How Does Intellectual Property Protection Work in the Pharmaceutical Industry?

intellectual property protection

When it comes to drug creation and formulation, ensuring that both the creator and the property are protected is key. That is why it is important to understand what your intellectual property rights are, and how to defend them even after FDA review and distribution.

With that in mind, check out our informational guide on intellectual property protection, and how it applies to the pharmaceutical industry.

An Overview of Intellectual Property Protection

Intellectual property protection was established to legally safeguard ideas and inventions of the mind. This includes original pieces of work, such as artistic creations, symbols, names, manufacturing processes, pharmaceutical formulas, and beyond.

Intellectual property also comes in various forms depending on the medium of the work. The main types that you should be familiar with relate to the following:

  • Patents
  • Data exclusivity
  • Trade secrets
  • Copyright
  • Trademarks
  • Regulatory exclusivity

Why Is Intellectual Property Protection Vital in the Pharmaceutical Industry?

The protection of intellectual property in the pharmaceutical industry allows pharmaceutical creators to benefit fiscally from both idea fabrication and product manufacturing. Additionally, some of the reasons that intellectual property is legally protected and closely monitored include the following:

  • Promotes continuous innovation – Since patents and other intellectual property types provide outside investors with the motive to put money into the research phase of drug creation, pharmaceutical scientists can continually work on evolving existing developments. Along with manufacturing and distributing current drugs, scientists can also create new drugs and start desired projects while knowing that their progression is being fully supported financially.
  • Increases economic growth – Due to the ongoing process and competition that comes with bringing new drugs to the market, the creation of pharmaceuticals can produce further economic opportunities, such as generating new jobs and boosting overall exports on a global scale.
  • Prevents misuse and confusion – With intellectual property protection, the rights to the formula and branding of a product belong solely to the company or individual who created it. That means consumers will know exactly who and where the product has come from, as well as what the intention of the specific product is. This will avoid misuse of the product itself, as well as confusion about the specifications of the product.

Overall, the protection of intellectual property increases innovative initiatives for companies looking to cultivate and expand upon drug development ideas and procedures. Alongside the developmental period for pharmaceuticals, intellectual property measures also legally protect creators from property infringement by competitors, ultimately boosting the production, distribution, and consumption of necessary medications.

A Brief History of Pharmaceutical Intellectual Property Protection

When it comes to protecting the creation of new drugs, applications, and research, intellectual property protection is crucial. The origins of intellectual property are not new ideas either, as the first instances of intellectual property disputes and one-year patent statements date back as far as 500 B.C.E.

In the modern era, there have been numerous cases that have shaped how we navigate property ownership and distribution. Alongside those cases, here are just some of the notable historical events that have progressed intellectual property rights:

  • 1928 – Alexander Fleming discovered penicillin at St. Mary’s Hospital in London. This discovery marked the beginning of the antibiotic age, which lasted until around 1970, with 1940 to the early 1960s being considered the true golden age of the antibiotic era. During this time as well, product patents for drugs became more prevalent as growth and expansion prospered, though global drug patents were first introduced for the pharmaceutical industry in the late 17th century.
  • 1984 – The Hatch-Waxman Act was established in the United States, laying the foundation both legally and economically for the U.S.’s generic pharmaceutical industry. And as more countries, such as Canada, began to recognize the importance of drug patents as well, multinational corporations (MNCs) within the pharmaceutical industry started to advocate on a global level for stronger intellectual property protection and patent laws for their products.
  • 1994The TRIPS Agreement was established in this year and set minimum enforceable standards for various forms of intellectual property across numerous industries. For the pharmaceutical industry, it required countries part of the World Trade Organization (WTO) to make patents available for any products or processes without discrimination, completely replacing the “process patent” system that was in place at the time.
  • 2000 onward – Patent thickets, evergreening, and consolidation practices become highly common in the pharmaceutical industry. Also during this time, we saw large lobbying efforts in the United States to try to prevent price controls from stopping skyrocketing prices on necessary drugs. This includes key bills, such as The Inflation Reduction Act of 2022.

FAQs – Additional Aspects to Consider

For more of an in-depth look at intellectual property protection and how to navigate the main types, check out the answers to some of our most commonly asked questions.

How long do patents last on new drugs?

As of this writing, patents last 20 years from the filing date listed on the patent application. Once a drug patent expires, manufacturers other than the original developer have the freedom to produce generic versions of the product. These drugs are usually clinically equivalent to the original.

Can generic drugs have the same trade name as the original drug?

No. Though the chemical composition may be almost exactly alike, trademarks protect the original brand name, and generic brands must accommodate these regulations to avoid consumer confusion.

Does intellectual property protection increase drug prices?

Yes, it can potentially lead to an increase in drug prices. This is because patent exclusivity both delays cheaper versions of a drug from being made, as well as allows drug companies to have complete control over the pricing of their products.

How are manufacturing processes and drug formulas protected today?

One of the key ways drug formulas and their processes are protected is via trade secrets, which provide companies with a competitive advantage. These secrets do not need to be registered and can be protected for an unlimited amount of time, though there are some conditions for protection, including the following:

  • The information must not be known to the general public
  • The formula or process must have commercial value to be secret
  • Reasonable steps must be taken by the information holder to keep it secret

Contact Oakwood Labs Today to Learn More

Have any additional questions? If so, reach out to our team at Oakwood Labs today. We look forward to answering your questions or discussing our services with you.

Mark Ilhan