Biological drug patents covering new methods of manufacturing and formulation are major contributors to delays in biosimilar market entry in the US, finds a new study published in Nature Biotechnology .
Biological drugs are big business. Biologicals accounted for almost half (48%) of net manufacturer revenue in 2019 – and 43% of total medicine spending – in the US in 2019.
Although biosimilars are also entering the market and therefore reducing prices for consumers, there remain barriers to access in the US. As of January 2022, only 33 biosimilars have been approved in the US, compared to 65 in the European Union (EU).
A recent published study  investigated the reasons for the slower growth of the US biosimilar market. The researchers investigated regulatory barriers, and in particular Biologics Price Competition and Innovation Act of 2009 (BPCI Act) related patent litigation cases, which have delayed availability.
The researchers investigated a total of 179 patents, spanning 21 litigation cases for nine originator drugs:
• adalimumab (Humira)
• bevacizumab (Avastin)
• epoetin alfa (Epogen)
• etanercept (Enbrel)
• filgrastim (Neupogen)
• infliximab (Remicade)
• pegfilgrastim (Neulasta)
• rituximab (Rituxan)
• trastuzumab (Herceptin)
They examined characteristics of the patents including their filing and issue dates, type of claimed invention, original assignees, and whether similar patents existed in other countries.
They found that only a minority of patents (11) covered an active ingredient, while the majority (119) covered uses or peripheral features of the drug, such as manufacturing process or formulation.
| Table 1: Patents alleged to be infringed in BPCI Act related litigation
| Patent type
|| Number of patents
| Manufacturing process claims
| Method of use claims
| Formulation claims
| Biological claims
| Device claims
| BPCI Act: Biologics Price Competition and Innovation Act of 2009.
The researchers say that patents covering new methods of manufacturing and formulations, which represented the majority of patents alleged to be infringed, offer minimal to no additional benefits to patients.
The authors also found that the median time taken between approval of the originator and patent filing dates was over 10 years. The researchers say that late-filed patents such as these are barriers to a robust biosimilars market in the US, because they prevent biosimilars manufacturers from successfully developing and marketing their biosimilars.
They also found that one-fifth of the patents had no equivalent in the EU, Canada, or Japan, citing criticism that the US Patent and Trademark Office (USPTO) may be too lax in approving patents.
In combination, these factors raise concerns about anti-competitive behaviour, the authors say. They say secondary patents effectively extend originator biological market exclusivity beyond the 12-year statutory period provided by the BPCI Act.
To promote more robust and timely US biosimilar competition, they make several recommendations:
• Lawmakers should limit patent enforceability. The Affordable Prescriptions for Patients Act for example, introduced in 2019, would allow a maximum of 20 patents covering the biological or a method/product used in its manufacturing. The Act could save US$507 million over 10 years.
• USPTO examiner time and resources should be increased. US patent examiners should be given more time to scrutinize patent applications. An increase in examination time has been associated with a reduction in issuing invalid secondary patents.
• Promote greater collaboration between the FDA (Food and Drug Administration) and USPTO. For patents with manufacturing process claims, the FDA could share chemistry, manufacturing, and control information with the USPTO. This would help determine if originator manufacturers were using methods claimed in patent applications more than a year prior to submission (a bar to patenting), while increasing collaboration between the FDA and the USPTO (which could help to address high drug prices).
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1. Van de Wiele VL, Beall RF, Kesselheim AS, et al. The characteristics of patents impacting availability of biosimilars. Nat Biotechnol. 2022;40:22-5. https://doi.org/10.1038/s41587-021-01170-5
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