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intellectual property

Reviewing USTR’s 2014 Special 301 Report

Yesterday, the Office of the U.S. Trade Representative (USTR) released its annual Special 301 Report, citing 37 countries for inadequate and ineffective protection of intellectual property. The listing included:


Priority Watch List: Algeria; Argentina; Chile; China; India; Indonesia; Pakistan; Russia; Thailand; and Venezuela; and

Watch List: Barbados; Belarus; Bolivia; Brazil; Bulgaria; Canada; Colombia; Costa Rica; Dominican Republic; Ecuador; Egypt; Finland; Greece; Guatemala; Jamaica; Kuwait; Lebanon; Mexico; Paraguay; Peru; Romania; Tajikistan; Trinidad and Tobago; Turkey; Turkmenistan; Uzbekistan; and Vietnam.


The 2014 report highlights continuing threats global U.S. intellectual property rights holders’ face in countries throughout the world. And because IP and innovative industries are so vitally important to the U.S. economy — for example, a Department of Commerce study estimates that in 2010, copyright-intensive industries accounted for $641 billion in value-added to GDP and 5.1 billion jobs — it is necessary to make sure the IP enforcement remains a priority for foreign policymakers.

USTR made minimal changes to the country designations from the 2013 Special 301. In fact, the ten countries listed on the Priority Watch List (PWL) remain completely unchanged. The only changes to

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The Economic Benefits of Life Science Innovation


The Economic Benefits of Life Science Innovation

We often hear from advocates of weak intellectual property regimes for medicines that they are needed to increase access. Weakening incentives to innovate, however, will have serious repercussions on our future health and economic outcomes. A recent study on Sweden provides a unique opportunity to see what the world would look like if pharmaceutical and biotech innovation had suddenly stopped for 13 years, which is what is likely if IP protections were taken away.

The recent study by Lichtenburg and Pettersson attempted to measure the impact of new drugs on life expectancy in Sweden. Aggregate level data was collected on drugs released since 1997 and changes in mortality rates for various diseases. Using differences-in-differences methodology, the authors calculate an estimate of what health results in the country would look like if doctors and hospitals were constrained to only using medicines and technology created before 1997.

Between 1997 and 2010, the average age of death in Sweden rose by 1.88 years. The authors estimate that pharmaceutical innovation is responsible for 5.6 months of this increase. Moreover, the study estimates that if no new

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We Are Never Ever Getting Back Together

A few days ago, Marvin Ammori published a piece on Slate titled, “Hollywood’s Copyright Lobbyists Are Like Exes Who Won’t Give Up”, in reference to  the House Judiciary Subcommittee on Courts, Intellectual Property and the Internet holding a hearing regarding the Digital Millennium Copyright Act (DMCA) notice and takedown system. In it, he alleges that the hearing’s existence, created to discuss the potential of voluntary initiatives among copyright stakeholders, is proof of a conspiratorial secret resurgence of the Stop Online Piracy Act (SOPA).

Ignoring the ludicrous nature of this claim — does every hearing that every committee holds in the entirety of the U.S. Congress have some secret ulterior purpose now? — his argument is demonstrably false.  Let’s start with the facts: the DMCA notice and takedown system is the process by which content creators notify service providers that they are illegally distributing content.  In exchange for working collaboratively with rights holders, service providers receive a “safe harbor” from prosecution. The House Judiciary subcommittee hearing tomorrow is an opportunity to discuss voluntary initiatives among stakeholders to curb piracy, not a chance to propose new legislation (and in case anyone

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Balancing Innovation: Managing Current Needs with Future Success in Developing Countries

No one disputes the benefits of innovative technology. It has resulted in IT, medical, and energy advancements that have revolutionized the way we live our lives. What often goes unappreciated, however, is the time and resources invested that ultimately yields this progress. As I discussed on Friday as part of a panel at the Global Intellectual Property Center’s IP Summit, failing to acknowledge and respect intellectual property puts future innovation in jeopardy, and it is critically important that we educate developing countries on the benefits of protecting IP before it has lasting effects on not just the global innovation economy, but their own individual innovation economies

At a time when developing countries are not only trying to recover from the Great Recession, but also working toward building more prosperous economies, access to innovation is increasingly important. Unfortunately, all too often developing countries believe that to achieve their economic and social goals, they must focus on getting access to technologies (including pharmaceutical products, sometimes through issuing compulsory licenses) in the near-term, instead of setting up an environment of strong IP protection where innovation can flourish over the long-term. These actions are

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A Nurse with a clipboard

The Healthcare Battle You Don’t Know About

While the very public battle over healthcare policy rages in Washington, teams of international negotiators in countries around the world are deciding a critical but much less well-known issue. The United States is leading an effort to build a free trade pact around the Pacific Rim, including Japan, Canada, Chile, and Australia, that represents over 40 percent of global trade. Wrapped up in these negotiations for the Trans-Pacific Partnership (TPP) is the issue of whether these countries will be able to free-ride on American innovation. We have a vested interest in ensuring they cannot.

The healthcare industry is a prime example of how failing to protect intellectual property in the TPP not only affects the U.S. economy, but would also have a lasting impact on patient health. The U.S. healthcare sector is the most innovative in the world, working every day to achieve breakthroughs to improve our quality of life. Some of the most cutting-edge technology is in biologic medicines – using biotechnology to improve human health. The advances we’ve made in this field led MIT researchers to believe it could usher in a revolution across scientific and engineering technology.

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Prescription Drug

Is it Useful? A Drug Patent Enigma

Obtaining a drug patent isn’t easy:  it requires, on average, 14.6 years and $1.2 billion in pre-approval research and development and clinical testing. In addition, it also requires the developer to meet a set of three internationally accepted conditions. According to the World Trade Organization’s (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, in order to obtain a patent, a drug must:

  1. Be new,
  2. Involve an inventive step, and
  3. Be capable of industrial application.

TRIPS also clarifies that “involving an inventive step” and “being capable of industrial application” are synonymous with “non-obvious” and “useful”, respectively. For being a WTO legal document, it’s actually surprisingly clear: be new, be non-obvious and be useful.

Typically, the patent is issued prior to a drug’s clinical testing, primarily because if a commercially viable drug is developed from the clinical testing, it is vulnerable to theft and copying. In other words, patents are filed upon discovery of a chemical formula, as part of the United States Patent and Trademark Office’s “first to file” rule. Without the patent, innovative pharmaceutical companies would not have an incentive to research and develop this formula into

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Intellectual Property Rights Key to Negotiating a Successful TPP Agreement

Negotiations toward completing the Trans-Pacific Partnership (TPP) continue this week in Malaysia. While this potential trade agreement would tie the United States more closely to several key Asian markets, a number of important details still need to be negotiated among the nations at the bargaining table. Perhaps the most important of these issues is the intellectual property protections that will be included in the final agreement.

As this marks the first round of negotiations since new United States Trade Representative Michael Froman was confirmed by the Senate, the United States needs to seize the opportunity to make an aggressive push for the inclusion of strong intellectual property rights in the TPP. While some developing nations condone or enact lax enforcement of intellectual property rights as a means of accelerating growth, in the long run strong intellectual property rights benefit all economies. The promise of economic reward that comes with intellectual property rights incentivizes innovation, enhances the development of domestic industries, and can ultimately help transform nations from developing to developed.

Given the size and scope of the nations in the agreement, the TPP will likely serve as the standard against

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Senate Finance Committee’s Hearing on TPP Needs to Address Intellectual Property Protection

With America’s economy continuing to plod along in a sluggish recovery, policymakers are searching for ways to spur U.S. economic growth. With the U.S. running massive trade deficits, we’ve realized in recent years that in order to grow America needs to increase its exports (hence the Obama Administration’s National Export Initiative, which seeks to double U.S. exports from 2010 levels by 2015), in part by encouraging the opening of markets throughout the world to freer trade. Having real access to foreign markets is crucial—it may mean the difference between a decade of stagnation or robust growth. Right now we are poised to make this essential leap forward with the Trans-Pacific Partnership (TPP), a 12-nation trade agreement that includes Australia, Canada, Japan, and Mexico as some of the major players. If enacted, the agreement would tie nations together that comprise 40 percent of the world’s gross domestic product. But before policymakers approve the TPP, the United States needs to make sure certain critical provisions are addressed. Some of the most important issues involve intellectual property (IP) protection.

IP is fundamental to America’s economy. With 40 million workers, or 30 percent

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Capitol Records v. ReDigi and Selling “Used” Digital Goods

I recently wrote about the potential impact on differential pricing caused by the Supreme Court decision in Kirtsaeng v. John Wiley and Sons which found that the first sale doctrine applies to copyrighted works lawfully made abroad. I noted in that article that since most digital goods are licensed, not sold, differential pricing is still possible for digital goods, but that licensing has had side effects, such as limiting the ability of consumers to resell their digital goods in the used goods market.

Generally, consumers are allowed to legally buy and sell used goods. For example, if you buy a music CD, you can listen to it as many times as you want and then, if you don’t plan to listen to it again and you haven’t made any copies, legally sell the CD. But the same isn’t true of digital goods that the consumer does not own but instead has only received a licensed to use.

For example, Amazon’s MP3 store license agreement includes the following restrictions:

“You must comply with all applicable copyright and other laws in your use of the Music Content. Except as set forth in

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