PATENTS IN THE PHARMACEUTICAL INDUSTRY
Patents promote development and innovation by offering the possibility of monetary benefits for an inventor and at the same time by facilitating the spread of new knowledge. Once a patent is obtained, the inventor acquires an exclusive territorial right on the patented invention which is a product or a process that provides a new way of doing something, or offers a new technical solution to a problem.
For an invention to be patentable, it must satisfy three requirements. Firstly, it must be novel. This means that it has to be different from previous inventions disclosed to the public. The difference may be insignificant; all that is important, is that there is a difference to what was previously known. Secondly, an invention must include an inventive step. If the invention is obvious to a person skilled in a particular field, it would not qualify for patent protection. Lastly, the invention must be susceptible of use for an industrial purpose beyond a mere theoretical idea.
In furtherance of what was previously explained, many inventions are improvements of existing inventions which may still be protected by someone’s patent. In such cases, the owner of the improved invention may exclude the original inventor from using their improvement and similarly the original inventor may exclude the owner of the improved patent from exploiting any form of the original patent. Due to this, the law caters for the possibility that patents may be licensed or acquired. License agreements are carefully drafted to ensure proper compensation for the efforts and costs invested in developing the patented invention.
One of the industries where patents play an integral role is the pharmaceutical industry, since it heavily relies on patent protection to support its endeavours in medical research. Manufacturing a drug can be imitated by competitors and thus, patents provide effective ways to protect the inventions of a particular company from competitors’ imitations. Indeed, patents protect an invention as it cannot be used, made or distributed without the inventor/patentee’s consent. They are the exclusive property rights of the patentee for a period of twenty years. In addition to a strong protection system, patents generate a return on investment. Developing and launching a new drug on the market is lengthy and costly; hence patents help recouping the costs incurred during research and development process and the marketing of the drug. Pharmaceutical companies try to extend the patent term for commercially successful drugs by obtaining patents for new formulations of the known compound for instance a reduced dosage. Moreover, obtaining patents for new methods of use for known compounds may help companies to increase the commercial life of the drug and increase their revenue.
Despite what has been said, there may be exceptions to the exclusive right of the patentee such as when the use of the patented invention may be authorised to a third party by a competent authority. In fact, this may be the case as the world struggles in its fight against the Covid-19 pandemic. From the initial outbreak, the race was on to produce the right medicines and devices including the development of a vaccine to stop people from falling ill in the first place, testing kits and drugs to treat those who fell ill with this new coronavirus. Generally, pharmaceutical companies would not collaborate in these endeavours for reasons already stated and there have been calls for these companies to waive their proprietary rights to facilitate the dissemination of the drugs and the devises which are useful in the fight against Covid-19. One drug-making company has indeed declared that it will not enforce its rights anywhere in the world over one particular drug which is being studied as a coronavirus treatment. Nonetheless, there have been other companies and institutes which filed for patent rights over experimental drugs used to treat Covid-19 patients. If companies fail to waive their legal and exclusive rights, one expects to see a spike in the use of compulsory licenses. The law provides for such mechanism to balance these rights with that of public interest. Several countries including Israel, Germany, Chile, Ecuador and Canada have already indicated that they may issue compulsory licences to facilitate access to Covid-19 treatment. Furthermore, patent pooling, which has been recently endorsed by WHO, is another mechanism to facilitate accessibility to patented inventions. Others have suggested that the EU should establish a publicly-owned patent pool to ensure that patents do not obstruct the fight against this virus.
To sum up, adequate patent protection provides the pharmaceutical industry a platform for economic growth and a way to recuperate the high costs incurred in research and development whilst ensuring breakthrough innovations and the development of new drugs. However, this may not always be the case since patent rights may be halted in the face of health emergencies. Balancing the rights of the inventors and the rights of the society at large to enable wider access to some patented drugs and medical supplies is, as WIPO director-general Francis Gurry said, “a hot issue and a very sensitive issue but extraordinary situations call for extraordinary measures”.
This article was written by Dr. Marija Caruana.
The information provided does not constitute legal advice.
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