Pharmaceutical industries invest billions of dollars, Euros in these highly risky health care solutions, for this Intellectual property protection is essential. Innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company for the same drug substance.
The Falsified Medicines Directive - Regulation Driving DigitisationAegate
"The Falsified Medicines Directive - Regulation Driving Digitisation" by Graham Smith of Aegate.
Presented at The European Generic Medicines Association’s Annual Conference, Madrid
June 25-27th 2014
This presentation by Italy was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Pharmaceutical industries invest billions of dollars, Euros in these highly risky health care solutions, for this Intellectual property protection is essential. Innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company for the same drug substance.
The Falsified Medicines Directive - Regulation Driving DigitisationAegate
"The Falsified Medicines Directive - Regulation Driving Digitisation" by Graham Smith of Aegate.
Presented at The European Generic Medicines Association’s Annual Conference, Madrid
June 25-27th 2014
This presentation by Italy was made during a workshop on “Recent Challenges in Competition and IP in Pharmaceutical Markets” held by the OECD in Paris on 26 February 2019. More papers and presentations on the topic can be found out at oe.cd/2tD
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel discussed actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union.
OECD EUIPO Trade in Counterfeit Pharmaceutical ProductsOECD Governance
Presentation of key findings from the OECD EUIPO report "Trade in Counterfeit Pharmaceutical Products". For further details see https://oe.cd/pharmatrade
This presentation by Duncan Matthews was made during the Workshop on Recent Challenges in Competition and IP in Pharmaceutical Markets on 26 February 2019. More material on the workshop can be found at www.oecd.org/daf/competition/workshop-on-recent-challenges-in-competition-and-ip-in-pharmaceutical-markets.htm
Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.
Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel discussed actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union.
OECD EUIPO Trade in Counterfeit Pharmaceutical ProductsOECD Governance
Presentation of key findings from the OECD EUIPO report "Trade in Counterfeit Pharmaceutical Products". For further details see https://oe.cd/pharmatrade
This presentation by Duncan Matthews was made during the Workshop on Recent Challenges in Competition and IP in Pharmaceutical Markets on 26 February 2019. More material on the workshop can be found at www.oecd.org/daf/competition/workshop-on-recent-challenges-in-competition-and-ip-in-pharmaceutical-markets.htm
Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.
Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
To recap the previous month's pharma highlights to members, Monthly magazine Volume 20 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
- Pernix Receives Form 483 for cGMP Violations
- FDA Hits Pfizer Subsidiary With Second Form 483 in Five Years
- Galena Hit With 10-Item Form 483 Over Unresolved Issues
Warning Letters
- Warning letter: Unimark Remedies Ltd., Mumbai, India
- Warning letter: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Health Canada Non Compliance Report
- Non Compliance Report: Unilever Canada Inc.
EMA Non-Compliance Report
- GlaxoSmithKline (Tianjin) Company Limited (Teda), China
- CARGILL FRANCE
Regulations of the Month
- Sec. 211.42 Design and construction features (c)(5) to (c)(10)
- Sec. 211.44 Lighting
As the UK Government prepares to publish the 'Repeal Bill' to give legal effect to the UK's withdrawal from the European Union, this paper looks at the possible implications for pharmaceuticals regulation. The paper by Andrew Hollingsworth gives a short overview of the current EU regulatory framework and looks at some of the options and potential outcomes in the forthcoming UK-EU negotiations.
Today's Healthcare Technology and the Regulatory StandpointAkshay Anand
Poster titled 'Today's Healthcare Technology and the Regulatory Standpoint' presented at 67th IPC (Indian Pharmaceutical Congress), held at Mysuru in December 2015.
Similar to SUI GENERIS PROTECTION FOR PHARMACEUTICALS AND ITS IMPACT ON GENERIC COMPANIES (20)
Today's Healthcare Technology and the Regulatory Standpoint
SUI GENERIS PROTECTION FOR PHARMACEUTICALS AND ITS IMPACT ON GENERIC COMPANIES
1. 1
COVER PAGE:
STUDENT ID: 150690388
MODULE NUMBER: QLLM194
MODULE NAME: INTELLECTUAL PROPERTY, TRADE
AND INVESTMENT LAW
WORD COUNT: 3598 (Including Bibliography)
2. 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. 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)
<http://www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf> accessed 17 January 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. 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>
accessed 30 March 2016.
11
Gargi Chakrabarti, 'Need Of Data Exclusivity: Impact on Access to Medicines' (2014) 19 Journal of
Intellectual; Property Rights.
5. 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)
<http://www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf> accessed 17 January 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
6. 6
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. 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. 8
term is over, depending on the factual circumstances. In this case, all the protections terminate
in 2030.
9. 9
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
Mary Atkinson, 'PATENT PROTECTION FOR PHARMACEUTICALS: A COMPARATIVE STUDY OF
THE LAW IN THE UNITED STATES AND CANADA' (2002) VOL. I I 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
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. 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
Mary Atkinson, 'PATENT PROTECTION FOR PHARMACEUTICALS: A COMPARATIVE STUDY OF
THE LAW IN THE UNITED STATES AND CANADA' (2002) VOL. I I 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
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>
accessed 11 April 2016.
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. 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>
accessed 11 April 2016.
12. 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
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