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Pharmaceutical drugs are essential to the healthcare sector, and their continued innovation has greatly enhanced the ability to treat more diseases. Drug patents help drug discovery companies achieve an ROI over the years of investments done in drug research, clinical trials and approvals.
To create new drugs that are both safe and successful at treating ailments, pharmaceutical companies dedicate time and years of research to innovation. They develop brand name drugs which they protect with patents. After the patents for a drug expire, other businesses (subject to necessary approvals) can manufacture and market the same drug formulation under a different brand name. Generic drugs, such as these, usually come at a much cheaper price and therefore help in making these medicines more accessible to the larger population.
In this article, we shall delve into pharmaceutical patents, their types, and relevant legislations that influence patent strategy in this industry.
Types of Pharmaceutical Patents
Patents can primarily be divided into four major types and each type serves to protect different aspects of an invention that has unique application requirements. Let’s take a look at these patent types and their applications.
- Process patents:
Process patents protect the specific processes of manufacturing, not the final product. These are commonly used in developing countries such as India and Argentina. These patents permit variations in processes, helping governments curb the monopoly of multinational firms and safeguard the needs of less affluent populations. However, they can deter investments in the pharmaceutical sector due to smaller profit margins, frequently resulting in mandatory licensing for public welfare.
- Product patents:
Product patents grant inventors sole rights to their creations, preventing others from making or selling the same item. Many developed countries, like the United States, the United Kingdom, France, Germany, and Canada along with the countries following the TRIPS agreement, offer product patent regimes. On the other hand, while they do safeguard inventors, these patents can create monopolies, which can be especially harmful in less developed places where people struggle to get basic needs.
- Formulation patents :
Formulation patents guard the specific forms or compositions of drugs, including certain drug classes and general formulations used in various medicines. Examples include slow-release technologies and transdermal patches. Knowing the patent type is important when doing a thorough patent search, as it helps to focus the search.
- Product-by-process patents
Product-by-process patents define a product by how it’s manufactured. They are issued when a product can’t be set apart from previous creations except by its manufacturing method. Nonetheless, what matters for getting a patent is the product, not how it’s made. If a product from a product-by-process claim isn’t new or unique, it won’t get a patent, even if the earlier version was made differently.
In conclusion, the four primary patent types each cater to distinct aspects of innovation, striking a balance between promoting invention, protecting inventors’ rights, and ensuring public well-being.
Types of Pharmaceutical Patent Claims
Pharmaceutical patents are often issued for the chemical components of drugs as well as the processes involved in producing or utilizing them. A patent application for a pharmaceutical product may contain any of the following claims:
1. Compound claims: These can identify a compound as a specific compound, a class of individual compounds, or a collection of distinct compounds.
2. Composition claim: These claims may cover a composition that comprises the chemical.
3. Article claims: These can refer to a piece of merchandise made of or containing the substance.
4. Process claims: These claims might refer to both the compound that is prepared by the process and the process itself.
5. Claims relating to the use of a substance in a particular way or under specified conditions are covered by these claims.
6. Claims involving a substance used to treat a medical condition: These claims may relate to the usage of the substance to treat a particular medical condition.
7. Claims regarding the treatment method: These claims may refer to using the substance to cure a polymer composition or treat a specific medical condition.
8. Claims relating to the use of a substance in the production of medicines: These claims, also referred to as “Swiss style” claims, can relate to the use of the importance in the production of a medicament for treating a specific medical condition.
In essence, pharmaceutical patent applications encompass a wide array of claims, each detailing unique aspects of drug development and usage.
Legislative Pharma-Patent Shifts
Major legislations and developments have significantly influenced the evolution of pharmaceutical patents over time. These regulatory changes have shaped the rules for patent protection, establishing the framework for innovators to secure their pharmaceutical inventions.
1. Supreme Court Decision in Mayo and Myriad: These were the two important decisions that changed how some patents work in medicine. In Mayo, the decision was that a method for figuring out the right dose of a drug couldn’t be patented because it was based on natural law. In Myriad, the decision was that DNA segments found in nature can’t be patented, even if they’re taken out of an organism’s genome. These decisions changed what can be patented and could affect the value of intellectual property in the field of life sciences.
2. Patent Term Extension and Hatch-Waxman Act: The Hatch-Waxman Act is a law that helps drug companies delay the expiration of patents on prescription drugs, allowing them to keep their monopoly on the drug for longer, which can lead to higher prices. The law also helps generic drug companies challenge patents and develop generic drugs while the brand-name drug is still under patent. This can help lower drug prices and healthcare costs.
3. TRIPS Agreement: The Agreement on Trade-Related Aspects of Intellectual Property Rights, is a global agreement that sets rules for protecting intellectual property. It requires countries to protect patents for products, including medicines. This has had a big impact on how pharmaceutical patents have evolved, especially in developing countries.
Pharmaceutical patent disclosure refers to the requirement that the patent applicant must disclose details of the invention in their application, which then becomes public information. This is a requirement of member governments under the WTO TRIPS agreement ¹.
Current Trends in Pharmaceutical Patents
The landscape of pharmaceutical patents is constantly evolving, reflecting the industry’s rapid innovation and shifting regulatory environments. Let’s take a dive into some notable current trends that are shaping the patenting activity of the pharmaceutical industry.
1. Biosimilars and Bio-betters: As the patents on major biological drugs expire, there is a growing trend towards the development of biosimilars and bio-betters, which are similar or improved versions of these biological drugs. These create unique challenges in the patent landscape due to their complexity compared to small molecule drugs.
2. The increase in Digital Therapeutics and Artificial Intelligence (AI): AI has transformative potential in drug discovery. It can deliver value in small-molecule drug discovery in four ways: access to new biology, improved or novel chemistry, better success rates, and quicker and cheaper discovery processes. AI can address many challenges and constraints in traditional R&D. AI-enabled digital therapeutics and personalized recommendations will empower consumers to prevent health issues from developing.
3. Increased focus on Personalized Medicine: The pharmaceutical industry is increasingly focusing on personalized medicine, which tailors treatment to an individual’s unique characteristics. Advances in molecular diagnostic technologies, data storage, and computing power, and machine learning algorithms are pushing the boundaries of treatment pathways. Personalized medicine has the potential to improve the effectiveness of diagnostics, treatment, and prevention, leading to more efficient and equitable healthcare.
In Canada, one of the biggest trends in 2021 was the focus on drug prices and the PMPRB (Patented Medicine Prices Review Board). There were also developments in the inventive concept, overbreadth, statute of monopolies, judicial review, and summary proceedings¹.
Future trends
Several trends could impact the future landscape of patent protection in the pharmaceutical industry. These trends provide insights into the future direction of pharmaceutical advancements and the legal frameworks that will be needed to protect them.
- Emerging technologies: Technological advancements such as gene editing, personalized medicine, and artificial intelligence are likely to influence how pharmaceutical ideas are generated and protected. These technologies may result in new sorts of innovations, necessitating regulatory changes to provide effective patent protection.
- Regulatory modifications: To address developing difficulties in the pharmaceutical business, governments, and regulatory organizations may modify patent laws and regulations. Finding a balance between stimulating innovation and promoting cheap access to medicines may be necessary.
- Societal factors: Growing worries about affordable healthcare and escalating drug costs may influence patent policies. To provide more access to life-saving pharmaceuticals, governments, and public opinion may advocate for measures to increase generic competition, shorten exclusivity periods, or impose forced licensing.
These developments may influence innovation and patient access to medications.
Conclusion:
A well-crafted patent strategy along with the right combination of product, formulation, or method patents around the drug and its production process is necessary to ensure that the competition doesn’t take a piece of the drug’s addressable market. That being said, while patent protection and the resulting exclusivity in the market are important in motivating companies to invest in pharmaceutical research and development, a balance must be struck that allows for innovation while also providing cheap and timely access to new therapies. The changing picture of patent protection is likely to continue as society, technology, and healthcare requirements evolve.
