A COMPARATIVE ANALYSIS ON PATENT LINKAGE ACROSS VARIOUS JURISDICTIONS BY - SENBAGAM S
A COMPARATIVE ANALYSIS ON PATENT LINKAGE
ACROSS VARIOUS JURISDICTIONS
AUTHORED BY - SENBAGAM S
ABSTRACT:
This research explores the legal frameworks governing patent linkage systems across different
jurisdictions and their
implications for global
healthcare. Patent linkage
refers to the mechanism
that connects the approval of generic drugs to the patent status of reference
brand-name drugs, creating a regulatory interface between patent protection and
market entry of generics. This comparative study examines key jurisdictions,
including the United States, Canada, European Union, and India,
highlighting the diverse regulatory approaches and legal complexities involved.
The study explores how various nations strike a balance between the interests
of patent holders and producers of generic drugs, assessing the impact of
patent linkage in promoting pharmaceutical innovation and perhaps postponing
the release of reasonably priced generics. The analysis highlights the legal
and regulatory gaps created by the Hatch-Waxman Act (U.S.) and the Notice of
Compliance (NOC) Regulations (Canada) by comparing them to other countries that
do not have formal patent linking systems. The study also looks into how patent
linking affects public health, specifically with regard to access to reasonably
priced medications in both developed and developing nations. It discusses the
implications for global healthcare, including issues with patent ever greening,
the lengthening of legal proceedings, and the purposeful exploitation of
linking systems to increase market exclusivity. The research offers
recommendations for harmonizing policies and enhancing access to key
medications globally through this comparative analysis, which offers crucial
insights into how patent linkage regimes impact the pharmaceutical landscape.
Keywords: Patent linkage, pioneer drug, generic drug, TRIPS
agreement, public health, Hatch- Waxman act, Food & Drug Administration
(FDA).
CHAPTER 1
1.
OVERVIEW ON INTRODUCTION
1.1.
INTRODUCTION:
Patent Linkage is the process of
connecting a drug's patent status to its marketing clearance. Patent linkage is
the relationship between a generic drug's permission for sale and the branded
drug's patent status. In the context of intellectual property (IP) regulations,
in particular, striking a careful
balance between promoting innovation and guaranteeing the public's access to
reasonably priced medications
continues to be a very difficult
task for legislators. This discourse centers on patent linkage schemes, which
tie the patent status of name-brand medications to the approval of generic drugs. While fostering competition
and protecting intellectual rights are their dual goals, the ways in which they are applied and what
happens as a result varied greatly between areas.
The Hatch-Waxman Act, passed in
the US in 1984, established a systematic procedure for the approval of generic
medications while upholding the validity of current patents, and thus helped
popularize the idea of patent linkage. In order to assist regulatory bodies in
identifying patent status prior to authorizing clearance for generics, this
legal framework developed the Orange Book, a crucial resource that includes
patented medications and their authorized generic equivalents. Since then,
additional countries have embraced comparable structures, each with its own set
of operational procedures and legislative frameworks, such as the European
Union and Canada.
However, not all countries
embrace patent linkage. Some, like India, have chosen to forgo tight adherence to patent
rights in favor
of legislative systems
that permit the independent clearance of generics, with the goal of facilitating wider access to
reasonably priced medications. The efficiency of patent linking systems in
fostering innovation and guaranteeing the fulfillment of public health demands
is seriously called into doubt by this discrepancy[1]. Legal problems frequently cause countries with strict patent protection systems
to delay the introduction of generics into the market. This can
result in increased
medicine prices and less access for patients, especially in low- and
middle-income areas where healthcare resources are tight.
These different strategies for
patent connection have significant ramifications. Not only is it important to
follow the law, but access to medications is a vital part of public health
policy that impacts millions of lives. The effectiveness of patent linking
systems is a critical problem for global health governance, since the World
Health Organization highlights the significance of access to important medications
as a fundamental human right.
Furthermore, in order to properly
respond to public health catastrophes, the COVID-19 pandemic has highlighted
the need of removing access restrictions and the necessity of reevaluating the
current patent regimes.
This research aims to conduct a
comparative analysis of patent linkage systems across key jurisdictions,
including the United States, Canada, the European Union, and India. This study
aims to determine the benefits and drawbacks of various patent linking strategies
by looking at legislative frameworks, regulatory procedures, and their effects
on pharmaceutical innovation and access to medications. Additionally, the study
will examine how international accords, including the TRIPS Agreement, have
shaped these systems and what that means for the world's health care system.
This study ultimately hopes to add to the current conversation about how to strike a
compromise between the urgent need for fair access to necessary medications and
the preservation of intellectual property. Through the identification of legal
gaps and obstacles in patent linkage systems, this research will put forth
practical policy suggestions that seek to improve global regulatory
harmonization, foster pharmaceutical innovation, and increase universal access
to medications. The research findings hold significance not just for legal
academics and politicians, but also for public health advocates, stakeholders
in the pharmaceutical sector, and global health organizations that strive to
provide innovative and easily accessible healthcare.
1.2.
SIGNIFICANCE OF THE STUDY:
Patent protection plays a major
role in the pharmaceutical industry's ability to recover the high expenses of medication research
and development (R&D)
and encourage innovation. With a patent, an inventor is granted exclusive
rights that, usually, last for 20 years and allow them to stop anyone from
producing, using, or marketing the patented medication. On the other hand,
generic drug producers may enter the market once these patents expire and
provide less expensive substitutes that encourage greater access to
medications.
Patent linkage schemes, which
connect the approval of generic pharmaceuticals to the patent status of
reference (brand-name) drugs, have been implemented by several nations as a way
to balance innovation with competition[2]. A related
patent dispute or current patent protection on the branded medicine essentially prevents
regulatory bodies in charge of drug approvals, such the U.S.
Food and medicine
Administration (FDA), from approving a generic drug application.
In the US, the Hatch-Waxman Act
of 1984 established one of the most well-known patent linkage schemes,
establishing a framework that permits the approval of generic drugs while
upholding patent rights. In order to help regulators determine the patent status
of pharmaceuticals, it also produced the Orange Book, a database listing
patents in that field. The result is a disjointed global regulatory
environment. Other jurisdictions, including the European Union and Canada, have
created their own patent linkage systems, each with distinctive characteristics.
Conversely, countries like India
have rejected formal patent linkage mechanisms, opting instead for a system where generic drug approvals are independent of patent status, emphasizing broader access to affordable medicines.
This divergence in approaches creates a significant contrast in how
pharmaceutical competition and public health priorities are managed globally.
International trade agreements
such as the TRIPS Agreement (Trade-Related Aspects of Intellectual Property
Rights) have impacted the global deployment of patent linking systems in
addition to national legal frameworks. But patent linking is still a
contentious issue, especially for low- and middle-income nations that mostly rely on reasonably priced
generics to address public health demands, despite TRIPS' aim of
striking a balance between intellectual property protection and public health
concerns.
This research is therefore
crucial in understanding the comparative legal frameworks that govern patent
linkage globally. By examining how different jurisdictions regulate patent
linkage and analyzing the implications for innovation, litigation, and access
to medicines, the research will provide insights into the legal vacuums and
challenges present in the current systems. Furthermore, it will explore the feasibility of global
harmonization of patent linkage systems and how such a move might impact
healthcare outcomes, particularly in developing countries.
1.3.
REVIEW OF LITERATURE:
Ø Intellectual
Property and Public Health in the Developing World, Monirul Azam, Open Book
Publishers, 2016
Here in this author clearly explains the
intersection between intellectual property rights, particularly patents, and
public health concerns in the developing world. It provides an analysis of the
TRIPS Agreement and the challenges faced by developing countries in
implementing IP provisions related to pharmaceuticals.
Ø Patent Law
and Policy: Cases and Materials, Robert Patrick Merges, John Fitzgerald Duffy,
Carolina Academic Press, 2017 (7th Edition)
Here in this authors clearly explains that
covers key cases and legal principles in patent law, this book is a valuable
resource for understanding the legal frameworks governing patents, including
issues related to patent linkage and pharmaceutical innovation.
Ø Pharmaceutical
Innovation, Competition, and Patent Law Reform: A Trilateral Perspective,
Jakkrit Kuanpoth, Edward Elgar Publishing, 2010
The authors
discusses the role of patents in pharmaceutical innovation,
examining how patent laws in the U.S., the EU, and developing countries affect
competition in the pharmaceutical industry. It also looks at reforms needed
to balance innovation with access
to medicines, making
it a good reference for understanding
comparative patent laws.
Ø Patent Policy
and Innovation in Pharmaceuticals, Ove Granstrand, Springer,
2020
This book focuses on the role of patents in
pharmaceutical innovation, providing an in-depth look at how patent policy
impacts the development and commercialization of new drugs. It also discusses
how patent linkage can shape competition and access to generics.
Ø Pharmaceuticals,
Patents, and the Law, Trevor Cook, Bloomsbury Professional, 2021 This book provides an overview of the relationship between patents and the
pharmaceutical industry, discussing legal frameworks, key cases, and the impact
of patent systems on drug pricing, market access, and generic competition.
Ø Intellectual Property, Pharmaceuticals, and Public
Health: Access to Drugs in Developing
Countries, Kenneth C. Shadlen, Samira Guennif, Alenka Guzmán, N. Lalitha,
Edward Elgar Publishing, 2011
This book focuses on the challenge of
balancing intellectual property rights and public health in developing countries, providing detailed analysis and case studies on the impact
of patents on access to medicines.
Ø Triveni Singal, Need for a patent linkage system in India,
https://www.mondaq.com/india/patent/871208/patent-linkage-and-indian- laws#:~:text=India%20has%20not%20adopted%20Patent,originator%20drug%20is%20i
n%20force (last visited on 22
Sep 2024 )
This article explains the concept of patent linkage is a
double-edged sword. India is
currently leading in the exportation of generic drugs to the world. We cannot
bear to pay exorbitant prices for drugs, which are provided by generic
companies for lesser amounts. As seen above, patent linkage incurs huge
expenses to the consumers and governments that sponsor health care.
Ø Bouchard R,
Empirical analysis of drug approval-drug patenting linkage for high value
pharmaceuticals, Northwestern Journal of Technology & Intellectual
Property, 8 (2) (2010) 174-227.
This Journal focuses on the examination of patent linkage
practices across the United States, Europe, and India reveals distinct
approaches and philosophies governing the intersection of pharmaceutical
patents and generic drug approvals.
Ø Orange Book: Approved Drug Products with Therapeutic Equivalence
Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. (last visited on 15 sep 2024)
Here in this authors clearly explain
that Before a drug can be tested in people, the drug company or sponsor
performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of
tests in people is begun to determine whether the drug is safe when used to
treat a disease and whether it provides a real health benefit.
Ø Manisha
singh & Swati Gupta, Patent Linkage And
Indian Laws, https://www.mondaq.com/india/patent/871208/patent-linkage-and-indian-
laws#:~:text=India%20has%20not%20adopted%20Patent,originator%20drug%20is%20i
n%20force Here in this authors clearly explain
that India has not adopted Patent
linkage yet. A
generic manufacturing company can apply forth marketing approval of a generic product even if the patent status of the
originator reference product is valid.
However, the approved generic drug cannot be brought to the market if the
patent of the originator drug is in force.
1.4.
RESEARCH GAP:
A thorough comparative analysis
that considers the ways in which the variations in patent linkage frameworks across major
international jurisdictions affect innovation, the global pharmaceutical
market, and the availability of reasonably priced medications is lacking,
despite the fact that patent linkage systems have been extensively researched
within individual jurisdictions. The Hatch-Waxman Act in the United States and the Notice of Compliance laws
in Canada are two examples of single jurisdiction patent linking systems that
are the subject of most of the
research now in publication. Just a little amount of study, nevertheless,
offers a comparative analysis across
several countries, particularly when it comes to looking
at how these disparate
systems as a whole affect public health and the worldwide pharmaceutical
industry. A lack of formal patent linkage systems in developing countries (like
India) can have an impact on global healthcare goals like access to affordable
medicines.
1.5.
RESEARCH PROBLEM
What is the impact
of differing national
patent linking schemes
on the prompt release of generic
medications?
What legal flaws or loopholes
exist in the present systems of patent linkage, and how may they be
fixed to better
strike a balance between
the protection of intellectual property
and the general public's access to healthcare?
1.6.
OBJECTIVES OF STUDY:
This study aims to perform a
comparative analysis of patent linkage systems in different international
jurisdictions. Specifically, it will examine the legal frameworks, regulatory
mechanisms, and their broader implications for pharmaceutical innovation, the
entry of generic drugs into the market, and global healthcare.
Examine the Legal and Regulatory Frameworks: The patent linking frameworks of important legal countries,
including the US, Canada, EU, and India, to learn how they function and how
they strike a balance between patent protection and generic competition.
Identify Legal and Regulatory Vacuums: Point out the flaws and
contradictions in the various patent linking schemes, such as legal hold-ups,
regulatory gaps, and patent ever greening, which impede timely access to
reasonably priced medications.
1.7.
HYPOTHESIS:
In comparison to various
jurisdiction lacking such laws, patent linking system cause a considerable delay in the entrance of
generic drugs into the market.
1.8.
METHODOLOGY:
This research is based on the
doctrinal method or it can be known as non-empirical method so the sources are from secondary sources
like books, article, journals and various online database materials.
This research is done by the
comparative analysis method to acquire the intricate details of the respective
topic.
1.9.
SCOPE AND LIMITATION:
The main goal of the study is to
compare patent linking systems in depth across important countries, such as the
US, Canada, EU, and India. These nations were picked for their varied
perspectives on the effects of patent linkage on their pharmaceutical markets,
as well as their differing legislative frameworks. The examination will
encompass the legislative structures, oversight procedures, and past case
studies that illustrate the practical applications of patent linking in various
areas. The research will look at how international agreements such as the TRIPS
Agreement (Trade-Related Aspects of Intellectual Property Rights) impact the
regulatory environment around patent protection in various nations and how they
shape patent linkage systems.
The study is restricted to
analyzing a few major jurisdictions, mainly the United States, Canada, the
European Union, and India. Although a wide range of regulatory procedures are
represented by these locations, other significant jurisdictions (such as South
Africa, Brazil, and Japan) will not be thoroughly covered, which will restrict the
findings' applicability to a worldwide setting. he study focuses on public
health and ethical concerns, such as the moral consequences of delayed access
to inexpensive medications. The ethical aspect, however, could not be as
thoroughly examined as it might be in a public health or ethics-focused study
because of the research's legal focus.
CHAPTER-2
2.
CONCEPT AND STRUCTURE OF PATENT LINKAGE
SYSTEMS
2.1.
PATENT LINKAGE:
The process of linking the
patent status of brand-name medications to the regulatory approval of generic
drugs is known as "patent linkage." To put it another way, think of
it as a generic medication traffic light system where the green light to enter the market is dependent on the validity or expiration of pertinent
patents. Patent linkage's main goal is to stop generic medications that could
violate already-existing patents from receiving regulatory approval. In
addition to guaranteeing that creative firms may profit from their R&D
investments, it creates a clear path for generic producers to join the market
when patents expire.
A drug is produced
using one of the two methods listed
below:
By a global or domestic
multinational pharmaceutical corporation following the approval of the patent
covering all phases of the research and development process, including clinical
trials, or by manufacturers of generic medications (The chemical makeup of a
generic medication is identical to that of the brand-name medication).
All drugs, regardless of how
they are made, must go through a procedure called drug marketing approvals and gain the national drug authority's permission before they can be sold. The
process by which a
nation links the status of the patents pertaining to the original
drug that is for sale to the drug marketing
approval of a generic medicine is known as patent linkage. This approach
prevents any generic medication from being granted marketing permission unless
the patent owner agrees, or until the original drug's patent expires or the
appropriate authority determines that the patent will not be infringed upon or
is invalid[3]. This makes it much more important for the
generic medication producer to demonstrate to the FDA that the medicine it
produces is not protected by a legitimate patent. The registration and
marketing of the generic medication must be stopped by the national regulatory
bodies if the same cannot be conclusively demonstrated. Consequently, the
regulatory body becomes a tool for patent enforcement.
The idea of "TRIPS
Plus" was created, encompassing acts aimed at enhancing the level of
protection afforded to right holders
beyond what is currently stipulated in the TRIPS Agreement.
The TRIPS Agreement's Article 28
protects a patentee's rights with relation to product patents, including the
ability to stop third parties from using the product for profit without the
patentee's consent. Confidential information on pharmaceutical or agro-based chemical products or pharmaceuticals is protected against
unfair commercial use under Article 39 of the Agreement. The legal stance on
patent linking differs widely and is not consistent in many jurisdictions. To
comprehend the necessity of patent linkage in India, one must first examine the
patent linkage systems of other jurisdictions.
2.2.
PIONEER DRUG:
The first medication that a
pharmaceutical firm develops and releases onto the market is referred to as a pioneer drug, innovator drug, or
both. A brand-new, never-before-approved active component is included.
Regulatory agencies such as the FDA approve pioneering treatments after they go through rigorous clinical
testing and research, and
they are patent protected. For the duration of the patent's expiration, these patents provide
the manufacturer the only authority to market the medication. In systems where
generic medicine approval is dependent on the original drug's patent status,
pioneer pharmaceuticals are essential.
A unique chemical compound or
biological entity is introduced by pioneer pharmaceuticals and is utilized to
treat a particular illness or condition. Following the discovery, the
pharmaceutical business requests a patent that would give them exclusive rights
to commercialize the product. There isn't another business that can make or
market a generic version of the medication during this time. Pioneer
medications must pass a rigorous approval procedure that includes preclinical
research and Phase I, II, and III clinical
trials in order to guarantee the drug's quality, safety, and efficacy[4]. Regulatory bodies that assess the data and
approve its use for public consumption include the European Medicines Agency
(EMA), the Food and Drug Administration (FDA) of the United States, and other
national health authorities. A pioneer drug's development frequently
necessitates a large financial, time, and resource commitment. A groundbreaking
drug's development and commercialization can cost billions of dollars and take
ten to fifteen years. After being
authorized, the pioneer medication usually has market exclusivity, which
prevents the production of generic equivalents until the patent expires. This
exclusivity allows the original business to recoup its R&D expenditures and
benefit from the drug's sales.
2.3.
GENERIC DRUG:
A generic medicine is one that
is manufactured to have all the same qualities, performance characteristics,
dosage form, strength, mode of administration, and intended use as an
authorized brand-name drug (also known as an innovator or pioneer drug). It
must adhere to the same safety,
effectiveness, and quality requirements as the brand-name version and has the
same active components. A generic medication differs greatly in price from its brand-name equivalent, which is the main distinction between the two. This
is so that generic manufacturers won't have to bear the expense of duplicating
the clinical studies and expensive research that the original manufacturer
carried out to demonstrate the efficacy and safety of the medicine.
The active component of generic
medications must be the same as that of the original (pioneer) medication, and
they must function, dose, and use in the same manner. This indicates that generic medications are bioequivalent to
name-brand medications, meaning they provide the body with the same quantity of active ingredient in the same period
of time. Generic medications may vary in terms of color, shape, size,
packaging, and non-active components (excipients), but the active substance
must always be the same. However, these variances do not influence the safety
or efficacy of the medicine. The cost of generic medications is far lower than that of
brand-name medications[5]. This is mainly due to the fact that
generic manufacturers are exempt from paying for the marketing expenses related
to introducing a new medicine to the market as well as the research and
development (R&D) expenses necessary for new pharmaceuticals. Rather, they
depend on the information gathered from the initial clinical studies carried
out by the well-known producer.
Prices decrease as a result of increased competition brought about by lower
production costs and the ability of numerous businesses to make the same
generic medication. Brand-name pharmaceuticals are covered by patents for a
period of time (usually 20 years from the date of filing). The drug's
development firm is the only one allowed to market it throughout this patent
term. Other businesses can produce and market generic copies of the medication
when the patent and any related exclusive rights expire. The major event that
facilitates the entry of generics
into the market and lowers the cost
and increases the accessibility of essential medications is the expiry of
patents. A regulatory agency such as the Food and medication Administration
(FDA) in the United States, the European
Medicines Agency (EMA), or other national regulatory bodies must approve
a generic medication before it may be sold. A generic
medicine maker needs to file an Abbreviated New medicine Application (ANDA)
proving the medication is bioequivalent to the brand-name counterpart in order
to get approval. Since the drug's safety and efficacy have already been
determined by the initial studies, the ANDA procedure is less expensive and
quicker than the New Drug Application (NDA) process needed for pioneer
medications.
2.4.
TRIPS AGREEMENT:
The TRIPS Agreement
(Trade-Related Aspects of Intellectual Property Rights) plays a significant role in
the patent linkage system and the broader
topic of pioneer
and generic drugs
in your research. The agreement, established under the World Trade
Organization (WTO) in 1995, sets minimum standards for intellectual property
(IP) protection, including patents, across all member countries. It has
direct implications for how pharmaceutical patents are handled globally and influences the availability of generic
drugs. WTO member nations are required by the TRIPS
Agreement to issue patents for pharmaceutical items and methods for a minimum
of 20 years after the patent's filing date. This guarantees the protection of
the pioneering (innovator) pharmaceuticals and permits the original producer to
market their product solely for the
duration of this time[6]. This is consistent with the patent linkage
system as generic manufacturers are unable to make or market the identical
medication until the patent expires. TRIPS has an impact on patent linking
because it creates a legal framework that prevents drug regulatory bodies from
approving a generic medication if the pioneering medicine still has an active
patent. This connection delays the release of less expensive alternatives by increasing the amount of time that a pioneering medication is the sole one on the market.
While patent linking systems are
not required by TRIPS, member nations are free to implement them. This allows
nations to experiment with diverse strategies for striking a balance between the demands of public health
and intellectual property
rights. Some nations
like India do not have explicit patent linkage systems and instead prioritize the quicker clearance of generic pharmaceuticals[7]. Other nations, including the United States
and Canada, have formal patent linkage systems in place that relate drug
approval to patent status. One TRIPS flexibility is allowed for under Article
31 of the TRIPS Agreement: forced licensing. A government may, by forced
licensing, permit a generic medication producer to create a patented medicine
without the patent holder's approval, typically in response to an emergency
involving public health. By encouraging innovation, this clause can mitigate
the limiting consequences of patent linkage.
The Doha Declaration on TRIPS
and Public Health was ratified in 2001 in response to worries about drug
availability, particularly in poor nations. It was reiterated that WTO
countries are entitled to apply TRIPS flexibilities, such as compulsory licensing,
to make sure that, in cases when it is required, the public health takes
precedence over patent rights[8]. Because it highlights that intellectual
property protection shouldn't stand in the way of access to reasonably priced
medications, particularly in instances of public health emergency, this
declaration is significant when it comes to talks about patent linkage. In
order to combine protecting patents (and encouraging innovation) with advancing access
to generics, it allows nations
greater flexibility to evade some of their TRIPS
responsibilities when they encounter public health issues.
CHAPTER-3
3.
GLOBAL PERSPECTIVES ON PATENT LINKAGE:
3.1.
PATENT LINKAGE
IN US:
In the US, the approval of
generic marketing is contingent upon the expiration of the patent for the
original medicine. Patents are awarded by the USPTO at any point during the
lifespan of medication development, while exclusivity refers to the exclusive
marketing rights granted by the FDA upon drug approval, which can occur simultaneously with or independently from a patent. The Drug Price Competition and
Patent Term Restoration Act of 1984, sometimes referred to as the Hatch Waxman
Act, legally acknowledges patent linkage in the United States.
In the US, the Orange Book,
officially titled “Approved Drug Products with Therapeutic Equivalence
Evaluations,” serves as a comprehensive reference for FDA-approved drugs,
offering critical information on their safety and efficacy evaluations. This
publication plays a crucial role in the pharmaceutical landscape by documenting details about approved drugs,
those that have been discontinued, and the associated patents. The Orange Book
not only lists the approved and discontinued drugs but also provides essential
information regarding patents and exclusivity. There are two types of
applications filed under the Hatch Waxman Act that become relevant here. A New
Drug Application (NDA) is typically submitted by the innovator or brand- name
drug manufacturer seeking approval for a new drug and is filed before the
marketing of a new drug begins. An Abbreviated New Drug Application (ANDA) is
filed by a generic drug manufacturer seeking approval to market a generic
version of an already approved innovator drug. The ANDA applicant must
demonstrate the bioequivalence of the generic drug to the reference-listed drug
(RLD) by referring to the safety and efficacy data of the RLD.
3.1.1.
ABBREVIATED NDAs:
The process of marketing of
generic drugs was statutorily enacted in the United States as part of the Drug
Price Competition and Patent Term Restoration Act 1984 (as amended) (commonly
called the "Hatch-Waxman Amendments"). The system of generic approval
provided by this statute is similar to legislation enacted in Canada and Europe
and has largely been harmonized internationally. Prior to the Hatch-Waxman
Amendments, an original generic application, called a "paper" new
drug application (NDA), had approval parameters that were subjectively
determined by the US Food and Drug Administration (FDA) on a product by-product
basis and the efficacy and safety were based
on the review of publicly available information. Further, there were no provisions for data
exclusivity nor, in particular, bars to product approval based on a patent
filed with the FDA.(1) As a result of
the enactment of the Hatch-Waxman Amendments, an additional
"abbreviated" process for approval of competitive generics after
expiry of the originator product's patent and data exclusivity was created.
To give an idea of the scope of "abbreviation", a typical full NDA is composed of:
·
two adequate and well controlled clinical trials;
·
formal statistical planning
and analysis;
·
human dose-ranging, pharmacokinetic and pharmacodynamic studies;
·
absorption, distribution, metabolism and excretion studies;
·
non-clinical safety pharmacology, pharmacology, pharmacokinetic, pharmacodynamic, genotoxicity, fertility
and toxicology studies; and
·
a full description of the chemistry, manufacturing and controls
(CMC).
Additional clinical safety or
efficacy studies that develop information on drug-drug interactions, human
safety pharmacology and special populations may also be required.
In contrast, an abbreviated NDA (ANDA) is composed only of:
·
a pharmacokinetic comparison of the generic to the
innovator/branded drug product or other FDA-designated reference drug that
demonstrates bioequivalence;
·
a copy of the innovator labeling revised to reflect
changes in manufacturer and contact information; and
·
The CMC section.
Said differently, an ANDA application is not required to repeat
preclinical and clinical safety and efficacy research so long as it can be demonstrated that
the generic product performs in the same manner as the innovator drug (ie, that the
generic product is bioequivalent to the innovator drug). The innovator/branded drug is listed in the FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations publication
(known as the "Orange Book") and is known as the "reference
listed drug" (RLD).
Occasionally, especially with
older drugs, the innovator may withdraw from the market, thereby effectively eliminating an RLD for new generics to
reference in their ANDA submission. In that event, the FDA may designate
another drug – typically one of the earlier generic drugs – as the reference
standard (RS) so that additional generics may
enter the market and use the RS in place of the RLD. New generics may
then enter on comparison to that RS.
To support the successful
development of generic drug products, the FDA issues product- specific guidance
for generic drug development. This guidance helps generic drug applicants
understand the data the FDA recommends providing within the ANDA to establish
bioequivalence for pharmaceutically equivalent drug products[9].
In the United States, the
current average review time from submission to final approval for ANDAs is
approximately 39 months (29 months to tentative approval). The recently enacted Generic Drug User Fee
Act and its successor, the FDA User Fee Reauthorization Act 2017, provide for
fee revenue to increase the Office of Generic Drug's resources. The FDA has
committed to assessing and acting on ANDAs within 10 months (or eight months
for priority track) of submission.
3.1.2.
ORANGE BOOK PATENT
LISTING:
By law, to take advantage of a
bar to FDA approval of an ANDA during the patent term, an NDA holder must list each patent that
claims the drug or a method of using the drug that is the subject of the NDA
(or amendment or supplement to it) and with respect to which a claim of patent
infringement could reasonably be asserted if a person not licensed by the owner
of the patent engaged in the manufacture, use or sale of the drug product.
FDA regulations further provide
that, when filing
an NDA, the applicant should
include:
patent that claim the drug or a
method of using the drug which consist of drug substance (active ingredient)
patents, drug product (formulation and composition) patents, and method-of-use patents.
The applicant should exclude process
patents [and] patents claiming
packaging under 21 Code of Federal Regulations section 314.53(b)(l).
The statute also separately
provides for periods of data exclusivity – for example, new chemical entity
exclusivity which may expire before or after the Orange Book patents. The
period of data exclusivity is largely impervious to third-party legal
challenges.
3.1.3.
CHALLENGING PATENTS LISTED
IN ORANGE BOOK:
For an ANDA to be accepted for review, the ANDA
applicant must certify against
each of the patents
then-listed in the Orange Book. If the ANDA applicant intends to launch its
generic product before an Orange Book patent has expired, it must certify to
the FDA and notify the patentee and NDA holder, that the patent
is invalid, unenforceable and/or that the ANDA product
does not infringe any valid and enforceable claim. Under the statute, the
patent holder is then authorised to seek a judgment of infringement. Generally,
if the patent holder files a complaint within 45 days of receiving the notice,
a 30-month stay of regulatory approval is automatically applied, although FDA
review may progress and tentative approval may be obtained.
Another avenue to challenge a
patent involves requesting that the FDA ask an NDA holder to confirm the patent
information in the Orange Book. When patent information is submitted to the FDA
for publication in the Orange Book, the NDA applicant attests to the accuracy
of the information[10]. The FDA does not evaluate the accuracy of
any information related to the patent listing. A challenger may write to ask
that that the FDA request the NDA holder to confirm the information listed in
the Orange Book. However, the FDA is unable to force delisting of the patent.
An improper listing was recently
successfully challenged in the First
Circuit as outside the scope of authorisation for listing and improper conduct
that could serve as the basis of an antitrust violation of section 2 of the
Sherman Act. Here, the patent claimed a part of the device used to administer
the drug. The First Circuit found that this was too tenuous a connection and
that Sanofi had improperly listed patent claims that "do not mention the
drug for which the sNDA was submitted" and therefore it could not have
claimed "the drug".
Another potential avenue for
challenging Orange Book listings involves a counterclaim in response to a
patent infringement suit filed by the
patent holder as part of a declaratory judgment following the certification of
non-infringement notice. In one such
case, a generic applicant filed a counterclaim seeking to delist a patent on
the basis that the patent did not claim or disclose either the drug substance,
drug product or method of use. The case was dismissed pursuant to a settlement agreement
before the court
ruled substantively. In 2012, the US Supreme
Court permitted a generic drug manufacturer to
assert a counterclaim alleging an improper use code listed in the Orange Book,
in response to allegations that the generic manufacturer's product infringed
method-of-use claim.
Since these rulings, the Orange
Book Transparency Act 2020 was passed, which requires the FDA to list and publish drug patent and exclusivity information. The FDA has created an internal
working group to improve the transparency of the Orange Book.
3.1.4.
PURPLE BOOK FOR BIOLOGICS:
The Purple Book for biologics
lists licensed biologics and their approved corresponding licensed biosimilars. In particular, the
Purple Book enables users to see whether biologics licensed under section
35l(k) of the Public Health Service Act (the PHS Act) have been determined to
be biosimilar to or interchangeable with a brand-name product (also known as a
"reference biological product"). Additionally, the Purple Book
provides information on existing reference biological product exclusivity. Although
the Purple Book includes exclusivity information, it does not include an
expiration date for all biologics, and the lack of an expiration date does not
mean a product is not eligible for statutory exclusivity. Moreover, the Purple
Book does not list patents for biologics or include manufacture or process
patents. In contrast to the Orange Book and the statutory requirements under
the Hatch-Waxman Amendments, the PHS Act does not prohibit the FDA from
receipt, review or approval of a biologic application that relies on a
reference biologic product with unexpired patent listings in the Purple Book.
3.1.5.
DISCLOSURES TO BRANDED
COMPANY AND OPPORTUNITY TO SUE:
An ANDA applicant seeking FDA
approval of a generic RLD must make certain disclosures related to patents for
the RLD. If an ANDA applicant seeks approval before a patent has expired on the basis
that the patent is invalid,
unenforceable or not infringed, the applicant must submit a paragraph IV certification to
the FDA. When doing so, the applicant must also provide the NDA holder and the
patent holder(s) notice of the paragraph IV certification. The notice must
describe the factual and legal basis for the ANDA applicant's claim that the
patent is invalid, unenforceable or not infringed.
The patent owner then has an opportunity to sue the ANDA applicant for patent infringement.
As noted previously, if the patent holder initiates a patent infringement
lawsuit against the ANDA applicant within 45 days of receiving notice, ANDA
final approval will be stayed for 30 months from the later of when the NDA
holder or patent owner(s) receives the paragraph IV certification, unless the NDA has new chemical entity
exclusivity. In this case, ANDA final approval will be extended to
seven-and-a-half years from the date of NDA approval.(7)
3.1.6.
ANDA FIRST-TO-FILE 180-DAY
EXCLUSIVITY PERIOD:
The first ANDA applicant to file
a paragraph IV certification is awarded exclusivity vis-a-vis other ANDA
applicants for a 180-day exclusivity period. This exclusivity period is given
to the first ANDA applicant in exchange for the ANDA applicant risking exposure
to patent litigation by filing a paragraph IV certification and giving the
requisite notice to the NDA holder and patent owner(s). An ANDA applicant does
not need to win a patent infringement suit to retain eligibility for the
180-day exclusivity period.(8)
3.1.7.
CHALLENGING PATENTS USING
USP TO IPR PROCEEDINGS:
An inter partes review
(IPR) is a type of post-grant proceeding before the Patent Trial and Appeal Board (PTAB) that allows parties to
challenge claims in a patent based on prior art and printed publications.
Introduced in 2012 under the America Invents Act, IPRs are now the most
utilised mechanism for challenging patents in postgrant proceedings at the
PTAB. Adjudicated by a
three-administrative judge panel of the PTAB, IPRs have a resolution deadline
of just 18 months, requiring careful preparation by the challenger and swift
responses from the patent owner.
According to statistics provided
by the US Patent and Trademark Office (USPTO), the institution
rate of IPRs has been decreasing from year to year. The rate was historically
higher than 60%, most recently in 2019,
and has now fallen to about
57% in 2021. However, drug patents continue to have a high institution rate.
As of June 2021, in IPRs involving Orange Book patents, 62% were instituted,
only 15% resulted in final written decisions finding all instituted claims
invalid.
This means that a well-drafted petition will more likely
than not result in an institution of
at least one ground asserted
in the petition. Importantly, of the instituted petitions that resulted in
final written decisions, 50% of the final written
decisions found at least one instituted claim to be
invalid, while 44% found all of the
instituted claims to be invalid.
This means that if a petition is instituted, at least one
asserted claim will more likely than not be invalidated, if not all of the
asserted claims. Therefore, an institution will put a heavy burden on the
patent owner as to whether a district court case should proceed to trial.
3.1.8.
PATENT TERM OF ORANGE BOOK PATENTS:
For patents granted by the USPTO
after 8 June 1995, in general, there is a 20-year patent life term from the
date of the first effective patent application filing. Having said this, the
practical term of protection of the marketed product is often less than 20
years because patents are often granted well before a product's actual
commercial marketing.
Many factors affect the
effective patent term length, including the pre-market approval requirements
applied to certain products regulated under the Federal Food, Drug and Cosmetic
Act (FD&C Act). Frequently, these products must undergo extensive testing
in humans (and possibly animals) to demonstrate their safety and efficacy to
the FDA before the agency will approve the product for commercial marketing.
As a result, to promote product
development and innovation, in 1984, Congress chose to enact legislation
affording the opportunity to extend patent terms under certain circumstances to
compensate patent holders for patent time lost while developing a product and
awaiting FDA premarket approval. The legislation allows these patent holders to
gain back some of the lost patent time.
While there is much focus given to patent term
restoration issues for
pharmaceuticals, often little attention is given to medical devices in this
regard. However, a subset of medical devices, class Ill devices subject to
pre-market approval under section 515 of the FD&C Act can qualify for
patent term restoration based on the development and pre-approval process
requirements established by the FDA for them.
In the relevant part, under
the patent term extension statute
at 35 US Code section
156, the owner of
record of a patent (or its agent)
must submit to the PTO an extension request within the 60-day
period beginning on the date the class Ill medical device received approval for
commercial marketing. For the purposes of an extension
request for a class Ill device subject to pre-market
approval, the "regulatory review period" that can be recouped is
defined as the sum of the following:
·
the period beginning on the date a clinical
investigation on humans involving the device was begun and ending on the date a
premarket approval application was initially submitted with respect to the
device to the FDA; or
·
the period beginning on the date the application was
initially submitted with respect to the device to
the FDA and ending on the date such application was approved by the FDA.
3.2.
PATENT LINKAGE
IN EUROPE:
No patent linkage is practiced
by the European Union (EU). It asserts that manipulating bolar provisions via
patent linkage will surely delay the release of generic medications. Any
patented product may be tested and its test findings produced; these can then
be submitted to the registration body for
marketing permission without breach of EU law. A medicine's patent status is
not taken into consideration when the European Medicines Agency (EMEA) makes
decisions about drug approval in the EU. Drug clearance may only be refused for
the reasons specified in Regulation EC
726/2004 and Directive EC 2001/83.
The absence of a relationship exists because
patent status is not one of the grounds.
However, to encourage the
companies that create new drugs, the EU gives them special rights to control
who can make generic versions. For a brand-new kind of drug, they get exclusive
rights for a very long time, up to 10 or 11 years. Out of the 10 years, 8 years
is the standard data exclusivity period
with an additional 2-year marketing exclusivity period. If there is a significant improvement in the existing
drug during the first 8 years, an additional 1 year can be added to the 10 years exclusivity period[11]. During this time, no one else can make and
sell a generic version. Some countries in the EU, like Hungary, Italy,
Portugal, and the Slovak Republic, still use a system where generic drug
companies have to declare related patents and not market their products before
the expiry of existing patents.
3.3.
PATENT LINKAGE
IN CANADA:
Major changes to the Patented
Medicines (Notice of Compliance) Regulations (Regulations), the patent linkage
structure that serves as the foundation for Canadian pharmaceutical and
biologics patent litigation, were proposed by the Government of Canada on July
15, 2017. Key modifications included in the proposed adjustments are as
follows:
1.
Actions rather than applications will henceforth be the
mode of procedure under the Regulations.
2.
Proceedings under the Regulations will now
ultimately establish whether alleged patent claims are
invalid or non-infringed by a prospective drug submission.
3.
First individuals may, under certain conditions,
assert inventions and patent claims that are not registered on the Patent Register.
4.
First people will no longer be liable for section 8
damages if they choose to forgo the 24- month regulatory stay, enabling quicker
competitive market entrance.
5.
Compensation to a second party for a permanent loss of market share may now be included in
section 8 damages, if any.
It is anticipated that these suggested
changes will be approved in September 2017 after a brief 15-day comment period.
3.3.1.
AN OVERVIEW OF
THE PROPOSED
MODIFICATIONS AND THEIR
BACKGROUND:
The Canadian version of the
Hatch-Waxman Act, known as the Regulations, was enacted in 1993 with the goal of striking a balance
between the rights of patent holders and generic businesses to request the
Minister of Health for expedited medication clearance. Nevertheless, the
Regulations' shortcomings became apparent over time, chief among them being the
necessity for patent holders to apply for an injunction barring the Minister of
Health from authorizing a generic medication. Because cases under the Regulations did not definitively resolve the issues
between the parties, patents were frequently re-litigated in follow-on
infringement or impeachment actions. These unfavorable consequences of the
scheme for litigants included the fact that patentees frequently could not
appeal the dismissal of applications for orders of prohibition against the
Minister of Health. This resulted
in a lack of certainty for the parties and “at risk” launches for generic companies. The
proposed amendments seek to address these, and other, perceived shortcomings.
The fundamental framework of the
Regulations will not alter, notwithstanding the magnitude of the proposed
modifications. The range of patents that can be included will not change. The Patent Register will stay frozen,
meaning that applicants for generic or biosimilar drugs (referred to as "second persons")
only need to mention patents that were present on the Patent Register when they
submitted their drug applications. In addition to section 8 damages remaining
available for generic or biosimilar firms kept off the market because of the
24-month stay, the approval stay for generic or biosimilar products will
continue to last for 24 months. But it's also suggested that the Regulations be
altered substantially in the following ways:
1.
Modifications to the Patent Register: The Patent
Register will now include "certificates of supplementary protection"
(CSPs), which were incorporated into Canadian law by the CETA Implementation
Act, which was enacted following the signing of the Comprehensive Economic and
Trade Agreement between Canada and the European Union. The Minister of Health
will be granted extensive authority to actively manage the Patent Register.
2.
Requirements for new notices of allegations (NOAs):
Generic and biosimilar producers (second persons) will still have to serve a
Notice of Availability (NOA) even if the procedures will be conducted through
an action. Only in regards to the claims of invalidity will the NOA need to be
specified. The parties will now have some flexibility under the Regulations to submit restricted non-infringement
material prior to the start of an action. There's no doubt that future lawsuits
will focus on the practical implications of the revisions and what constitutes
sufficient information in the NOA.
3. papers/information to be included
with NOAs: NOAs must contain copies of any papers cited to substantiate
invalidity claims, as well as a searchable electronic copy of the pertinent
sections of the second person's drug submission. For the duration of the
lawsuit under the Regulations, the second
party will be required to provide information about its medication submission continuously.
The first person may ask to have these reasonable secrecy duties altered, or
the second person may impose them on them.
4.
Nature of the action: First persons will no longer
seek a prohibition order against the Minister of Health, but rather
declarations that making, using,
selling or constructing a drug
in accordance with the second
person’s drug submission will infringe the patent or CSP, along with other
available remedies. Counterclaims may be filed by second parties in an attempt
to invalidate a patent or CSP or to get a non-infringement declaration. In the
event that a second party's regulatory submission potentially leads to
infringement of these collateral patents, first persons/patentees may claim
unlisted patents or patents not subject to the NOA upon receipt of the NOA.
5.
24-month stay: The right to renounce the 24-month
stay, without affecting one's rights under the Patent Act, shall be granted to
the first person to file an action under the Regulations. With this tactic, a
first party will be able to minimize the possibility of section 8 damages and
have more control over the extent of the action.
6.
Section 8 damages:
A second party may sue
all previous plaintiffs for section
8 damages in the
event that a patent infringement case initiated under the Regulations is
unsuccessful. The first party, the patent holder, or any other party making a
claim under the patent might all be plaintiffs. By the conclusion of the
process conducted under the Regulations, the section 8 damages.
3.3.2.
NEW CHALLENGES:
The purpose of the new
Regulations is to provide finality for litigants and grant patentees complete
rights of appeal, two goals that are thought to be lacking in the present
Regulations. But there will be additional difficulties as a result of the new regulations, such as the following:
New strategic flexibility: First
persons and patentees will have to make novel and maybe challenging decisions to manage their legal and
commercial risks in light of new rules that allow them to assert claims that
were previously irrelevant or to abandon the 24-month stay.
Application of current case law:
Regarding a number of problems impacted by these amend- ments to the
Regulations, litigants will be unsure for a number of years as to the
applicability of current case law. These concerns will involve the standard of
patent listing evaluation as well as the sufficiency of NOAs.
Effect on biologics: There are
no special rules for biosimilars or other non-generic goods under the modified
regulations. In contrast to the US, the Canadian government did not establish a
patent linkage system or regulatory pathway to meet the special patent,
regulatory, and commercial characteristics of biosimilars. Whether the
Regulations framework will operate effectively with this new product class is
still up in the air.
3.4.
PATENT LINKAGE
IN INDIA:
There is no provision for patent
linking in India. Two different Acts address different facets of novel
medications. The 1940 Drugs and Cosmetics Act (DCA) governs the import,
manufacturing, sale, distribution, and marketing approval of pharmaceuticals,
agricultural chemicals, and cosmetics. In order to receive marketing clearance,
new medications must demonstrate their safety and efficacy through test data
that is submitted to the Drug Regulatory Authority, also known as the Drugs
Controller General of India (DCGI). The DCA Rules of 1945 specify the need for test data for new drugs. A new
medicine is one that has not received Indian approval before. The
bio-availability/bioequivalence research must be submitted for later marketing
clearance.
The Patent Act of 1970 addresses
pharmaceutical medication patenting. The Act's Bolar type provision permits
generic medicine producers in India to conduct trials using any patented
medication in order to gather information that may subsequently be submitted to
a drug regulatory body[12]. The purpose of this Bolar-type provision
is to expedite the introduction of generic drugs into the market, hence
facilitating public access to more affordable generic medications.
There is no provision for
protection of undisclosed test data submitted to the regulatory authorities in
either of the above acts and also no separate legislation for the same. By not giving exclusive protection
to undisclosed test data the Indian government has used TRIPS flexibility.
The Declaration of TRIPS agreement on public health (14 November
2001) states that the TRIPS provisions should not prevent member
countries from taking measures for protecting public health rather it’s
provisions should be interpreted to support protection of public health and access to medicines.
The Satwant Reddy Committee was
established in 2004 to address the matter of Article 39.3 of the TRIPS
Agreement. The committee turned in its findings in 2007. The committee believes
there is no need for separate test data protection laws, although it does
recommend adding a "data
exclusivity"-like mechanism to DCA and DCA guidelines to stop others from
unfairly using the patent owner's unreported test data for commercial purposes.
It recommended a model to be used during the TRIPS Agreement's transition phase
in order to safeguard pharmaceutical companies' and traditional medicine
companies' unreported test data. It was advised that, in the case of patented
medications, the duration of data
protection should never exceed India's 20-year patent protection period.
Additionally, the new drug's validity
will expire if it is
not promoted for twelve consecutive months or within
six months of the marketing approval being granted.
Even the Ranjit Roy Committee
suggested doing bioequivalence (BE) studies on people and bridging Phase III
trials for first-time producers in India. Pre-clinical development and bridging
Phase III clinical trials are recommended for comparable
biologics, or biosimilars, in accordance with the criteria provided by the
Department of Biotechnology (DBT) and the Central Drugs Standard Control
Organization (CDSCO).
The Satwant Reddy Committee's
recommendations were addressed in the Syngenta case. Syngenta said that in this
instance, test data submitted for market approval by the agrochemical and
pharmaceutical sectors had to be protected under Article 39.3 of TRIPS. In the
absence of a protection framework, the petitioner raises
concerns over vulnerability arising from data leak and its use by applicants for the same
product to support their registration claim. The petitioner also makes
reference to a study by the "Reddy Committee," which concluded that
changes should be made to the Act and the Rules to prevent others from unfairly
using the originator's test results for commercial purposes without disclosure.
The court dismissed Syngenta's argument, ruling that it was not within its
authority to declare policy since it had been invited to do so.
In 2007, the Satwant Reddy
Committee made the recommendation that giving India data exclusivity would
not be in its best interests. Similar
to the Satwant Reddy Committee's stance, a legislative study has affirmed that data
exclusivity should not be provided at this time. In addition to actively advocating for the same cause, foreign
pharmaceutical corporations are also at the center of the FTAs India is
negotiating with the European Union (EU).
3.4.1.
CASE LAWS:
In the case, Bristol-Myers Squibb
Co. vs. Hetero
Drugs Ltd (CS (OS) No. 2680/2008):
The disputes in India about patent linking
began with this case.
The medication, "Sprycel," which
was prescribed for chronic myeloid leukemia, was
patented by the plaintiff in India. Their application was for an ex-parte
injunction, which would prevent the medication Controller from granting access
to the defendants' generic medication, Dasatinib. The court had placed the defendant's application for marketing
clearance of its medication on hold. This ruling was criticized and viewed as
cancerous since it placed additional duties on the Drugs Controller to oversee
patent rights and decide their validity—issues that belong in the hands of the
patent officer or the court.
Bayer Corporation & Ors vs. Cipla, Union of India & Ors (2009 (41) PTC 634(Del)):
In this case, Cipla applied for
a marketing license for its drug “Soranib” to the Drug Controller, following
which Bayer filed a writ petition seeking a restraint on the grant of license
to Cipla.
The supreme court ruled that patent
linking was invalid and refused its admission in India, stat- ing the following
grounds:
The Patents Act does not govern
the Drug Controller's authority or jurisdiction, and he is not qualified to
handle matters concerning the validity of patents. Instead, the DCA's
regulations govern these matters.
Since India is a party to the
TRIPS Agreement, it is not required
to embrace the idea of the patent
linking system, which is a component of "TRIPS Plus."
The courts are unable to
recognize the patent linkage system by any pronouncements as the notion of
patent linkage could not be included into the current Indian legal laws.
Bayer Corporation and Anr. v Union of India and
Ors:
In this case, the court made the following
important observations-
The government is not required
to take proactive steps to enforce and safeguard patents under Section 156 of
the Indian Patents Act, 1970. It just places a negative duty on the government
to refrain from violating the patent. The Drug Controller cannot be held
responsible for encouraging the
violation of any patent when he approves a generic medication for commercialization.
The control of the import,
production, distribution, and sale of pharmaceuticals and cosmetics is the only
goal of the DCA. It doesn't go so far as to uphold a patent awarded under the
Patents Act and then prevent a
generic version of a patented medicine from being approved for sale. When
requesting market approval, the maker of generic drugs need merely prove to the
Drug Controller that their product is bioavailable and bioequivalent to the
patented one. The DCA makes no mention of the problem of prohibiting the
medicine Controller from approving the generic version of the original patented
medicine for marketing use for the first three years (or until a mandatory
license may be granted).
The court also pointed out the
following drawbacks which could arise if the patent linkage system was given
recognition in India:
As long as the original patented
drug's period of protection does not expire, the Drug Controller will be forced
to reject the application of any maker of generic drugs, which goes against
both the Patents Act and the DCA's
rules.
Rather than verifying the
patent's validity, the Drug Controller will need to assume it. He will then
have to decide whether to fully reject the applicant's request for marketing
permission or to "hold" the application until the applicant
resolves the patent's validity via legal procedures before an appropriate body. The Drug Controller is not
qualified to handle issues pertaining to the legitimacy of drugs, and such a
procedure is outside the purview of their authority.
Any generic producers who would
have been able to get the medication into the market at a reasonable price
would be blocked by the patent holder. Therefore, until the patent holder
chooses differently, the patented medicine will essentially stay inaccessible
in India even if they choose not to seek for marketing permission.
CHAPTER – 4
1.
IMPACT OF PATENT LINKAGE:
Legal voids in patent linking
system have a profound and wide-ranging effect
on public access
to reasonably priced
medications as well as pharmaceutical innovation. Different jurisdictions have
different standards since there is
no universal agreement. In certain countries,
the introduction of generic drugs is delayed because there are unclear
frameworks for patent linking. This keeps brand-name medicine monopolies in
place longer, which raises drug prices and restricts access, especially in poor countries. These delays are made worse by actions
like patent evergreening, in which new patents are applied for in order to
prolong market exclusivity. Furthermore, it is challenging for generic
manufacturers to contest patents because to the opaque nature of patent listings,
which prolongs monopolies and reduces the availability of reasonably priced alternatives.
The inconsistent application of
TRIPS flexibilities, such as compulsory licensing, especially in response to
public health emergencies, prevents countries from using legal tools to address
high drug prices[13]. Litigation delays, such as the U.S.
30-month stay when a patent is challenged, extend market exclusivity for
brand-name drugs, which impedes the entry of generics. For biologics, the
unclear patent linkage framework and the patent dance process further
complicate the introduction of biosimilars, reducing competition in this
crucial segment of healthcare.
Because TRIPS-plus clauses lengthen
exclusivity periods and limit the use of TRIPS
flexibilities, they disproportionately harm low- and middle-income nations
by strengthening patent protections through regional trade agreements.
Lastly, by limiting competition from other generics, market exclusivity periods
such as the 180-day exclusivity granted to the first generic to challenge a patent can keep costs higher for longer. These gaps raise
the expense of healthcare worldwide
and put major obstacles in the way of access to inexpensive, life-saving
medications.
CHAPTER - 5
2.
SUGGESTION & CONCLUSION:
a.
SUGGESTION:
Engaging stakeholders through
surveys or interviews to give practical insights, such as legislators,
representatives from the pharmaceutical business, and legal experts, helps
deepen the analysis. It is possible to provide empirical evidence for your results
by including case studies of
particular pharmaceuticals and quantitative analysis of generic drug entry
timetables and lawsuit outcomes. Assessing the effects on public health,
especially in low- and middle-income nations, and investigating alternative models
such as flexible
patent regimes or open-access licensing will enhance the analysis even further. Aim to include ethical
viewpoints about the consequences of patent linkage schemes for public health and access to necessary medications, and stay abreast of new developments in the fields
of biosimilars and digital health technology. Examine possible opportunities
for regional collaboration and how regional trade agreements may unify patent
linking systems to enhance access to healthcare globally. In order to involve
the larger academic and policy community, provide concrete policy suggestions
and arrange for the dissemination of your results through conferences, papers,
or workshops.
b.
CONCLUSION:
There are notable differences in
the legislative frameworks and their effects on the pharmaceutical industry
among the major jurisdictions when patent linkage systems are compared, such as
the US, Canada, the EU, and India. Strong patent protection can encourage
innovation in nations with strong patent linking systems, but it can also
unintentionally delay the introduction of generic treatments,
limiting patients' access to reasonably priced medications. Conversely, nations without rigorous patent linking procedures frequently enjoy speedier market
entry for generics, benefiting public health outcomes
but potentially eroding
incentives for pharmaceutical
development.
CHAPTER - 6
3.
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3.
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Data Exclusivity/Patent Linkage in the Context of EU Generic and Biosimilar
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