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intellectual property

Manufacturers in America Need a Modernized WTO

By | General, intellectual property, Shopfloor Policy, Trade | No Comments

Manufacturers and their workers across America depend on global commerce to grow U.S. production, provide innovative and high-value products to consumers at home and abroad and create well-paying jobs at home. Consider that nearly half of U.S. manufacturing production is exported and about six million manufacturing workers depend on U.S. manufactured goods exports for their jobs.

With international trade so important to health and growth of the U.S. manufacturing sector, it is no surprise that manufacturers have long relied on and been at the forefront of promoting a strong, respected and fair rules-based global trading system. Under the current system, embodied by the Geneva-based World Trade Organization, manufacturers in the United States have benefited broadly from the substantial reduction in tariffs and many other trade barriers in markets big and small around the world, as well as through the adoption and enforcement of stronger and fairer standards than existed before WTO was established in 1995.

Yet, the rules-based system is now at a crossroads. It has failed to deliver broad-based trade liberalization in more than 25 years, except in a few sectors, leaving substantial tariffs and other barriers in place. It has failed to update rules in important areas that are critical to a fair and fully-functioning global trading system, including on digital trade, state-led competition and other issues. Too often, countries ignore WTO requirements small and big and the dispute settlement system is overloaded and subject to serious levels of concern in the United States and elsewhere.

Manufacturers in the United States need a fully-functioning, trade-liberalizing WTO that is respected by all of its 164 members. That is why, this week, National Association of Manufacturers President and CEO Jay Timmons and I are in Geneva to meet with senior WTO officials. During our meetings, we will focus on the need for WTO reform and modernization across a number of critical areas, including negotiations, dispute settlement and full implementation of existing WTO commitments. 

It is also critical that the WTO serve as the central voice on trade policy issues and that it proactively engages with other organizations like the World Health Organization to prevent trade-harmful policy recommendations. The NAM formed the Engaging America’s Global Leadership (EAGL) Coalition to address just such issues.

There can be no question that the WTO system is in need of reform. Manufacturers are committed to being allies in that reform process. The NAM looks forward to working with stakeholders around the world on a constructive WTO modernization agenda to strengthen the WTO as an effective rules-based system that is respected by its members, provides appropriate and strong enforcement of its rules and moves forward trade liberalization broadly.

Innovation Should Not Be A Scapegoat for Rising Health Care Costs

By | Around the States, Health Care, Innovation, intellectual property, Shopfloor Main, Shopfloor Policy | No Comments

Cutting-edge advancements in pharmaceutical medicine improves lives and reshapes the health care industry as we know it every day. Innovation fuels progress, and America’s biopharmaceutical manufacturers are leading the way toward developing solutions to the greatest health care challenges, as they always have. The results are clear: more new medicines are created in the United States than every other country in the world combined. Unfortunately, some states have pursued and continue to pursue legislation to address rising health care costs that would stifle innovation—neither improving care for patients nor reducing health care costs in the process.

Minnesota House File 1246 would threaten intellectual property rights by requiring manufacturers to disclose highly-sensitive proprietary information, creating unnecessarily burdensome requirements that are contrary to the free and competitive market that has allowed biopharmaceuticals to develop new life-saving treatments. Our country far outpaces others in the discovery of new cures because of our emphasis on innovation that is carried out through robust research and development and protected by vigorous intellectual property rights. Degrading those rights degrades the progress they make possible.

The legislation being considered in Minnesota will not lower prescription drug costs nor address the rising cost of health care. Manufacturers support solutions to address rising health care costs, but as the manufacturing sector accounts for more than three-quarters of all private sector R&D in the United States and receives more patents than any other industry, proposed solutions must not come at the cost of crippling the biopharmaceutical sector’s innovation.

Price Controls Harm Innovation and Interfere with Competitive Markets

By | Innovation, intellectual property, Shopfloor Policy | No Comments

Some members of the Oregon legislature continue to propose unwieldy requirements and burdensome rebates on manufacturers of pharmaceuticals in an effort to cap drug prices. These efforts will not “control” the price of drugs for consumers but will instead create scenarios that will likely limit choice, restrict supply and increase costs. Moreover, price controls discourage innovation and act as a disincentive for robust research and development (R&D) efforts.

While rising health care costs are a significant concern for Americans, there are very few examples in history where price controls have worked for a full segment of the population. Artificially setting prices does not take into account all of the costs and factors that go into creating a new product, such as numerous failed clinical trials or drugs whose revenue fail to cover development costs. Price controls distort incentives in the market and result in product shortages, which could ultimately increase future health care costs.

Lawmakers must consider carefully the negative impacts of imposing price controls and diminishing any intellectual property protections. Attempts to jeopardize all of the investment and years of work associated with the creation of new medicines and products will discourage R&D and innovation—all at the expense of manufacturers’ competitiveness and the future well-being of patients. As the legislative session winds down in Salem, we urge elected officials to be mindful of these adverse impacts.

Protect Innovation and the Advancement of New Medicines

By | Innovation, intellectual property, Shopfloor Policy | No Comments

Today, the House Energy and Commerce (E&C) Committee will mark up the FDA Reauthorization Act (FDARA) of 2017 (H.R. 2430). To ensure this critical legislation passes Congress far ahead of a September 30 deadline, manufacturers urge swift action by the committee to keep H.R. 2430 on schedule. Any delay of the FDARA risks future gains in medical discovery and harm to our global standing.

In a March letter to E&C Health Subcommittee members, the National Association of Manufacturers (NAM) expressed strong support for a timely reauthorization of the Prescription Drug User Fee Act of 2017.

The FDA’s user fee program is the ultimate publicprivate partnership. If approved, this agreement will help the federal government and pharmaceutical and medical device manufacturers continue to drive innovation and usher in competition to bring new and groundbreaking therapies to patients.

Manufacturers urge members of the E&C Committee to support FDARA and avoid any needless risk to public health by opposing drug importation amendments.  Any amendment that eases restrictions on the importation of medicines is a distraction. The NAM opposed a similar importation effort in the Senate earlier this year in a key vote letter because it could expose consumers to counterfeit and adulterated therapies. The focus must be on the advancement of new medicines and treatments as well as unambiguous support for scientific innovation by ensuring the FDARA moves forward unimpeded.

European Court of Justice Sets Aside Judgment Requiring Disclosure of Confidential Business Information

By | intellectual property, Manufacturers’ Center for Legal Action, Shopfloor Legal | No Comments

On November 23, the European Court of Justice (ECJ) released its decision in European Commission v. Stichting Greenpeace, setting aside a lower court judgment requiring disclosure of confidential business information (CBI). While the ECJ’s decision is certainly good news for manufacturers, it is not yet a clear victory.

The plaintiffs requested the public disclosure of a massive amount of CBI relating to certain pesticides used both in the United States and Europe, including how products were manufactured and their final composition in order to assess potential environmental emissions. The lower court broadly interpreted EU emissions disclosure rules in favor of the plaintiffs, which left two options for companies selling goods in the European Union. Either they accept that their trade secrets will be made public, meaning that their data can be used and abused anywhere in the world by competitors, or they decide not to market their products in the European Union altogether, with obvious adverse consequences for the companies and the European Union as a whole.

In 2015, the ECJ granted the National Association of Manufacturers (NAM) intervener status, and in so doing, the court recognized the interest of the U.S. industry in this case. The NAM argued that the lower court’s interpretation was excessively broad and that the lack of adequate protection for the confidentiality of proprietary data in the European Union would be a significant barrier to market access for U.S. manufacturers of many products. The NAM is a strong supporter of global trade and investment rules that promote trade on a level playing field and provide a system in which all countries abide by core principles, including the protection of intellectual property. Governmental protection of CBI is needed to justify the considerable time, cost and effort involved in developing and marketing new technology as well as updating and improving older technologies.

The ECJ agreed with the NAM that the lower court erred by broadly interpreting EU disclosure for the emissions rule. The ECJ set aside the judgment and provided a more limited interpretation of EU disclosure rules. However, the ECJ did not assess whether the CBI in this case falls under that limited interpretation, and it sent the case back to the lower court to decide. Once the lower court decides whether the CBI at issue must be still disclosed under the limited interpretation, this case will potentially be appealed again. In the meantime unfortunately, the exact scope of the rule remains unclear. We prevailed on the larger attack against disclosing the CBI, but the fight will continue on this issue and in future cases concerning whether specific fact patterns fall within the emissions rule.

Discouraging Innovation at State or Federal Levels Is Not the Answer

By | Innovation, intellectual property, Shopfloor Policy | No Comments

For manufacturers and all innovators in the United States, the protection of intellectual property (IP), including trade secrets, helps drive not only success but also a continuous cycle of innovation. As such, the United States has historically upheld a very strong record of protecting IP through both federal and state laws. After all, if the government can’t ensure sufficient protections, all incentive is lost in spending billions of dollars on research and development (R&D) only to have the resulting product stolen or devalued. Read More

Lose–Lose Proposal from UNHLP Panel Represents a Missed Opportunity and Poses a Real Threat

By | Health Care, Innovation, intellectual property, Shopfloor Policy, Trade | No Comments

A highly flawed report that employs the mantle of global health to take aim at innovation and manufacturing was released today by a U.N. panel, representing a real missed opportunity to focus the world on collaborative and effective solutions that could make a substantial difference for real people facing access barriers.  Read More

California’s Manufacturers Deserve Strong IP Protections

By | Innovation, intellectual property, Shopfloor Policy | No Comments

From cutting-edge advances in information technology, energy-efficiency and lifesaving medical devices and medicines, California’s manufacturers are global leaders in innovation.

At the forefront of innovation is research and development (R&D). The manufacturing industry in California spent $81.7 billion on R&D in 2012—ranking it first nationally. From years of R&D stems manufacturers’ trade secrets and proprietary intellectual property (IP), which is the lifeblood of the industry and the key to creating new consumer goods and generating more effective and efficient technologies. Therefore, there is nothing more critical to California’s manufacturers than the guarantee that their IP will be protected.

Unfortunately, recently introduced legislation would require manufacturers in the pharmaceutical, biopharmaceutical and biotech-related industries to disclose proprietary operational information and data. The bill’s sponsors likely had the best intentions in mind, as it is important that we work to reduce our nation’s health care costs and access. However, this legislation would have the opposite effect. Mandating manufacturers of medical devices and medicines to turn over sensitive data, such as the cost of R&D, would have no impact on controlling costs, but would severely hamper their ability to compete.

The legislation singles out one industry, but devalues the work of all innovators and would send a chilling effect across the manufacturing industry. R&D is risky and expensive, but the rewards are tremendous and should not be desensitized. In California alone, total output from manufacturing was $255.53 billion in 2014, employing 1,271,000 Californians. Manufacturers are the lead drivers of innovation, creating economic growth and jobs. Legislators in California must understand how critical strong IP protections are to protecting the industry and the state’s economy.

Minnesota “Transparency” Legislation Threatens Manufacturers’ Competitiveness

By | Innovation, intellectual property, Shopfloor Policy | No Comments

Protection of trade secrets and other forms of intellectual property are a fundamental necessity for manufacturers to succeed in today’s intensely competitive global marketplace. No industry should be forced to turn over to the government highly sensitive, proprietary information that tears down longstanding intellectual property protections and weakens their ability to innovate and grow their businesses.

Yet, there are proposals currently in the Minnesota state legislature that would require manufacturers in the pharmaceutical industry to disclose historically protected confidential information about their businesses, such as research and development costs, pricing strategies and production and marketing expenses. This information lies at the very heart of the operational strategy of any business in any industry and is a critical component for success, and the unintended consequences of transparency legislation would put Minnesota manufacturers at a serious disadvantage, undercutting their ability to innovate and compete. Read More

“Transparency” Proposals Would Stifle Innovation

By | Innovation, intellectual property, Shopfloor Policy | No Comments

Recent proposals that would require manufacturers in the pharmaceutical industry to disclose sensitive and proprietary business information, such as pricing on specific products, marketing costs, planned research investments, anticipated profits and manufacturing production costs, would set a dangerous precedent that will deliver chilling impacts to our global competitiveness and further dampen prospects for more robust economic growth.

President Obama introduced the idea in his 2017 budget proposal, and the issue is occasionally amplified in the Halls of Congress and on the campaign trail.

Such a move would certainly be sweeping and dramatic, directly impacting the innovators who are leading research and developmentpharmaceutical, bio-pharmaceutical, bio-tech and related industries. Even thought these proposalssome at the state and others at the federal leveltarget one sector, manufacturers across all sectors don’t like the idea of hampering innovation. Read More

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