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14.2 THE PATENT DANCE
Intellectual Property Issues for Scientists
The emergence of biosimilars has advanced healthcare by offering more accessible treatments.
However, developing and commercializing biosimilars present challenges, notably patent disputes
between manufacturers and reference product sponsors. The “patent dance,” established under the
Biologics Price Competition and Innovation Act (BPCIA) in the United States, aims to resolve these
challenges. This essay comprehensively explores the patent dance, discussing its history, current
status, resolved and pending cases, and its impact and future prospects.
The patent dance began with the BPCIA in 2010, aiming to balance competition while protecting
reference product sponsors’ intellectual property rights of reference product sponsors. The BPCIA
introduced a regulatory framework for biosimilars and outlined the patent dance process as a means
of resolving patent disputes. Over time, legal challenges and court rulings, particularly the landmark Amgen v. Sandoz case in 2017, have shaped the interpretation and implementation of the
patent dance.
This process continues to evolve, guided by regulatory directives and ongoing legal developments.
The US Food and Drug Administration (FDA) has issued guidance documents clarifying aspects of
the patent dance, such as information exchange and timing, streamlining the process to efciently
resolve patent disputes.
Additionally, the patent dance has led to an increasing number of resolved cases. Both biosimilar
manufacturers and reference product sponsors have utilized this process to negotiate settlements,
exchange patent information, and occasionally proceed to litigation. These resolutions showcase the
effectiveness of the patent dance in resolving patent disputes and facilitating the entry of biosimilars
into the market.
Resolved and Pending Cases: Several signicant cases have found resolution through the patent
dance process, highlighting its effectiveness. Examples include the legal disputes between Amgen
and Sandoz over Zarxio and Genentech and Celltrion over Truxima. These cases have not only
inuenced the interpretation of the patent dance but have also established legal precedents, offering
guidance for future disputes.
However, it is important to note that the number of resolved cases through the patent dance
is relatively low compared to overall biosimilar applications. Many disputes are settled through
negotiations outside this formal process. Several cases remain pending, awaiting resolution
through continued negotiations or potential litigation. These pending cases underscore the
ongoing importance and necessity of the patent dance in balancing competition and intellectual
property rights.
The patent dance plays a crucial role in the biosimilar landscape by providing a structured framework to resolve patent disputes. From a comprehensive standpoint, it presents both advantages and
challenges. It serves as a platform for communication between biosimilar manufacturers and reference product sponsors, enabling the exchange of patent information and potentially reducing uncertainty surrounding disputes. Moreover, it offers an avenue for early resolution of patent infringement
issues, thereby facilitating more efcient market entry for biosimilars.
However, challenges persist, notably the complexity and costs associated with the patent dance
process. Critics argue that its intricacies can be time- consuming and burdensome, potentially
delaying biosimilar market entry. As the biosimilar market expands and new disputes arise, striking
a balance between safeguarding intellectual property rights and promoting competition for the
benet of patients and the healthcare system becomes increasingly critical.
In the future, renements and modications to the patent dance may address these challenges and
streamline the process. Efforts toward international harmonization of patent dance procedures could
promote consistency across jurisdictions.
Furthermore, as the eld of biosimilar evolves, monitoring the evolving legal landscape and
regulatory developments remains crucial. Ongoing court cases and potential legislative changes
can signicantly impact the effectiveness. It is important for stakeholders, including biosimilar
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349
manufacturers, reference product sponsors, regulatory authorities, and policymakers, to collaborate
and actively engage in discussions to ensure that the patent dance process continues to strike an
appropriate balance between competition and intellectual property protection.
From a broader perspective, the patent dance stands as a signicant component of the regulatory framework for biosimilars. It not only fosters innovation and biosimilar product development
but also safeguards intellectual property rights, encouraging continued investment in research and
development. Ultimately, an effective patent dance process can foster a vibrant and competitive
biosimilar market, enhancing patient access to affordable therapies.
The patent dance has become a pivotal process for settling patent disputes within the biosimilar
sphere. Its history, characterized by legal hurdles and signicant court decisions, has heavily
inuenced how it is understood and executed. While the procedure is still developing, regulatory
advice and resolved cases showcase its efcacy in resolving patent conicts and enabling the introduction of biosimilars into the market. Nevertheless, hurdles persist, necessitating ongoing endeavors
to strike a delicate balance between fostering competition and upholding intellectual property rights.
The future trajectory of the patent dance hinges on continual renements, global coordination
efforts, and the capacity to adapt to the shifting biosimilar landscape. Successfully navigating these
challenges could see the patent dance bolster a thriving biosimilar market, delivering advantages to
patients, healthcare providers, and the pharmaceutical industry.
Pending U.S. District Court BPCIA Litigations
Aibercept+
Denosumab+
Natalizumab+
Tocilizumab
Resolved U.S. District Court BPCIA Litigations
Adalimumab+
Bevacizumab+
Epoetin alfa+
Etanercept+
Filgrastim+
Iniximab+
Peglgrastim+
Rituximab+
Trastuzumab+
Ustekinumab+
Source: Courtesy of Big Molecule Watch, https:// www.bigmo lecu lewa tch.com/
bpcia- pat ent- liti gati ons/ , Last updated: June 1 2023
The history of the patent dance for biosimilars traces back to the enactment of the Biologics Price
Competition and Innovation Act (BPCIA) in the United States in 2010, as part of the Affordable Care Act
(ACA). It aimed to establish an abbreviated pathway for biosimilar product approval and market entry.
The patent dance provisions in the BPCIA aimed to balance competition and protect the intellectual property rights of reference product sponsors. Although the legislation doesn’t explicitly
mention the term “patent dance,” it outlines the process for resolving patent disputes between
biosimilar manufacturers and reference product sponsors.
The key milestones in the history of the patent dance are as follows:
1. Enactment of the BPCIA (2010): Introduced a regulatory framework for biosimilars and
included provisions for the patent dance, aiming for an efcient approval pathway while
allowing reference product sponsors to assert patent rights.
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2. Legal Challenges and Interpretation: Post- enactment, legal debates arose about interpreting
BPCIA provisions, particularly the patent dance. Scrutiny focused on aspects like timing and
requirements for exchanging patent information.
3. Amgen v. Sandoz Case (2015– 2017): A signicant event involving a dispute between Amgen
and Sandoz regarding Zarxio, a biosimilar of Amgen’s Neupogen. The case reached the U.S.
Supreme Court, leading to a landmark ruling that claried certain patent dance aspects.
In Amgen v. Sandoz, the Supreme Court addressed whether the biosimilar applicant was
obligated to complete the entire patent dance process and if the reference product sponsor could le
an infringement lawsuit before the biosimilar product was commercially marketed.
The Supreme Court ruled that biosimilar applicants aren’t obligated to complete the entire patent
dance process and can opt out of certain steps. Moreover, the Court held that the reference product
sponsor could le an infringement lawsuit even before the biosimilar product was commercially
marketed. This ruling offered crucial guidance and clarication on the patent dance process.
4. Subsequent Legal Developments: Following the Amgen v. Sandoz ruling, subsequent legal
cases and disputes have arisen regarding the patent dance, contributing to the ongoing evolution of this regulatory process. These cases have played a signicant role in shaping the interpretation and understanding of the patent dance provisions.
5. Continued Renement and Regulatory Guidance: In the years after the Amgen v. Sandoz case,
regulatory authorities and organizations have offered additional guidance to further rene
the patent dance process. The US Food and Drug Administration (FDA) has issued draft and
nal guidance documents addressing various aspects of the patent dance, such as information
exchange, timing, and dispute resolution.
These regulatory guidance documents aim to bring more clarity and predictability to the patent
dance process, providing stakeholders with a clearer framework for resolving patent disputes.
They cover issues such as the types of patents involved in the exchange, the timing of information
exchange, and the consequences of non- compliance with the patent dance provisions.
6. International Perspectives and Harmonization Efforts: While the patent dance is primarily
associated with the United States, other countries and regions have developed their own
procedures for settling patent disputes related to biosimilars. International perspectives on
patent dance- like processes differ, with some jurisdictions adopting similar steps, while others
use different mechanisms.
Efforts to harmonize patent dance procedures have emerged to streamline processes across
different jurisdictions. Organizations like the World Health Organization (WHO) and the International
Federation of Pharmaceutical Manufacturers & Associations (IFPMA) have engaged in discussions
and initiatives to encourage global consistency in resolving patent disputes for biosimilars.
7. Ongoing Evolution and Future Directions: The history of the patent dance continues to evolve
with new legal challenges, court rulings, and rened regulatory guidance. The patent dance
process remains relatively new, and stakeholders are still gaining experience and adapting to
its complexities.
Looking ahead, ongoing discussions and debates about the patent dance include suggestions for
potential improvements, such as increased clarity, more dened timelines, and reduced litigation
burdens. These discussions are likely to inuence the future of the patent dance, along with possible
legislative and regulatory changes aimed at improving its effectiveness and efciency.
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TABLE 14.2
351
Total Patent Applications and Awarded Patents
at the USPTO from 1790 to 2019
Type of Application Total Filed Percentage Approved
Utility 19,774,364 53%
Design 870,770 69%
Plant 35,161 89%
All 21,064,418 54%
Foreigners 4,051,671 35%
FIGURE 14.3 Yearly global patent ling 2004– 2018
Additionally, the rising signicance of biosimilars in healthcare and the increasing number
of biosimilar approvals globally may prompt further international harmonization efforts and
collaborations across jurisdictions to establish consistent approaches to resolving patent disputes.
Numerous patents on biological molecules pose challenges for scientists and technicians
involved in developing and producing biopharmaceutical products, hindering the design of manufacturing procedures. A Freedom- to- Operate Document, as later described, sets the boundaries for
technology used in creating a new process. Safeguarding patent rights entails formal actions such as
non- disclosure agreements, validating inventions, and timely patent lings. Consequently, scientists
and technicians require a basic understanding of intellectual property protection to collaborate
effectively with legal teams.
14.3 PATENT LANDSCAPE
This chapter delves into patents, a pivotal aspect of intellectual property. Patents, commonly
granted across various legal jurisdictions, primarily delineate invention boundaries concerning
novelty, non- obviousness, and utility. Intellectual property encompasses additional components
(Figure 14.1).
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TABLE 14.3
Intellectual Property Issues for Scientists
Patent Search Resources
US: http:// www.uspto.gov
India: http:// www.ipindia.nic.in/
Europe: http:// www.european- patent- ofce.org
Japan: http:// www.jpo.go.jp/
Korea: http:// www.kipo.go.kr
Italy: http:// www.info- brevetti.org/
Canada: http:// strategis.ic.gc.ca/ sc_ mrksv/ cipo/
Australia: http:// www.ipaustralia.gov.au/
African region: http:// www.aripo.wipo.net/
New Zealand: http:// www.iponz.govt.nz/
Singapore: http:// www.ipos.gov.sg/
UK: http:// www.ukpats.org.uk
WIPO: http:// www.wipo.int/ patentscope/ en/
PCT: Patent Cooperative Treaty http:// www.wto.org/ engl ish/ trato p_ e/ trip s_ e/ trip s_ e.htm http:// www.
pctlearningcenter.org/
Public Patent Foundation http:// www.pubpat.org/ index.html
Intellectual Property Owners Association: http:// www.ipo.org/
Global: Espacenet https:// worldwide.espacenet.com/ patent/
China http:// english.sipo.gov.cn
Trilateral: the US, Japan, the EU https:// www.trilateral.net/ index
ASEAN https:// www.aseanip.org
As of May 2020, over ten million patents had been issued in the US. The initial US patent was
granted in 1790 (three patents that year), and the rst patent to a foreigner was not issued until 1836.
The rate of patent rejections varies widely based on technology and, interestingly, on the inventor’s
US citizenship (Table 14.2).
“Everything that can be invented has been invented.”
Charles H. Duell, United States Patent Ofce Director, telling
President McKinley to abolish the ofce in 1899
The global ling of patents is shown in Figure 14.2 from 2004 to 2018, as reported from 160
patent ofces worldwide.
Table 14.3 lists links to patent search resources around the world. There are over 160 patent
ofces around the world.
14.4 PATENT LAW BASICS
Patents bestow the holder the right to prohibit others from producing, using, selling, or importing
a patented invention in the United States (or the patentee’s nation) for a specied period (usually twenty years from the patent application date). Unauthorized actions infringe upon the patent,
leading to potential monetary penalties and legal repercussions. The purpose of patent exclusivity is
to incentivize innovation by enabling the patent holder to recover research and development costs.
Patentees benet from exclusivity by shielding themselves from competition and setting higher
prices for patented goods. This protection is particularly crucial for expensive- to- produce commodities like pharmaceuticals, which are easily replicable once on the market.
Pharmaceutical patents extend beyond the active ingredient, covering various facets of a medica-
tion or biologic. Among the claims of such “secondary patents” are
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• Methods of employing the pharmaceutical (e.g., to treat a specic ailment); methods of manufacturing or technologies utilized to create the pharmacological
• Additional substances connected to the active ingredient, such as intermediates; or techniques
or technologies for administering the pharmaceutical.
14.4.1 PhaRMaceutical Patenting PRactices
The practices outlined, perceived as legitimate exercises of patent rights by patent holders, are
critiqued by opponents as exploitative strategies that misuse the patent system, contrary to Congress’s
intentions.
• Moreover, evergreening, also known as patent “layering” or “life- cycle management,” is a
process in which some drug rms allegedly attempt to extend their drug patent monopolies by
acquiring new patents as old ones expire. It’s noted that a single pharmaceutical product can
be covered by numerous patents since different aspects of pharmaceutical goods are patentable. Critics of evergreening argue that secondary patents typically cover minor alterations
or auxiliary components of a pharmaceutical product, effectively extending patent protection
beyond the intended term set by Congress. However, defenders contend that additional patents
must incorporate signicant new discoveries or improvements to existing products, going
through the same patentability and inspection procedures as any other patent.
• Furthermore, “product hopping” describes the process wherein a brand manufacturer leverages
its dominant market position to encourage the shift from a drug with expiring patents to a
newer version with later- expiring patents. This can involve introducing an extended- release
form, a different dosage, altered administration methods, or slight chemical modications
to the medication. Marketing campaigns, discounts, and rebates are employed by the brand
manufacturer to incentivize this transition, commonly in the form of a “hard switch” or a “soft
switch.” Critics of product hopping argue that the new product often provides minimal or no
clinical benet, primarily serving to delay generic competition. Conversely, defenders assert
that manufacturers have legitimate reasons to develop and patent new products, often resulting
in clinical advantages such as fewer side effects or improved patient compliance.
• Moreover, “patent thickets” refer to a brand manufacturer’s strategy of acquiring multiple
patents related to a single product, hindering competitors from entering the market or making
it too costly and risky to do so. Manufacturers got an average of seventy- one patents on
each drug, according to a recent survey of the top twelve drugs by gross US sales. Concerns
about patent thickets are prevalent, especially in biologics versus small- molecule chemical
medications, partly due to the complexities involved in developing drugs from living cells,
offering various options for patenting novel techniques or the use of different mediums for cell
growth or dosage changes. Critics argue that patent thickets are formed by patenting minor
or secondary innovations, signicantly delaying competition as generics or biosimilars must
navigate or challenge each patent, incurring high costs and complexity. Proponents, however,
argue that these patents represent advancements encouraged by patent laws, each validated
during the patent examination process.
• “Pay- for- Delay” Settlements. When generic (or biosimilar) manufacturers submit shortened
applications for products covered by certain unexpired patents, brand manufacturers may
commence patent litigation under Hatch- Waxman and the BPCIA procedures. Some brand
manufacturers have paid (or otherwise compensated) generic producers in exchange for the
generic manufacturers agreeing to postpone market launch. The Supreme Court has ruled
that this method, known as “reverse payment” or “pay- for- delay,” may be a legal exercise
of patent exclusivity in some cases but may violate antitrust laws in others. Pay- for- delay
agreements, according to critics, are used by brand manufacturers to safeguard weak patents
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Intellectual Property Issues for Scientists
from invalidation; yet, because pay- for- delay agreements end the litigation, patent validity
and infringement problems remain unanswered. As a result, critics argue that pay- for- delay
harms competition by allowing the brand manufacturer to (1) avoid the danger of having its
patents invalidated, (2) postpone generic competition from entering the market, and (3) extend
the company’s exclusive marketing rights for the specied medicine. Defenders argue that
settlements are a reasonable means to decrease the cost and risk of litigation, pointing out that
most claims are settled in all areas of law. Furthermore, defenders claim that the case might
end with the brand maker winning, thereby barring competition until the patent period expires.
Defenders argue that settling the case ensures generic entry before the patent period expires.
• Lastly, despite being discussed separately, opponents argue that these strategies can be
combined. For instance, brand manufacturers might use a pay- for- delay settlement along with
product hopping to postpone generic entry. By transitioning the market to a new product
protected by patent exclusivity, the brand manufacturer can effectively delay competition.
14.4.2 united states Patent eleMents
A patent functions as a license that restricts others from using or practicing an invention. If an
inventor’s creation infringes on other inventions even in part, they cannot practice their own invention. For instance, when patenting a new application of an unexpected drug, others are barred from
using that drug for the specic treatment the inventor has devised. However, if the drug molecules are
safeguarded under a chemical patent, the inventor retains the right to use the drug for the treatment
they’ve developed. Essentially, a patent inherently restricts the usage of an invention.
For an invention to be eligible for a patent, it must satisfy certain criteria: uniqueness, nonobviousness, and signicant utility. The term “new and novel” signies that the invention must not
have been publicly disclosed anywhere globally more than a year before the patent application’s
ling date. Importantly, this one- year grace period isn’t applicable in other countries. Uniqueness
and non- obviousness necessitate a creative process in the innovation’s development.
A utility invention, distinct from utility ling in the EU, can fall under various denitions:
• A kit for achieving a useful purpose
• A method or process of synthesis or processing
• A machine
• An article of manufacture
• A matter composition (such as a chemical compound), or
• Enhance any of the above categories.
The specication, a comprehensive description of the invention, also includes instructions for
its creation and utilization. It should be articulated in a manner that enables an expert in the eld
to replicate and apply the innovation. For current regulations and methods on preparing a patent
application, the US Patent Ofce’s URL (https:// mpep.uspto.gov/ RDMS/ MPEP/ curr ent) should be
consulted, current as of June 2020, the publication date of this book.
Patents are granted to individuals in the United States, who may subsequently transfer them to
others or le patents in other jurisdictions. An individual artistic contribution from each co- inventor
is required for at least one argument of the patent, excluding co- authorship on a research paper.
A patent application is a structured document encompassing various elements, following a typical format across most patent ofces globally but may differ in naming of headings and presentation order.
14.4.2.1 Title of Invention
The title of the invention should be concise, limited to 500 characters, and as precise as possible.
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14.4.2.2 Cross- Reference to Related Applications
355
In a non- provisional utility patent application claiming benet from prior- led co- pending
applications, a reference to each prior application must be provided in the specication after the
title, as per laws 120, 121, or 365(c).
14.4.2.3 Statement Regarding Federally Sponsored Research or Development
If applicable, a declaration concerning rights to innovations developed under federally nanced
research grants or intramural programs should be included.
14.4.2.4 Background of the Invention
This segment encompasses a statement about the intended use of the invention, along with a summary of the relevant US patent classication denitions or the subject matter of the invention. This
part was previously referred to as “FIELD OF INVENTION” or “TECHNICAL FIELD.” This part
should also offer a summary of the information.
14.4.2.5 Brief Summary of the Invention
This section should present the alleged invention’s content, purpose, or general concept in its
summarized form. The benets of the invention and how it addresses previously known problems in
the specication will be highlighted in the overview. The description is not the same as the abstract.
14.4.2.6 Background of the Invention
Elements to be included in the invention’s background are as follows: (1) Invention’s Field: Describing
the art form to which the invention belongs, potentially summarizing relevant patent classication denitions from the United States. This should specically pertain to the subject matter.
(2) A description of the relevant art, as well as a data disc where applicable.
14.4.2.7 Brief Description of the Drawing
In cases with accompanying drawings, a numbered list of all gures (e.g., Picture 1A) is presented,
accompanied by clear explanations delineating the content of each gure.
14.4.2.8 Detailed Description of the Invention
The description within the specication is distinct from the abstract. Here, a detailed, yet precise
explanation of the innovation, its creation, and application is provided. This section should differentiate the invention from previous works and other inventions. Biomedical patent descriptions frequently integrate experiments involving materials and procedures.
14.4.2.9 Claim or Claims
These arguments serve as the dening features of the invention, forming the legal basis for its
defense. The claims or arguments must specically identify and assert the subject matter regarded
as the invention. They establish the extent of the patent’s protection.
The most crucial part of a claim include:
• Scope: Each argument should contain one sentence, which can be broad or narrow, but not
simultaneously both. Narrow claims provide more specic details than wider ones, potentially
enabling legal ownership of various parts of the invention through multiple claims with distinct scopes.
• Characteristics of Signicant Importance: When formulating the claim, consider various
factors:
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• Patent examiners assess each claim’s validity, approving or rejecting it based on its merits.
Therefore, the language used in claims often repetitively emphasizes the novelty of the
invention.
• The initial phrase in a claim denes the innovation’s category and, in some instances, its
purpose, like “a diagnostic test kit” or “a cancer- treating composition.”
• Claim Evaluation: Each claim is individually assessed by the Patent Examiner. Crafting claims
covering various aspects of the invention maximizes coverage. Creating an initial claim and
referencing it in narrower scope claims ensures the inclusion of specic inventive features in
some or all claims.
14.4.2.10 Abstract of the Disclosure
The abstract summarizes the disclosure found in the introduction, statements, and drawings; the
summary must indicate the technological area to which the invention relates, providing a clear
understanding of the technical issue, the gist of the invention’s solution to a technical problem, and
the primary application or use of the invention.
14.4.2.11 Drawings
If sketches are necessary to understand the subject matter for a patent, they must be included in
the patent application. Every feature of the invention, as stated in the claims, must be depicted in
the sketches. An application may be considered incomplete if drawings are missing. In each patent
drawing, every aspect of the invention listed in the claims must be shown.
14.4.2.12 Oath or Declaration
An oath or declaration must include the following information: (1) the legal name of the inventor
or joint inventor executing the oath or declaration; (2) the application to which it is directed; and
(3) certication that the person administering the oath or announcing the true inventors is one of the
declared or joint inventors. The declaration, a brief document, is required for each inventor to claim
ownership of the invention.
14.4.2.13 Sequence Listing (When Necessary)
Amino acid and nucleotide sequences, considered conceptual, must be used if part of the invention.
This section must disclose a nucleotide and amino acid sequence, complying with patent rules 1.821,
1.822, 1.823, 1.824, and 1.825 (37 CFR 1.821 Nucleotide and amino acid sequence disclosures in
patent applications and WIPO Standard ST.25 (1998)).
14.4.3 tyPes of Patents
Utility patents cover novel methods, formulations, or gadgets, while a design patent protects a
new decorative design for a manufactured item. Plant patents provide protection for any asexually
reproduced distinct and novel type of plant.
Patents for utility and plant inventions typically last 20 years from the date of issuance. The
appropriate maintenance payments must be made on time. Design patents are granted for 14 years
from the date of issuance, without ongoing maintenance expenses.
A patent is personal property, allowing the owner to sell, assign, or transfer it at any time.
Differences may be arbitrated by competent authorities or jurisdiction in cases of infringement.
Sanctions and compensation for the rightful owner may be decided upon identifying a violation.
In the 1990s, the World Trade Organization established a minimal set of rights for all patent
owners, including a 20- year patent duration from the application ling date.
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14.4.4 unPatentable inventions
357
Natural products that remain unaltered cannot be awarded patents. Natural chemicals, genes,
proteins, or unmodied animal or plant species cannot be patented. However, a modied version of
a natural object could be copyrighted if the alteration is benecial. Natural ingredients used in useful
devices, chemicals, or diagnostic tests may be patented.
In summary, rather than attempting to patent a gene or protein as a composition of matter, patent
claims should focus on the non- obvious functional use or altered form of the gene or protein.
Nature’s laws, physical facts, abstract notions, and various artistic works are exempt from patent
protection. Such elements are not copyright- protected but can be replicated. Patents will not be
granted for technologies considered non- useful, technically impossible (e.g., perpetual motion
machines), or objectionable to public morality by the USPTO.
Section 101 of the Patent Act (the “congressional categories”) allows the patenting of any process, machine, manufacture, or composition of matter. However, certain inventions, such as abstract
ideas, natural facts, and natural laws, do not fall into these categories and are considered judicial
exceptions.
Since 2012, the Supreme Court has issued three signicant rulings prohibiting the patenting of
certain types of inventions. These rulings outlawed patents on medical diagnosis and research (Mayo
v. Prometheus), articial DNA characterized by a natural nucleic acid sequence (Association with
Molecular Pathology v. Myriad Genetics or Myriad Genetics), and computer hardware/ software
used in nancial transactions or other “abstract concepts” (Alice ruling). While some anti- patent
factions, notably Silicon Valley and the generic drug industry, have welcomed these decisions (collectively known as the “Alice” decisions), organizations reliant on creativity, such as research universities, solo inventors, and biotechnology rms, have criticized them. The Alice trifecta overturns
long- standing legal precedent, diverges from international patenting standards, and breaches TRIPS
Section 5 Article 27 Part 3. Although Congress has introduced legislation to address the Alice trifecta, no tangible progress has been made at the time of this writing.
Molecular proling and customized therapy offer new insights into illness management, providing novel tools and treatments. Although genomic and proteomic research isn’t new, the patentable knowledge derived from these molecular insights constantly challenges existing health and
patent rules.
The economic well- being of every country hinges on advancements in software, medical
methods, and business methods. It is widely acknowledged that sustained investment in these elds
necessitates fair compensation for innovators. However, the grant of patents for such ideas requires
meticulous consideration, and many governments are still deliberating on how to handle such
requests.
14.4.5 softWaRe Patents
The basic theory in the United States is that a software invention is patentable if it meets two
criteria:
• It’s one- of- a- kind, which means it’s something different.
• It’s connected to a computer, in the sense that the type of hardware platform on which the
program runs is dened, ensuring that a patent isn’t awarded for the interpretation of an
abstract process but rather for something that necessitates a particular type of physical hardware. (As we’ll see, this is a little more open- ended than the machine specications in other
countries.)
• However, there are three forms of applications that aren’t patentable:
• An algorithm is not patentable.
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