Changes In Biologic Drug Revenues After Administrative Patent Challenges.

Area of Science:

• Pharmaceuticals
• Intellectual Property Law
• Health Economics

Background:

• Brand-name drug manufacturers, particularly for biologics, secure numerous patents.
• These patents can impede the market entry of lower-cost biosimilar alternatives.
• The America Invents Act introduced inter partes review (IPR) for patent challenges.

Purpose of the Study:

• To analyze the utilization and impact of inter partes review (IPR) on biologic drug patents.
• To assess the effectiveness of IPR in facilitating biosimilar competition.
• To evaluate the economic consequences of patent invalidation on originator drug revenues.

Main Methods:

• Analysis of administrative patent challenges (inter partes review) for biologic drugs from 2012-2021.
• Categorization of challenges by user (biosimilar vs. biologic manufacturers) and patent type.
• Examination of revenue changes for originator products following patent invalidation.

Main Results:

• Forty-three final written decisions in IPRs involving biologic drugs (2012-2021).
• Biosimilar firms invalidated 14 patents (in 20 challenges), primarily method-of-treatment patents.
• Biologic firms invalidated 17 patents (in 23 challenges), primarily active ingredient patents.
• Patent invalidation by biosimilar firms correlated with decreased originator product revenues.

Conclusions:

• Inter partes review is a significant pathway for challenging biologic drug patents.
• Biosimilar manufacturers effectively use IPR to overcome patent barriers.
• Successful patent challenges by biosimilars enhance market competition, potentially lowering drug costs for patients and payers.