi
d=WC0b01ac05800240ce
 European Medicines Agency. (2013). Medicines for children.
http://www.ema.europa.eu/ema/index.jsp?
curl=pages/special_topics/general/general_content_000302.jsp
 Chakraborty B.S. (2011). Towards New Horizons in Pharma
Research. Ingredients South Asia, October 16-31 issue, 34-36.
 Janodia M.D., Chauhan A., Hakak S.M., Sreedhar D., Ligade
V.S., Udupa N. (2008) Data Exclusivity Provisions in India:
Impact on Public Health. Journal of Intellectual Property
Rights, 13, 442-446.
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23. SHAH
THANK YOU VERY
MUCH
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