Germany Scrutinizes Pharma 'Evergreening' Tactics to Lower Drug Costs
The pharmaceutical industry's patent practices are under scrutiny in Germany. Companies like Bayer and Boehringer Ingelheim have been increasingly filing patents on slightly altered medications, a tactic known as 'evergreening'. This extends exclusivity and delays generic competition, driving up drug costs. Experts suggest stronger integration of regulatory data into the patent system to discourage minor tweak patents.
Evergreening involves making small changes to existing drugs to extend patent protection. This practice is common, with many new drugs being slight variations of existing treatments. However, it can lead to higher drug costs as it delays the entry of cheaper generic alternatives into the market.
Transparency in the approval process can help combat this issue. Disclosing full trial results after marketing approval can act as a safeguard, protecting both scientific advancement and public access to medicine. This transparency can lead to a sharp drop in weak follow-up patents. Clinical trial data, when disclosed, serves as prior art for patent examiners to judge new applications, helping to sort out genuine innovations from minor changes.
In Europe, drug makers can withhold trial data for up to seven years. This weakens the patent office's ability to filter out low-value drug patents, potentially hindering patient access to affordable medicines.
Stronger integration of regulatory data into the patent system could help discourage minor tweak patents, promoting genuine innovation and improving patient access to affordable medicines. Transparency in the approval process, including full trial results disclosure, is crucial. However, current data withholding practices in Europe may hinder this progress.
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