Evergreening

Evergreening is a strategy employed by some pharmaceutical companies to extend the market exclusivity of a drug beyond the original patent period. This practice involves making slight modifications to an existing drug, such as changes in formulation, dosage, or method of delivery, and then obtaining new patents for these modifications. Evergreening can delay the entry of generic drugs into the market, thereby maintaining higher prices and market share for the original drug.

Mechanisms of Evergreening

Evergreening can be achieved through various mechanisms, including:

• Formulation Changes: Altering the composition of the drug, such as creating a slow-release version.
• New Uses: Discovering and patenting new therapeutic uses for the drug.
• Combination Patents: Combining the drug with another compound to create a new product.
• Polymorphs: Patenting different crystalline forms of the drug.
• Method of Use: Patenting new methods of administering the drug.

Impact on Healthcare

The practice of evergreening has significant implications for healthcare systems and patients:

• Cost Implications: By delaying the entry of cheaper generic drugs, evergreening can lead to higher healthcare costs.
• Access to Medication: Patients may face limited access to affordable medication due to prolonged market exclusivity of branded drugs.
• Innovation: Critics argue that evergreening stifles true innovation by focusing on minor modifications rather than developing new drugs.

Regulatory and Legal Aspects

Regulatory bodies and legal systems in different countries have varying approaches to addressing evergreening:

• United States: The Hatch-Waxman Act provides a framework for generic drug approval but also includes provisions that can be exploited for evergreening.
• European Union: The European Medicines Agency (EMA) has guidelines to prevent evergreening but faces challenges in enforcement.
• India: The Indian Patent Act includes Section 3(d), which aims to prevent evergreening by setting stricter criteria for patentability.

Criticism and Controversy

Evergreening is a controversial practice and has faced criticism from various quarters:

• Public Health Advocates: Argue that evergreening prioritizes profits over patient welfare.
• Generic Drug Manufacturers: Claim that evergreening unfairly extends monopolies and hinders competition.
• Legal Challenges: Several high-profile legal cases have been fought over the validity of evergreening patents.

Examples of Evergreening

Several well-known drugs have been involved in evergreening practices:

• Prozac: The manufacturer extended its market exclusivity by patenting a weekly dosage form.
• Nexium: A slightly modified version of Prilosec, which extended the patent life of the original drug.

Related Pages

• Pharmaceutical patent
• Generic drug
• Hatch-Waxman Act
• Indian Patent Act
• European Medicines Agency

See Also

• Drug patent
• Pharmaceutical industry
• Intellectual property

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