Medical Procedures and Intellectual Property Law: Is there any justification for granting pharmaceutical patents?

ABSTRACT

Many individuals around the world every day undergo many painful Medical procedures and surgeries without being able to feel the pain. What these people might not know is that their ability to sleep peacefully and not feel the pain while the doctor cuts into their body stems from a victory within a complicated field of intellectual property law i.e., Pharmaceutical patents. The paper titled “Medical Procedures and Intellectual Property Law: Is there any justification for granting pharmaceutical patents?” focuses on Pharmaceutical patents as well as the justification behind their grant.

A pharmaceutical patent is sought for the creation of a new molecular composition.  It is a fairly growing field that has brought about a host of exciting innovations, from new treatments for diseases to various medical procedures and instruments. Economic incentives for inventors, which encourage the invention of novel processes through research and development, have been used to support the patenting of medical methods. The Paper talks about the legal framework of India and the United Kingdom when it comes to Medical patents.

The patentability of medical procedures has been a topic of debate for many years. The last 40 years have seen a rise in the practical significance of a medical process’s patentability. The paper elaborates on the Medical procedures that have been famously patented since medical patents came into existence.  Legal authorities in the US estimate that 15 medicinal techniques are patented every week. Medical professionals are suddenly required to have their inventions and innovations of new methods validated. A medical procedure patent was one that only provided rights to simple steps in the production of medical devices, not actual medical devices themselves. The practice of granting patents for medical procedures was rapidly denounced as unjustified by major medical organizations. As a result, more than 80 nations are sceptical of the patentability of medical procedures, whether they be therapeutic, diagnostic, or surgical, and some only permit patents on diagnostic model inventions. It was seen as an infringement on the altruistic nature of medical practitioners’ ethics as well as a threat to the spread of new procedural expertise and information.^[1] In the conclusion, it speaks about the criticism as well as the justification for granting pharmaceutical patents.

Keywords: Pharmaceutical Patents, Medical Procedures, Intellectual property rights, Patents, Inventions, Medical Techniques.

INTRODUCTION

In general, technology has been an important factor in the growth of civilization, and this is particularly evident today because it is closely related to science. Technology today includes not only manufacturing, but also research, design, and other creative endeavours. Technology supports our ability to change the world. We use technology to try to change the world to make it work better for us. However, the end result of world change is often complex and unpredictable. They may consist of unexpected benefits, costs, and risks.

The commercialization of pharmaceuticals has led corporations to seek patent protection for their pharmaceutical inventions. Pharmaceuticals help mankind in manifold respects. In the areas of the health sector due to inventions made by the pharmaceutical industries, human life and standard of living have improved alarmingly. However, in the present era of intellectual property, which grants inventors the sole right to use their created technology, it is becoming a more expensive notion and is not in the hands of the average middle-class man.^[2]

Research Methodology

This paper is of a descriptive nature and the research is based on secondary sources for the deep analysis of the Pharmaceutical and Medical Procedural Patents. Secondary sources of information like blogs, journals, books, Government portals, and websites are used for the research.

Indian, UK, & US Legal Framework

Indian

The TRIPS [Trade-Related Aspects of Intellectual Property Rights] agreement exempts surgical, therapeutic, and diagnostic methods of treating humans and animals from the scope of patentable subject matter in India under Section 3(i) of the Indian Patents Act, 1970. Prior to the adoption of The Patents (Amendment) Act, of 2002, plants were included in this category. One of the main justifications for their exclusion from patenting was that medical treatments were used for non-industrial purposes, which is a crucial factor in the examination and granting of patents.

Medical processes include, for example, the exact administration of medications, the diagnosis of a medical condition, and the performance of surgery. For instance, a stitch-free incision used during cataract surgery is not protected by copyright. On the other hand, diagnostic methods for external tissues or fluids might be patented. Furthermore, in the case of Lalit Mahajan’s [Patent Application No. 693/KOL/2007 decided on 11.01.2010 ],¹ The grey area between the patentability of a device and a diagnostic or therapeutic method was defined in a patent application relating to a “device for detection of antibodies to HIV and p24 antigen of HIV1 in human serum or plasma.” The opposition claimed that the apparatus in question was ineligible for patenting under Section 3(i) because it lacked diagnostic features. The Patent Examiner recognized the inventive step but pointed out that the invention was a device rather than a diagnostic technique.

Likewise, in M/s. Applied Research Systems Ars Holding, Netherlands [2003.],¹ The issue was whether a “kit for the treatment of infertility for women having several dosages of FSH”21 may be excluded under Section 3(i) of the Act. The choice was made in Favor of the product because it was only being used in medical procedures. The second application satisfied the criteria for an industrial use of the approach, whereas the first application did not.

UK

Up until 1997, the UK likewise forbade the patenting of medical processes. After that, the UK permitted the patenting of particular medical procedures—but only provided they satiated the requirements for novelty, innovative steps, and industrial usefulness.

An innovation, concept, or method must have “industrial applicability” in order to be eligible for patenting under UK law, which dates back to the country’s foundation. Patents for medical procedures were exempt from this criteria since they were seen to be unethical and to have no industrial application. The Patents Act of 1977 was later updated by the Parliament to comply with the European Patent Convention, but the ban on the patenting of surgical, medicinal, and diagnostic medical procedures remains in effect.

US

Any novel and economically advantageous method, piece of machinery, or process is legally eligible for patent protection in the USA. While patents for medical procedures are awarded, there is no explicit provision for legal action in the case of a breach. This indicates that while the innovator may have a monopoly, enforcement is impossible. Following the Ex parte Brinkerhoff, Ex parte Scherer, and Pallin cases, the Court established this norm. The Pallin case resulted in the Court overturning the first two cases, emphasizing the need to balance the public good with social benefit and placing restrictions on the capacity to patent medical, surgical, and therapeutic procedures.

Public Health vs. Pharmaceutical Patents

1. Fundamental Rights (Right to Health):

It is crucial to remain cognizant that our Constitution’s Article 21 guarantees the right to life, which also encompasses the right to health. The courts came to the conclusion that the right to life also includes the right to health and “access to medical treatment” through judicial pronouncements.^[3] The government must use all reasonable means to ensure that its citizens have access to life-saving medications.^[4] The State has a responsibility under the constitution to ensure that no one’s fundamental rights are violated.^[5] Our Constitution’s Preamble and Directive Principles of State Policy call for policies that strike a balance between social and economic rights. Therefore, it is necessary to strike a balance between the interests of the pharmaceutical companies’ bottom line and public health when drafting patent policy.

The Ayyangar Committee Report^[6] claims that because India is a developing country, granting patents confers monopolistic powers that will prevent the majority of our population from accessing medications. Therefore, laws that give monopolistic privileges are against both the Preamble and the fundamental liberties protected by Article 21 of our Constitution. Priority was given to addressing the needs of its own citizens before those of outside innovators. The vision of a better-ordered world is one in which medical advancements will be free from patents and there will be no profit from life and death, according to former Indian Prime Minister Indira Gandhi, who made this statement in 1982 at the World Health Assembly.

2. Right to Health and Patents:

Access to healthcare is a fundamental human right, and it is a fundamental instrument for ensuring health. However, the right as well as the means to secure the same are facing a major issue in the current regime.  Pharmaceutical patents are very important for ensuring that everyone has access to medicine. It has been proposed that the price of these products and the affordability of access would be inversely correlated in a fully operational patent system. The possibility that patents are preventing regular people from accessing medications and exercising their “right to health” has led some to speculate that the global intellectual property system may be experiencing a crisis of public legitimacy.²

Patenting of Medical Procedures

A medical procedure patent is one that grants rights to simply procedural steps rather than the development of any medical devices. However, this tendency peaked and then quickly faded. Major medical institutions soon banded together to condemn the practice of issuing patents for medical operations as unjustified. It was interpreted as a threat to the dissemination of new procedural knowledge and information, as well as a violation of the philanthropic nature of medical professionals’ ethics.¹

“Patenting of human medical treatment methods is a complicated matter because it is based both on medical law and patent law.” The Hippocratic Oath, whose aim is to preserve human life, serves as the cornerstone of medical law. The goal of patent law, in contrast to medical law, is to encourage innovation by compensating innovators. As a result, it is a matter of public policy that in order to offer the most effective healthcare possible, doctors must always be free to choose the course of treatment.

Pros and Cons of Medical Procedural Patents

Pros of Patenting the Medical Procedures

• Medical procedures were patented to boost efficiency and productivity. In essence, it was thought that productive efficiency would advance societal goals.
• Medical procedure inventions were financially rewarded through patenting. Such financial incentives would encourage additional research and development, which is necessary to create novel medical techniques.
• Economic analysis suggested that if medical methods are not legally protected by patents, market competition may drive prices down to the point where the innovator has no incentive and just the opportunity cost is recovered. This could ultimately lead to a loss of innovation, which would be detrimental to the general public.
• The demand-supply principle had a big effect on how often medical techniques were patented. In the past, medical procedures were patented if there was a greater demand for them than there was an expense to create them. Finally, patents on medical techniques aid in maintaining a particular product’s exclusivity.

Cons of Patenting the Medical Procedures

• The licensing of medical processes is one of the most significant drawbacks of patenting them. The price of the procedures is substantially raised by royalties and licensing fees. This would make it more difficult for everyone to gain access to healthcare.
• Many argue that the patenting of medical techniques may possibly interfere with the doctor-patient relationship from an ethical point of view. This stems from the reality that a doctor’s options for the best diagnostic and treatment approaches for a patient are severely constrained by patents.
• The cost of the drug transaction makes it very challenging to enforce such medical procedure patents.
• Many opponents of medical procedure patenting contend that the right to health of the general public should take precedence over any potential financial rewards from such patents. It is argued that by making medical procedures more accessible, the quality of public health must be prioritised. It is crucial that medical processes are not patented in order to increase accessibility.^[7]

Famously Patented Medical Procedures

1. X-Ray: The first patent for an X-ray tube was prepared by Siemens & Halske (S&H), based on the Crookes tube. On March 24, 1896, a mere three months after the discovery of X-rays, S&H received a Deutsches Reichs Patent “Eine neue Röntgenlampe mit regulierbarem Vakuum” for ‘a new X-ray lamp with regulated vacuum’, patent number DE91028. The innovation considered that ‘for the first time it was possible to manually regulate gas pressure in the X-ray tube’.^[8]
2. Disposable Catheter: The patent for a Disposable Catheter was made by Martin Mattler stating, ‘A disposable catheter formed of a rigid, elongated catheter tube having an inflatable ring mounted upon the tube, the ring being formed of a latex-like, flexible material, thin-walled balloon having opposed originally out Wardly nipples opening into the balloon.’ On December 24, 1968.^[9]
3. Cardiac Defibrillator: The principle of defibrillation has been known for decades and is one of the most remarkable innovations. A seemingly dead individual had not been brought back to life in a clinical setting until Claude Beck, a Cleveland cardiovascular surgeon, successfully defibrillated the heart of a little boy during surgery. November 23, 1982 saw the date of its patent.
4. CT Scanner: Medical professionals needed access to even more detail after the X-ray revolutionised examination specifics, which led to the development of the CT scanner, which shows various levels inside numerous X-ray images. The first commercial CT scanner was created by Dr. Godfrey Hounsfield, and it was used on a patient in London for the first time. Later, for his efforts, he was awarded the 1979 Nobel Prize in Physiology or Medicine.
5. MRI: Nuclear magnetic resonance is a method that was patented by Dr. Raymond V. Damadian for separating healthy tissue from malignant tissue. Millions of patients worldwide now have access to significantly better healthcare because to its subsequent development into the M.R.I.

REVIEW OF LITERATURE

Originally, the word “Industrial Property” only applied to patents, trademarks, and industrial designs, but today, the definition of “Intellectual Property” is far broader. The following ways that IPR advances technology: ^[10] 

(a) It outlines a procedure for dealing with unlawful usage, piracy, and infringement.

(b) Since all types of IP are published with the exception of trade secrets, it gives the general public access to a wealth of information.

A range of intellectual endeavors can be protected by IP, including

(i) Patents

(ii) Industrial designs are features that are applied to products in any shape, configuration, surface pattern, the composition of lines, and color, whether they are 2-D, like textiles, or 3-D, like toothbrushes. ^[11]

(iii) Trademarks are any name, mark, or logo used in commerce to identify the maker or provider of a good or service and to identify goods or services. You can purchase, sell, and license trademarks. A trademark is only as good as the reputation of the good or service it represents. ^[12]

(iv) Copyright pertains to the expression of ideas in material form, which includes computer software, audio recordings, literary, musical, dramatic, and aesthetic works.^[13]

(v) Geographical indications are indicators that place a good’s quality, reputation, or other attribute primarily due to its geographic origin in the country’s territory or a specific region or locality within that territory.^[14]

When an invention satisfies the requirements of general novelty, non-obviousness, and industrial or commercial use, a patent is granted. Products and processes are eligible for patent protection. According to the Indian Patent Act of 1970, a patent had a period of 14 years from the date of filing, with the exception of preparation techniques for medications and food products, for which the term was either 7 years from the date of filing or 5 years from the date of the patent, whichever came first. Drugs and food products were not the subject of any product patents. ^[15] A copyright created in one of the Berne Convention’s signatory nations immediately enjoys protection in all other signatory nations without the need for registration.

Rationale of Patent

A patent acknowledges the IP form that manifests in an invention. Under the rigorous examination and opposition procedures outlined in the Indian Patents Act, of 1970, patents are issued for patentable inventions that meet the standards of novelty and utility. However, there is not even a prima facie presumption as to the validity of the patent that has been granted.

The majority of nations have put in place national systems to protect IPR that fall under their purview. Except in the case of copyrights, the inventor’s or creator’s protection is limited to the territory where protection is sought and is not applicable in other countries or regions, such as India or the European Union. For instance, an Indian patent is only good for India and not the USA. The primary goal of obtaining a patent for an innovation is to profit from exclusivity; otherwise, the inventor or his assignee would hold a monopoly.

• A significant invention has been developed by the inventor as a result of the alterations made by the consumer, and
• The resulting patent would grant the patent owner an exclusive market if the patent agent accurately described and claimed the innovation in the patent specification written.

The subsequent would not be considered patents:

(i) A frivolous innovation or one that makes claims that are obvious or go against well-established natural law. An innovation whose primary or intended usage would violate morality, the law, or the interests of the public

(ii) A finding, a scientific hypothesis, or a mathematical technique

(iii) The simple application of a known process, device, or apparatus without producing a novel product using at least one novel reactant, or the mere discovery of any novel property or use for a known substance.

(v) A simple arrangement, re-arrangement, or replication of a recognized device, each of which functions independently of the others in its own way. (iv) A material created by a simple mixing that simply aggregates the attributes of its components.

(vii) Any technique for the medical, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatment of humans or any technique for the similar treatment of animals to make them disease-free or to increase their economic value or that of their products. (vi) A technique for agriculture or horticulture

(viii) An invention relating to atomic energy

(ix) An invention, which is in effect, traditional knowledge

Nature of Pharmaceutical Industry

The rush to discover the human genome’s mysteries has resulted in a flood of scientific knowledge and sparked the creation of novel technologies that are changing the economics of medication development. Everyone will have their own genome mapped and saved in a chip, therefore biopharmaceuticals are likely to have a specific place in the future with tailored therapies as the end objective. Doctors will examine the data on the chip(s) and issue prescriptions if necessary. The protection of such personal information databases would be the key IP issue involved. More and more pharmaceuticals created using biotechnology will enter the market.

Such pharmaceuticals will have a slightly different protection process than those ordinary drugs that have not undergone biotechnological development. It is necessary to list the microbial strains utilized while creating a medicine or vaccination in the patent document. The situation is straightforward if the strain is well-known and has been described in the literature that scientists typically consult. The Budapest Treaty requires that numerous novel strains be lodged with international depository authority as they are continuously identified and created. The databases of these depositories should also be checked when conducting a novelty search. Companies don’t often publish their work, but it’s a good idea to make it a rule to hold off from disclosing an invention through publications or seminars until it has been submitted for a patent.

IPR are being unjustifiably strengthened and misused at the expense of competition and consumer welfare, according to the situation of the pharmaceutical sector today. The drug industry’s lack of innovation and risk-taking highlights the injustice that is occurring at the expense of the common good. It is an injustice that cannot be resolved solely by legislative change. Antitrust law must adequately intervene, even while congressional efforts to plug gaps in existing laws and new legislation to stop additional unfair economic practices by the pharmaceutical industry may offer some alleviation.^[16]

While the pharmaceutical industry’s commercial activities, such as mergers and acquisitions and agreements not to compete, have been carefully reviewed by antitrust laws, there are still a number of additional practices that require attention. Antitrust law can help maintain the equilibrium between rewarding innovation and preserving competition in a number of situations, including the granting of patents on insignificant components of outdated medications, reformulating outdated medications to obtain new patents, and using advertising and brand name development to raise barriers for generic market entrants.^[17]

Writing patent specifications requires a high level of professional ability that must be developed over time and requires a strong balance of legal, technological, and scientific knowledge. Any patent specification’s claims are what give the patent its essential legal proprietary status. A known material cannot be patentable when a new property is discovered in it. A practical use of the property qualifies as an innovation that might be eligible for patent protection. A railway sleeper built of the material could very easily be copyrighted, but the finding that a known substance can tolerate mechanical shock would not be patentable. Even though a material may not be new, a new property has been discovered in it. If it is combined with some other known compounds and produces a novel result, it might be possible to patent the combination. The cause is because no one has ever utilized that combination to create a pesticide, fertilizer, or medication in the past. It’s entirely feasible that someone has invented a novel molecule whose exact structure is unknown. The description of the chemical, together with its qualities and the process used to create it, will be crucial in this situation.^[18]

Justification for Grants of Pharmaceutical Patents

One of the primary arguments in favour of the patent system is the encouragement of invention, which is a catalyst for both economic development and growth.^{[19] [20]}The patent system works to achieve this goal by giving patent holders a period of exclusivity as payment for their inventive work and as an inducement to continue innovating.^[21] As a result, it is believed that patents in particular, and laws governing intellectual property are crucial for ensuring fair competition on the internal market. These exclusive rights are viewed as an essential motivator to spend in R&D and innovation, especially in industries like pharmaceuticals where the expenses of R&D are substantial but the costs associated with reproducing the results are minimal.^[22]

SUGGESTIONS & CONCLUSION

The extent and enforcement of intellectual property rights in pharmaceutical products are governed by a number of underlying legal and regulatory frameworks, including FDA regulation, patent law, and particular specialised dispute resolution processes. Depending on whether a medicinal product comes from biological or chemical sources, the FDA regulates it differently. In particular, nonbiological “drugs” must receive FDA approval before being promoted or sold under the Federal Food, Drug, and Cosmetic Act (FD&C Act), while “biologics” must be licenced by FDA under the Public Health Service Act (PHSA).^[23] Because patents on pharmaceutical medications or biologics are subject to various specialised patent dispute resolution procedures, this regulatory distinction has implications for patent law and may limit a manufacturer’s ability to introduce a generic drug or biosimilar to the market. Given these intricacies, an understanding of the law is crucial to comprehend how pharmaceutical producers obtain and enforce intellectual property rights and how IP rights may affect drug prices.

It is apparent that managing IP and IPR requires a variety of activities and techniques, all of which must be in compliance with local laws as well as international conventions and standards. It is no longer solely influenced by a national viewpoint. The market’s demands, its reaction, the expense of converting IP into a business enterprise, and other factors have a significant impact on IP and its related rights. In other words, the administration of IPR must take into account issues relating to trade and commerce.^[24] Distinct IPR forms require distinct management, planning, and strategies, as well as the involvement of people with a variety of subject-matter expertise, including science, engineering, medicine, law, finance, marketing, and economics. Depending on its area of specialization, each industry should have its own IP rules, management practices, strategies, etc. A developing IP strategy is now used by the pharmaceutical business. Antitrust law must therefore intervene to prevent the wrongful assertion of invalid IPR in order to create and sustain illegitimate, if temporary, monopolies within the pharmaceutical business, given the greater likelihood that some IPRs are illegal. In this context, there are still a lot of issues to be handled.

Author Details

Dhriti Kathuria

Maharishi Dayanand University, Rohtak, India

Student (BALLB) (HONS.)

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[1] IIPR, 30 March 2022, Patent Policy In Medical Terms | Understanding The Relationship Between Medical Procedures and Patent Policy.

[2] SCC, 3 September 2019, Pharmaceutical Patents And Healthcare: A Legal Conundrum.

[3] L.M. Singhvi and Jagadish Swarup (2006), Constitution of India, Vol. 1, Modern Law Publications.

[4] All India Drug Action Network v. Union of India, (2011) 14 SCC 479.

[5] People’s Union for Democratic Rights v. Union of India, (1982) 3 SCC 235.

[6] Report on the revision of the patent law, Rajagopal Ayyangar Committee, September 1959.

[7] Mondaq, 16 November 2021, India: An Overview On Patenting Of Medical Procedures.

[8] Science Direct, Brief history of X-ray tube patents by Marcio Luis Ferreira Nascimento

[9] Disposable catheter and method for forming same by Martin Mattler, 1968, Available at <https://patentimages.storage.googleapis.com/e6/81/ee/95607c4c4ad9ac/US3417753.pdf >

[10] Singh R. Vol. 1. New Delhi: Universal Law Publishing Co. Pvt. Ltd; 2004. Law relating to intellectual property (A complete comprehensive material on intellectual property covering acts, rules, conventions, treaties, agreements, case-Law and much more)

[11] New Delhi: Universal Law Publishing Co. Ltd; 2004. Anonymous. The Design Act. 2000 along with Design Rules 2001.

[12] New Delhi: Commercial Law Publisher (India) Pvt. Ltd; 2004. Anonymous. The Trademarks Act 1999 along with trade Marks Rules 2002.

[13] New Delhi: Commercial Law Publisher (India) Pvt. Ltd; 2005. Anonymous. The Copyright Act 1957 as amended up to 1999 along with Copyright Rules 1958 and International Copyright Order 1999.

[14] New Delhi: Universal Law Publishing Co. Ltd; 2004. Anonymous. The Geographical Indications of Goods (registration and protection) Act, 1999 along with Geographical Indications of Goods (registration and protection) Rules 2002.

[15] New Delhi: Commercial Law Publisher (India) Private Ltd; 2005. Anonymous. The Patents Act, 1970 as amended by Patents (amendment) Act 2005.

[16] Gottlieb S. Drug firms use legal loopholes to safeguard brand names.

[17] Glasgow LJ. Stretching the limits of intellectual property rights: Has the pharmaceutical industry gone too far? IDEA J Law Technol. 2001

[18] Subbaram NR. Hyderabad: Pharma Books Syndicate; 2003. What everyone should know about patents?

[19] When do generics challenge drug patents? By Hemphill S, Sampat B.

[20] Justifying intellectual property rights by Hettinger EC, 1989.

[21] Curbing unfair drug prices, a primer for states, Berman A, Lee T, Pan A, Rizvi Z, Thomas A (2017), Yale Global Health Justice Partnership Policy Paper.

[22] The interface between intellectual property rights and competition policy, Anderman S, Schmidt H. EC competition policy and IPRs. In: Anderman S, editor, 2007.

[23] Drug Prices: The Role of Patents and Regulatory Exclusivities, Congressional Research Service February 10, 2021.

[24] Intellectual property rights: An overview and implications in pharmaceutical industry, National Liabrary of Medicine, 2011 Apr-Jun