How Patents Affect Biosimilar Market Entry: Navigating the Complex Landscape of Biologic Drug Competition

The introduction of biosimilars – lower-cost versions of biologic drugs – was meant to usher in a new era of competition and affordability in the pharmaceutical industry. However, the complex web of patents surrounding original biologic drugs has created significant hurdles for biosimilar manufacturers looking to enter the market. This “patent thicket” strategy employed by originator companies has become a contentious issue, pitting innovator protections against the push for greater patient access and cost savings.

The Patent Thicket Strategy

Biologic drugs, which are large, complex molecules produced in living cells, have revolutionized the treatment of many serious diseases. However, they are also extremely expensive, putting immense pressure on healthcare budgets. To protect their lucrative products, originator companies often file numerous patents covering various aspects of the drug, its manufacturing process, and methods of use.

Ha Kung Wong, a patent attorney specializing in the biologics industry, explains:

“For biologics, patent thickets may be created by obtaining a number of different types of patents that cover a product. For example, there may be patents that cover the antibody, then the formulations of the antibody, methods of using the drug, ways that drugs are manufactured, devices for administration of the drug, or even ways of packaging the drug.”[1]

This layering of patents creates a dense thicket that potential biosimilar competitors must navigate, often through lengthy and costly legal battles.

Impact on Biosimilar Market Entry

The effects of these patent strategies on biosimilar competition have been significant. In the United States, biosimilar uptake has lagged far behind that of Europe, where patent protections are generally less extensive.

A study published in Nature Biotechnology found that many of the patents blocking biosimilar entry were filed years after the original drug’s approval:

“Secondary patents with filing dates ten years after originator approval and for which one-fifth of patents did not have equivalents in other jurisdictions constituted a key hurdle to biosimilar market entry.”[2]

This practice of continually filing new patents long after a drug’s initial approval has been criticized as an attempt to unfairly extend monopoly protections.

Economic Consequences

The delayed entry of biosimilars due to patent thickets has significant economic implications. A 2019 analysis estimated that patent thickets around just five reference biologics cost US patients and payers $7.6 billion in lost savings opportunities[4].

Dr. Ameet Sarpatwari, Assistant Professor of Medicine at Harvard Medical School, notes:

“Prolonging monopolies has proven profitable. Four blockbuster drugs – Humira, Avastin, Rituxan, and Lantus – generated 56% of their overall revenue after their initial patents expired.”[3]

This extended profitability for originator companies comes at the expense of patient access to more affordable treatment options.

Policy Responses and Proposed Solutions

Policymakers and industry stakeholders are increasingly recognizing the need to address the patent thicket issue. Several approaches have been proposed:

  1. Limiting enforceable patents: The Affordable Prescriptions for Patients Act, introduced in the US Senate, would cap the number of patents that can be asserted in infringement proceedings.
  2. Improving patent quality: Increasing resources and examination time at the US Patent and Trademark Office could help ensure only high-quality patents are granted.
  3. Enhanced inter-agency cooperation: Greater collaboration between the FDA and USPTO could help identify potentially invalid patents earlier in the process.
  4. Market-based incentives: European-style purchasing practices that favor lower-priced alternatives have led to more extensive biosimilar uptake in those markets.

The Path Forward

Balancing innovation incentives with the need for market competition remains a challenge. Wong emphasizes the importance of finding this balance:

“There’s certainly some balance that has to be struck here, as we also don’t want to unduly inhibit the ability of biosimilars to reach the market and potentially increase accessibility to patients. I think we have to be kind of vigilant about that kind of give and take.”[1]

As the biosimilars market continues to evolve, finding solutions to the patent thicket problem will be crucial in realizing the full potential of these drugs to increase patient access and reduce healthcare costs.

“Patent thickets can create barriers to biosimilar entry, which could limit patient access to these more affordable medications.” – Ha Kung Wong, Patent Attorney

Sources:

[1] Center for Biosimilars: “Navigating the Patent Thicket: Balancing Innovation, Biosimilar Access in the Biologics Market”

[2] Nature Biotechnology: “The Characteristics of Patents Impacting Availability of Biosimilars”

[3] Forbes: “Inflation Reduction Act May Curb Patent Practices That Forestall Market Entry Of Biosimilars”

[4] BioProcess International: “Patent Thickets Constrain US Biosimilars Market”

Citations:
[1] https://www.centerforbiosimilars.com/view/navigating-the-patent-thicket-balancing-innovation-biosimilar-access-in-the-biologics-market
[2] https://communities.springernature.com/posts/the-characteristics-of-patents-impacting-availability-of-biosimilars
[3] https://www.forbes.com/sites/joshuacohen/2023/10/02/inflation-reduction-act-may-curb-patent-practices-that-forestall-market-entry-of-biosimilars/
[4] https://www.bioprocessintl.com/intellectual-property/patent-thickets-constrain-us-biosimilars-market
[5] https://www.sciencedirect.com/science/article/abs/pii/S0168851023001033

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