Category US Domestic Policies

“Let’s Spark a Global Dscussion on Copyright Exceptions for Education and Research!

[David Edwards] Today it’s World Intellectual Property Day – a good day to remind us that it’s time to reform copyright law. We need action to change copyright systems that are hindering free expression and failing to promote diverse and prosperous societies for the benefit of all. Copyright legislation has a major impact on daily teaching and learning activities at all levels of education – from early childhood to higher education.

At Forum Honoring Prue Adler, Experts Recount Last Quarter-Century Of Copyright Advocacy

On April 17, several generations of experts gathering at American University law school to remember, retell and relive highlights of 25 years of public interest advocacy around copyright and information access, and to look ahead – all with a focus on the unifying guidance of library advocate Prudence Adler, known to all as “Prue.”

Is the FDA Misleading Congress About the Safety of Imported Medicines?

The one issue that unifies our divided America is the high cost of prescription drugs... On of the solutions currently working its way through Congress would permit patients to obtain lower-cost medication from pharmacies in Canada and other countries, where drug prices are frequently as much as 80 percent lower than those at US pharmacies. Americans haven’t waited for Congress to act, however: Despite the fact that it’s federally prohibited under most circumstances, an estimated 19 million Americans have already imported medicines for personal use because of cost.

Industry Weighs In on DOJ’s Standards Essential Patent Policy Reversals

Beginning in November 2017, Makan Delrahim, head of the U.S. Department of Justice Antitrust Division, signaled that he would reverse many of the DOJ’s prior positions regarding technical standardization and, especially, patents covering technical standards (so-called Standards Essential Patents or SEPs) (the 2017 announcement is discussed in detail here). The latest step in this DOJ reversal of direction came in December 2018, when Mr. Delrahim announced that the DOJ would withdraw from a 2013 joint Policy Statement that the DOJ issued with the U.S. Patent and Trademark Office (PTO). The DOJ’s unexpected withdrawal from the Joint Policy Statement has prompted significant reactions within the industries affected by standardization, including statements of strong support for the DOJ’s new position by an inventors’ alliance and a coalition of large SEP holders, and statements urging the DOJ’s reconsideration by the American Antitrust Institute (AAI) [note: the author serves on the Advisory Board of the AAI] and a coalition of technology companies.

Legislative and Regulatory Takings of Intellectual Property: Early Stage Intervention Against a New Jurisprudential Virus

[Frederick Abbott] Abstract: During the past year various members of the United States Congress have introduced legislation intended to ameliorate the high cost of pharmaceuticals, as well as to stimulate innovation using alternative mechanisms to the traditional patent system model. Several of the legislative proposals would authorize third-party importation of prescription pharmaceutical products from one or more countries. One issue considered by drafters of these legislative proposals was whether to include amendment of the United States Patent Act to authorize importation of pharmaceutical products first put on the market under the authority of the patent owner outside the United States. In other words, whether to provide for international exhaustion of patent rights, at least as to pharmaceutical products.

ReCreate South Africa and Wikimedia ZA Panel on Copyright Amendment Bill

[ReCreate South Africa] The Copyright Amendment Bill has provoked a number of negative reactions in the wake of its passing before the National Assembly, with summits and symposiums by Copyright elitists claiming that the Bill will infringe on their copyrights. ReCreate in partnership with Wikimedia ZA feel that there is a need to remind the public of the true benefits and reasons we support the Copyright Amendment Bill.

OPEN SCIENCE ON THE MOVE IN SERBIA

[Milica Sevkusic] In July 2018, the Ministry of Education, Science and Technological Development (MESTD) of the Republic of Serbia adopted a national open science policy. As the MESTD is the main national funder of research in Serbia, this policy, titled the Open Science Platform, serves as the national open science policy. The MESTD policy mandates deposits of all publicly-funded research in open access (OA) repositories, and recommends OA to research data. It also states that research institutions should adopt institutional open science policies within six months of the launch of the policy, using the national policy as a framework - and thus ensuring implementation of the national policy at the institutional level.

Time to put a Stop to The Abuse of Orphan Drug Regulation: The Latest Scandal

[Ellen 't Hoen] Today, the Dutch Medical Journal (Nederlands Tijdschrift voor Geneeskunde) reported on the case of lutetium-octreotaat, a cancer drug developed by researchers in the Dutch Erasmus medical centre in Rotterdam. For the last 18 years, the hospital pharmacy made the medicine to treat their patients, keeping prices relatively low. But now the drug is being marketed by Swiss pharmaceutical giant Novartis, and its price has skyrocketed to Euro 23,000 an infusion from an original price of Euro 4,000 an infusion. This takes the price of a complete treatment of 4 infusions to nearly Euro 100,000, a price point at which health insurers no longer wish to reimburse its use.

Pharmaceutical Import Prices Rise More Rapidly After Countries Enact Data Exclusivity

This post will demonstrate that prices of pharmaceutical imports have grown more quickly after countries adopted data exclusivity in their laws. It is also intended to show that trade data can be a useful source of information for studies of drug pricing. The post is based on my presentation given at pre-Global Congress workshop on empirical research into the effect of TRIPS-Plus trade agreements on access to medicines.

The Trump Administration’s New Green Paper is Full of Give-Aways to Big Pharma

On December 6, the Trump Administration released a new Return on Investment Initiative Draft Green Paper full of give-aways to Big Pharma and other private companies that piggyback on U.S. funded research and reap monopoly rights to sell resulting innovations at bloated prices. These IP-maximalist proposals, including curtailing of government-use rights and march-in rights with respect to technology transfer of federally funded research, (if implemented) would inevitably lead to higher prices contrary to President Trump’s rhetoric about lowering drug prices.

New Database Documents the Power of TRIPS Flexibilities

[Ellen 't Hoen] Medicines Law & Policy has published an on-line database of instances of the use of TRIPS flexibilities in public health contexts, titled the TRIPS Flexibilities Database. The publication of the TRIPS Flexibilities Database merits sharing a bit of its history because it has been a work in progress for some time. The database includes cases of actual use of TRIPS flexibilities and instances in which countries planned or threatened to use them.