IP Basics in Life Sciences

The Inseparable Bond Between Medicines and Patents

Most people understand that patents are important in the life sciences industry, including pharmaceuticals and biotechnology. However, many might feel that the complexities of patents make them difficult to fully grasp.
In this column, I’ll focus on folks who think that way by providing an easy-to-follow explanation of intellectual property (IP) such as patents and trademarks.

Vol. 1: First, Let’s Talk About Medicine Classification and Patents

When you hear the word medicine, what comes to mind?
Perhaps things like “cold medicines, blood pressure treatments, COVID-19 vaccines, and anticancer drugs” come to mind. That’s right! These are all indeed examples of medicines classified by their intended use. But now let’s change our perspective a bit and think about medicines in a different way.
First, let’s talk about medicine classification and patents.

Instead of classifying medicines by how they are used, what if we classified them by how they are obtained? If we do this, medicines can then be divided into two categories: ethical drugs purchased with a doctor’s prescription and OTC (“over the counter”) drugs, which are available to anyone at pharmacies or drugstores.
Ethical drugs are highly specialized products that are strictly regulated by health authorities that govern the manufacturing, sales, and pricing of pharmaceuticals. In Japan, pharmaceuticals are regulated by the Ministry of Health, Labor and Welfare (MHLW); in the U.S., the FDA (U.S. Food and Drug Administration); and in Europe, the EMA (European Medicines Agency). So, regardless of the region, pharmaceuticals are overseen by regulatory bodies to ensure safety and efficacy.

Ethical drugs are further classified into “brand” and “unbranded” drugs.
Brand drugs are medicines that have new properties and effects, and whose efficacy and safety have been confirmed through clinical trials and other means, and subsequently approved by the health authorities. They are so-called new drugs, but also referred to as “original” or “branded” drugs. As you can imagine from this definition, in order for a brand drug to be approved, an application for approval must be submitted to the Ministry of Health, Labor and Welfare, accompanied by the results of clinical trials confirming the drug’s efficacy and safety, and the application must be reviewed and approved.
In contrast, unbranded drugs are medicines that are approved after the patent for a brand drug has expired and are recognized as being biologically equivalent to the brand drug in terms of ingredients and specifications. Now the key phrase here is “after the patent for the brand drug has expired”? Patents are involved in determining the medicine category, which forms the basis for the title of this column “The Inseparable Bond Between Medicines and Patents.”

Furthermore, the definition of unbranded drugs includes the phrase “approved as being biologically equivalent to the brand drug in terms of ingredients, specifications, etc.” This means unbranded drugs do not need to undergo clinical trials to confirm their efficacy and safety like brand drugs, but only need to undergo equivalence tests to confirm that they are “identical to the brand drug in terms of ingredients, specifications, etc. and biologically equivalent.”¹

Now that we understand how patents relate to medicine classification, let’s take a closer look at how we classify medicines.
Brand drugs and unbranded drugs are further subdivided based on their active ingredients. Among brand drugs, those with small-molecular compounds as active ingredients are called small-molecular drugs, while those with large-molecular compounds such as antibodies, peptides, and vaccines as active ingredients are called biologics. Correspondingly, among unbranded drugs, those with small-molecular active ingredients are called generic drugs (hereinafter referred to as “generics”), and those with large-molecular active ingredients are called biosimilars.

Medicine classification is shown in the following chart.

Finally, looking at the chart above, think about how the examples mentioned at the beginning of this article –cold medicines, blood pressure treatments, COVID-19 vaccines, and anticancer drugs– are classified.
Cold medicines are often purchased at drugstores or convenience stores, without the need to go to a doctor, so would fall under the OTC category. Blood pressure treatments (antihypertensive drugs) are generally purchased with a doctor’s prescription after being told “Your blood pressure is slightly high” during a medical checkup, and therefore, they are considered ethical drugs. There are many types of blood pressure medicine, but most of the brand drugs have expired patents, so now most of them are available as generics. The COVID-19 vaccines are new, so the patents have not yet expired. This means that the COVID-19 vaccines are classified as biologics (brand). Anticancer drugs include small-molecule drugs and biologics, but recently there has been an increase in biologics that use antibodies as their active ingredient. Herceptin (brand drug), which is used to treat breast and stomach cancers, has already seen its patent expire, so biosimilars are available.

¹ In some cases, accelerated testing is also required to confirm stability.

Author Profile

Yasuko Tanaka
President & CEO, S-Cube Inc. / Patent Attorney, S-Cube International Patent Office
Outside Director, Strategic Capital Inc.; Part-time Lecturer, Tokyo University of Agriculture and Technology Graduate School; Expert Committee Member in Intellectual Property Litigation

After working in the intellectual property departments of Teijin, Pfizer, and 3M Japan, she gained experience in domestic and international IP practices, IP strategy development, contract negotiations, IP education, and project management. In April 2013, she founded S-Cube Inc., an IP consulting company aimed at strengthening the international competitiveness of Japanese companies through IP utilization. In August of the same year, she established a patent office to provide seamless services including rights acquisition. Graduated in March 1990 from Chiba University, Faculty of Science, Department of Chemistry (Biochemistry).