Pharma companies are putting more time and effort into patent extensions of old products - at the expense of price and innovation development
A new study by Robin Feldman, director of the Institute for Innovation Law at the University of California, examines all patent applications and extensions of drugs on the U.S. market between 2005 and 2015 with an astonishing result.
About 74 % of drugs associated with new patents were for medicines already established on the market. Moreover, in three of the years considered during that period, it even reached 80 %.
Patent applications and extensions are permitted for new indications, different dosing methods or amended production processes. Interestingly, the study titled „May Your Drug Price Be Ever Green“ shows that the active search for extendable properties in order to extend the patent is a very common practice. in the industry. This is referred to as evergreening and contributes to an increase in drug prices.
„This study definitively shows that stifling competition is not limited to a few pharma bad apples,“ criticized the authors. „Rather, it is a common and pervasive problem to the pharmaceutical industry.“
Almost 80 % of the top 100 drugs had their patent extended at least once – 50 % of them even more than once. The world’s best-selling drug Humira, manufactured by AbbVie, is protected by more than 100 patents. This way the initial patent which expired last year, was renewed through further patents in recent years. Hence, AbbVie was able to raise its 2021 sales forecast to $21 billion – nearly $3 billion more than expected.
Overall, the scientists identified an increasing trend towards aggressive patent extension by the pharma companies. In 2005, 37 drugs were granted three or more patents – by 2015 the amount had increased to almost 80 drugs. „The data suggests that the current development restricts and harms pharmaceutical innovations. The companies focus their time and effort extending the patent life of old products“, Feldman wrote. „This, of course, is not the innovation one would hope for.“
Within the German “Arzneimittelversorgungsstärkungsgesetz” (AM-VSG), an adjustment of the AMNOG’s rules of procedure came into force recently, which grants the opportunity of assessing the benefit of existing products. The adjusted “AMNOG-rules” can counteract the present problem. By combining industry expertise and know-how of numerous projects concerning the support of benefit assessments, SKC is considered, even after changed legal frameworks, as the leading partner in strategic consultancy in the German health care sector.
Please click on the following links for more background information:
http://www.fiercepharma.com/pharma/pharma-s-pervasive-evergreening-driving-prices-up-study-says?mkt_tok=eyJpIjoiT1RkbVptRXdZamhoTjJRMSIsInQiOiJ4NGlyWlFRbDdGVHdUTVFYYVNzV0pEUFFaOVRMZ1wvK0RydW0wdStqMllNZU50NUZOOHJWbnltWjBTaHE5MGxQY2hYejYzeVoxZHJkNmliTHoyaE8ySGFJTTR4WXJYZG1oZXIxaTErRER0ZTh4KzV0eXZFUGJ6U3FGYld1VkpsY1QifQ%3D%3D&mrkid=695240&utm_medium=nl&utm_source=internal
https://www.bloomberg.com/news/articles/2017-11-01/most-new-drug-patents-are-for-old-remedies-research-shows