Amgen Refutes Academic Claims Regarding Biologic Patent Practices

The ongoing pharmaceutical patent debate has been increasingly dominated by voices opposed to the patent system, including organizations with financial motives to undermine it, according to recent industry analyses. These critics often circulate questionable reports that continue to be cited by mainstream media despite containing demonstrable inaccuracies.

A prominent example highlighted by industry watchdogs involves the Initiative for Medicines, Access & Knowledge (I-MAK), which has become the target of a campaign by the Council for Innovation Promotion (C4IP) to expose alleged misinformation. As recently as July 2023, I-MAK’s website claimed there was “no generic alternative to Pfizer’s drug Lyrica approved by the FDA or available on the market,” despite the FDA having approved multiple generics in July 2019 following the expiration of Lyrica’s compound patent.

Similar discrepancies have been identified regarding other medications. I-MAK claimed patents would prevent generic competition for Revlimid until at least 2028, yet Teva launched a generic version in 2022. For Gleevec, I-MAK suggested patent protection would last until 2029, though Sun Pharma had introduced a generic in 2016.

The organization has also been criticized for misleading statements about patent quantities. I-MAK claimed Novartis’s Gleevec was protected by 73 patents when only six patents actually cover the drug. The inflated figure reportedly included expired patents, pending applications, and dozens of abandoned patent applications.

Amid this contentious landscape, biotechnology company Amgen has entered the debate, specifically addressing criticisms of biologic manufacturing patents. In a letter published in Nature Biotechnology, Amgen responded to academic claims that such patents unfairly delay biosimilar entry to the market.

Drawing on its experience as both a biologics innovator and biosimilar manufacturer, Amgen argued that the academics’ positions are disconnected from industry reality. The company pointed to the growing number of FDA-approved biosimilars – now exceeding 70 – noting that development timelines and capital requirements, rather than patents, primarily determine launch timing.

Amgen also refuted claims about insufficient patent notice for biosimilar developers, highlighting existing mechanisms like the “patent dance” under the Biologics Price Competition and Innovation Act and the FDA’s Purple Book, which publishes relevant patent information. The company emphasized that biosimilar manufacturers, being sophisticated enterprises investing over $100 million in development, possess the resources to conduct thorough patent searches.

The biopharmaceutical giant defended the value of manufacturing patents in protecting complex biologics production technology. Unlike small-molecule drugs, biologics involve living cells engineered to express specific proteins through intricate processes requiring significant innovation at each stage – from cell line development to purification techniques.

Amgen illustrated the importance of continuous innovation through its own product evolution. The company developed Aranesp as an improvement to Epogen, extending the half-life to reduce required dosing from three times weekly to once every three weeks. Similarly, Neulasta improved upon Neupogen by allowing patients to receive treatment once every 2-3 weeks rather than daily.

Beyond molecular improvements, Amgen highlighted innovations in drug delivery, such as the OnPro on-body injector for Neulasta. This device allows patients to receive medication at home 24 hours after chemotherapy, eliminating additional doctor visits and resulting in improved compliance (from 58% to 94%), reduced hospitalizations (down 50%), and higher patient satisfaction.

Addressing claims that manufacturing patents filed after FDA approval are likely invalid, Amgen explained that while product specifications are “locked” at approval, manufacturing processes commonly evolve afterward. The FDA has established procedures for approving post-approval manufacturing changes, and patents protecting these innovations are legitimate. Amgen noted it has not encountered manufacturing patents invalidated due to prior commercial use in its extensive litigation experience.

Based on these real-world observations, Amgen cautions against proposals like the Interagency Patent Coordination and Improvement Act of 2023, which would mandate sharing confidential manufacturing information between the FDA and USPTO. The company maintains that existing regulations provide sufficient incentives for consistency in patent applications without compromising innovation.

Amgen’s conclusion emphasizes that the current system effectively balances innovation with access, ultimately benefiting patients. While acknowledging room for improvement in patent policy, the company advocates for discussions grounded in practical experience rather than predetermined biases.