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What steps should the U.S. take to protect and strengthen IP rights domestically and overseas?

Contributors Respond

Mark Elliot

Mark Elliot

EVP

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Read Mark Elliot's bio

We all know that intellectual property (IP) rights are important. Patents, copyrights, trademarks, and trade secrets provide the backbone for innovative industries to engage in oftentimes resource-intensive research and development, which in turn spawns great technological innovations and medical breakthroughs. These very same industries also employ 40 million Americans with well-paying jobs and propel 60% of U.S. exports and $5 trillion in gross domestic products.

However, IP rights are rendered virtually useless unless they are properly protected and enforced. The United States has many opportunities to bolster IP rights, particularly in the enforcement sphere. This includes enhancing penalties for criminal counterfeiters who frequently peddle dangerous fakes, like bogus medications or mimicked fire extinguishers.

We also need to make sure that enforcement bodies, like U.S. Customs and Border Protection, the National IPR Coordination Center, Department of Homeland Security, and the Office of the U.S. Intellectual Property Enforcement Coordinator (just to name a few), have dedicated resources to tackle the growing epidemic of counterfeiting and piracy. With the increased sophistication of these illicit entrepreneurs and the mushrooming of online sales of fake goods, agencies are challenged in time and money to go after these bad actors and protect American business, public health and safety.

Public-private partnerships and dedicated enforcement are essential to developing practical solutions to tackle the profitable, burgeoning, and downright harmful business of online counterfeiting and piracy. The United States can also work on streamlining information-sharing between rights holders and enforcement agencies at the border as well as increase public awareness of the consequences of IP theft.

Though intellectual property is indicative of the U.S. economy, the benefits of IP know no borders. Both developed and developing nations have a strong interest in protecting IP and fostering innovative economies; and the United States must continue to lead by example. This means advocating for high-standard, meaningful, and enforceable IP chapters in trade agreements, like the Trans-Pacific Partnership (TPP) Agreement. Particularly, the TPP Agreement must secure commercially meaningful opportunities for all biotech and pharmaceutical companies to enter the TPP markets, as well as provides 12 years of regulatory data protection for biologic products that is already provided under U.S. law.

The United States should also initiate greater bilateral engagement with key, notorious markets overseas. American businesses cannot ignore emerging juggernauts like China and India, but face incredible challenges within the countries, whether it’s China’s rampant piracy and counterfeiting economy or India’s industrial policies, including patent revocations and compulsory licenses. The U.S. government must bilaterally apply pressure to ensure American IP and the resulting jobs and innovations relying on it aren’t undercut by lackluster foreign economic and enforcement practices.

It’s clear that the success of our innovation-dependent economy needs a lot more than just the expropriation of IP rights. Equal parts enforcement and protection that address emerging threats domestically and abroad are utterly necessary to maintain and further the integrity of IP rights system. The tremendous opportunities the United States can take to protect IP rights breeds tremendous opportunities for the innovations and jobs for the future.

Steven P. Caltrider

Steven P. Caltrider

VP, Deputy General Patent Counsel, Eli Lilly

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Clearly patents play an important role in developing more effective treatments and even cures for the more than 133 million Americans living with one or more chronic conditions.

But that doesn’t mean we shouldn’t critically evaluate the effectiveness of patents in driving innovative new therapies for unmet medical needs. The patient community, working under the umbrella of the National Health Council, has identified two significant challenges that must be addressed. 

First, and contrary to general knowledge, social utility is not a factor in securing a patent. You could develop a cure for a deadly disease like cancer or ALS but that doesn’t mean you would be awarded a patent. By some estimates, 80-90% of the most promising treatments don't qualify for a strong patent and consequently are never developed or commercialized. From a patient perspective, this makes no sense.

Second, a 20-year patent now runs concurrently with the clinical development of the medicine, not after the point of approval. The underlying assumption was that a burning platform – the looming end of patent protection – would make a pharmaceutical company innovate faster. This might work well in conditions that progress quickly, but most diseases progress over years and even decades. To show that a medicine alters the progression of a disease, you must study it over a long period of time, investing billions of dollars, yet ending up with little or no time to market the medicine without generic competition. Even our best scientists can’t engineer around that.  From a patient perspective, this makes no sense.

The patient advocacy community believes our country must take steps now to modernize our drug and diagnostics evaluation and regulatory network. We need to create a patent substitute for products with high social value that don’t meet the technical requirements for a patent or require a long research period to address a slowly progressing disease like Alzheimer’s.

It's time to begin a national discussion about how we promote the development of high-value products that will help people live longer and better lives. 

Jay Taylor

Jay Taylor

Vice President, International Affairs, PhRMA

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The US should take a strategic approach which considers both administrative pressure and enforcement measures to address instances of outlying IP policies which harm innovation and particularly innovative pharmaceutical companies.  For example, the IP policies of India and Canada share the common problems of discrimination against biopharmaceutical patents and erosion of patent protections. 

Both India and Canada are placing increased, unjustified burdens on U.S. biopharmaceutical innovators in a manner that unfairly prevents patent protection entitled to under international rules established under the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement.  In both India and Canada, they are moving the goal posts on core patentability requirements, and the result is that innovative pharmaceuticals are discriminated against vis-à-vis other inventions.  Neither country should get a free pass.  Our industry is concerned about India and Canada because without U.S. engagement other countries could look to these countries as models to erode their own patent protections accordingly.  In this way, concern for India and Canada go hand in hand and both must be addressed.  Canada, for example, routinely strikes down patents on pharmaceuticals that clearly meet the requirements for IP protection under TRIPS, and if we do not address Canada, contagion can occur -- countries will just look to the Canadian model rather than the India model.  Contagion risk calls for raising both countries as problems and calling for a robust U.S. Government enforcement response in both cases. 

Canada shows that unfortunately erosion of IP is not just a problem for developing countries.  By focusing its enforcement priorities on countries with outlying IP policies like Canada, the U.S. government can send a strong and consistent message to developed and developing countries alike.

Karen Kerrigan

Karen Kerrigan

President and CEO, SBE Council

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The United States’ approach to intellectual property (IP) will have a significant impact both in terms of our ability to compete economically with other nations and the biopharmaceutical sector’s capacity to continue developing new lifesaving medicines for  the world’s patients. Strong IP protection has received overwhelming bipartisan support in our Congress here at home and has catalyzed the development of numerous new treatments, permitting patients to lead longer, happier lives.  More than 5,000 medicines are now in the pipeline.  To foster this ecosystem, the United States must strengthen global IP norms by seeking high standards of protection, that reflect U.S. law, in our trade agreements and fully-enforce existing obligations.

Innovative biopharmaceutical companies rely heavily on IP rights to protect the major investments in time and capital required to shepherd a new medicine from discovery through development and FDA approval. It is a cornerstone of our industry, helping to pave the way for medical breakthroughs of the past and future, and protection of IP must be paramount if we are to find success in developing new treatments for the world’s most pressing health needs.

Some nations have become increasingly aggressive in denying basic IP rights to foreign competitors, going against internationally recognized norms (India and Canada are two examples of such behavior). Fortunately, two pending international trade agreements provide the United States an opportunity to significantly shape a path forward for other nations. The Trans-Pacific Partnership (TPP) and Transatlantic Trade and Investment Partnership (TTIP) would establish formal trade ties between the United States and two vital economic regions – Asia/Pacific and the European Union.

Aside from the economic benefits that will be derived from these agreements, the IP provisions they contain will likely serve as a starting point for future trade agreements with other regions or individual countries. As the largest economy in the world, the United States comes to the bargaining table with immense clout. The U.S. government needs to use that influence to ensure the IP rights of innovators – both home and abroad – are adequately protected in a way that allows for and encourages future discovery of life-saving medicines.