Patent Requirements and Biotechnology Patents: Patentability, Protection, and Application Process Explained

 

TABLE OF CONTENTS

• Introduction: Biotechnology and Society
• Public Perception of Biotechnology
• Conclusion
• Patents in Biotechnology
• The Purpose of a Patent
• Patentable Inventions
• Biotechnology Patents
• Patent Requirements
• The Patent Application
• Patent Licensing

INTRODUCTION: BIOTECHNOLOGY AND SOCIETY

• New technologies affect society in many different and complex ways.
• Their introduction can lead to economic, social, and ethical consequences, both from the adoption of new methods and from the replacement of traditional processes.
• Major technological developments, particularly molecular biotechnology, are rarely introduced without controversy and public debate.
• Molecular biotechnology has the potential to influence important areas of modern society, especially food production and medical treatment.
• Because of its wide impact, significant ethical, legal, economic, and social issues must be carefully considered.
• Since the development of recombinant DNA technology in 1973, some individuals have raised serious concerns about its safety.
• Questions focused on whether genetically modified organisms could escape laboratory control and pose risks to human health or the environment.
• To address these concerns, official regulatory guidelines were created to ensure:
• Recombinant microorganisms could not survive or spread outside the laboratory
• Laboratory workers were protected from potential hazards
• These regulations were formulated in 1974–1975 through open meetings that were monitored by the press, increasing public awareness.
• As a result, the public became more informed about both the positive possibilities and potential dangers of genetic manipulation.
• In 1998, a strong campaign began opposing the planting of genetically modified crops and the marketing of GM-derived products.
• This response was driven by multiple concerns, including:
• Human health and food safety
• Environmental impacts, such as effects on biodiversity and ecological balance
• Corporate control of the food industry
• Monopolies in global agricultural trade
• Trust in public institutions
• Integrity and independence of regulatory agencies
• Loss of individual consumer choice and reduced farmer autonomy
• There has also been ongoing debate about the ethics of genetically modifying animals, including issues of animal welfare and moral responsibility.
• Overall, the applications of molecular biotechnology raise complex ethical, legal, and social questions, and there are no simple or easy answers to these issues.

PUBLIC PERCEPTION OF BIOTECHNOLOGY

• Biotechnology is both valued and feared because of its potential effects on the environment and on human life.
• Due to its ability to influence social values, social relationships, and environmental issues, biotechnology has become a major focus of debate between different socio-ethical viewpoints.
• Two major factors dominate public perception of biotechnology:
• Lack of trust
• Ignorance or lack of scientific understanding
• It is very difficult to have a meaningful discussion with people about biotechnology if they do not understand the science behind it.
• Scientific ignorance leads many individuals to develop anxieties and fears about biotechnology.
• When people do not understand the issues, their opinions can easily be influenced by arguments claiming that all biotechnology is morally dangerous, mainly due to a fear of the unknown.
• Several religious and social groups interpret developments in biotechnology in very different ways.
• Two major socially and ethically important questions often raised are:
• Should humans be allowed to “play God”?
• Should humans be allowed to genetically modify organisms through genetic engineering?
• Should humans be allowed to clone animals or even humans?
• Who owns the technology and its creations?
• In genetic engineering, who is the owner of a genetically modified organism?
• In cloning, who are considered the parents of a cloned organism?
• There are two major opposing ideologies regarding the use of science and technology in society:

1. Holistic ideology
2. Reductionistic ideology

1. Holistic ideology

• Holistic ideology supports the use of traditional methods in all areas of life, including agriculture and industry.
• It argues that modern society places too much importance on formal scientific knowledge while ignoring informal and traditional knowledge systems.
• According to this view, there is no real agricultural production problem in the world.
• The Earth is capable of producing enough food for the entire global population if people return to consuming traditional grains that are easier to grow.
• This ideology recommends:
• Use of chemical manures
• Use of pesticides and herbicides
• Minimum tillage practices to conserve soil and maintain productivity
• It claims that the main global problem is unequal distribution of food, not food shortage.

2. Reductionistic ideology

• Reductionistic ideology, in contrast, supports the use of modern scientific knowledge and technology to improve agriculture and crop quality.
• It emphasizes the need for continuous research and development to discover new solutions to agricultural and environmental problems.
• Both ideologies, along with their variations, present different perspectives on sustainable development, particularly regarding how to achieve progress while ensuring minimum environmental impact.

CONCLUSION

• Biotechnology has great potential as a powerful tool to:
• Preserve and improve environmental quality
• Help address food production problems
• Improve human health
• However, if there is no proper public understanding, acceptance, and support, the ability of biotechnology to contribute to solving environmental issues and food security challenges will be limited and obstructed.
• In discussions and debates about biotechnology, it is important that different groups actively participate, including:
• The general public
• Scientists
• Governments
• Religious groups
• These discussions should focus on the social implications of biotechnology, considering it as:
• A scientific field
• A technological tool
• A rapidly growing industry
• There is a need to develop organized programs that include activities aimed at:
• Harmonizing and clarifying biotechnology regulations
• Understanding consumer attitudes toward biotechnology
• Identifying and addressing the social and ethical concerns raised by biotechnological developments

PATENTS IN BIOTECHNOLOGY

• A patent is a formal agreement between the government and an inventor.
• In exchange for the inventor providing a complete public disclosure of the invention, the government grants the inventor certain exclusive rights.
• These rights allow the inventor to exclude others from:
• Making the invention
• Using the invention
• Selling the invention
• Importing the invention
• These exclusive rights are granted only for a limited period of time.
• The property rights granted by a patent are different from ordinary property ownership.
• Owning a patent does not mean physical possession of something, but rather the legal right to prevent others from commercially exploiting the invention.
• In the United States, patent applications are examined by the United States Patent and Trademark Office (PTO).
• The PTO is responsible for evaluating patent applications and granting patents if the invention meets legal requirements.
• A patent generally lasts for 20 years from the date the patent application is filed, not from the date the patent is granted.
• Because of the time taken for examination, the effective enforceable term of a patent is usually between 17 and 20 years, depending on how long the application remains under review at the PTO.
• After the patent expires, the invention enters the public domain.
• At that point, anyone is legally free to:
• Make
• Use
• Offer for sale
• Sell
• Import
• the invention without needing permission from the original patent holder (patentee).

THE PURPOSE OF A PATENT

• The main reason for having a patent system is to provide a benefit to society as a whole by encouraging and rewarding the creation of new inventions.
• The patent system is designed around two fundamental objectives:

1. To promote the advancement of science and technology
2. To protect the rights and interests of the inventor

• To be granted a patent, an inventor must clearly teach the public how to:
• Make the invention
• Use the invention
• in the best way known to the inventor.
• This means the patent system rewards only those inventors who are willing to share technical knowledge with society instead of keeping it secret.
• The information disclosed in a patent application often becomes available to the public before the patent is officially granted.
• When a patent application is filed internationally, it is usually published 18 months after the initial filing date.
• After publication, the patent application and all technical details become accessible to anyone, which helps:
• Spread scientific knowledge
• Encourage further research
• Stimulate technological innovation
• Because patents encourage innovation, knowledge sharing, and technological growth, countries with strong patent protection systems tend to be among the most scientifically and technologically advanced in the world.

PATENTABLE INVENTION

Under U.S. patent law, several categories of inventions are eligible for patent protection. These include:

• A process
• A method or procedure for doing something
• Examples include:
• A process for manufacturing a chemical substance
• A method of treating a cancer patient by administering a specific drug
• A machine
• A device or mechanical system designed to perform a function
• Examples include:
• A flat-screen device
• A gene gun
• An X-ray machine
• An article of manufacture
• A man-made item produced from raw or prepared materials
• Example:
• A silicon computer chip
• A composition of matter
• A chemical composition or mixture of substances
• Example:
• A new pharmaceutical drug
• Certain things cannot be patented under U.S. law. These include:
• Naturally occurring organisms
• Laws of nature
• Natural or physical phenomena
• Abstract ideas

BIOTECHNOLOGY PATENTS

• Biotechnology inventions typically fall into several major categories of patentable subject matter.
• One major class includes new compositions of matter, such as:
• Newly discovered and isolated nucleic acids
• Proteins
• Pharmaceutical products developed from these nucleic acids or proteins
• Cell lines transformed using specific nucleic acids
• A naturally occurring gene or protein in its original state inside the body cannot be patented.
• However, a gene or protein that has been isolated from the body and has a specific practical use can be patented.
• Such isolated biological materials may be patented if they are useful as:
• A drug
• A screening assay component
• Part of another scientific or medical application
• Another category includes methods of making these biotechnology products, for example:
• Production using transformation technology
• Use of cell culture technology to produce proteins or other biomolecules
• Biotechnology patents also cover methods of medical treatment, such as:
• Treating a particular disease using a specific gene
• Treating patients with a particular protein-based therapy
• Even if one inventor holds a patent on a particular gene or protein, another inventor may still obtain a patent on a new use of that same gene or protein, provided that:
• The new use is different
• The new use is novel and non-obvious
• Another important category involves methods of detecting or monitoring diseases, including:
• Diagnostic methods
• Detection assays used to identify disease states or monitor progression

PATENT REQUIREMENTS

• To obtain a patent for a new invention, an inventor must demonstrate that several key legal requirements are satisfied.
• The first requirement is novelty.
• The invention must be truly new.
• It must not have been previously described, known, or discovered by someone else before the inventor filed the patent application.
• The second requirement is non-obviousness.
• The invention must not be something that would be obvious to a person skilled in the relevant field based on prior knowledge or existing work.
• In the case of patenting a gene or protein, meeting the novelty and non-obviousness criteria usually requires that the inventor knows the chemical structure of the gene or protein.
• If the structure of that gene or protein is already known, the inventor generally cannot satisfy this requirement.
• The third requirement is usefulness (utility).
• The invention must have a specific and practical real-world use.
• Simply discovering a new gene or protein is not sufficient.
• The inventor must clearly state how it can be used, for example:
• As a drug for a particular disease
• As a target for treating another disease
• As part of a diagnostic or therapeutic application
• Another essential requirement is adequate disclosure in the patent application.
• The application must describe the invention in sufficient detail so that others can understand it.
• The inventor must “enable” people who are skilled in the relevant technological field to:
• Make the invention
• Use the invention
• based on the information provided in the application.

THE PATENT APPLICATION

• To obtain patent protection, an inventor must submit a patent application in each country where protection is desired.
• Patent rights are territorial, meaning protection in one country does not automatically provide protection in another.
• In the United States, a patent application generally includes several essential components:

1. A written document in English (the specification)

• This document must clearly and fully describe the invention.
• It explains how the invention works and how it can be made and used.

2. Drawings of the invention (when necessary)

• Drawings are included if they are needed to properly understand the invention.
• They help illustrate the structure, design, or operation of the invention.

3. An oath or declaration by the inventor

• The inventor must formally state that they believe they are the original inventor of the claimed invention.
• This establishes inventorship.

4. A filing fee

• A fee must be paid when submitting the application.
• The amount of the fee can vary depending on the type and details of the patent application.

PATENT LICENSING

• A patent license is a legal contract between:
• The owner of a patent (licensor), and
• An independent party who wants to make, use, or sell the patented invention (licensee).
• Through this contract, the patent owner essentially promises not to sue the licensee for patent infringement, as long as the licensee follows the agreed terms and conditions.
• In return, the licensee usually agrees to provide financial compensation to the patent owner, which may include:
• A percentage of revenue earned from selling the invention (royalties)
• Additional license fees
• Patent licensing is particularly useful when a patent owner does not have the resources, facilities, or expertise to fully develop and market the invention alone.
• By granting a license to another party, the patent owner can collaborate with that party to commercialize the invention.
• In some situations, using an invention may require licenses from more than one patent owner.
• For example:
• One person may hold a patent on a new protein.
• Another person may hold a patent on a new use of that same protein.
• A third party wishing to sell the protein for that new use would need a license from both patent holders.
• If both patent owners want to market the protein for the new use themselves, they may need to grant licenses to each other.
• Such mutual agreements are known as cross-licenses.
• In fast-moving and rapidly advancing technological fields, cross-licensing is very common, as multiple patents often overlap in complex inventions.