Primary vs. Secondary Patents in Pharma Industry – What Is the Difference?

In the pharmaceutical industry, primary and secondary patents are two important types of intellectual property (IP) protection that drug companies use to secure their innovations. They serve different purposes and provide varying levels of protection for a drug. “Big Pharma” companies rely on both primary and secondary patents to beat competition in the market. These patents play a big role in medicines’ cost and market availability. In this article, you will learn about the differences between primary and secondary patents and how they are used.

Primary Patents (Composition of Matter Patents)

• Let’s start with what primary patents are:
  Primary patents are also known as composition of matter patents. They are granted for the active ingredient or compound in a drug that has never been disclosed or patented before. These patents are the most important for a drug because they cover the chemical structure of the drug, no matter how it is manufactured, used, or formulated.
• These patents offer the strongest protection for a drug because they prevent competitors from making, selling, or using the exact same compound. As long as the chemical structure remains unchanged, no one else can produce or sell the drug until patent expiration.
• Here’s what’s covered in primary patents:
  A composition of matter patent, aka primary patent, typically includes:
  • Broad structural claims: These describe the general chemical family or structure of the compound.
• • Narrower claims: These focus on the specific compound itself, providing even more protection.
  Primary patents are typically filed early in the development process and represent the core innovation of the drug. As with most patents, the narrower the claims, the more likely the patent is to be granted. This is why most pharmaceutical companies often apply for at least two separate patents, one covering the specific compounds that they intend to develop and one covering a broad range of similar compounds in an attempt to prevent competitors from developing “me-too” drugs from the same compound family. This allows the companies to ensure that no generic company can copy their product until the primary patent expires, making it the strongest defense for a brand.

Secondary Patents

• Here’s what secondary patents are:
  Secondary patents cover other aspects of the drug beyond the core compound itself. These patents often come later in the development process and protect modifications or improvements to the original drug. They are typically less robust than primary patents because they don’t cover the base compound, but they still provide additional protection.
• Why They’re Important:
  While secondary patents don’t protect the drug’s active ingredient directly, they can extend the drug’s exclusivity in the market, delaying the entry of generics. They focus on protecting aspects like new formulations, uses, or manufacturing processes. Historically, secondary patents have been one of the most successful strategies for maintaining post-patent sales. Typically, the new formulation is introduced 1-2 years before the primary patent expires. Once this patent is approved, the sales team in a pharmaceutical company convinces physicians to prescribe the new formulation. This way, by the time the generic brands arrive with the old formulation, the market will have already moved on to the new formulation. This strategy benefits the original drug brands, but it hurts the sales of the generic brands.
• Examples of Secondary Patents:
  1. Formulations: These patents protect specific ways to prepare the drug, such as in tablet form, liquid form, or sustained-release versions.
  2. Method of Treatment/Use: These patents cover specific ways to use the drug to treat particular diseases or conditions. For example, a secondary patent could cover a new use of an existing compound for a different illness.
  3. Minor Modifications: These can include patents on polymorphs (different forms of the same drug), isomers (chemically similar compounds), prodrugs (a compound that converts into an active drug in the body), esters (chemical modifications), or salts (chemically modified versions of the drug).
  4. Manufacturing: These patents cover new methods of producing the drug, potentially making the production process more efficient or cost-effective.

Overview of Main Differences Between Primary and Secondary Patents:

• Primary Patents:
  • Focus on the core drug compound.
  • Provide the strongest protection.
  • Are typically filed early in development.
  • Offer protection for longer periods (usually 20 years from the filing date).
• Secondary Patents:
  • Focus on modifications to the drug (e.g., formulations, uses, methods of manufacturing).
  • Offer less robust protection than primary patents.
  • Are filed later in the development process.
  • Extend market exclusivity

• To put it in perspective, think of roadblocks as a generic company’s path to the pharma brand. One strong primary patent would be virtually impossible to get past. However, when choosing secondary patents, you would have to rely on multiple of these, such as indications, formulations, and dosage to ensure that it is most effective. One single of the secondary is not sufficient to fully block the road.

Conclusion

Both primary and secondary patents are important tools in protecting pharmaceutical innovations. Primary patents ensure that a drug’s core active ingredient is protected from competitors, while secondary patents help to extend the lifespan of the drug’s market exclusivity by covering enhancements or changes to the original product. Together, they help pharmaceutical companies maintain their competitive edge in the market, from the development of a new compound to its ongoing production and use. However, if you look at the other side, one can also say that the way “Big Pharma” is looked at today is much different than it was years ago. Over 2 decades ago, branded drug companies were looked up to for their innovation, social awareness, and ethical measures. This shifted over the years as the profitability of branded drug companies rose drastically. Some “Big Pharma” started exploiting sick people for profit while failing to deliver worthwhile and innovative drugs to justify this. Many people now lost trust in a lot of “Big Pharma” companies due to years of untrustworthiness and dishonest behavior. However, things have been improving slowly as more regulations are being placed.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC7106985/#ref3
2. The book “Pharmaceutical Lifecycle Management” by Tony Ellery and Neal Hansen: