Pharmaceutical Patents and Intellectual Property

Protecting new treatments, technologies, and drugs is extremely important for pharmaceutical companies, and the simplest and most effective way of preserving any invention is pharmaceutical patents. A patent is a government authority granting a person or an entity the exclusive right to sell an invention for a set period.

While most people assume that patents give the holder the exclusive right to make the product, the reality is different—patents prevent others from making or selling the patented product. For example, Johnson & Johnson has patented Bedaquiline. Other companies cannot manufacture or sell Bedaquiline during the patent period, giving Johnson & Johnson exclusivity over the drug.

All pharmaceutical companies patent their inventions to preserve their interests and ensure they can financially benefit from the technology.

What can (or can’t) you patent?

The invention can only be patented if novel, useful, and non-obvious. The invention is considered “novel” only if it provides a new and inventive solution to a technical problem. Hence, ideas, scientific principles, or human lives are patentable. Furthermore, the patent should never have been publicly disclosed.

In the context of the pharmaceutical industry, companies can patent just about everything—drugs/compounds, formulations, processes, and designs. Hence, there are many different types of pharmaceutical patents.

Types of Pharmaceutical Patents

The following are some of the most common types of pharmaceutical patents companies use: 

Product patents

Product patents are filed specifically for compounds and tangible products. These patents can be filed by an individual as well as pharmaceutical companies. When in effect, the same product cannot be created, developed, or manufactured by any other manufacturer using the same or different process.

Process patents

These pharmaceutical patents are specifically applicable to processes for creating or manufacturing a product. Under these patents, the manufactured product is not patented, but the process is. Hence, a competitor can manufacture the same product if they do not use the same process.

Product-by-process patents

These pharmaceutical patents govern both the product and its manufacturing process. Product-by-process patents are generally granted when the final product can be distinguished from its competitor only via the method used to manufacture it.

Formulation patents

Formulation patents protect the pharmaceutical dosage form of a drug. They are also called composition patents and are usually used for slow-release technologies and patches. Formulation patents help companies extend protection beyond the original patent. They also cover excipients and drug delivery mechanisms.

Combination patents

Combination patents govern the combination of two or more active ingredients. Hence, competitors cannot use the same combination of active ingredients when the patent is in effect. These pharmaceutical patents also protect using multiple drugs to treat specific conditions.

Method-of-use patents

Method-of-use patents protect a specific method or procedure for using a product to achieve a particular result. For example, a pharmaceutical company can patent the technique via which a drug can be used to treat a specific disease. In this type of patent, the focus is on the use of the product rather than the product’s innovativeness or manufacturing process.

Pharmaceutical companies can file as many patents as they need to protect their intellectual property rights over the product. However, each patent must demonstrate that the innovation is novel, useful, and non-obvious. While there are many types of patents, the filing process for each is generally the same.

Pharmaceutical Patent Filing Process

Step 1: Application drafting

The inventor needs to draft a detailed application stating all the details of the invention. Generally, a patent application includes the following:

• Title: A crisp and precise title for the invention.
• Abstract: A summary of the invention.
• Background: A clear explanation of the problem the invention solves.
• Description: Detailed information regarding the drug, manufacturing process, formulation combination, and method of use.
• Claims: Detailed legal boundaries of the invention, e.g., how the patent will protect the invention?
• Drawings: Detailed and labeled illustrations of the invention.

Once the application is complete, most inventors consult a patent attorney to ensure it is legally sound.

Step 2: Jurisdiction decision

Once the application is partially or fully complete, inventors must decide the filing region. Inventors can file patents in the various areas:

• National filing: A national patent protects the invention only in a specific country. For example, if a patent is filed in India, it is enforceable only in India. Hence, competitors based in the UK or other countries may use the technology without breaching patenting laws.
• International filing: Under the Patent Cooperation Treaty (PCT), inventors can file a patent for their invention in multiple countries using the same application. Most countries are parties in the PCT, and only a few exceptions like Argentina, Uruguay, Venezuela, and Pakistan remain.
• Regional filing: Regional filing can be done through organizations like the European Patent Office or the African Regional Intellectual Property Organization. When filing through such organizations, the filed patent would be applicable in all countries that recognize the organization.

The documentation requirements for each region may be different. Hence, deciding on the filing route before patent submission is necessary.

Step 3: Patent Submission

Inventors can submit two types of applications: a provisional application and a complete application:

1. Provisional application: A provisional application is just a placeholder of the actual complete application. It is usually fined to establish an early filing date (or a priority date), which may be crucial if competitors file competing patents because patent offices will consider it as “prior art” when the competitor files their patent. The provisional application needs to be completed within 12 months to ensure it will be considered for approval.
2. Complete application: A complete application includes all the details mentioned in Step 1. This is the final application submitted and examined by the patent offices. The patent office decides whether the patent request will be granted or not based on the complete application.

The patent applications are submitted to the offices of the respective patent office, who then examine them.

Step 4: Patent examination

Once the patent is filed, the patent office examines the application. This generally includes two stages:

• Formal examination: A formal examination generally includes the evaluation of compliance, e.g., checking whether all required documents are attached and forms are submitted.
• Substantive examination: A substantive examination includes the evaluation of the novelty, use, and non-obviousness of the invention. The invention’s industrial applicability and originality are also evaluated.

The patent office may share objections or queries at either stage, and the inventor must provide sufficient data to support their patent claim.

Step 5: Patent granting

If the pharmaceutical patent meets all the legal and technical requirements, it is granted, and the inventor gets the intellectual property rights over the technology. However, even after the patent is granted, the inventor has to pay maintenance fees to keep the patent active. Pharmaceutical patents usually last 20 years from the date of filing. Due to regulatory delays, pharmaceutical companies can request patent term extensions for up to 5 years.

What’s Next?

Once the patent is filed, the inventor has exclusivity for 20 years. In this period, pharmaceutical companies can obtain the necessary product approvals and manufacture and market the product. While 20 years may seem like a long period—and for many products, it is!—in the pharmaceutical industry, it is a mere drop in the bucket!

Since 2020, the patents of many Big Pharma companies have expired. This decade will see the expiration of 15+ blockbuster patents, all from major companies like Merck, Johnson & Johnson, Pfizer, GSK, Amgen, and Novo Nordisk. As these patents expire, we may be able to see new partnerships or strategic alliances as pharma companies scramble to maintain their position in the industry.

FAQs

1. What does “non-obviousness” mean in the context of patents?

A patent cannot be filed for an invention whose use is obvious or general knowledge. For example, Newton could not patent gravity because it was apparent.

2. Can patents be challenged?

Yes, patents can be challenged before and after they are granted. Competitors or generic drug manufacturers may also file lawsuits to revoke pharmaceutical patents.

3. How do generic drug manufacturers bypass pharmaceutical patents?

They file patent revoke lawsuits, manufacture the drug after the exclusivity period/patent has expired, use different processes, or launch in regions with weak patent enforcement.