patent opposition updated
Millions of people in the developing world do not have access to the medicines they need because they – or their government – cannot afford them.
There are many reasons why people lack access to essential medicines, but one of the major barriers is the high price of drugs.
One of the contributing factors to high drug prices is patents. New drugs, diagnostic tests and vaccines needed to treat, detect or prevent a whole range of diseases are patented.
Patents prevent the open competition that could drive prices down to lower, affordable levels.
Patents are by no means the only barrier to accessing life-saving medicines, but they can play a significant, or even determinant, role in that they grant the patent holder a monopoly on a drug for a number of years. The patent holder’s freedom to set prices has resulted in drugs being unaffordable for the majority of people living in developed countries.
The result is that, all too often, life-saving drugs are priced out of the reach of people in developing countries. Millions of people are, in effect, too poor to be treated.
What are patents?
Patents are awarded to pharmaceutical companies when they develop a new drug. The patent grants that company the right to exclusively make, use and sell that drug for 20 years. It stops other producers from making the drug and means the patent-holding company can charge high prices without other companies undercutting them. The most effective and sustainable way to reduce the price of a drug is competition, but patents block other producers from entering the market.
A functioning patent system should guarantee that the public at large benefits from any innovation, including medicines. Patents on medicines are supposed to encourage research and development (R&D) for new medicines. But research shows that in recent decades, while profits from patents have gone up, investment in R&D has actually gone down. (1)
While the vast majority of R&D that is happening is focused on diseases that commonly afflict people in developed countries, neglected diseases which primarily affect people in developing countries – such as sleeping sickness, Chagas disease or leishmaniasis – receive very little R&D attention. This is because a patent holder will never be able to make a profit by charging high prices on drugs to treat diseases for people in developing countries. Whether or not the patent system delivers the right R&D for diseases that afflict developed or developing countries, patent monopolies will always mean a higher price than necessary has to be paid for patented medicines.
Countries have deployed various strategies to strike a balance between private and public interests in their intellectual property systems, but they have had varying degrees of success. It is crucial that decisions are made carefully about what can and cannot be patented for medicines. Getting the balance just right is particularly important for governments of developing countries, as they work to protect public health while introducing patent laws required under trade agreements.
There is no single definition of the standard by which a patent is granted or not and different countries have taken different approaches, choosing definitions that best suit their needs. Which medicines receive a patent is ultimately determined by each country or region, its patent law, and international agreements on intellectual property and trade and other agreements that a country is bound by. Most importantly, a patent is generally granted only if it fulfils the country’s own definition and application of the standard for patentability: ‘novelty’, ‘inventiveness’ and ‘industrial application’.
However, a patent might not be valid even though it has been granted by a patent office. This might be because the patent office may have made a mistake in applying the national rules of patentability; the patent office may not have examined the patent application; the patent office may have made a judgement which turns out to be incorrect; a document may exist which was unknown to the patent office when it granted the patent; and so on.
Patent laws should provide mechanisms to challenge granted patents. It is important that a patent office’s decision to grant a patent is not seen as final. These decisions are frequently questioned in developed countries, and in the final analysis, it is often a court that settles the matter. Asking questions or bringing an action to challenge the grant of a patent is not necessarily a bad reflection on the patent office or its staff, but part of a system of necessary checks and balances intended to protect the public interest.
No patent office is perfect. Many patents issued by, for example, the European Patent Office or the United States Patent Office, have turned out to be invalid when tested by a court. No patent office is, or ever could be, in such a position of perfect knowledge that they grant only valid patents. The fact that patents in OECD countries, for example, get revoked now and again shows that there are checks and balances in place to catch cases where a patent should not have been granted. One of these checks is the ability to allow relevant interest groups to oppose a patent on set grounds, and for a court to ultimately determine whether the patent should be upheld.(2)
When there are no patents, and competition is possible, manufacturers can produce ‘generic’ versions of medicines, which are more affordable but equally effective. Generic copies of patented drugs can have a tremendous impact on people’s access to medicine. Generic competition has helped to reduce the price of some HIV drugs by 99 percent over the past decade. First-generation HIV medicines have decreased from US$10,000 per person per year in 2000 to just over $100 today. This dramatic drop in prices has played a major role in the scale-up of HIV/AIDS treatment to more than eight million people in developing countries.(3)
This is why overly-strong patent protection, where patent-holders charge high prices for the drugs they produce, is a major concern for civil society groups and international organisations attempting to reach the millions of people waiting for treatment.
About the Patent Opposition Database
This database is a tool which can be used to explore how to challenge unfair patents and their negative impact on access to medicines.
Patent systems were originally designed to promote new innovations to benefit the public; if they do not deliver on this, then the patents they grant should be contested.(4) In some countries, this is possible through a process of either filing an opposition to a patent application before it is granted (‘ pre grant opposition’), or after a patent has been granted ( ‘post grant opposition’).
Understanding a patent application and the various tactics used by pharmaceutical companies to build them requires technical expertise which can be difficult to find. Fortunately, past experience – some of which is included in this database – shows that this difficulty can be overcome in a number of cases, and a successful system of patent opposition promoted, by collaboration between different parties. Arguments can be replicated, documents can be shared and new alliances can be built between interested parties based all over the world.
Patents are by no means the only barrier to accessing lifesaving medicines, but they do play a significant role. Challenging invalid patents is therefore of crucial importance in order to prevent unwarranted patent monopolies and make treatment available to the people who need it.
Under international agreements, there are some mechanisms that can be used to override a patent monopoly when a public health need is at stake, such as compulsory licensing. The use of these licenses relies mostly on political will.
There are also mechanisms that can be used to ensure that drug patents are not granted frivolously, such as patent oppositions. This mechanism allows any person, non-governmental organisation (NGO), lawyer, health organisation, researcher or market competitor to oppose a patent application, whether it has already been granted or is still under analysis by a patent office.
Challenging a patent is therefore a key way to protect public health interests. It has already been used successfully by civil society groups in several countries. The increasing use of patent oppositions, where it is possible, can help to address problems within the patent system, including:
Patent systems were devised to foster innovation. Nonetheless, out of the huge number of patent applications, only a few refer to genuine inventions.(5) Studies have shown that most patent applications made by pharmaceutical companies are for minor variants of already known pharmaceutical substances. In some cases, these 'secondary innovations' do not provide any therapeutic benefits and have a low standard of ‘inventiveness’ and ‘non-obviousness’, criteria which must be fulfilled in order to warrant a patent.
Such 'low-quality' patents can be avoided if countries provide strict standards in their patent-granting process, but even then there is no guarantee that patent offices will enforce them.
Patent opposition procedures can apply pressure for more rigorous standards during the patent examination process, reinforcing the need to reject non-qualifying patents. They can also present new arguments which were not previously considered by the patent office, thus improving the patent quality.
Monopoly extension or ‘evergreening’
Pharmaceutical companies have a clear interest in extending their patent monopolies on profitable medicines for as long as possible. To fulfil this goal, many use the patent system to delay the entry of competitors into the market. But it is not as simple as extending just one patent. Medicines can have several patents, including one on a specific molecule, one on how the drug is manufactured, and another on the form it ends up in to allow someone to take it.
To extend a patent, a company can, for example, change the medicine from a powder to a pill, or add another existing compound to the original compound if it has found it works better with this addition. These minor variations allow pharmaceutical companies to then make secondary applications for additional 20 year patents to extend their monopoly on the drug. This is known as evergreening, and it’s a common practice in the pharmaceutical industry.
In keeping with the patent bargain, the subject matter of each patent must become available in the public domain, for public use, at the end of its 20 year patent term. Evergreening prevents this.
Patent oppositions can be useful in deterring 'evergreening' methods. In many cases, patent oppositions have been followed by patent rejections, with the final result of a pharmaceutical substance being brought into the public domain.
(1) Ben Hirschler, Big Pharma strips down broken R&D engine (11 May 2011) at http://www.reuters.com/article/2011/05/11/us-summit-rd-idUSTRE74A3JA20110511
(2) Médecins Sans Frontières. Drug patents under the spotlight: Sharing practical knowledge about pharmaceutical patents. 2003 May. Available from URL: http://www.msfaccess.org/content/drug-patents-under-spotlight-sharing-practical-knowledge-about-pharmaceutical-patents
(3) Medecins Sans Frontieres, Untangling the Web of Antiretroviral Price Reductions (14th Edition July 2011) at http://utw.msfaccess.org/
(4) Eric Williams, Remembering the Public's Interest in the Patent System - A Post-Grant Opposition Designed To Benefit the Public (7 November 2006) http://bciptf.org/wp-content/uploads/2011/07/27-EricWilliamsIPTF2006.pdf
(5) Carlos M. Correa, Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing (September 2011) . Available from URL: http://www.southcentre.org/index.php?option=com_content&view=article&id=1601%3Apharmaceutical-innovation-incremental-patenting-and-compulsory-licensing&catid=41%3Ainnovation-technology-and-patent-policy&lang=en
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