It is not like that patent or copyrighted material is being used in all the industries out there except pharma. Nah! And to prove that, we here have the Breo Ellipta Lawsuit, where a pharma company is being sued because they used a patent of another company for their inhaler technology. And that too without even the other company knowing about it, and without taking proper permission to build up on that patent or technology.
Is the Breo Ellipta Lawsuit Really a Big Thing Or It is On The Way to Becoming One?
Kinda, but not exactly the way headlines would have you believe.
Breo Ellipta, you know, the once-daily inhaler for asthma and COPD, has been a subject of legal challenges on various counts, which can be broadly categorized into two main issues. Like? Oh, firstly, there is a huge patent battle going on between the drug’s manufacturer, GlaxoSmithKline (GSK), and a lesser-known British company, Vectura Limited. That’s the reason behind the $90 million verdict. Moreover, there have been individual injury claims from people alleging that Breo caused them severe side effects.
But yes, there are lawsuits; but the thing actually is that these are quite common for major pharmaceutical companies and do not necessarily indicate that the inhaler is unsafe or about to be withdrawn from the market.
Why Did This Lawsuit Start in the First Place?
Let’s go back a little. Shall we? So, going a bit into the backstory here, Breo Ellipta was first green-lighted in the U.S. for chronic obstructive pulmonary disease (COPD) in May 2013. In April 2015, the FDA also allowed its use in asthma. The product is a joint effort between GSK and Theravance and has two main components such as fluticasone furoate (a glucocorticoid that soothes the inflammation) and vilanterol trifenate (a long-acting beta agonist that relaxes the muscles around the airways). That sounds like a super technical thing, right? That’s because it really is that way.
So what’s the issue? (Well, there are two!)
Oh, firstly, a number of people disclosed severe side effects, for instance, pneumonia, bone fractures, or heart rhythm problems, and they believed that they were not adequately warned. And? Actually, such people, in fact, are the ones who filed cases that are mostly focused on consumers.
Secondly, the matter of patent infringement of breath-taking scale, which is between GSK and Vectura Ltd., a small drug technology company, is also there; we can’t just overlook that one, either. Vectura claimed that GSK, without their permission, used the method that is patented for making the powder inside the Breo and other “Ellipta” inhalers. This disagreement turned out to be one of the biggest elements of the entire Breo story.
What Has Happened So Far?
This is what the timeline looks like.
Breo Ellipta became available in 2013 after FDA approval for COPD. It was also authorized for asthma in 2015, you know, with developmental studies with over 7,700 patients.
Next, around three years later, we are in 2016, and pretty much that’s the year when Vectura filed a lawsuit against GSK for the Breo, Anoro, and Incruse Ellipta inhalers, claiming that the company had used its patented powder process. After a five-day trial in May 2019, the jury sided with Vectura and decided that $89.7 million in damages be awarded.
Sure enough, since it was a big thing or verdict, GSK did not take it lying down. Nah! They requested the U.S. Court of Appeals for the Federal Circuit to review the case. But in actuality, in November 2020, the appeal judges confirmed the lower court verdict and sided with Vectura. That means GSK was still required to pay the money.
