SUI GENERIS PROTECTION FOR PHARMACEUTICALS AND ITS IMPACT ON GENERIC COMPANIES

1
COVER PAGE:
STUDENT ID: 150690388
MODULE NUMBER: QLLM194
MODULE NAME: INTELLECTUAL PROPERTY, TRADE
AND INVESTMENT LAW
WORD COUNT: 3598 (Including Bibliography)

2
ACKNOWLEGEMENT:
THE AUTHOR THANKS DR. GAIL EVANS FOR HER GUIDANCE AND SUPPORT.
TABLE OF CONTENTS:
CHAPTER PAGE No.
INTRODUCTION 3-4
DATA AND MARKET EXCLUSIVITY 4-5
EUROPE 6-8
THE UNITED STATES OF AMERICA 9-11
CONCLUSION 12
BIBLIOGRAPHY 13-15
ABBRIVIATIONS:
1. Pharma - Pharmaceuticals
2. EU - EUROPEAN UNION
3. ANADA - Abbreviated New Drug Application
4. NDA - New Drug Application

3
SUI GENERIS PROTECTION FOR PHARMACEUTICALS AND ITS IMPACT ON
GENERIC COMPANIES:
INTRODUCTION:
The pharmaceutical industry is composed of two main groups: the research-based
pharmaceutical industries (innovators) and the generic industries. The former discovers and
develops new medicines while the later replicates, manufactures and distributes the
bioequivalent or biosimilar “copies” of the innovative product. 1
These research-based pharma industries, undoubtedly invest billions of dollars and many years
of research to finally produce a drug.2
Moreover, these drugs are further tested through the
preclinical and three phases of clinical trials.3
These trials normally take 10-15 years before the
final result is approved by the respective drug regulatory authority.4
The trials are conducted
by the pharma industries after the particular drug has been granted a patent license. Hence,
such trials eat up into the 20 years of patent term protection given to the pharmaceuticals. So
usually, the pharma industries are left with just 5-10 years of patent protection, and more
importantly to cover up the costs and make profits out of it. Such a procedure is unique and
applies just too pharmaceutical and other related innovations.5
Due to the strict and exhaustive procedure, the pharma industries are a granted patent extension
and other forms of protection. Data exclusivity is a form of product exclusivity right for
1
Ravi H. Mistry and Dr. Dilip G. Maheshwari, 'REGULATORY EXCLUSIVITY STRATEGIES: FURTHER
PROTECTION FOR PHARMACEUTICALS IN US, EUROPE AND JAPAN' (2014) Volume 4, WORLD
JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES.
2
Dr. Harvey E. Bale, Jr, Encouragement of New Clinical Drug Development: The Role of Data Exclusivity (1st
edn, 2000 by IFPMA, International Federation of Pharmaceutical Manufacturers Associations 2016)
<http://www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf> accessed 17 January 2016.
3
Gargi Chakrabarti, 'Need Of Data Exclusivity: Impact on Access to Medicines' (2014) 19 Journal of
Intellectual; Property Rights.
4
Dr. Harvey E. Bale, Jr, Encouragement of New Clinical Drug Development: The Role of Data Exclusivity (1st
edn, 2000 by IFPMA, International Federation of Pharmaceutical Manufacturers Associations 2016)
5
Bruce Lehman, 'The Pharmaceutical Industry and the Patent System' (2003)
<http://users.wfu.edu/mcfallta/DIR0/pharma_patents.pdf> accessed 9 April 2016.

4
medicinal products and a market exclusivity is a related form of additional protection.6
The
rising economic significance of data exclusivity is a combination of three factors:7
(i) The lengthy and costly process of clinical trials;
(ii) The ongoing innovative productivity challenges faced by the pharmaceutical industry and
(iii) The legal disputes between research-based and generics-based pharmaceutical companies.
This essay will deal with the implementation of data and market exclusivity in the European
Union and the United States of America and its effect on the generic pharma industries.
DATA AND MARKET EXCLUSIVITY:
“Investments in discovering and developing a single new biologic (including the cost of failures
and cost of capital) are now estimated at over a billion dollars with an increasingly focused
Food and Drug Administration (FDA) requiring more, not less, investment prior to approval.
Given these high upfront costs, data exclusivity is designed to provide a sufficient period of in-
market exclusivity to encourage innovation when patent protection is limited or uncertain in
value”8
. The United States and the European Union systems go a step beyond the minimum
obligations as set out under the TRIPS.9
Data Exclusivity is a period of time during which a company cannot cross- refer to the data in
support of another marketing authorization. 10
Data exclusivity is designed to preserve
innovation, incentives and recognizes the long, costly and risky process necessary for the
innovator company to gain regulatory appeal.11
The protection of this test data is a legally
required and economically necessary component of the intellectual property that provide
6
Tamsin Cornwell, 'Data Exclusivity for Medicinal Products in Europe' (United-kingdom.taylorwessing.com,
2016) <http://united-kingdom.taylorwessing.com/synapse/regulatory_dataexclusivity.html> accessed 30 March
2016.
7
Meir Perez PUGATCH, 'Intellectual Property and Pharmaceutical Data Exclusivity in the Context of
Innovation and Market Access' (http://www.iprsonline.org/, 2014)
<http://www.iprsonline.org/unctadictsd/bellagio/docs/Pugatch_Bellagio3.pdf> accessed 2 March 2016.
8
Henry Grabowski, 'Data Exclusivity for Biologics: What Is the Appropriate Period of Protection?' (AEI, 2009)
<http://www.aei.org/publication/data-exclusivity-for-biologics-what-is-the-appropriate-period-of-protection/>
accessed 20 March 2016.
9
Judit Rius Sanjuan, U.S And E.U Protection Of Pharmaceutical Test Data (2nd edn, Creative Commons, 543
Howard Street, 5th Floor, San Francisco, California, 94105, USA 2016).
10
<http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/05/WC500143122.pdf>
11
Gargi Chakrabarti, 'Need Of Data Exclusivity: Impact on Access to Medicines' (2014) 19 Journal of
Intellectual; Property Rights.

5
incentives for the development of innovative pharmaceutical products.12
Further, this data is
important for the innovator company so as to get a market authorization from appropriate drug
authority. Some experts consider data exclusivity as an independent intellectual property right
and not part of patent protection. 13
Hence, data protection is available even if the drug is not
protected by a patent.
The Trade Related Intellectual Property Rights (TRIPS) agreement also recognises the need to
protect such an undisclosed data under Article 39.3. TRIPS Article 39.3 states that “Members,
when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural
chemical products which utilize new chemical entities, the submission of undisclosed test or
other data, the origination of which involves a considerable effort, shall protect such data
against unfair commercial use. In addition, Members shall protect such data against
disclosure, except where necessary to protect the public, or unless steps are taken to ensure
that the data are protected against unfair commercial use” 14
The phrase “a considerable effort” in the TRIPS article 39.3 (in the case of pharma industries)
means the pre-clinical testing and the three phases of the clinical trials, which have to be
conducted before the market approval is granted. Article 39(3) essentially imposes three
obligations on governments15
:
1. To protect data on new chemical entities, the collection of which involved considerable
effort, against unfair commercial use.
2. To protect such data against disclosure, except where necessary to protect the public.
3. To protect such data against disclosure, unless steps are taken to ensure that the data is
protected against unfair commercial use.
12
Dr. Harvey E. Bale, Jr, Encouragement of New Clinical Drug Development: The Role Of Data Exclusivity By
(1st edn, 2000 by IFPMA, International Federation of Pharmaceutical Manufacturers Associations 2016)
13
ibid
14
WTO TRIPS Agreement
15
Anatole F Krattiger, Intellectual Property Management In Health And Agricultural Innovation (MIHR
2007).<http://www.iphandbook.org/handbook/authors/A36>http://www.iphandbook.org/handbook/authors/A
36

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EUROPE:
Data exclusivity was first introduced in the European Union in 1987 with the 87/21/EEC
Directive, which amended the 65/65/EEC Directive.16
In July 2001 the E.U. revised key aspects
of the pharmaceutical legislation; data exclusivity being one of the key topics.17
Subsequently,
the changes were brought into the 2004/27/EC Directive that amended the 1987 Directive.18
It
is not retroactive directive; it does not affect exclusivity periods for products for which
applications were submitted before the effective date, ie, late 2005. Hence, if an application is
made before November 2005, then the data exclusivity will depend on the earlier laws of the
member state, where data exclusivity varied from 6 -10 years.19
The EU Pharmaceutical Legislation, Directive 2004/27/EC adopted in 2004 created a
harmonised eight year data exclusivity provision with an additional two years market
exclusivity provision.20
This effective ten year market exclusivity can be extended by an
additional one year for new therapeutic indications.21
This is also referred to as the “8+2+1
formula”. This formula applies to all new chemical entities (NCEs) from 1st
November 2005
onwards.22
This formula allows the generic company to file a patent application after the first
8 years of the data exclusivity but would be restrained to market the drug due to the extended
market authorization with the innovator company. Therefore, if a generic company wants to
apply for a generic product within the stipulated 8 years of the data exclusivity time period,
then it will have to perform its own clinical trials and other safety and toxicology work.23
The E.U. data exclusivity does not grant additional periods of protection for subsequent
improvements (like the concept of “ever greening” in the U.S.A) brought to a drug, for example
new therapeutic indications, dosage forms, doses and dosage schedule.24
Any new strengths,
pharmaceutical forms, routes of administration, and presentations, as well as any extensions or
16
Judit Rius Sanjuan, U.S And E.U Protection Of Pharmaceutical Test Data (2nd edn, Creative Commons, 543
Howard Street, 5th Floor, San Francisco, California, 94105, USA 2016).
17
ibid
18
ibid
19
'DRUG REGULATORY AFFAIRS INTERNATIONAL' (DRUG REGULATORY AFFAIRS
INTERNATIONAL, 2016) <https://amcrasto.wordpress.com> accessed 30 March 2016.
20
Elias Mossialos, Monique Francine Mrazek and Tom Walley, Regulating Pharmaceuticals In Europe (Open
University Press 2004).
21
ibid
22
'Business Intelligence Consultancy & Patent Expiries, Spcs, Licences and Authorisation Data for the
European Pharmaceutical Industry | MPA Business Services' (Mpasearch.co.uk, 2016)
<http://www.mpasearch.co.uk/> accessed 30 March 2016.
23
'Anna Mckay' (Annamckay.com, 2016) <http://www.annamckay.com/article10.html> accessed 28 March
2016.
24
R v MCA (“The RPR Zimovane Case”) (1994) C-94/98.

7
variations, are to be considered as belonging to the same “global authorization” for purposes
of the abridged application rules 25
and therefore there is no data protection for these changes.26
Comprehensive Economic and Trade Agreement between Canada and the European
Union (CETA):
Article 10 of the intellectual property chapter in CETA provides protection of undisclosed data
in relation to pharmaceutical products.27
Clause 2(b) of the said article states that no person
other than the person that submitted the undisclosed information may, without the latter's
permission, rely on such data in support of an application for marketing authorisation during
a period of not less than six years from the date on which the Party granted approval to the
person that produced the data for approval to market its product, and no Party shall grant to
any person who relies on such data during a period of not less than eight years from the date
on which the Party granted authorisation to the person that produced the data for authorisation
to market its product, unless the person or entity who produced this data provides its
permission.28
In CETA, there are two levels of protection, firstly, the data authorization; which is valid for 8
years after it is submitted to the respective drug authority. Secondly, the market authorization;
which is valid for 6 years from the date the innovator pharma company was granted the
permission to market the drug.
EXAMPLE:
A pharma company ‘X’ is granted a patent in 2010. After its preclinical and clinical trials, it
submits the data in 2020, ie 10 years after the grant of the patent. After the data is submitted,
this undisclosed information gets data protection through 8 years of data exclusivity in
accordance with the clause (b) of Article 10 in CETA, as mentioned above. Hence, the generic
pharma companies cannot rely on the data till 2028. The other incentive provided to the
company ‘X’ is the marketing exclusivity for 6 years. If the said company gets authorization
to market the drug in the year 2024, it will last till 2030.
While reading the above example, it must be kept in mind that the patent term protection will
last till 2030 (as the patent term is 20 years). Hence, as the data and market exclusivity are
treated separately from patents, such exclusive rights may terminate or exist after the patent
25
Article 6.1 of the Directive 2001/83/EC, as amended
26
Novartis Europharm -v- Commission [2014] CJEU, T-511/14 (CJEU).
27
(2016) <http://trade.ec.europa.eu/doclib/docs/2016/february/tradoc_154329.pdf> accessed 8 April 2016.
28
ibid

8
term is over, depending on the factual circumstances. In this case, all the protections terminate
in 2030.

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THE UNITED STATES OF AMERICA:
The United States has a very strong domestic pharmaceutical industry.29
In the United States,
both U.S. Patent Law and U.S. Food and Drug Administration (FDA) law govern the
exclusivity rights for new pharmaceutical products.30
In addition, the U.S. Federal Food, Drug
and Cosmetic Act (FDCA), provides several exclusivity opportunities, including 1) new
chemical entity (NCE) exclusivity; 2) clinical investigation exclusivity; 3) orphan drug
exclusivity; and 4) paediatric exclusivity.31
This essay will specifically deal with the NCE
exclusivity.
Obtaining the U.S. patents is not enough but the drug must be properly listed in the FDA
Orange Book for them to have the desired exclusivity effect in delaying the approval of any
ANDA for that drug.32
A pharmaceutical manufacturer can gain NCE Exclusivity in the United States by introducing
a drug that contains an “active moiety” that has not been previously approved by FDA in a new
drug application (NDA).33
An “active moiety” is defined as the molecule or ion responsible for
the drug substance’s physiological or pharmacological action.34
"HATCH-WAXMAN ACT" AMENDMENTS:
The Drug Price Competition and Patent Term Restoration Act, 1984 ("Hatch-Waxman"
amendments) acts as a compromise between the interest of generic manufacturers obtaining
29
Mary Atkinson, 'PATENT PROTECTION FOR PHARMACEUTICALS: A COMPARATIVE STUDY OF
THE LAW IN THE UNITED STATES AND CANADA' (2002) VOL. II PACIFIC RIM LAW & POLICY
JOURNAL <https://digital.lib.washington.edu/dspace-
law/bitstream/handle/1773.1/750/11PacRimLPolyJ181.pdf?sequence=1> accessed 10 April 2016.
30
Richard B. Racine, 'The Interplay between U.S. Pharmaceutical Patents and FDA Law | Articles | Finnegan'
(Finnegan.com, 2010) <http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=ad4b058b-0150-
4ec7-90f4-57e6641272a6> accessed 10 April 2016.
31
Carolyne Hathaway, John Manthei and Cassie Scherer, 'Exclusivity Strategies in the United States and
European Union' [2016] FDLI <https://www.lw.com/upload/pubcontent/_pdf/pub2655_1.pdf> accessed 10
April 2016.
32
THE LAW IN THE UNITED STATES AND CANADA' (2002) VOL. I I PACIFIC RIM LAW & POLICY
law/bitstream/handle/1773.1/750/11PacRimLPolyJ181.pdf?sequence=1> accessed 10 April 2016
33
'New Chemical Entity Exclusivity Determinations For Certain Fixed combination Drug Products: Guidance
for Industry' [2014] Centre for Drug Evaluation and Research (CDER)
<http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386685.pdf>
accessed 11 April 2016.
34
ibid

10
faster entry into the market, and the interest of brand-name pharmaceutical companies in
regaining patent term lost during the regulatory process.35
Mechanism of the Hatch-Waxman Amendments:
Before the amendment, a generic drug company could offer competing drug products to
consumers after intense FDA scrutiny but they could not manufacture and conduct studies on
competing products during the term of the patent without infringing.36
The United States Drug Price Competition and Patent Term Restoration Act 1984 (“Hatch-
Waxman”) 35 U.S.C. Sec. 271(e) (1) states: “It shall not be an act of infringement to make,
use, offer to sell, or sell within the United States or import into the United States a patented
invention…solely for uses reasonably related to the development and submission of
information under a Federal law which regulates the manufacture, use, or sale of drugs…”37
Moreover, Section 21 U.S.C. 355(j) (2) (A) (vii) establishes a more streamlined route for the
ANDA approval process and hence entry of generics into the market.38
An ANDA can be filed for a new drug if the applicant can show that the new drug has the same
active ingredients, as a previously approved drug requiring only a demonstration of
bioequivalence.39
The ANDA is subject to automatic approval within 180 days of submission
unless it fails to meet one of the criteria mentioned in the section.40
Anyone filing an ANDA has to make a certification.41
Paragraph IV42
of the section requires a
certification that the original patent is invalid or will not be infringed by the generic drug’s
manufacture, use or sale. The paragraph IV certification complicates things.
A paragraph IV applicant must give notice to each owner of the patent and each holder of the
approved application that an ANDA has been filed.43
The patent holder then has 45 days from
35
THE LAW IN THE UNITED STATES AND CANADA' (2002) VOL. I I PACIFIC RIM LAW & POLICY
law/bitstream/handle/1773.1/750/11PacRimLPolyJ181.pdf?sequence=1> accessed 10 April 2016
36
Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984).
37
See 35 U.S.C Sec 271(e)(1)
38
'New Chemical Entity Exclusivity Determinations For Certain Fixed combination Drug Products: Guidance
for Industry' [2014] Centre for Drug Evaluation and Research (CDER)
<http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386685.pdf>
39
See 21 U.S.C. § 355(j)(1)
40
See 21 U.S.C. § 355(j) (4).
41
See 21 U.S.C. § 355(j)(2)(A)(vii)
42
ibid
43
See 21 U.S.C § 355(j)(5)(B)(iii)

11
receipt of this notice.44
If an action is not brought, approval will be made effective immediately.
However, if an infringement action is brought, approval will be made effective at the end of
the thirty-month period beginning with receipt of this notice45
unless, before this period
expires, the court finds the patent is invalid or not infringed.
But there are certain limitations on how early a brand name drug’s exclusivity can be
challenged. "An ANDA, or a NDA for a previously approved drug, cannot be filed within five
years of the approval date of the first application for the drug, unless the new drug ANDA or
NDA contains a paragraph IV certification, in which case it can be filed within four years of
the approval of its predecessor, but if the thirty month suspension of approval is triggered by
the initiation of an infringement action in the fourth year, the suspension of approval must be
extended (by up to twelve months) such that it terminates seven and a half years after the initial
approval".46
Protection of Undisclosed test or other data under Trans-Pacific Partnership (TPP):
Under TPP Chapter 18, Section C (Article 18.50): Protection of Undisclosed Test or Other
Data w.r.t pharmaceuticals says that “A party will not be permit any third person, without a
prior consent or authorization of the person that previously submitted such information, to
market the same or a similar product on the basis of: (i) that information; or (ii) the marketing
approval that has been granted to the person that submitted such information, for at least five
years from the date of marketing approval of the new pharmaceutical product in the territory
of the Party".47
44
ibid
45
See § 355(j)(5)(B)(iii)
46
'The Hatch-Waxman (Im) Balancing Act' (Dash.harvard.edu)
<https://dash.harvard.edu/bitstream/handle/1/10015297/Paper1.html?sequence=2> accessed 11 April 2016.
47
(2016) <https://ustr.gov/trade-agreements/free-trade-agreements/trans-pacific-partnership/tpp-full-text>

12
CONCLUSION:
It is clear that national laws and international trade agreements are trying to protect the
investment and the interests of the research-based pharma companies, which severely affects
the entry of generic medicines into the market. Even though legislative frame works like the
Hatch-Waxman Act, try to seek a balance between the research-based and the generic
manufacturers, but the former have learned to exploit loopholes in the Act prolonging their
monopolies. 48
Such a monopolistic approach results in expensive medicines (especially
lifesaving drugs) in the market. This directly influences the consumers who may not be able to
buy such high priced drugs and hence, infringe their right to access affordable medicines.
In conclusion, there is no obligation in TRIPS to provide the high standards to protect
undisclosed information. But as the protection of such information been held necessary in the
case of pharmaceuticals by various developed countries, the implementation of these laws
should be viewed through the eyes of the consumers as they are the ones who will ultimately
be affected.
48
'The Hatch-Waxman (Im) Balancing Act' (Dash.harvard.edu)
<https://dash.harvard.edu/bitstream/handle/1/10015297/Paper1.html?sequence=2> accessed 11 April 2016

13
BIBLIOGRAPHY:
1. (2016)<http://trade.ec.europa.eu/doclib/docs/2016/february/tradoc_154329.pdf>
2. (2016)<https://ustr.gov/trade-agreements/free-trade-agreements/trans-pacific-
partnership/tpp-full-text> accessed 11 April 2016.
3. (2016<http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/0
5/WC500143122.pdf> accessed 30 March 2016.
4. 35 U.S.C Sec 271(e)(1)
5. 'Anna Mckay' (Annamckay.com, 2016) <http://www.annamckay.com/article10.html>
6. Atkinson M, 'PATENT PROTECTION FOR PHARMACEUTICALS: A
COMPARATIVE STUDY OF THE LAW IN THE UNITED STATES AND
CANADA' (2002) VOL. II PACIFIC RIM LAW & POLICY JOURNAL
<https://digital.lib.washington.edu/dspacelaw/bitstream/handle/1773.1/750/11PacRim
LPolyJ181.pdf?sequence=1> accessed 10 April 2016.
7. B. Racine R, 'The Interplay between U.S. Pharmaceutical Patents and FDA Law |
Articles|Finnegan'(Finnegan.com,2010)
<http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=ad4b058b-
0150-4ec7-90f4-57e6641272a6> accessed 10 April 2016.
8. 'Business Intelligence Consultancy & Patent Expiries, Spcs, Licences and
Authorisation Data for the European Pharmaceutical Industry | MPA Business Services'
(Mpasearch.co.uk, 2016) <http://www.mpasearch.co.uk> accessed 30 March 2016.
9. Chakrabarti G, 'Need Of Data Exclusivity: Impact on Access To Medicines' (2014) 19
Journal of Intellectual; Property Rights.
10. Cornwell T, 'Data Exclusivity for Medicinal Products in Europe' (United-
kingdom.taylorwessing.com,
2016<http://unitedkingdom.taylorwessing.com/synapse/regulatory_dataexclusivity.ht
ml> accessed 30 March 2016.

14
11. 'DRUG REGULATORY AFFAIRS INTERNATIONAL' (DRUG REGULATORY
AFFAIRS INTERNATIONAL, 2016) <https://amcrasto.wordpress.com> accessed 30
March 2016.
12. E. Bale, Jr D, Encouragement Of New Clinical Drug Development: The Role Of Data
Exclusivity By (1st edn, 2000 by IFPMA, International Federation of Pharmaceutical
ManufacturersAssociations2016
<http://www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf>
accessed 17 January 2016.
13. Grabowski H, 'Data Exclusivity for Biologics: What Is the Appropriate Period Of
Protection?' (AEI, 2009) <http://www.aei.org/publication/data-exclusivity-for-
biologics-what-is-the-appropriate-period-of-protection/> accessed 20 March 2016.
14. H. Mistry R and G. Maheshwari D, 'REGULATORY EXCLUSIVITY STRATEGIES:
FURTHER PROTECTION FOR PHARMACEUTICALS IN US, EUROPE AND
JAPAN' (2014) Volume 4, WORLD JOURNAL OF PHARMACY AND
PHARMACEUTICAL SCIENCES.
15. Hathaway C, Manthei J and Scherer C, 'Exclusivity Strategies In The United States And
EuropeanUnion'[2016]FDLI.
<https://www.lw.com/upload/pubcontent/_pdf/pub2655_1.pdf> accessed 10 April
2016.
16. Krattiger A, Intellectual Property Management in Health And Agricultural Innovation
(MIHR 2007).
17. Lehman B, 'The Pharmaceutical Industry and the Patent System' (2003)
<http://users.wfu.edu/mcfallta/DIR0/pharma_patents.pdf> accessed 9 April 2016.
18. Lexchin J and Gagnon M, 'CETA and Pharmaceuticals: Impact Of The Trade
Agreement Between Europe And Canada On The Costs Of Prescription Drugs' (2014)
10 Globalization and Health.
19. Mossialos E, Mrazek M and Walley T, Regulating Pharmaceuticals In Europe (Open
University Press 2004).
20. 'New Chemical Entity Exclusivity Determinations For Certain Fixed combination Drug
Products: Guidance for Industry' [2014] Centre for Drug Evaluation and Research
(CDER)

15
<http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/gui
dances/ucm386685.pdf> accessed 11 April 2016.
21. Novartis Europharm -v- Commission [2014] CJEU, T-511/14 (CJEU).
22. PUGATCH M, 'Intellectual Property and Pharmaceutical Data Exclusivity in the
Context of Innovation and Market Access' (http://www.iprsonline.org/, 2014)
<http://www.iprsonline.org/unctadictsd/bellagio/docs/Pugatch_Bellagio3.pdf>
23. R v MCA (“The RPR Zimovane Case”) (1994) C-94/98.
24. Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984).
25. 'The Hatch-Waxman Balancing Act'(Dash.harvard.edu)
<https://dash.harvard.edu/bitstream/handle/1/10015297/Paper1.html?sequence=2>

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