Intellectual Property in the Pharma Industry

From trademark search to patent protection, discover the importance of intellectual property (IP) in the pharma sector, including key steps to take for pharmaceutical drug naming and the role of patents and trademarks.  

The requirement for registering and protecting intellectual property (IP) is not optional for many products in the pharma sector. Excluding certain health supplements and cosmetics, pharmaceutical companies are required to trademark medicinal products they plan to bring to market—including a requirement for legal and regulatory trademarks. In addition, a company will usually seek to protect the fruits of its research and development (R&D) investment by patenting the composition, process, machinery, and any other aspect of the product that is proprietary. 

• 1. Trademark Searching in the Pharmaceutical Industry
• 2. Pharmaceutical Drug Naming: Name Creation for Medicinal Products
• 3. Adding Value with Branding and Trademarks
• 4. Patents for Pharmaceutical Inventions
• 5. Other IP Management Requirements 

Trademark searching is one of the most important stages in bringing a product to market. Like many other consumer products, the process for non-medicinal products is more straightforward. However, trademark searching for a medicinal product is generally more complex and lengthy, beginning in the early stages of product development. Obtaining a legal trademark for a medicinal product is not usually the main challenge; the complexity arises when obtaining a regulatory trademark, which requires specialist industry experience and knowledge.  

The level of scrutiny on trademarks for medicinal products is extremely high. While a pharmaceutical company will seek a trademark that works well for its brand, it is also important to use a generic name and brand name that cannot be confused with other existing products. As such, pharmaceutical trademark attorneys and branding specialists will develop a large selection of potential names—sometimes up to 5,000 or more. The company’s marketing and legal specialists will consider these candidate names before the shortlist is carefully reduced to a more manageable selection for preliminary screening.  

Most pharmaceutical companies will opt for a global trademark search to ensure the broadest potential reach for their product. At this point, there will be significantly fewer potential candidate names, perhaps less than 10; these names will be carefully selected to proceed to the final screening stage. This will include a more thorough legal and regulatory search, the latter of which requires reviewing sources such as the Orange Book (FDA), United States Approved Names, and other sources depending on the target markets for the product (find out more about the relevant pharmaceutical databases). 

When considering patents for pharmaceutical inventions, a business must also understand the distinction between patents and exclusivity, namely in the U.S. as governed by the FDA. A company may hold a patent for a pharmaceutical drug, even if it has not been approved yet. In this way, a patent can be issued at any time in the product lifecycle and may run concurrently with the exclusivity of a medicinal product.    

Exclusivity refers to the delay or prevention of competitor products that may become available on the market. This is used to encourage new product development by delaying generic versions of a drug from becoming available. There are different periods of exclusivity depending on the specific situation. Obtaining a patent and exclusivity is critical from a business perspective as it protects a product from being sold by competitors and also provides a level of control over how a drug may be priced in the market. It is advisable to consult with a specialist experienced in pharmaceutical patents to understand how patents and exclusivity can be used to protect and benefit your business. 

New medicinal products will comprise three names: a chemical name, a generic non-proprietary name, and a branded name. For example, a commonly used antidepressant used worldwide is known by the chemical name N-methyl-3-phenyl-3[4-(trifluoromethyl)phenoxy]propan-1-amine, the generic name fluoxetine, and the brand name Prozac. While the chemical name would be impossible to market to consumers, the difference between the generic and brand names is usually to provide a medical name independent of a specific brand.  

Name creation is considered one of the most challenging aspects of IP in pharma due to the high level of name rejection by organizations such as the U.S. Federal Drug Agency (FDA). Between 20% and 35% of brand names are rejected every year as a measure to reduce the risk of error in prescribing, dispensing, or taking medication, which can result in health issues, such as worsening symptoms, injury, or death. The source of inspiration for a generic name and brand name can be a simplification of the chemical name for the drug and/or the desired effects someone may expect from taking the drug.  

Several agencies and standards must approve a new generic name depending on where the drug will be marketed, including but not limited to the World Health Organization’s International Nonproprietary Names (INN), the United States Adopted Names (USAN), the FDA, and the European Medicines Agency (EMA). For this reason, many companies work with pharmaceutical IP specialists to create suitable and distinguishing names for their products, thereby avoiding potential rejection during the review process. 

The relationship between the consumer and a pharmaceutical brand is based strongly on trust. Pharmaceutical companies invest time, money, and resources to develop a brand that delivers trustworthy products that provide specific results and consumers entrust their health and well-being to a company when using those products. Therefore, it is important to distinguish and protect the brand on a company and product level. Consumers should not confuse or easily mistake your company or product brand with that of another company. Building and protecting a brand with trademarks protects your consumers and bottom line. 

The strict requirements for trademarks within the pharmaceutical industry make the trademark registration process very complex since it covers legal and regulatory reviews. While it can be relatively straightforward to obtain a trademark, the challenges posed by pharmaceutical trademarks are much more complicated, as they are subjected to a higher level of scrutiny by multiple agencies. For this reason, it is important to consult with a pharmaceutical IP specialist to ensure you navigate the process as easily as possible while ensuring your brand is adequately protected within a realistic budget for your business.