scholarly journals Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?

2017 ◽  
Author(s):  
Yaniv Heled
Keyword(s):  
Affordable Care Act ◽  
Price Competition ◽  
Pharmaceutical Products ◽  
Market Exclusivity ◽  
President Obama ◽  
Biological Products ◽  
New Class ◽  
Patient Protection ◽  
Legal Regimes

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products are based. This seeming “double dipping” raises questions regarding the need and justification, if any, for such parallel, double protection of this particular class of biological products. This article seeks to address these questions. Analyzing the fundamentals and underlying assumptions of the legal regimes of patents and statutory exclusivities, this article examines their applicability to the context of bio-pharmaceuticals. Based on the conclusions reached, this article then further examines the proposition that statutory exclusivity regimes could become a blueprint for “patentless” areas of technology, replacing the traditional patent regime with a new class of incentives to invent and invest in the development of new technology.Published: Yaniv Heled, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?, 18 Mich. Telecomm. Tech. L. Rev. 419 (2012).

What the patent dance of the Biosimilars Act means for biosimilars

2014 ◽  
Vol 20 (4) ◽  
Author(s):  
David A. Fazzolare ◽  
Joanna Brougher
Keyword(s):  
Price Competition ◽  
Market Entry ◽  
Patent Protection ◽  
Reference Product ◽  
Title Vii ◽  
President Obama ◽  
Biological Products ◽  
Related Information ◽  
The Us ◽  
Biologic Product

There are currently only two biosimilars on the market in the US in contrast to the 21 biosimilars have been approved in Europe since 2006. Part of the reason for the lack of biosimilars is that until recently, there has been no abbreviated pathway for a biosimilar to reach the market meaning that biosimilars had to undergo the long and costly process of obtaining approval just like an innovator biologic product. After years of negotiation, however, the Biologics Price Competition and Innovation Act (the “Biosimilars Act”) was signed into law on March 23, 2010, by President Obama as Title VII of the Patent Protection and Affordable Care Act. The Biosimilars Act established an abbreviated pathway by which the FDA could approve generic versions of previously licensed biological products. The Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information before the biosimilar can enter the market. In this article, we will explore what the Patent Dance is and what it means for biosimilars that are seeking market entry in the US. 

scholarly journals The Biologics Price Competition and Innovation Act 10--A Stocktaking

2021 ◽  
Vol 7 (1) ◽  
pp. 81-109
Author(s):  
Yaniv Heled
Keyword(s):  
United States ◽  
Price Competition ◽  
Original Data ◽  
The United States ◽  
Measurement Tool ◽  
President Obama ◽  
Current Form ◽  
Track Record ◽  
Patient Protection ◽  
Before And After

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (“Obamacare”). The purpose of BPCIA was to create for biologics a regime similar to that of the Drug Price Competition and Patent Term Restoration Act (Hatch–Waxman Act) and, in so doing, to open biologics markets to competition and, subsequently, lower the price of these expensive and increasingly important pharmaceuticals. Using original data, this Essay takes stock of the decade that has passed since the enactment of BPCIA. This Essay surveys the state of competition in United States biologics markets, entry of follow-on biologics into these markets, and the effects such entry has had on biologics prices. This Essay’s main findings are that, as of March 23, 2020—exactly ten years since the signing of BPCIA into law—the FDA has approved a total of 26 follow-on biologics deemed biosimilar to 9 original products (ratio: 2.63 follow-on/original products), with only 16 of these deemed biosimilar to 7 original products (ratio: 1.78 follow- on/original products) actually available on the market. None of these follow-on products have been approved as interchangeable with their reference products, which means that substitution of the 7 original products with one of their 16 approved biosimilars cannot be done automatically. The price of these products was 10%–37% lower than the price of the original biologic, with the average price savings being 24% or 27%. All 35 approved follow-on and reference products are owned by a total of 11 pharmaceutical companies. The number of years of market exclusivity of the 9 original biologics before the approval of the first biosimilar ranged between 13.5–28.92 with an average of 18.27 years or 15.33–29.42 with an average of 19.87 years before the launch of the first competing biosimilar. This Essay further puts forward a new method of measuring comparative levels of competition in drug markets by comparing the ratio of total approved follow-on products per total approved original products at certain critical benchmarks. Using this measurement tool, this Essay compares BPCIA’s track record with the levels of competition in small-molecule drugs before and after the Hatch– Waxman Act, showing that that BPCIA significantly underperforms in comparison and fails to instigate levels of competition that would lead to significant price drops and increase access to biologics in the United States. A short survey of the most likely reasons for BPCIA’s underperformance follows. This Essay concludes by presenting the following question: if BPCIA’s current track record is (still) not enough to convince that it is failing to meet its goals, what more would it take to reach such a conclusion, and how much longer should policymakers wait before it is possible to surmise that BPCIA in its current form has failed to significantly increase access to biologics in the United States?

Assessing the 2010 Affordable Care Act: Perspectives of Future Health Care Professionals

2011 ◽  
Vol 33 (4) ◽  
pp. 44-48 ◽  
Author(s):  
Heide Castañeda ◽  
Nolan Kline ◽  
Mackenzie Rapp ◽  
Nicole Demetriou ◽  
Naheed Ahmed ◽  
...  
Keyword(s):  
Health Care ◽  
Affordable Care Act ◽  
Health Care Professionals ◽  
Future Health ◽  
President Obama ◽  
Patient Protection ◽  
National Debate ◽  
Social Security Act ◽  
Future Health Care ◽  
The 1960S

In March of 2010, President Obama signed into law the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (known together as the Affordable Care Act or ACA). The largest legislative overhaul of the US health care system since the expansion of the Social Security Act in the 1960s, it invoked a fierce national debate about the elements required for reform. Many of the ACA's provisions do not take effect until 2014, creating a unique liminal space after passage but before implementation in which uncertainties and anxieties are expressed. This gulf between the intentions of policy and the results of implementation can lead to productive moments of investigation. Since they will undoubtedly be impacted by this legislation, this research examined the perspectives of future healthcare professionals who will enter the workforce around the time the ACA is fully implemented.

Implications of the Supreme Court's ACA Medicaid Decision

2013 ◽  
Vol 41 (S1) ◽  
pp. 77-79 ◽  
Author(s):  
Jane Perkins
Keyword(s):  
Affordable Care Act ◽  
Medicaid Expansion ◽  
Federal Poverty Level ◽  
Poverty Level ◽  
President Obama ◽  
Patient Protection ◽  
General Welfare ◽  
The Supreme Court ◽  
Medicaid Eligibility ◽  
Over Time

Congress implemented the Medicaid Act in 1965, acting pursuant to its Spending Clause authority to “provide for the…general Welfare.” Over time, the Act has been amended more than 50 times. Most recently, as part of the Patient Protection and Affordable Care Act (ACA), Congress required participating states to extend Medicaid eligibility to childless, non-disabled, and non-elderly adults with incomes below roughly 133% of the federal poverty level (referred to as childless adults).Within hours of President Obama signing the ACA into law, four lawsuits were filed challenging the con-stitutionality of the ACA, including a case in Florida that eventually made its way to the Supreme Court as National Federal of Independent Business v. Sebelius (NFIB). As part of this case, officials from 26 states argued that Congress was improperly coercing them into participating in the Medicaid expansion.

Physician Knowledge of and Attitudes toward the Patient Protection and Affordable Care Act

2013 ◽  
Vol 150 (2) ◽  
pp. 229-234 ◽  
Author(s):  
Daniel J. Rocke ◽  
Steven Thomas ◽  
Liana Puscas ◽  
Walter T. Lee
Keyword(s):  
Affordable Care Act ◽  
Physician Knowledge ◽  
Patient Protection
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