Patent protection for 42 yrs for Humira/32 yrs for Keytruda

with evergreening

It was analyzed that Humira maintained its patent protection period for at least 42 years and Keytruda for at least 32 years after filing for material patents with the Evergreening patent strategy.

 

Evergreening refers to extending the term of a patent or extending the term of a patent for more than 20 years in the case of a patent to obtain more exclusive rights during the patent protection period.

 

The types of evergreening strategies are representative of salt compounds, solvates, crystalline forms, optical isomers, dosage forms and pharmacokinetic data, manufacturing methods, and uses.

 

Kim Tae-Kwon, responsible for the Korea Institute of Patent Technology Advancement, held on the last day of the 'Bio Korea 2023' event held on the 12th, 'Strategies for responding to original drugs and late-comer drugs according to the expiration of blockbuster drug patents'.

 

Introducing the patent strategy.

 

Kim Tae-kwon, head of the Korea Institute of Patent Technology Promotion

The reason Humira and Keytruda are cited as examples is that the two medicines, excluding vaccines, respectively, ranked first and second in global sales in 2021, with sales of Humira at $20.694 billion and Keytruda at $17.186 billion that year.

 

Humira applied for a substance patent in the United States in 1996, was registered as a patent in 2000, and received FDA approval in 2002.

 

Since then, it has received FDA approval for additional indications such as psoriatic arthritis, ankylosing spondylitis, and Crohn's disease, and the substance patent period expired in 2016.

 

So far, Humira has confirmed 746 patents based on 79 original patent applications.

 

By type, 23 family groups (29.11%) for medicinal use and manufacturing method were distributed the most, followed by other 9 (11.39%), 8 diagnoses (10.13%), 7 formulations (8.66%), and 4 compositions.

 

(5.56%), and 2 material improvements (2.53%).

 

Responsibility Kim said, “Before the substance patent of Humira expired, we continuously extended the patent period with patents for medicinal use, formulation and composition patents, manufacturing method patents, diagnostic patents, automatic administration device patents, and pharmaceutical improvement patents.” It maintained its monopoly." In other words, Humira used an ever-greening patent strategy, such as forming a relatively superior patent barrier in the field of pharmaceutical use and manufacturing methods and forming a patent barrier in the pharmaceutical field as well.

 

As a result, Humira was able to have a protection period of at least 42 years after applying for a substance patent and 35 years after FDA approval.

 

After applying for a material patent in 2008, Keytruda registered a patent in 2013 and received FDA approval in 2014.

 

Based on 67 original applications for patents, a total of 345 patents were confirmed.

 

Looking at the distribution by type, 48 (71.64%) of the medicinal uses showed an overwhelming distribution.

 

Next, 7 drugs (10.45%), 4 double antibodies (5.97%), 3 substances (4.48%), 3 diagnoses (4.48%), and 2 others (2.99%) are shown.

 

Kim said, "There was also a case where the dosage and usage were changed as a barrier patent for the evergreening strategy of Keytruda products." "There was also data that it was to block the development of biosimilars as the patent term expires in 2028." and interpreted.

 

In the case of Keytruda, it used the evergreening patent strategy, and it was analyzed that it had a protection period of at least 32 years after the substance patent and about 26 years after FDA approval.

 

Kim explained, "As a result of the analysis of patent applications by type of biopharmaceutical, material patents must be filed, and based on material patents, applications are filed in the order of pharmaceutical use, composition, formulation, manufacturing method, diagnosis, and material improvement patents." As a result of comparing the evergreening strategy of biopharmaceuticals and synthetic drugs, there are patents for use, manufacturing methods, and formulations after substance patents, but synthetic drugs have many improved patents such as crystal forms, optical isomers, polymorphs, and intermediate patents for chemical formulas.

 

However, as for biopharmaceuticals, there were patents for improving antibody or protein drugs.

 

In addition, substance patents are important, but in the case of manufacturing method patents, it was noted that the distribution of biopharmaceuticals was high and the distribution of synthetic drugs was low.

 

Kim said, "One thing to look carefully at is the expiry of the duration of a biopharmaceutical, but we need to look at changes in the patent for formulation, usage, and dosage in the use patent."