Transcript Non-Patent Exclusivities

NON-PATENT
EXCLUSIVITIES
Presented at the ASSOCHAM Conference on “IPR in
Pharmaceuticals: Balancing Innovation & Access”
Pride Hotel, Ahmedabad, October 7, 2015
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Dr. Bhaswat S. Chakraborty
Sr. VP & Chair, R&D Core Committee
Cadila Pharmaceuticals Ltd.
DISCOVERY AND DEVELOPMENT OF
NEW PHARMACEUTICALS
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Entail enormous intellectual and financial resources
Thus, incentives and protections are required
Motivation
 Fair ROI
 Term of market exclusivity
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NCE, NBE api/galenic products
Internationally, 20 yr patent term from the date of filing
 Translates to ~8-12 years of exclusive sales rights
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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
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Chakraborty BS (2014). Pharma Bio World, June, 31-34
PATENT & NON-PATENT
EXCLUSIVITIES
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FDA,EMA, CDSCO
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Provide legal opportunities to extend the period free of competition
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Called non-patent exclusivity provisions
Both patents and exclusivity are similar concepts and both work in
a similar fashion
Differences:
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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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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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FIVE TYPES OF NON-PATENT
EXCLUSIVITIES IN THE USA
S. No. Exclusivity
Term
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Orphan Drug Entity (ODE)
7 years
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New Chemical Entity (NCE)
5 years
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"Other" Exclusivity (Mainly new clinical study 3 years
exclusivity)
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Pediatric Exclusivity (PED) – added to existing 6 months
Patents/Exclusivity
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Patent Challenge (PC ) – this exclusivity is for 180 days
ANDAs only
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ORPHAN DRUG ENTITY (ODE)
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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
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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
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However, a clinically superior or safer same orphan drug
for the same indications may be granted by the FDA
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NEW CHEMICAL ENTITY (NCE)
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An NCE is an active moiety for which no NDA was
previously filed to FDA
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The emphasis of exclusivity here is on the new active moiety
that is directly or indirectly responsible for the drug’s
pharmacological action
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The NCE exclusivity granted by the FDA is valid for 5 yrs
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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
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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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NEW CLINICAL STUDY EXCLUSIVITY
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New clinical study exclusivity
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Granted for reports of new clinical investigations (other than
BA/BE studies) essential to the approval
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E.g., formulations; salts; indications; dosing regimens; patient
populations; OTC switches; or other label changes
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Requirements include
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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
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However, FDA can review an ANDA with the same drug during
this exclusivity period
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PEDIATRIC EXCLUSIVITY (PED)
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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
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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
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exclusivity formerly granted.
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ANDA FILINGS TO US FDA
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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
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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
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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
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day of marketing of the product
PATENT CHALLENGE (PC)..

For approval process of paragraph IV, the generic
applicant must:
Certify in its ANDA that the patent in question is invalid
or is not infringed by the generic product
Notify the patent holder of the submission of the NDA
1.
2.
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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
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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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PARAGRAPH IV PATENT CHALLENGES
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EUROPE: SUPPLEMENTARY PROTECTION
CERTIFICATES (SPCS)
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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
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In Lithuania, however, an SPC may be obtained for any approved
patented product, provided the basic patent was filed after
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February 1st, 1994
OTHER EXCLUSIVITIES IN EUROPE
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Under the data exclusivity directive, pharmaceutical
companies may receive up to 11 years to market their
product without risk of competition
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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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OTHER EXCLUSIVITIES IN EUROPE..
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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
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Once an orphan MA in centralized procedure or by all member
states
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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
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exclusivity
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for products developed exclusively for use in the pediatric population
EUROPEAN EXCLUSIVITIES
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THE INDIAN SCENARIO
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Until 1994, India had relatively weak patent laws so that all lifesaving 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
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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
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non-patent exclusivity to the extent described above for US or EU.
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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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REFERENCES
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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/regulatio
n/general/general_content_000029.jsp&mid=WC0b01ac058002
40ce
European Medicines Agency. (2013). Medicines for children.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_t
opics/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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ACKNOWLEDGEMENT: NILESH M SHAH
THANK YOU VERY MUCH
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