Economists are unable to provide a clear answer to how effective the patent system is in encourag... more Economists are unable to provide a clear answer to how effective the patent system is in encouraging innovation. At best, they point to certain sectors, such as pharmaceutical and biotechnology, which benefit from a robust patent scheme. Conversely, sectors such as software and, ironically at the same time, biotechnology may be harmed by an overly broad patent scheme. The question emerges: Why do the various stakeholders in all industrial sectors, Congress, the Patent and Trademark Office ("PTO"), and the courts (in particular, the Federal Circuit) continue to center the development of patent law around the "innovation presumption" despite the lack of theoretical and empirical evidence to answer the fundamental question: Do patents actually create more incentive to innovate, more actual innovation, and hence more economic growth? Preparing for this Symposium on the Federal Circuit, innovation, and disruptive technologies has allowed me to reflect further on why it is necessary to challenge the innovation presumption and explore alternative paradigms, such as the use of innovation "policy levers" for this problematic narrative.
Fordham Intellectual Property, Media & Entertainment Law Journal, 2013
centered paradigm. The flaw in the modernist patent narrative is that by focusing the measure of ... more centered paradigm. The flaw in the modernist patent narrative is that by focusing the measure of societal progress on technological advancement and economic growth, we fail to adequately balance other equally important measures of progress such as improving public health, sustainability and access to basic research tools. A radicalized modern view of patent law allows us to challenge the incentive-centered narrative of promoting progress and consider this narrative's impact on future discoveries, humanism, morality and the environment. The Supreme Court recently took a step in this direction by restoring a balanced view of subject-matter eligibility and questioning whether Congress needs to explore other paradigms for protecting certain patent-ineligible subject matter.
This Article analyzes whether patent property rights confer monopoly power or power overprice, be... more This Article analyzes whether patent property rights confer monopoly power or power overprice, being per se "monopolistic" in the antitrust sense. Courts often assume that patent rights (unlike other exclusive property rights) inherently confer the power to charge supernormal prices. This results in a negative presumption surrounding patent rights, providing the impetus for courts to define narrowly and sometimes stifle the promotion of these rights. The early patent misuse cases (1930-1950) are replete with references to patents as anticompetitive monopolies and illustrate how narrowly viewing the patent right led to an increased likelihood of invalidating this right. The latest battle over the survival of the doctrine of equivalents in Warner-Jenkinson Co. v. Hilton Davis Chemical Co. 1 further substantiates the courts' struggle with defining and properly limiting patent rights. Preliminary statistical analysis also indicates that negative judicial sentiment adversely affects patent filings and negatively impacts economic growth. There is a correlation between the proportion of patents adjudicated not invalid by appellate courts (validity adjudication), patent filings in the Patent and Trademark Office (patents filed) and Gross Domestic Product (GDP). Within a few years following a cycle of judicial hostility, the number of patent applications decreases. Negative judicial sentiment thus adversely affects patent filings (.646 Pearson's, .66 rank correlation). Moreover, there is a strong statistical relationship between patents filed and GDP (.887 Pearson's, .944 rank correlation). These data powerfully suggest that patent rights provide incentives
This paper explores the conflict between the PTO Rules of Professional Conduct and the state rule... more This paper explores the conflict between the PTO Rules of Professional Conduct and the state rules of ethics. This conflict is not readily apparent as a patent attorney would be justified in assuming that conduct deemed ethical under the state requirements would be acceptable under the PTO ethics rules. However, the PTO's "Duty of Candor" potentially presents the patent attorney with a seemly unresolvable conflict. Specifically, the "Duty of Candor" may require the patent attorney, during simultaneous patent prosecution, to disclose confidential information from the file of one client in order to properly prosecute the patent of another client. The courts have made it clear that the attorney-client privilege is applicable to all communication between a patent attorney and the client. In light of this ruling, the question becomes whether federal rules of ethics preempt the applicability of state ethics rules. We specifically explore the conflict between state confidentiality/privilege rules and the PTO Duty of Candor and the ramifications of failure to resolve this conflict for both the attorney and the client. An overview of patent prosecution is included as well as a comparison of the of the ABA Model Rules of Professional Conduct and the PTO Code of Professional Responsibility. We argue that the state rules of ethics should dominate the practice of all law and should supercede enforcement of the PTO Duty of Candor where conflicts arise during simultaneous patent prosecution.
for their invaluable advice and editorial assistance. Special thanks to my research assistant, Ma... more for their invaluable advice and editorial assistance. Special thanks to my research assistant, Mark Vaders, for his assistance and his insightful scientific critique. John Perry Barlow deserves credit for the phrase "new wine for a new bottle," coined in reference to digital technology as new intellectual property subject matter and a misfit for the existing Copyright Law Bargain.
The strain between balancing pharmaceutical innovation and competition in the United States (U.S.... more The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars. To help stimulate the U.S. biosimilar market, the Food and Drug Administration (FDA) issued the Biosimilar Action Plan (BAP) in July 2018. BAP focuses on four key strategies: 1) streamlining the biosimilar approval and product development process; 2) increasing biosimilar informational resources; 3) maximizing scientific and regulatory clarity; and 4) “getting competitively priced biosimilars into the market by reducing the gaming of FDA requirements and other attempts to unfairly delay competition.” An enhanced informational platform and streamlined approval process should increase the biosimilar approval rate and accelerate biosimilar product development. However, the FDA’s regulatory powers are insufficient to curb the gaming and other anticompetitive behaviors that most negatively impact access, such as: 1) rebating schemes; 2) pay-for-delay agreements; 3) leveraging innovator patent rights to impede biosimilar market entry and 4) other regulatory abuses. Partnerships with key stakeholders, such as Congress, the Federal Trade Commission, States, Non-Governmental Organizations, and Payors are therefore crucial to achieving the BAP’s overarching goal of “promoting competition and affordability [of biosimilars] across the market.” The recently proposed Biologic Patent Transparency Act provides an example of how Congress can work in tandem with the FDA and other stakeholders to foster innovation and build a competitive and sustainable biosimilar marketplace for patients in the U.S.
Economists are unable to provide a clear answer to how effective the patent system is in encourag... more Economists are unable to provide a clear answer to how effective the patent system is in encouraging innovation. At best, they point to certain sectors, such as pharmaceutical and biotechnology, which benefit from a robust patent scheme. Conversely, sectors such as software and, ironically at the same time, biotechnology may be harmed by an overly broad patent scheme. The question emerges: Why do the various stakeholders in all industrial sectors, Congress, the Patent and Trademark Office ("PTO"), and the courts (in particular, the Federal Circuit) continue to center the development of patent law around the "innovation presumption" despite the lack of theoretical and empirical evidence to answer the fundamental question: Do patents actually create more incentive to innovate, more actual innovation, and hence more economic growth? Preparing for this Symposium on the Federal Circuit, innovation, and disruptive technologies has allowed me to reflect further on why it is necessary to challenge the innovation presumption and explore alternative paradigms, such as the use of innovation "policy levers" for this problematic narrative.
There remains, however, the legal impediment of handling the intellectual property rights that at... more There remains, however, the legal impediment of handling the intellectual property rights that attach to digital transmissions for education and research. The fair use doctrine of the Copyright Act shields public schools from liability for copying portions of printed material for research or teaching. 11 Similarly, the first sale doctrine of the Copyright Act enables schools or libraries to obtain hard text and control its future lending. 12 Unfortunately, the Copyright Act is silent concerning protection of public schools and libraries from liability for supplying access to electronic transmissions. This article analyzes how copyright law can be harmonized with the ethics of providing equal access to high technology information in public libraries and schools. Part I establishes that libraries and public schools are presently unable to provide uniform access to high technology information. I argue that lack of funding for copyright licenses and fear of vicarious liability for copyright infringement are key factors that impede increased access to the Internet. Part II analyzes the existing inadequacies in copyright law 10. The Telecommunications Act of 1996, Pub. No. 104-104, 110 Stat. 56 (codified at 47 U.S.C. § § 151-173 (1996)) (hereinafter 1996 Act) includes provisions for establishing funding to ensure universal Internet access to health providers, public schools, and libraries. Section 254 of the 1996 Act directs the Federal Communications Commission (FCC) to implement a program to meet Universal Service Goals that includes setting up a program funded by certain ISPs and telecommunications carriers to subsidize telecommunications service to rural health providers, libraries, public schools and certain low income consumers. 47 U.S.C.A. § 254 (West Supp 1997). Interestingly, "universal service" does not include copyright and other licensing fees, but merely refers to "a reimbursement to telephone companies for the difference between the cost of providing service and the amount charged to any one consumer." Arturo Gándara, Essay, Equity in an Era of Markets: The Case of Universal Service, 33 WAKE FOREST L. REV. 107, 108 n.4 (1998). Gándara further notes that "[t]o maintain service, for example 'universal service,' to such customers, all Customers are 'taxed.' Thus, the 'taxes' collected are redistributed to those companies that maintain those customers on the network at below cost rates, in order to make those companies whole." Id. On May 8, 1997 the FCC adopted the recommendations of its Federal-State Joint Board and issued its first implementing Order which clarified that only "telecommunications carriers" must contribute to the Universal Fund, although some non-telecommunications carriers may also provide some services (for example, Internet access and inside wiring services). Federal-State Joint Bd. on Universal Serv., Report and Order, 7 Comm. Reg. (P & F) 109 (1997) (hereinafter Universal Serv. Report and Order). 11. See discussion infra II.B. 12. See discussion infra II.C. 19 Section 109 of the Act states that "[n]otwithstanding the provisions of section 106(3) [the distribution right], the owner of a particular copy or phonorecord. .. is entitled, without the authority of the copyright owner, to sell, or otherwise dispose of the possession of that copy. .. ." 20 65 Clause 8 is the enabling provision for the Copyright Act of 1976 (the Act) that protects certain types of "original works of authorship fixed in any tangible medium of expression." 66 Copyright pertains to the literary, musical, graphic or artistic form in which the author expresses intellectual concepts. 67 Ideas, procedures, processes, systems, methods of operation, concepts, principles or discoveries are not copyrightable.
Patent "Monopolyphobia": A Means of Extinguishing the fountainhead? Simone A. Rose* Thi... more Patent "Monopolyphobia": A Means of Extinguishing the fountainhead? Simone A. Rose* This Article analyzes whether patent property rights confer mo-nopoly power or power over price, being per se "monopolistic" in the antitrust sense. Courts often assume that patent rights ( ...
The strain between balancing pharmaceutical innovation and competition in the United States (U.S.... more The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars. To help stimulate the U.S. biosimilar market, the Food and Drug Administration (FDA) issued the Biosimilar Action Plan (BAP) in July 2018. BAP focuses on four key strategies: 1) streamlining the biosimilar approval and product development process; 2) increasing biosimilar informational resources; 3) maximizing scientific and regulatory clarity; and 4) “getting competitively priced biosimilars into the market by reducing the gaming of FDA requirements and other attempts to unfairly delay competition.” An enhanced informational platform and streamlined approval process should increase the biosimilar approval rate and accelerate biosimilar product development. However, the FDA’s regulatory powers are insufficient to curb the gaming and other anticompetitive behaviors that most negatively impact access, such as: 1) rebating schemes; 2) pay-for-delay agreements; 3) leveraging innovator patent rights to impede biosimilar market entry and 4) other regulatory abuses. Partnerships with key stakeholders, such as Congress, the Federal Trade Commission, States, Non-Governmental Organizations, and Payors are therefore crucial to achieving the BAP’s overarching goal of “promoting competition and affordability [of biosimilars] across the market.” The recently proposed Biologic Patent Transparency Act provides an example of how Congress can work in tandem with the FDA and other stakeholders to foster innovation and build a competitive and sustainable biosimilar marketplace for patients in the U.S.
Economists are unable to provide a clear answer to how effective the patent system is in encourag... more Economists are unable to provide a clear answer to how effective the patent system is in encouraging innovation. At best, they point to certain sectors, such as pharmaceutical and biotechnology, which benefit from a robust patent scheme. Conversely, sectors such as software and, ironically at the same time, biotechnology may be harmed by an overly broad patent scheme. The question emerges: Why do the various stakeholders in all industrial sectors, Congress, the Patent and Trademark Office ("PTO"), and the courts (in particular, the Federal Circuit) continue to center the development of patent law around the "innovation presumption" despite the lack of theoretical and empirical evidence to answer the fundamental question: Do patents actually create more incentive to innovate, more actual innovation, and hence more economic growth? Preparing for this Symposium on the Federal Circuit, innovation, and disruptive technologies has allowed me to reflect further on why it is necessary to challenge the innovation presumption and explore alternative paradigms, such as the use of innovation "policy levers" for this problematic narrative.
Fordham Intellectual Property, Media & Entertainment Law Journal, 2013
centered paradigm. The flaw in the modernist patent narrative is that by focusing the measure of ... more centered paradigm. The flaw in the modernist patent narrative is that by focusing the measure of societal progress on technological advancement and economic growth, we fail to adequately balance other equally important measures of progress such as improving public health, sustainability and access to basic research tools. A radicalized modern view of patent law allows us to challenge the incentive-centered narrative of promoting progress and consider this narrative's impact on future discoveries, humanism, morality and the environment. The Supreme Court recently took a step in this direction by restoring a balanced view of subject-matter eligibility and questioning whether Congress needs to explore other paradigms for protecting certain patent-ineligible subject matter.
This Article analyzes whether patent property rights confer monopoly power or power overprice, be... more This Article analyzes whether patent property rights confer monopoly power or power overprice, being per se "monopolistic" in the antitrust sense. Courts often assume that patent rights (unlike other exclusive property rights) inherently confer the power to charge supernormal prices. This results in a negative presumption surrounding patent rights, providing the impetus for courts to define narrowly and sometimes stifle the promotion of these rights. The early patent misuse cases (1930-1950) are replete with references to patents as anticompetitive monopolies and illustrate how narrowly viewing the patent right led to an increased likelihood of invalidating this right. The latest battle over the survival of the doctrine of equivalents in Warner-Jenkinson Co. v. Hilton Davis Chemical Co. 1 further substantiates the courts' struggle with defining and properly limiting patent rights. Preliminary statistical analysis also indicates that negative judicial sentiment adversely affects patent filings and negatively impacts economic growth. There is a correlation between the proportion of patents adjudicated not invalid by appellate courts (validity adjudication), patent filings in the Patent and Trademark Office (patents filed) and Gross Domestic Product (GDP). Within a few years following a cycle of judicial hostility, the number of patent applications decreases. Negative judicial sentiment thus adversely affects patent filings (.646 Pearson's, .66 rank correlation). Moreover, there is a strong statistical relationship between patents filed and GDP (.887 Pearson's, .944 rank correlation). These data powerfully suggest that patent rights provide incentives
This paper explores the conflict between the PTO Rules of Professional Conduct and the state rule... more This paper explores the conflict between the PTO Rules of Professional Conduct and the state rules of ethics. This conflict is not readily apparent as a patent attorney would be justified in assuming that conduct deemed ethical under the state requirements would be acceptable under the PTO ethics rules. However, the PTO's "Duty of Candor" potentially presents the patent attorney with a seemly unresolvable conflict. Specifically, the "Duty of Candor" may require the patent attorney, during simultaneous patent prosecution, to disclose confidential information from the file of one client in order to properly prosecute the patent of another client. The courts have made it clear that the attorney-client privilege is applicable to all communication between a patent attorney and the client. In light of this ruling, the question becomes whether federal rules of ethics preempt the applicability of state ethics rules. We specifically explore the conflict between state confidentiality/privilege rules and the PTO Duty of Candor and the ramifications of failure to resolve this conflict for both the attorney and the client. An overview of patent prosecution is included as well as a comparison of the of the ABA Model Rules of Professional Conduct and the PTO Code of Professional Responsibility. We argue that the state rules of ethics should dominate the practice of all law and should supercede enforcement of the PTO Duty of Candor where conflicts arise during simultaneous patent prosecution.
for their invaluable advice and editorial assistance. Special thanks to my research assistant, Ma... more for their invaluable advice and editorial assistance. Special thanks to my research assistant, Mark Vaders, for his assistance and his insightful scientific critique. John Perry Barlow deserves credit for the phrase "new wine for a new bottle," coined in reference to digital technology as new intellectual property subject matter and a misfit for the existing Copyright Law Bargain.
The strain between balancing pharmaceutical innovation and competition in the United States (U.S.... more The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars. To help stimulate the U.S. biosimilar market, the Food and Drug Administration (FDA) issued the Biosimilar Action Plan (BAP) in July 2018. BAP focuses on four key strategies: 1) streamlining the biosimilar approval and product development process; 2) increasing biosimilar informational resources; 3) maximizing scientific and regulatory clarity; and 4) “getting competitively priced biosimilars into the market by reducing the gaming of FDA requirements and other attempts to unfairly delay competition.” An enhanced informational platform and streamlined approval process should increase the biosimilar approval rate and accelerate biosimilar product development. However, the FDA’s regulatory powers are insufficient to curb the gaming and other anticompetitive behaviors that most negatively impact access, such as: 1) rebating schemes; 2) pay-for-delay agreements; 3) leveraging innovator patent rights to impede biosimilar market entry and 4) other regulatory abuses. Partnerships with key stakeholders, such as Congress, the Federal Trade Commission, States, Non-Governmental Organizations, and Payors are therefore crucial to achieving the BAP’s overarching goal of “promoting competition and affordability [of biosimilars] across the market.” The recently proposed Biologic Patent Transparency Act provides an example of how Congress can work in tandem with the FDA and other stakeholders to foster innovation and build a competitive and sustainable biosimilar marketplace for patients in the U.S.
Economists are unable to provide a clear answer to how effective the patent system is in encourag... more Economists are unable to provide a clear answer to how effective the patent system is in encouraging innovation. At best, they point to certain sectors, such as pharmaceutical and biotechnology, which benefit from a robust patent scheme. Conversely, sectors such as software and, ironically at the same time, biotechnology may be harmed by an overly broad patent scheme. The question emerges: Why do the various stakeholders in all industrial sectors, Congress, the Patent and Trademark Office ("PTO"), and the courts (in particular, the Federal Circuit) continue to center the development of patent law around the "innovation presumption" despite the lack of theoretical and empirical evidence to answer the fundamental question: Do patents actually create more incentive to innovate, more actual innovation, and hence more economic growth? Preparing for this Symposium on the Federal Circuit, innovation, and disruptive technologies has allowed me to reflect further on why it is necessary to challenge the innovation presumption and explore alternative paradigms, such as the use of innovation "policy levers" for this problematic narrative.
There remains, however, the legal impediment of handling the intellectual property rights that at... more There remains, however, the legal impediment of handling the intellectual property rights that attach to digital transmissions for education and research. The fair use doctrine of the Copyright Act shields public schools from liability for copying portions of printed material for research or teaching. 11 Similarly, the first sale doctrine of the Copyright Act enables schools or libraries to obtain hard text and control its future lending. 12 Unfortunately, the Copyright Act is silent concerning protection of public schools and libraries from liability for supplying access to electronic transmissions. This article analyzes how copyright law can be harmonized with the ethics of providing equal access to high technology information in public libraries and schools. Part I establishes that libraries and public schools are presently unable to provide uniform access to high technology information. I argue that lack of funding for copyright licenses and fear of vicarious liability for copyright infringement are key factors that impede increased access to the Internet. Part II analyzes the existing inadequacies in copyright law 10. The Telecommunications Act of 1996, Pub. No. 104-104, 110 Stat. 56 (codified at 47 U.S.C. § § 151-173 (1996)) (hereinafter 1996 Act) includes provisions for establishing funding to ensure universal Internet access to health providers, public schools, and libraries. Section 254 of the 1996 Act directs the Federal Communications Commission (FCC) to implement a program to meet Universal Service Goals that includes setting up a program funded by certain ISPs and telecommunications carriers to subsidize telecommunications service to rural health providers, libraries, public schools and certain low income consumers. 47 U.S.C.A. § 254 (West Supp 1997). Interestingly, "universal service" does not include copyright and other licensing fees, but merely refers to "a reimbursement to telephone companies for the difference between the cost of providing service and the amount charged to any one consumer." Arturo Gándara, Essay, Equity in an Era of Markets: The Case of Universal Service, 33 WAKE FOREST L. REV. 107, 108 n.4 (1998). Gándara further notes that "[t]o maintain service, for example 'universal service,' to such customers, all Customers are 'taxed.' Thus, the 'taxes' collected are redistributed to those companies that maintain those customers on the network at below cost rates, in order to make those companies whole." Id. On May 8, 1997 the FCC adopted the recommendations of its Federal-State Joint Board and issued its first implementing Order which clarified that only "telecommunications carriers" must contribute to the Universal Fund, although some non-telecommunications carriers may also provide some services (for example, Internet access and inside wiring services). Federal-State Joint Bd. on Universal Serv., Report and Order, 7 Comm. Reg. (P & F) 109 (1997) (hereinafter Universal Serv. Report and Order). 11. See discussion infra II.B. 12. See discussion infra II.C. 19 Section 109 of the Act states that "[n]otwithstanding the provisions of section 106(3) [the distribution right], the owner of a particular copy or phonorecord. .. is entitled, without the authority of the copyright owner, to sell, or otherwise dispose of the possession of that copy. .. ." 20 65 Clause 8 is the enabling provision for the Copyright Act of 1976 (the Act) that protects certain types of "original works of authorship fixed in any tangible medium of expression." 66 Copyright pertains to the literary, musical, graphic or artistic form in which the author expresses intellectual concepts. 67 Ideas, procedures, processes, systems, methods of operation, concepts, principles or discoveries are not copyrightable.
Patent "Monopolyphobia": A Means of Extinguishing the fountainhead? Simone A. Rose* Thi... more Patent "Monopolyphobia": A Means of Extinguishing the fountainhead? Simone A. Rose* This Article analyzes whether patent property rights confer mo-nopoly power or power over price, being per se "monopolistic" in the antitrust sense. Courts often assume that patent rights ( ...
The strain between balancing pharmaceutical innovation and competition in the United States (U.S.... more The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars. To help stimulate the U.S. biosimilar market, the Food and Drug Administration (FDA) issued the Biosimilar Action Plan (BAP) in July 2018. BAP focuses on four key strategies: 1) streamlining the biosimilar approval and product development process; 2) increasing biosimilar informational resources; 3) maximizing scientific and regulatory clarity; and 4) “getting competitively priced biosimilars into the market by reducing the gaming of FDA requirements and other attempts to unfairly delay competition.” An enhanced informational platform and streamlined approval process should increase the biosimilar approval rate and accelerate biosimilar product development. However, the FDA’s regulatory powers are insufficient to curb the gaming and other anticompetitive behaviors that most negatively impact access, such as: 1) rebating schemes; 2) pay-for-delay agreements; 3) leveraging innovator patent rights to impede biosimilar market entry and 4) other regulatory abuses. Partnerships with key stakeholders, such as Congress, the Federal Trade Commission, States, Non-Governmental Organizations, and Payors are therefore crucial to achieving the BAP’s overarching goal of “promoting competition and affordability [of biosimilars] across the market.” The recently proposed Biologic Patent Transparency Act provides an example of how Congress can work in tandem with the FDA and other stakeholders to foster innovation and build a competitive and sustainable biosimilar marketplace for patients in the U.S.
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