Intellectual Property Johnson & Johnson believes that the protection of intellectual property (IP) is essential to rewarding innovation and promoting medical advances. We are committed: to raising awareness of innovation in human health care and the importance of IP protection in driving that innovation; to providing economic incentive and safeguard mechanisms to foster healthcare solutions; and to promoting local economic growth. As part of our commitment to compassionate health care, Johnson & Johnson believes in helping the world s poorest countries face local public health crises. We are committed to extending lifesaving medical technologies and addressing unmet medical needs in developing countries around the world. We believe that the best way to address these needs is for companies to work with local governments to develop approaches that benefit all involved parties, while continuing to uphold the value of IP in all parts of the world. Johnson & Johnson recognizes the importance of international efforts that seek to improve and harmonize IP protection throughout the world. We continue to work with international organizations, national governments and regulators on topics involving international trade agreements, national laws and enforcement efforts to provide for the integrity of effective and strong IP protection systems globally. To ensure a sustainable system that balances the societal goals of both the innovator and the public, Johnson & Johnson works together with other key stakeholders on many IP topics, including those described in some detail below. These topics are relevant to all of our businesses, although in some instances they are particularly applicable to one portion of our business, such as Pharmaceuticals or Medical Devices. Patents Johnson & Johnson believes in the merits of a strong and effective patent system that supports, protects and stimulates innovation, economic growth, the transfer of technologies and the introduction of high-tech products. The effective patenting of our technologies, including our pharmaceuticals, provides Johnson & Johnson with an 1
incentive to invest in those technologies, and forms the foundation for maintaining a well-resourced and motivated workforce. The patent system in turn benefits society by requiring patent applicants to disclose their inventions to the world, and by motivating people and industry to compete to develop technologies, which generates sustained product improvement over time. Incremental Pharmaceutical Innovation Johnson & Johnson believes incremental pharmaceutical innovation plays an important role in improving the safety and effectiveness of pharmaceutical therapies. Incremental pharmaceutical innovation may include the discovery of new forms and uses of existing chemical compounds or substances that lead to the development of safer, more efficacious, and more useful treatments, better-suited to particular patient profiles or needs. For example, the development of a sustained-release dosage form of a known drug may result in an increase in patient adherence, which can deliver a profound patient benefit. Adequate incentives should be provided by patent systems to support and encourage the development of incremental pharmaceutical innovations, particularly when there is demonstrated improvement in the safety or effectiveness of the therapies. Johnson & Johnson does not endorse the practice of evergreening, which we view as distinct from incremental pharmaceutical innovation. Incremental Pharmaceutical Innovation Johnson & Johnson believes incremental pharmaceutical innovation plays an important role in improving the safety and effectiveness of pharmaceutical therapies. Incremental pharmaceutical innovation may include the discovery of new forms and uses of existing chemical compounds or substances that lead to the development of safer, more efficacious, and more useful treatments, better-suited to particular patient profiles or needs. For example, the development of a sustained-release dosage form of a known drug may result in an increase in patient adherence, which can deliver a profound patient benefit. Adequate incentives should be provided by patent systems to support and encourage the development of incremental pharmaceutical innovations, particularly when there is demonstrated improvement in the safety or effectiveness of the therapies. Johnson & Johnson does not endorse the practice of evergreening, which we view as distinct from incremental pharmaceutical innovation. 2
Patent Linkage Patent linkage refers to legislation that postpones marketing approval for any generic product covered by a patent until the expiration of all applicable data and/or patent exclusivities, or until a challenger establishes that the patent protection on the original product to be copied does not apply to the proposed generic version. Johnson & Johnson believes strong patent linkage acts as an effective safeguard measure. Linkage should be adopted by national authorities as an integral part of their patent systems. Data Exclusivity Data exclusivity is a type of IPright that is distinct from patent rights, one that is based on proprietary clinical test data. Data exclusivity is awarded in return for the originator/ owner of the clinical test data allowing later-filed generics the right to base their regulatory filings on that data. Johnson & Johnson believes that data exclusivity periods should be provided for all new drugs, including biologics, and the length of those periods should be commensurate with the generally high level of investment spent on developing these drugs. New drugs have the potential to fundamentally change the treatment of many diseases. National authorities should enact legislation authorizing abbreviated pathways for new drugs that appropriately balance the incentives to develop new medicines (which provide an opportunity for better health outcomes and overall cost savings) with the savings associated with entry of generic drugs and biosimilars into the marketplace. Enacting legislation that defines a base period of exclusivity plus a significant additional period of exclusivity for new indications or new formulations is one way to achieve this balance (in conjunction with other forms of protection such as patents and trade secrets). Compulsory Licensing A compulsory license is when a government allows someone else, usually a generic drug manufacturer, to produce a patented product or process without the consent of the patent owner. Johnson & Johnson supports the Doha Declaration and the flexibilities provided to national authorities under the Trade-Related Aspects of 3
Intellectual Property Rights (TRIPS) Agreement. At the same time, we believe that compulsory licenses to patent rights under the TRIPS Agreement should be used only in urgent circumstances, when all other alternatives have been exhausted. We oppose the regular use of compulsory licenses, for example, to support industrial policy objectives aimed at favoring domestic industries or simply as a cost-containment measure. Instead, Johnson & Johnson endeavors to offer other effective approaches that provide drug accessibility in developing and least developed markets, and provide local patients in those markets with high-quality product. Patent-Term Restoration, Adjustment and Extension Johnson & Johnson seeks to engage national patent authorities to explain the effectiveness of extending patent terms to compensate for patent protection lost because of delays in the regulatory approval process. We encourage the timely adoption of policies that fully compensate patent owners for the loss of such protection to ensure innovation in health care is adequately rewarded as an appropriate return for the investments made in research and development. Trademark Infringement Johnson & Johnson believes strong and effective trademark protection is in the interests of consumers, patients and governments as well as the innovative health care technologies industry. Remedies including administrative measures, civil actions or even criminal charges should be enacted and enforced effectively against trademark infringers who pose a serious risk to the health and safety of consumers worldwide. Voluntary Licensing Intellectual Property and Access and Affordability of Healthcare in Developing Countries Johnson & Johnson believes we have a responsibility to contribute to providing sustainable access to health care around the world, and that includes improving access to medicines in developing countries, particularly in least developed countries (LDCs). Our responsibility expresses itself in our tradition of philanthropy, the medical products we research and develop, the access and pricing programs we implement for those products, and the policy positions Johnson & Johnson supports in all parts of the world. 4
While IP may be one of many issues to be taken into account when considering access, importantly it plays no role in limiting access to the vast majority of essential medicines, which are not protected by IP. In certain circumstances, where patents describe an essential medicine, Johnson & Johnson has addressed the concerns of the LDCs by pledging not to enforce those patents, provided the generic versions of the drugs are quality products, medically acceptable and used in the defined territory. Under other circumstances, access-based voluntary licensing of IP covering Johnson & Johnson products and research tools has proven to be an effective method of striking a sustainable balance between public and commercial interests. Such licenses provide assurances to the licensee that the ancillary investments needed to make their licensed product available will enjoy a degree of protection against unlicensed users of the patented inventions. Johnson & Johnson believes public policy is best served when the licensing of IP is voluntary rather than compulsory, as inventors and developers of new medical technologies are better positioned to be fairly rewarded for their contributions, and incentivized to invest in the discovery, development and enhancement of needed new therapies. Last updated: May 2017 5