This article has been written by Vinotha S, pursuing a Remote freelancing and profile building program from SkillArbitrage.

This article has been edited and published by Shashwat Kaushik.

Introduction

Biotechnology is a newly emerged field and when it comes to patent filing, debate revolves around how life can be patented? In contradiction to classical fields like physics or chemistry, biotechnology involves life and always has controversies about whether these fall under invention or discovery, as it involves microorganisms, plants, animals and their organs, bio-fluids, cells and biological processes. The use of microorganisms like yeast in bread making has occurred for years.

With recent advances and developments in the biotech field, the globe has restructured itself to be a part of bio-economy. Growing population, outburst of new diseases, requirement of new drugs, vaccines, and food supply to satisfy the basic needs of people made it inevitable to rely on biotechnology and its related fields. Following which new rules and regulations come into effect. Lawmakers found it imperative to establish ethical and moral regulations for this newly booming industry and non-obviousness is one of the major challenges while approving biotechnology patents.

What is non-obviousness

The ‘claims’ in the patent should not be obvious to a skilled person in the same field and should not be identical to the prior art information. The invention should be novel and unique.

Overcoming non-obviousness problems

The first preliminary step to overcome the problem of non-obviousness is to do a patent search on the respective country’s websites or global databases. E.g., https://ipindia.gov.in/e-gateways.htm for India, patent.google.com, etc.

• Following the guidelines framed for a specific country or region is important.
• A detailed prior art analysis of the related field is important to get a vague idea about the topic research going on.
• Non-patent literature search, analysing the work/strategies of competitors, mapping current new technologies and continuous monitoring are also necessary.
• Checking the legal status of patents will avoid obviousness while patenting.

Biotechnology patent laws around the world

The beginning of biotech patents occurred during the 1970s for obtaining a patent for cloned genes encoding therapeutic proteins. In 1980, the U.S. Supreme Court, in Diamond v. Chakrabarty, approved the first patent on a newly created bacteria for degrading crude oil in oil spills. Thereafter, patenting genes and their therapeutic proteins becomes very evident all over the world. Subsequently, many disputes have arisen in the context of patenting microorganisms and DNA.

The Human Genome Project’s development of high-throughput sequencing techniques in the early 2000s, which identified, isolated, and understood the function of a gene and its role in diseases, raised the possibility of patenting.

Countries like the United States, European Union, Japan, China, United Kingdom, India, Australia, Brazil, and South Africa started filing patents.

With the advancement of genomics and proteomics, expressed sequence tags (ESTs) continue to be a problem for patent authorities, as much of the value of ESTs lies in databases rather than as tangible molecules in wet labs. Although the USPTO initially resisted the patent protection of information technology, it later attenuated the restriction, as genomics and proteomics information are important for future therapeutic and diagnostic research. The USPTO contradicted its counterparts in Japan and Europe in many cases.

Why is non-obviousness more concerning in biotechnology

The nonobviousness requirement in U.S. law is almost the same as its counterpart in Japanese and European law, i.e., the concept of “inventive step.” But still, there are differences.

The European Patent Convention considers an invention to involve an inventive step if, “having regard to the state of the art, it is not obvious to a person skilled in the art.” 

Section 29(2) of the Japanese patent law mandates that a claimed invention will lack an inventive step when that step easily could be made by a person with ordinary skill on the basis of inventions publicly known or worked prior to the filing of the patent application.

It is important to note that “Inventive step” is more complex while obtaining a European or Japanese patent, whereas interpretation of “non-obviousness” is a hurdle while obtaining United States Patents.

In India, according to Section 2 (1) (j) of the Act, an “invention” means a new product or process involving an inventive step and capable of industrial application. According to the Patents Act, 1970, and the Patents Rules, 2003, Section 2 (1) (j), Section 3 (b, c, d, e, h, i, j, k, p), and Section 10 (4, 5) are applied while examining biotechnology patents.

Compulsory licence

Compulsory licencing also differs for different countries. The United States considers that there should not be any special category for compulsory licencing of patents. In the United Kingdom, if the patent is not commercialised, then the patent would come under compulsory licencing. German patent law states that the patentee is willing to release the patent if he is provided with ‘reasonable compensation’.

Patent pooling

Pooling refers to the collaborative arrangement between two organisations or patent holders to mutually licence the patents either to each other or to a third party, thereby enabling the shared advantages derived from the respective patents. However, this is sometimes complex as the use of patents may vary between the parties and distort competition. Also, there is the possibility of a joint monopoly on the market. In the realm of biotechnology patents, the practice of patent pooling has been relatively limited thus far and may require future regulation to ensure its effective and fair implementation.

Examples of approval after controversies of non-obviousness

Dimminaco A.G. vs. Controller of Patents and Designs: In 2001, the applicant applied for the newly developed Bursitis vaccine – a live vaccine for poultry to prevent Bursitis infection. The court has rejected as it involves a live organism, under Section 12 of the Patent Act, 1970 and did not meet the requirements of an “invention” under Section 2 (j)(i) of the Act. The appellant had then appealed to the Controller of Patents and Designs. Later, the Calcutta High court said that, meeting the threshold of novelty, inventive step, and industrial applicability, the application is eligible for granting a patent under Section 2(1) and Section 5. In India, until 2002, no patent was granted for living things or biological material.

This is a landmark judgement in India in the field of microorganism patentability. In 2002, the Indian parent law was amended and came into effect in 2003. After this, the Indian Patent System was aligned with the TRIPS agreement by allowing patents for microorganisms under Section 3(j) of the Act, expanding the scope of patentability to include microorganisms in India.

 Diamond vs. Chakraborty (1980): Chakrabarty (the applicant in US), a microbiologist working at General Electric Co. in 1972, filed a patent application with 36 claims for the invention of a bacterium called ‘Pseudomonas putida’ containing at least two stable energy-generating plasmids providing a separate hydrocarbon degradative pathway. This genetically engineered bacterium has the capability of breaking down crude oil. The claims were of three types.

• Method of producing the bacteria
• The inoculum consisted of a carrier material and the new bacteria.
• Bacteria itself.

The examiner approves the first two but rejects the third one. Chakrabarty appealed to the Patent Office Board of Appeals. The Board concluded that Section 101 was not intended to cover living things such as laboratory created microorganisms. Referencing the Plant Patent Act, 1930 and the Plant Variety Protection Act, 1970, the judges stated that the Congress intended to grant patent protection to certain asexually reproduced plants. After many arguments and discussions, the board granted the patent in 1980.

This case is also a milestone in the field of biotechnology, after which there has been a dramatic increase in filing biotechnology patents. Many researchers and scientists find their way to claim rights for their work to get recognised.

International collaboration to simplify patent process

In developed countries, the evaluation of patentability commonly revolves around a standard set of three principals: novelty, inventiveness (or non-obviousness), and industrial application (or utility). These criteria serve as key benchmarks in determining whether an invention is eligible for patent protection in the respective jurisdictions. 

European patent laws follow a list of patent exclusions which are not present in US patent law. The European Parliament’s Directive 98/44/EC excluded the use of Human parts and thus could not be claimed. It says “human body, at the various stages of its formation and development, and the simple discovery of one of its elements”—although notably not these elements once taken out of the body—and “uses of embryos for industrial purposes.”

The European Patent Office has invoked these provisions in denying a number of patent applications in the field of stem cell research, a decision upheld on appeal.

In order to overcome the differences and make the patent process easy and applicable, a few steps were taken. They are as below.

The Patent Cooperation Treaty (PCT), 1970

This international patent law treaty was established to streamline the international patent filing process. The goal is to establish a standardised procedure for securing patents across multiple countries so that a patentee can simultaneously protect his invention in a large number of countries. The usefulness of the treaty is: it makes the world reachable, reduces the budget for filing patents across different countries, helps streamline universal patent laws, and collaborates with pharmaceutical corporations, industries, universities and experts.

Budapest Treaty, 1977

This treaty functions to deposit the biological material/microorganism to be patented with a common “international depositary authority” in order to avoid having the patentee submit it to each country. This increases security, the uniform deposit system, and the recognition and furnishing of samples. At present, there are around 89 countries and India joined the treaty on December 17, 2001.

“The patent offices of Australia, Austria, Brazil, Canada, Chile, China, Egypt, Finland, India, Israel, Japan, the Philippines, the Republic of Korea, the Russian Federation, Singapore, Spain, Sweden, Turkey, Ukraine, the United States of America, the European Patent Office, the Nordic Patent Institute and the Visegrad Patent Institute act as International Preliminary Examining Authorities under the PCT (status on May 20, 2019).”

TRIPs

In 1995, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) was established, setting forth a set of minimum standards for intellectual property protection that signatory states were expected to adopt and adhere to. This comes under the WTO and encourages the knowledge trade and helps policymakers and others stay updated on current patterns of technology and changes in knowledge patterns across the globe. This would be helpful in framing or amending the legal policies.

Role of patents in biotechnology

Patents play a crucial role in biotechnology by providing exclusive rights to inventions and discoveries. They encourage innovation, protect intellectual property, and promote commercialisation.

1. Fostering innovation:
   • Patents incentivise research and development (R&D) activities in biotechnology by offering a potential return on investment.
   • They enable biotech companies to recoup their substantial investments in cutting-edge research.
   • Patent protection stimulates competition and drives continuous innovation to stay ahead.
2. Protecting intellectual property:
   • Patents grant legal protection to novel inventions, ensuring that the rights of inventors and companies are safeguarded.
   • This protection prevents the unauthorised use, reproduction, or distribution of patented technologies and products.
   • It encourages the sharing of knowledge and technology transfer, while safeguarding the interests of innovators.
3. Commercialisation and market exclusivity:
   • Patents provide a period of market exclusivity, allowing biotech companies to recoup their R&D costs and generate profits.
   • This exclusivity enables companies to establish a competitive advantage, attract investors, and secure funding for further development.
   • It also facilitates partnerships and licencing agreements with other companies, contributing to the commercialisation of biotechnology products.
4. Technology transfer and collaboration:
   • Patents facilitate the transfer of technology from academia to industry by enabling universities and research institutions to partner with biotech companies.
   • Collaborative research efforts can leverage complementary strengths and accelerate the translation of scientific discoveries into practical applications.
   • Patent licencing agreements provide a framework for sharing technology and ensuring fair compensation for inventors and institutions.
5. Patent litigation and enforcement:
   • Patents can also lead to patent litigation when there are disputes regarding infringement or validity.
   • Patent enforcement actions aim to protect the rights of patent holders and deter unauthorised use of patented inventions.
   • Litigation can have significant financial and reputational implications for the parties involved.
6. Balancing public interest and access:
   • While patents promote innovation, they also raise concerns regarding access to essential medicines and technologies, particularly in developing countries.
   • The balance between intellectual property rights and public health considerations is a complex issue that requires careful consideration.
7. Global patent landscape:
   • The global patent landscape in biotechnology varies across countries, with different patent laws, regulations, and enforcement mechanisms.
   • International patent cooperation initiatives, such as the Patent Cooperation Treaty (PCT), aim to streamline the patent process and facilitate global protection of intellectual property.
8. Ethical considerations:
   • Ethical considerations arise in biotechnology, especially when patents involve genetic engineering, stem cell research, or other sensitive technologies.
   • Balancing the potential benefits of innovation with ethical concerns requires careful evaluation and societal discourse.
9. Future trends:
   • The role of patents in biotechnology is likely to evolve with technological advancements and changing global dynamics.
   • Emerging areas such as gene editing, synthetic biology, and personalised medicine may present new challenges and opportunities for the patent system.

Types of biotechnology patents

Biotechnology patents are a type of intellectual property that protects inventions in the field of biotechnology. They can cover a wide range of technologies, including:

• Genetic engineering patents: These patents protect inventions that involve the manipulation of genes and genomes. This can include the development of genetically modified organisms (GMOs), such as plants and animals that have been modified to have new traits. Genetic engineering patents can also protect inventions related to gene therapy, which is the use of genes to treat diseases.
• Protein engineering patents: These patents protect inventions that involve the design and modification of proteins. This can include the development of new proteins for therapeutic or industrial applications. Protein engineering patents can also protect inventions related to protein folding and stability.
• Cell culture patents: These patents protect inventions related to the development and use of cell cultures. This can include the development of new cell lines, as well as methods for growing and maintaining cell cultures. Cell culture patents can also protect inventions related to the use of cell cultures for research, drug discovery, and other applications.
• Bioinformatics patents: These patents protect inventions related to the use of computational tools to analyse biological data and design new technologies. This can include the development of new algorithms for analysing DNA and protein sequences, as well as methods for designing new drugs and vaccines.
• Bioremediation patents: These patents protect inventions related to the use of biological processes to clean up environmental contaminants. This can include the development of new microorganisms that can degrade pollutants, as well as methods for using these microorganisms to clean up contaminated sites.

Biotechnology patents can be granted for a variety of inventions, including:

• New products: This includes genetically modified organisms, proteins, drugs, and other products.
• New processes: This includes methods for genetic engineering, protein engineering, and other biotechnology techniques.
• New uses for existing products and processes: This includes new medical uses for existing drugs and new industrial uses for existing biotechnology processes.

Landmark cases in biotechnology Patent Law

Diamond vs. Chakrabarty

Diamond vs. Chakrabarty is a landmark case in biotechnology patent law that established that genetically engineered microorganisms are patentable subject matter. This decision, issued by the Supreme Court of the United States in 1980, had a profound impact on the biotechnology industry and paved the way for the patenting of other living organisms.

The case involved Ananda Chakrabarty, a microbiologist who developed a genetically engineered bacterium capable of breaking down crude oil. Chakrabarty filed for a patent on his invention, but the Patent Office rejected his application, arguing that living organisms were not patentable. Chakrabarty appealed the decision to the Supreme Court, which ultimately ruled in his favour.

In its decision, the Supreme Court held that genetically engineered microorganisms are patentable subject matter because they are “new and useful” inventions under the Patent Act. The Court reasoned that the bacterium was not a product of nature, but rather a “human-made invention” that was the result of Chakrabarty’s “ingenuity and hard work.”

The Diamond v. Chakrabarty decision had a number of important implications for the biotechnology industry. First, it opened the door to the patenting of other living organisms, such as genetically engineered plants and animals. Second, it provided a framework for determining which living organisms are eligible for patent protection. Third, it helped to establish the United States as a leader in the field of biotechnology.

The decision has also been criticised by some, who argue that it could lead to the patenting of human beings or other higher life forms. Others have raised concerns about the potential impact of gene patents on biodiversity and the environment.

Despite these concerns, the Diamond v. Chakrabarty decision remains a landmark case in biotechnology patent law and has played a major role in the development of the biotechnology industry.

Myriad Genetics vs. Association for Molecular Pathology

In 2013, the Supreme Court of the United States ruled in a landmark case known as Myriad Genetics vs. Association for Molecular Pathology (AMP). The decision determined that naturally occurring genetic material, such as human genes, cannot be patented. This ruling overturned two patents held by Myriad Genetics, which had claimed exclusive rights to the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer.

The case was brought by the Association for Molecular Pathology (AMP) and several other organisations, arguing that gene patents stifle medical research and limit patient access to genetic testing and healthcare. Myriad Genetics, on the other hand, defended their patents, asserting that they were necessary to recoup the significant costs of gene discovery and development.

The Supreme Court’s decision in Myriad Genetics had a profound impact on the biotechnology industry. It has been hailed as a victory for patient rights and medical research, as it allows scientists to freely study and develop tests related to these genes without fear of patent infringement. Additionally, the ruling has raised questions about the future of gene patents and the patentability of other naturally occurring substances.

The decision in Myriad Genetics has also spurred discussions about the appropriate balance between intellectual property rights and public health. It highlights the need for a patent system that encourages innovation while also ensuring that essential medical technologies are accessible and affordable to all.

The implications of Myriad Genetics extend beyond the United States. It has influenced patent laws and policies in other countries, leading to a more nuanced approach to gene patenting. The decision has also contributed to a broader debate about the ethics of profiting from genetic information and the role of the government in regulating the healthcare industry.

Conclusion

Biotechnology Patent laws vary around the world. Biodiversity, culture, technological advancements, ethical considerations, and social considerations make differences while patenting biological systems. The courts continue to grant patents to the biotechnology field to claim ownership of genetically altered biological material after perfect scrutiny, along with some restrictions like forbidding “limited DNA sequences.”

In spite of all these differences, the main aim of all patenting authority lies in non-obviousness, inventiveness, novelty, utility and industrial application. Collectively, if any biological material/microorganism is discovered by a person, it will not fall under patentable subject matter. However, when it is genetically modified to express a new characteristic and is useful to mankind, it qualifies as an invention and is eligible for patent protection.

The debate continues and is necessary to enhance the life of all living beings around the world.

References

• https://www.ncbi.nlm.nih.gov/books/NBK19867/
• https://ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_38_1_4-biotech-guidelines.pdf
• https://www.ijlmh.com/wp-content/uploads/Non-Obviousness-in-Bio-patents-The-US-and-the-EPO-Position.pdf
• https://www.wipo.int/treaties/en/registration/budapest/summary_budapest.html
• https://www.nottingham.ac.uk/ncmh/documents/bger/volume-15/bger15-8.pdf
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4382726/
• https://www.oecd.org/sti/futures/long-termtechnologicalsocietalchallenges/40181372.pdf
• https://blog.ipleaders.in/dimminaco-g-v-controller-patents-designs-paving-way-microbiological-patent-regime-india/
• https://supreme.justia.com/cases/federal/us/447/303/
• https://blog.ipleaders.in/diamond-vs-chakraborty-1980-an-analysis/
• https://www.wipo.int/treaties/en/registration/pct/summary_pct.html
• https://www.wto.org/english/tratop_e/trips_e/trips_e.html 

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