Posted: August 15th, 2022

Patent Law Conflicts

PATENT LAW CONFLICTS

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Patent Law Conflicts
Introduction
Patents protect works of innovations in the market which gives incentives to the owners to create new inventions. However, as the need for the protection of intellectual property rises, critical questions remain for the policymakers, the regulators, the patent owners, and users as well. One of the issues worthy of consideration is the type of protection that is appropriate . Since patents aim to protect intellectual creations which ensure further inventions into the future, questions remain on whether the protections achieve the purpose. In most cases, patent protections make it difficult to use the innovations until sufficient authorization has been obtained from the owner. This leaves issues on the real purpose of the patent law if it is not to protect the work and facilitate its use. The other issue that is yet to be tackled is how policymakers and regulators can maximize the value of the patents for the owners and users alike. By the rule of thumb, the value of a patent can be maximized if the ease of use is allowed. However, patent law dictates how intellectual creations can be used, transferred, and disseminated. This gives the inventors and owners of the patents monopoly over their work . As a result, if users cannot meet such specifications, they are limited to the extent they can use intellectual creations. This becomes even more worrying for critical sectors such as medicines and healthcare where the right of access to the patent is critical. Consequently, the view that patent law conflicts with the right of access to medicines and healthcare is founded on verifiable truths and experiences from the developing and developing world. The controversy surrounding the patent law signifies that the mere issuance of compulsory licenses cannot address the challenges in the use of the intellectual property related to patents. Instead, a severe reduction of the patent monopoly will help to address the controversies involved. This involves coming up with a consensus on the appropriate level of the monopoly granted to the patent owners, enough to grant them the incentive to innovate, while also promoting that the consuming public possesses sufficient access to the innovations.
Overview of the Law and the TRIPS Agreement
To appreciate more about how the patent law restricts access to medicines and healthcare, one needs to examine the provisions under the TRIPS agreement. When it was drafted in January 1995, the TRIPS agreement becomes the first international agreement setting out procedural and substantive standards for the protection of intellectual property rights . All the global members of the World Trade Organization (WTO) are required to abide by the provisions of the TRIPS agreement . One particular clause within the TRIPS agreement that has brought contention in the field of medicine is Article 27. The article extends patent protection to all technology fields . Consequently, medicine is an area of technology and cannot be excluded from patent protection. Patents have a life of 20 years from the date of filing. This means that medical and healthcare products remain as the properties of the owner for that period and this limits the use within the industry. Besides, Articles 28 and 33 of the TRIPS Act require that the WTO members grant members exclusive rights which include prohibiting third parties from using, making, importing, or selling the patented product without permission for 20 years . This means that the WTO members, bound by the TRIPS agreement cannot freely grant the right of use of patents to third parties. Coincidentally, the WTO members, who are mandated to implement the TRIPS agreement, are drawn from the developing and developed world. This means that even in the developed world, the patent law conflicts with the right of access to medicines and healthcare.
How Patent Law Hinders Access to Medicine and HealthCare
The implementation of the patent law under the TRIPS agreement brings a connection to the extent to which the member states can independently come up with policies that guarantee free access to medicine and healthcare products. According to the TRIPS agreement, members should enjoy a certain level of flexibility in patent protection while also safeguarding public interests . Article 7 and 8 of the Act recognizes that intellectual property rights should strike a balance between enhancement of the technological innovation and the dissemination or transfer of the technology. This is one of the proposals by the developing nations contained I Article 7 but applies to all countries. Nevertheless, in striking the balance, the countries must always abide by the provisions of the patent law and the agreements under the TRIPS Act . However, critics point out that WTO members cannot adequately determine the level of flexibility they can exercise in the enforcement of patent rights against the competing needs of the public . Even though WTO members have an obligation to fulfill the TRIPS requirements, exercising flexibility may bring conflicts no matter how much the countries may be doing in the interpretation of the Act. In fear of exhibiting inconsistencies and non-adherence to TRIPs obligations, the countries may opt to follow the requirements of the agreement as opposed to enjoying the flexibility suggested. If this is to prevail, then the countries follow the TRIPS agreement which sacrifices the flexibility required to guarantee access to healthcare and medicine products. In this regard, the success of the patent law in guaranteeing access to healthcare and medicine products depends on the interpretation and implementation of the TRIPs agreement which is lacking in most countries.
Additionally, the restriction of free access to medicine and healthcare products has also been cited by scholars as a major shortcoming of the TRIPS agreement. According to Hilty and Lamping, when the patent systems across the world came up, nations could participate in independent regulatory designs. However, the development of the TRIPS agreement brought changes and took away some of the autonomy in the patent regulation process . Patents became issues of international concern that often conflict with the goals of public policy. Since then, the autonomy of states in coming up with patent laws that guarantee free access to medicine and healthcare products has been eroded. Consequently, countries face institutional and legal regimes consisting of bilateral, multilateral, and regional agreements that cripple regulatory freedom. As a result, the ability of nations to keep an appropriate balance of protection of knowledge and freedom of access to medicine and healthcare products that further public interest has progressively declined.
Another point that shows that the patent law conflicts with the right of access to medicines and healthcare is that it creates restrictions of use . The owners have monopolies over their inventions and this affects how the innovations are to be used. According to the World Health Organization, regardless of whether a medicine patent has expired, drug manufacturers cannot make a certain drug due to national laws that protect the test data. The WHO notes that test data represents critical piece of information that have been acquired through clinical trials and experiments in the making of a certain drug. Some of these data have not been authorized for public release and remain to be intellectual property which should be protected for the owner. Ideally, medicines and healthcare are public goods in which the users should have unrestricted access. By this, it means that the users or practitioners in healthcare have restrictions on how they can use the products and the access to information to make them. Consequently, when intellectual property data is withheld from use, it becomes difficult for drug manufacturers to come up with healthcare products. This restricts the general access to the products.
Furthermore, economic studies show that patents play a role in determining the availability and prices of pharmaceutical products in the market. According to researchers, the willingness of pharmaceutical companies to offer their products in the market depends on the existing incentives . Incentives can be in the form of profits that are likely to accrue from the new creations, which, if lacking in the market may deter the launch of the products. Since the investors and owners have patent protection, they have exclusive rights to revise or set new prices for their products. If the firms select to withhold their products from the market until the incentives are generated, this creates market shortages for the pharmaceutical products. On the other hand, a decision to revise prices can adversely impact the affordability. Although the developing world, which has lower purchasing power, has been through to be the hardest hit, the developed world is also experiencing the same challenge. Pharmaceutical companies price their products differently depending on the income distribution of the people . In high-income jurisdictions, such as those of the developed world, the firms, through tiered pricing, would sell small quantities at high prices. This limits access to the medicine to the lower-income groups. Since the focus of the pharmaceutical firms holding the patents is to generate maximum profits possible, it becomes difficult to ensure drug access to everyone. Also, the cost of a patented pharmaceutical product has been made to be exceptionally high by the expenses incurred. The inventors spend a lot of funds on the clinical research and to patent new drugs. To recoup the initial investments, they have to avail of the drugs at high prices. This becomes a hindrance to the access of medicines to the public.
Critics of the patent law also point that it diminishes healthy competition. By granting exclusive rights to the owners for their inventions, the patent law creates monopolies and makes it difficult for other players to enter the market . The critics warn that the patent holders may manipulatively use the protection to prevent second investors entering the industry . For instance, they may engage in unjustified lawsuits against potential investors to create fear on other possible entrants for the sole aim of being the only players in the industry. Even if the patent holder may lose the case, the situation places unnecessary cost and time burden on second inventors that prevent other inventions. The same situation can be replicated in the pharmaceutical industry where inventors of particular drugs may hold patents for them and use unjustified means to prevent others from developing similar medicines. Unjustified lawsuits started by the big players would prevent other players from coming up with innovations or they would shy away from the activities due to the financial and time burden to deal with the challenges created by the patent law. If this occurs, the cost of the medicine becomes high due to the natural monopolies created by the patent law. Also, there is a limited variety of medical and healthcare products in the market which prevents access.
Finally, a large body of knowledge has supported the view that the prevailing patent laws skew biomedical studies to medications that generate the highest profits for the investors. Scholars note that whereas the burden caused by malaria, diarrhea, tuberculosis, and pneumonia accounts for approximately 21 of the global disease menace, only 0.31 percent of all private and public funds are channeled to research . However, approximately 1 billion people across the world, most located in the developing world are affected by diseases. The reason for this phenomenon is that medications to control tropical diseases earn meager profits for pharmaceutical manufacturers. As a result, the biomedical research in the field has attracted less attention compared to other infections that fetch high prices for the medications. Arguably, patent rights have been blamed for the situation since the manufacturers of the drugs have the discretion to determine which drugs to produce. The patents prevent potential entrants in the market who would have spent more on biomedical research to control the most burdensome diseases.
Evidence of Patent Law Conflicts in the Developed World
Whereas the problem of access to medicine and healthcare products has been cited to be rampant in the developing nations, it is also evident that the developed countries such as the UK and the US are experiencing a similar problem. In a research conducted by Thambisetty, hyper-inflationary and erratic pricing of pharmaceutical products has been witnessed in several developed countries . In the UK, in 2018: 2024 – Write My Essay For Me | Essay Writing Service For Your Papers Online, the Competition and Markets Authority reported that Concordia and Actavis, two of the pharmaceutical manufacturers colluded to raise the values of hydrocortisone tablets by 80 percent between 2013 and 2016: 2024 – Do my homework – Help write my assignment online . Also, in the US, a study conducted in 2015 – Research Paper Writing Help Service showed that anti-cancer drugs had been overpriced by more than 100,000 pounds per patient each year . The firms in the pharmaceutical industry in both countries have been enjoying monopolies for the drugs due to the patents they hold. Given the situation, the pricing strategies threaten the accessibility of medicine not only to consumers in those countries but other nations where they are exported . This represents a significant concern over the decline in the quality of life because of drug inaccessibility but also has significant moral implications given that healthcare is a human need.
Additionally, Germany has been another country that has been hit by patent law in an attempt to promote access to medicines and healthcare products. In a case presented before a German court, the proposed user of the license of a patent produced and offered a medicament since 2008 – Affordable Custom Essay Writing Service | Write My Essay from Pro Writers . The medicament was to be used in the treatment of infections of HIV. In the case, the patentee sued based on the infringement of the patent and thus, sought an injunction on the same. At the time the lawsuit was filed, two medicaments having similar effects had been offered in the market. According to the patentee, the two medicaments were sufficient alternatives to the issued product and therefore, public interest was lacking in the continued offering of the contested product. However, the defendant filed for a compulsory license. In the case, the court, evaluating all the evidence granted the defendant an interim license that would ensure that the medicament was available for use by the patient as an alternative was sought. Although the contested drug continued to be offered under the interim license issued by the court, the case affirmed how critical the patent law had become in influencing access to medicine in the developed world, a problem that was perceived to exist in the developing nations. In the future, there are likely to be more lawsuits barring the release and use of medicaments without proper authorization of the patent holders. This will restrict access to medicine and affect the delivery of healthcare in the developed world.
In the case of Germany, the issuance of a temporary license for the medicament narrowed down to only one thing. That the medicament or product offered serviced the public interest. The medicament targeted a highly fatal and infectious disease and therefore, it was important for the court to issue a ruling that safeguards the greater good. However, if such vested public interests are lacking, the ruling may be done in favor of the patent owners mandating the restriction on the sale of drugs. In such instances, there will be limited access to medication. Such an outcome would dramatically conflict with the purpose and function of the patent regulation, which is to enhance invention and reward the original creators of innovations. This is because it scares away potential innovators who may fear litigation by the first investors.
Reflections on the TRIPS Agreement and Recommendations
Reflecting on the challenges that have been associated with the TRIPS agreement in facilitating access to medicine and healthcare products, it is clear that compulsory licenses are not the solution for the conflict. Following the TRIPS agreement, the patent owners enjoy protection for 20 years that allows them to engage in monopoly and other market exploitation activities. Worse still is the fact that inventors can apply for patent protection for innovations at an early stage even before they start conducting clinical trials . During that time, other potential innovators cannot perform similar trials. This prevents the generation of healthcare products which limits free access to medicine. Thus, one of the solutions to the problem is shortening the duration of the patent protection from 20 years to perhaps 5, 4, or 3 years. Ideally, the underlying reason for patent rights in healthcare and the field of medicine is to encourage inventors to bring innovations in the market through clinical trials . However, it appears that the reliance of the patents to spur innovation is already limiting access to medicine. As a result, the benefits of encouraging innovation in medicine are being offset by high costs and inhibitions place by the patent owners. Consequently, finding alternative ways to spur innovation without crippling the growth of innovation would be a suitable solution. If the length of patent protection is shorted from the current 20 years to about 5 or fewer years, it will allow other investors to come into the market and enable competition that will reduce the market monopoly. However, to ensure that the inventors are still motivated, they can be awarded a one-off prize that is awarded to them to allow the innovation to be used without the restrictions of the patent rights. This can be done after allowing the owners some unrestricted patent rights for a few years, like 5 or fewer years, and after expiry, there would be unrestricted access.
Besides, scholars have recommended a range of policy interventions that will overcome the monopoly enjoyed by patent owners that prevent free access to medicines and healthcare. One of the policy recommendations is coming up with a central organization, foundation, or facility that coordinates the process of procurement and purchasing of medications on a global scale . Under this arrangement, the monopoly of pharmaceutical product pricing enjoyed by the patent owners is eliminated. This will promote the affordability of medicines across the globe and increase access to the most vulnerable members of society. An alternative policy recommendation to control the pricing of the pharmaceutical products would be standardizing the duties charged on the process across border trade. For example, countries can collaborate to exempt medicines from sales taxes and customs duties. When the custom duties and sales taxes are waived for medicine and healthcare products, it translates to less cost by the pharmaceutical manufacturers who can then reduce the pricing through the patents that they possess.
Additionally, there is a need to include more healthcare products in the essential medicines list of the WHO organization. Started in 1977, the essential medicines list provides a model for availing certain medicines for free or the lowest price possible. In particular, the antiretroviral medicines have been included on the list since 2002 . The list has provided a framework for more nations to have an essential medicines list for their jurisdictions. However, despite the prevalence of essential medicines list, there are still challenges in access to medicines for upcoming diseases such as cancer. In this regard, cancer has been regarded as one of the costly infections to treat. These points to the fact that patents for such drugs need to be re-looked to reduce the duration the inventors enjoy the protection. Government-sponsored interventions such as those that involve paying the inventors of drugs for emerging infections such as cancer can help to overcome the restrictions and have the medicines included in the WHO essential medicines list.
Another possible solution to the issue of access to the pharmaceutical product due to patenting is the widening of the range of products that can be offered under compulsory licensing. Article 31 of the TRIPS Agreement provides for compulsory licensing of the lowly-priced generic drug . Under article 31, a country or entity can use a patent freely without consulting the owner. It is granted after a request, for instance, by a generic manufacturer after they fail to obtain permission from the owner of the patent. In such a case, the state can use the patent without the owner’s authority but for a non-commercial purpose. This is mainly done for the general welfare of the public who would be disadvantaged if the license is not availed. Just like the provision under article 31, there is a need to make amendments to the TRIPS guidelines to include highly-priced medicines that are critical for the general welfare of the public. Currently, new critical drugs are in most cases patented which make them highly-priced. For example, cancer drugs can be availed by the government through compulsory licensing since they are essential drugs. Limiting the compulsory licensing to only the low-priced drugs means that the public is denied essential products that are necessary for the improvement of their health states.
Finally, in the long term, the solution for the problem of monopoly can be solved through a change in the approach to medical research and production. In particular, adopting a non-for-profit model of pharmaceutical product development can help to overcome the challenge of monopoly by individual patent holders . A not-for-profit model approach will be financed by national and international governments and institutions. This means that there are effective cost allocations rather than the current system where an individual entity incurs the research costs that eventually get transferred through drug pricing. However, while adopting the not-for-profit model of product development, care should be taken to avoid crippling innovation by commercially-oriented entities. In such a case, patents can still be granted but for a shorter duration upon which the rights can be transferred through a rights purchase agreement. In this way, the patent holders will have a chance to enjoy the fruits of their innovation but then will not be in a position to engage in monopoly that restricts access to medicine and healthcare products.
Conclusion
In a nutshell, global access to medicine and healthcare products has been hampered by the patent law. Drawing from the TRIPS agreement, the patent law gives the holders rights over their innovative work for 20 years. This allows them to engage in monopolistic practices which hinder access to the products under the patents. The problem has been cited to be critical across the world with the developed nations also being hit by the restricted access to patented products. Also, the patent holders can over-price their products which limit affordability by the most vulnerable members of the society. As a result, reducing the patent monopoly to a shorter duration can eradicate the problem. Also, having a central organization for regulating drug supply and pricing, applying for compulsory licenses, and adopting a not-for-profit model of drug manufacturing can help to overcome the problem.

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