Law Commons^™

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

The 2009 H1n1 Swine Flu Pandemic: Reconciling Goals Of Patents And Public Health Initiatives, Michelle Kaplan

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.

Dangers In Prescription Drugs: Filling A Private Law Gap In The Healthcare Debate, David G. Owen

Faculty Publications

No abstract provided.

Cost-Effective Healthcare – How Patent Framework Can Be Re-Designed To Help Fulfil This Objective, Mian Atif Saeed

Mian Atif Saeed

The issue of prices of medicinal products is not only limited to third world countries alone and it is now becoming relevant in developed nations too. Governments all over the world are being pressurised to address the issue of providing better healthcare to every citizen. In order to address this issue the payers are becoming more and more cost conscious and the industry is being pressurised on reducing the cost of medicinal products. However, we have not seen any industry friendly developments in the legislative and business framework in which pharmaceuticals operate. Instead, the framework in which pharmaceuticals operate is …

How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette

Michigan Telecommunications & Technology Law Review

As described by Professors Dan Burk and Mark Lemley, drugs are[...] special because of the low number of patents per product: "In some industries, such as chemistry and pharmaceuticals, a single patent normally covers a single product. Much conventional wisdom in the patent system is built on the unstated assumption of such a one-to-one correspondence." Although many have repeated this one-patent, one-drug assumption, there has been little empirical analysis of how many patents actually protect each drug. In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over five …

It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü

Michigan Telecommunications & Technology Law Review

Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …

The Adoption Of Intellectual Property Standards Beyond Trips – A Misguided Legal & Economic Obsession By Developing Countries?, Ferris K. Nesheiwat

Ferris K Nesheiwat

This paper looks at the effect intellectual property standards have had on technology transfers in Jordan, in light of the implementation of stricter intellectual property standards with the adoption of the Agreement on Trade Related Aspects of Intellectual Property (TRIPS)' and "TRIPS-plus" standards. Both the TRIPS and TRIPS-plus standards ushered in new legal requirements, which were justified and marketed under the theoretical assumption that greater protections of intellectual property rights are essential to both technology transfer and investment promotion. This paper intends to examine the level of technology transfer and the flow of intellectual property-related foreign direct investment into Jordan …

21st Century Healthcare - A New Scenario Needs New Rules Of The Game, Mian Atif Saeed

Mian Atif Saeed

We are witnessing a changing paradigm of healthcare sector in view increasing pressure on governments to provide free healthcare to citizens and increasing cost-consciousness of governments/payers to address this public issue. This changing paradigm in healthcare requirements requires a holistic review of the legislative framework in which industry operates. All stakeholders and all applicable regulatory and legal frameworks need to be appraised in order to address the requirements of 21st century healthcare. Drug development is very risky, costly and lengthy process and inventors and investor deserve financial gains for their efforts. Pharmaceutical industry requires the money to keep investing back …

The Great Pharmaceutical Patent Robbery, And The Curious Case Of The Chemical Foundation, Christopher Wadlow

Christopher Wadlow

In 1918, the United States confiscated virtually all German-owned intellectual property assets within its jurisdiction. Out of 6,000 patents in the chemical field, 4,500 were assigned for a very modest consideration to an newly-established entity, the Chemical Foundation, which was incorporated with the objective of licensing and managing them for the benefit of the United States chemical industry. This article describes the origins and activities of the Chemical Foundation, and considers whether it provides a useful model, or at least useful lessons, for the collective management of patents today.

These Statements Have Not Been Approved By The Fda: Improving The Post-Approval Regulation Of Prescription Drugs, Christopher R. Page

Christopher R. Page

The American public’s confidence in the FDA is waning in the midst of increased reporting of inefficiencies in the agency. The missteps by the FDA in the post-approval regulation of prescription drugs are magnified by the pervasive use of prescription drugs in the market. This article identifies these missteps. It also chronicles the response of the state attorneys general to this void in regulation, from the famous class action suit against the tobacco industry to the Oxycontin litigation to the recent Vioxx settlement.

This response to the public’s lack of confidence is accomplished through lawsuits against pharmaceutical companies under state …

Two Masters, Carl E. Schneider

Articles

American government rests on the principle of distrust of government. Not only is power within the federal government checked and balanced. Power is divided between the federal government and the state governments. So what if a state law conflicts with a federal law? The Constitution says that the "Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; ... any Thing in the ... Laws of any State to the Contrary notwithstanding." Sometimes the conflict between federal and state law is obvious and the Supremacy Clause is easily applied. But sometimes ...

Pharmaceutical Patent Bargains: The Brazilian Experience, Bruno Meyerhof Salama, Daniel Benoliel

Bruno Meyerhof Salama