Breo Ellipta is a popular inhaler produced by the pharmaceutical giant GlaxoSmithKline (GSK), widely used for managing asthma and chronic obstructive pulmonary disease (COPD). The device is celebrated for its convenience and efficacy, given its once-daily dosage. However, the Breo Ellipta has also brought GSK into legal battles. The company faces significant lawsuits involving allegations of patent infringement and anticompetitive practices. These legal hurdles challenge GSK’s position in the pharmaceutical market and raise questions about industry practices and consumer interests. Let’s explore the intricate details of these lawsuits to understand their broader implications for GSK and its stakeholders.
Patent Infringement Case
In 2016, Vectura Ltd., a company specializing in developing inhaler technology, claimed that GSK’s Ellipta-brand inhalers – including Breo, Anoro, and Incruse – infringed on Vectura’s patent. The dispute revolves around Vectura’s U.S. Patent No. 8,303,991 (‘991 patent), which details the production of “composite active particles” meant for pulmonary administration. This technology plays a critical role in dry-powdered inhalers like Breo Ellipta.
Vectura argued that GSK incorporated magnesium stearate in their inhalers in a manner that violated claim 3 of the ‘991 patent. Magnesium stearate acts as an additive material, playing a crucial role in the efficacy of inhalers by helping the medication to disperse evenly when inhaled. This claim formed the basis of Vectura’s patent infringement lawsuit against GSK.
The lawsuit reached a decisive conclusion when the jury sided with Vectura. The verdict declared the ‘991 patent valid and confirmed GSK’s infringement. As a result, Vectura was awarded damages amounting to nearly $90 million. This figure was based on a 3% royalty applied to sales worth $2.99 billion of the inhalers in question. GSK’s attempt to overturn the decision fell flat, as the Federal Circuit affirmed the jury’s verdict, addressing issues related to infringement, patent validity, and the extent of damages.
Anticompetitive Practices Allegations
Alongside the patent infringement case, GSK is embroiled in allegations of anticompetitive behavior, particularly concerning its strategy to preserve market dominance over its asthma inhalers, including Breo Ellipta. A key accusation is the use of “device hopping,” a tactic where existing inhalers are phased out and replaced with new, slightly altered versions. Although these new products have the same active ingredients, they come with different designs or delivery methods. This allows GSK to secure fresh patents and extended regulatory protection periods.
Critics argue that this strategy has enabled GSK to secure extensive protection for its products, blocking generic competitors from entering the market. This alleged device hopping has supposedly extended the uninterrupted market protection of GSK products like Ventolin for over 60 years, and similar protection for Flovent and Arnuity Ellipta for more than 35 years.
This practice has profound implications for market competition and consumer prices. By delaying the introduction of affordable generic versions, these anticompetitive tactics keep inhaler prices artificially high. The financial burden on individuals with respiratory conditions, who rely on these essential medications, is considerable. The impact on public health is equally significant, as inflated prices can limit access for those in need.
World Market News reports that the lawsuit underscores a critical debate about the ethical responsibilities of pharmaceutical companies. It raises questions about balancing innovation with fair market practices and consumer welfare.
Conclusion
The lawsuits focusing on GSK and its Breo Ellipta inhaler highlight two significant issues in the pharmaceutical industry: patent rights and competitive ethics. The patent infringement case, which resulted in substantial damages, underscores the importance of respecting intellectual property rights and the complexities involved in pharmaceutical innovations.
Meanwhile, the anticompetitive practices allegations shed light on strategies like device hopping, bringing attention to their potential to hinder competition and drive up drug prices. These legal challenges are not just isolated incidents but parts of a broader narrative about the conduct and responsibilities of large pharmaceutical companies.
For GSK, these lawsuits could impact both its reputation and its financial standing. As the legal proceedings unfold, stakeholders both within and outside the industry will be watching closely. This case emphasizes the need for a transparent and fair pharmaceutical landscape that prioritizes consumer access and innovation alike. Both cases serve as a reminder of the delicate balance between progress and ethics in shaping the future of healthcare.
