Big pharmaceuticals are not known for rolling over when a generic drug maker encroaches on the territory of their prized super drug patents. They have carried out huge, long, and costly court case battles to defend these lucrative drugs for decades. Pfizer now could be called the poster child for this unswerving corporate determination. They researched and created a branded drug called Lyrica, then fought tooth and nail to maintain their rights to this cash cow drug for as long as possible.
Lyrica was the wonder drug answer to epilepsy. Pfizer developed this effective and expensively priced medication now called pregabalin generically. In testings of the drug, they discovered that it served a dual purpose. It also aided patients who suffered from neuropathic pain. This became such a successful side treatment use of the drug that doctors actually write the majority of prescriptions for it today for helping with pain and not with epilepsy.
Pfizer’s Original Patent Expired but the Drug Maker Doggedly Fought On
Pfizer did not get to be among the largest big pharmaceutical firms in the world by making short sighted assumptions and mistakes. They soon understood that a second patent would serve their goals of keeping the lucrative drug protected for years longer when they uncovered the success of the second use of the medication. Pfizer received a secondary drug patent on pregabalin for pain that remained in force through July of 2017. The American big pharma company then fought to defend their dominant position in this high profit sector of the drug market even after the original primary patent expired.
The pharmaceutical giant’s primary and first patent on pregabalin covering its use for epilepsy treatment expired back in 2014. This allowed companies such as Allergan (formerly known as Actavis) and other generic producing competitors to roll out less expensive generic versions to treat general anxiety disorder and epilepsy.
Pfizer’s Second Patent Gave It the Ability to Battle the Generic Drug Makers In Court
Thanks to the secondary use patent Pfizer secured on pregabalin (for treating pain) not expiring until July of 2017, the giant pharmaceutical waged a vigorous patent defense case against Allergan. This became a highly complicated lawsuit that observers in both the United States and United Kingdom watched closely as it was sure to set important legal precedent. Pfizer made the case that the generic competitor produced by Allergan and other generic drug makers would be prescribed and utilized inevitably for treating pain. The opposing generic drug maker insisted that the generic expressly targeted only uses that were not patent protected for pain. Yet Pfizer battled it all the way to the high court, determined to keep its secondary patent from being infringed. This ended up not in front of one court, but three separate courts in Britain before the matter became settled finally.
A High Court in England had ruled earlier that pregabalin’s patent for pain did not cover the generic versions of the drug nor infringe on Pfizer’s patent. The Court of Appeals then took up the case and ruled on October 13, 2016 that the High Court was correct. More damaging still for Pfizer and other big pharma drug makers was the additional ruling. The Court of Appeals stated that those patent claims generally associated with either neuropathic pain or all around pain are not valid.
Eventually the case made its way to the highest and last court of resort in the United Kingdom. The Supreme Court heard the competing arguments of Pfizer and Allergan, and then ruled that the Court of Appeals was correct. It upheld their assertion that patent claims pertaining to even neuropathic pain uses of the drug are not valid.
This watershed moment represented the final avenue that Pfizer had open to pursue regarding its pregabalin Lyrica drug. It was a heavy and final defeat in the United Kingdom of their long-lasting efforts with pregabalin. Pfizer’s Lyrica for pain relief had been one of the firm’s dependable cash machines, raking in a cool $5 billion per year for the drug making behemoth. As a dependable earnings mainstay for the multinational drug making giant, it is not hard to understand why they pursued it with such zeal and determination.
The Implications of These Rulings on Drug Pharmaceuticals Are Enormous
Pfizer issued a statement that summed up the huge implications of this decision. They claimed it would have a substantial effect on public health innovation. Their argument is that patent life span in a drug’s life cycle is what pushes drug and discovery innovation. Implied in the statement was a veiled threat that drug makers simply will stop discovering and creating expensive drugs if they are not hugely financially rewarded for this time consuming and costly process.
Other analysts worried that it will lead drug makers to raise their prices as they will now claim that the costs of getting and enforcing their patent rights will be significantly higher. For sure, 80 percent or more of a super drug’s market share typically vanishes in the face of generic brand competition.
The Effects of the Case Mean That Cheaper Generic Drugs Will Flourish Going Forward
For drug buying consumers, the end-results of this ruling are enormous and quite positive. It will allow for generic drug makers to pursue less expensive versions of the costly original drugs sooner and easier than in the past. This means that the law has sided with the often smaller, pro-free market competition generic drug makers over the rights of the greedy big pharmaceutical giants. In the end, it is a huge win for those people who need medications and who realistically can not afford to pay the high costs of these technologically leading super drugs from the likes of Pfizer and the other profit-centered, mega international pharmaceutical conglomerates.