Intellectual Property Principles for Advancing Cures and Therapies (IP PACT)
Innovation and Patients at the Heart of 10 Key IP Principles Unifying the Biopharmaceutical Industry
The IP PACT (IP Principles for Advancing Cures and Therapies) is a groundbreaking, unified declaration of 10 key intellectual property (IP) principles by members of the innovative biopharmaceutical industry to affirm our strong commitment to innovation and to keeping the needs of patients at the heart of our IP practice. This is particularly crucial today, at a time when IP is proving to be a fundamental enabler to breakthrough medical innovation and significant scientific advances. While the IP PACT is a set of voluntary commitments, it sets out a framework for greater trust and collaboration and guides the signatories’ approach to IP.
Pfizer’s Commitment to Patients Reflected in New IP PACT
Pfizer’s purpose – Breakthroughs that change patients’ lives – fuels everything we do and reflects both our passion for science and our commitment to patients. It’s important to us that patients and society understand the way we use IP and why it matters for our efforts to take on the toughest healthcare and medical challenges around the world and provide life-changing therapies to patients. These principles reflect our long-standing commitment to keeping patient and societal benefit at the center of our IP practice; check out Pfizer’s Intellectual Property Policy Position to see how we are living up to that commitment.
Learn more about why we joined from our Chief Medical Officer and Head of Worldwide Medical and Safety, Dr. Aida Habtezion
Intellectual Property 101
What is intellectual property (IP)?
Intellectual property (IP) refers to a variety of different creations of the mind. Within a legal framework, IP rights allow the owner of the IP to benefit from their creation by giving them control over how their property is used.
What are the different types of IP?
- Patents for inventions: new and improved products and processes that are capable of industrial application;
- Trademarks for brand identity: of goods and services allowing distinctions to be made between traders;
- Designs for product appearance: of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colors, shape, texture or materials of the product itself or its ornamentation;
- Copyright for material: literary and artistic material, music, films, sound recordings and broadcasts, including software and multimedia.
- Trade Secrets for confidential information that provides a competitive advantage: most commonly technical or business information; for example: manufacturing processes, pharmaceutical test data, distribution methods.
Why do government’s protect IP and who benefits?
Governments establish and enforce intellectual property protection primarily to stimulate innovation in knowledge-intensive fields and encourage the production of useful goods and services arising from knowledge-based inventions. The establishment and protection of IP rights reflects a balance intended to advance the interests of inventors and society.
Through IP rights, governments enable the right-holder to exercise ownership rights over his/her invention for a limited period of time, and in return the IP benefits society by stimulating the development and commercialization of goods and services, promoting economic growth and job creation, and expands society’s supply of technical and scientific knowledge.
Why is IP protection, particularly patents, important to the pharmaceutical industry?
The incentives provided by IP support the development of new knowledge that results in useful innovation that benefits society. Because knowledge-based inventions differ from tangible forms of property, they need specific legal protection. This is especially true for those inventions, such as biopharmaceutical products, where there is a significant difference between the very high cost of developing the original product for sale and the relatively low marginal cost of manufacturing a product once known. The value of a new drug resides in the intellectual content that it embodies, not just the material of which it is made.
Because they are often easily and inexpensively copied, knowledge-based products require special protection to enable their creators to earn a return on their investment. In addition, the limited duration of patents encourages the rapid development of inventions into commercial products thereby enabling consumers to enjoy the benefits of these products sooner rather than later.
How does IP enable Pfizer to bring breakthroughs that change patients’ lives?
Safeguarding innovations through strong protection and enforcement of patents, regulatory test data and other intellectual property provide powerful incentives that drive and sustain investments in valuable treatments and cures for patients. Where inventions can be protected and patents enforced, biopharmaceutical innovators have the predictability and certainty that’s needed to invest in research, collaborate with partners, compete successfully and accelerate the launch of new medicines.
For example, the incentives provided by the IP system enabled Pfizer to build an infrastructure that allowed us to quickly mobilize and devote the resources, technical knowledge and know-how that is required to combat the COVID-19 pandemic. Maintaining that system is what will fuel the next generation of solutions and allow us to tackle any future crisis.
What is the WTO TRIPS Agreement?
In 1994, the World Trade Organization’s (WTO) Agreement on Trade-Related Aspect of Intellectual Property Rights (TRIPS) set down minimum standards for many forms of IP rights. To date, all members of the WTO have been required to adopt TRIPS-compliant IP laws, with the exception of least developed countries (LDCs) which have a time-limited extension.
By establishing minimum levels of protection that each government has to give to the intellectual property of fellow WTO members, the TRIPS Agreement strikes a balance between the long-term benefits and possible short-term costs to society. Society benefits in the long term when patent protection, for example, encourages creation and invention, especially when the period of protection expires and the invention enters the public domain for all to freely use. Governments are allowed to reduce any short-term costs through various exceptions, including the authorized use of the patent by a third party without consent of the right holder in limited circumstances (commonly referred to as a ‘compulsory license’). When there are trade disputes over intellectual property rights, the WTO’s dispute settlement system is available.
What is the 2001 Doha Declaration on TRIPS and Public Health?
In the Doha Declaration, WTO member governments reaffirmed the importance of IP protection in creating incentives for the discovery and development of new medicines, particularly for infectious diseases. The Declaration also supports WHO Members’ right to protect public health and notes certain exceptions to patent rights, or “flexibilities,” that countries can use in cases of national emergency to gain access to medicines.
Does IP, particularly patents, restrict access to medicines in the developing world?
Patent protection stimulates research and development for new and improved medicines for diseases, including those which are prevalent in the developing world. Without intellectual property protection, the medicines that are needed in the developing world are less likely to be developed.
The vast majority of medicines prescribed around the world today are off-patent generic or biosimilar treatments. In fact, most of the products on the World Health Organization’s Essential Medicines List are off-patent; however, many patients are still unable to access these medicines. There are many factors that influence access, including poverty, lack of health education, limited healthcare infrastructure, regulatory delays, shortage of trained healthcare workers, distance to hospitals, high taxes, fees, markups, etc.—and the biopharmaceutical industry regularly partners with governments and third parties to address these factors.
Does IP protection promote or hinder innovation and technology transfer?
Protecting intellectual property promotes innovation and encourages technology transfer. Strong IP systems foster an innovative culture, where innovators can develop new products and technologies knowing that their inventions and creativity are secure—and they can securely share such knowledge and inventions with partners and collaborators. Strong IP protection afforded by effective patent systems, in particular, provides incentives for increases in technology transfer, foreign direct investment, and local research and development (R&D) capacity. Additionally, the disclosure of the information and knowledge necessary to practice an invention allows the innovative community to learn and build upon prior advances.
What is regulatory data protection (RDP) and why is it important?
Regulatory data protection prevents the reliance, by a competitor (usually a generic company), on the data submitted by an innovator company to a regulatory authority, to provide evidence that a medicinal product meets the national standards of quality, safety and efficacy. RDP lasts for a limited period at the end of which the data may then be relied upon to support the authorization of similar products.
The incentives provided by the patent system and regulatory data protection are independent yet complementary. Both serve to incentivize continued innovation and though complementary they are distinctly different, independent and may run in parallel. A patent is a set of exclusive rights granted to an inventor for a limited period-of-time in exchange for detailed public disclosure of an invention, while RDP is an exclusive right of non-reliance on test and trial data, granted upon approval of a new drug.