The legal dispute between the two pharmaceutical majors Gilead Sciences Inc. and Merck & Co. Inc. involving Hepatitis C drugs clearly indicates the high stakes involved when it comes to intellectual property.
It all began in 2013, back in the day when Gilead Sciences Inc, filed for a New Drug application (NDA) with the FDA for the treatment of HCV which includes Sofosbuvir. Sofosbuvir was known to treat multiple genotypes of the disease with a higher cure rate and lesser side effects. On administration of Sofosbuvir, duration of the treatment reduced when compared to conventional medical therapy. Gilead launched and marketed the drug with the trade name Sovaldi which was a combination of Sofosbuvir and anti viral agent ribavarin. Gilead launched another drug Harvoni with sofosbuvir as one of its components. In 2013 itself, FDA approved Sovaldi, and it earned the company huge profits.
Legal issues arose when Idenix Pharmaceuticals, filed a complaint stating that by manufacturing Sovaldi and Harvoni Gilead had infringed their U.S patent 7608600. The patent claims a method of treating persons affected by HCV by administering the drug orally via a capsule or tablet containing hydrogen, amino acid ester and a nitrogen base like thymine or adenine. This patent was granted in October 2009.
Although Gilead did have patents of its own in the field of HCV treatment, Idenix claimed that the patents infringed on their '600 patent. Gilead was granted a U.S patent 8415332, which mentions that the drug is effective in preventing multiplication of the virus when administered in combination or alternation with an antiviral, antibacterial or anti cancer treatment. This patent was filed by Pharmasset in 2010, a pharmaceutical company which was then purchased by Gilead in 2011.
The '600 patent was the first patent mentioned in the case, the following patents were also claimed to be infringed by Idenix:
U.S Patent No. 6915054
U.S. Patent No. 7105499
U.S. Patent No. 7608597
U.S. Patent No. 8481712
In the case of infringement against patent '597, the case fell in the favour of Idenix who then received 10% of the total revenue as royalties which was $25.4 billion. They received a total of $2.5 billion.
Merck (which acquired Idenix in 2014) claimed that the use of Sofosbuvir , key ingredient in Gilead's Sovaldi and Harvoni contributed to the infringement of their patents '499 and '712.
'712 deals with compounds of a specific structure, whereas '499 claims methods of administration of the drug alone or in combination with other HCV treatment.
Gilead mentioned in their case that the patent claims were invalid and agreed to pay the charges if proven otherwise. On reviewing the case, the court came to a decision that Gilead's claims were false. During the court proceedings it was found that the claims in the patents '499 and '712 were not invalid. In March 2016, the jury awarded Merck $200 million in damages for the sales of Sovaldi and Harvoni. In April of the same year Gilead filed for a motion to reopen the case and to allow evidence to be submitted against Merck. The motion was passed and the case was reopened.
Gilead claimed that Merck tried to write off the patent rights and attempted to receive permanent licence of the compound from Pharmasset (Gilead's company of interest). It also claimed that Merck scientist stole the structure of the compound and failed to mention the details of these happenings during the court procedures. It was proven later that the scientist turned patent lawyer did try to deceive Gilead, and also lied to the court. The jury found the evidence provided by Gilead in support of Merck's misconduct and as a result passed an order to Merck to return the $200 million.
The ongoing case between these two drug conglomerates reached a new high when Merck lost another $2.5 billion to Gilead with respect to its patent '597 in 2018. The legal dispute began when it was not clear if Pharmasset derived Sofosbuvir on its own or from an Idenix patent.
The US District Court judge in Delaware passed the judgement stating the patent claims were too broad. The patent should be such that, a skilled person should be able to develop a drug without considerable experimentation. The judge also determined that the drug couldn't easily be developed from the Idenix patent, favouring Gilead's defence. Merck believes there is more to the case than what meets the eye. Unless either one of them decides to settle, they will continue to battle it out in the court.
Both the drug developing giants have lost and gained in billions in the past few years. In the era of biosimilars, such cases will be seen more often in the near future. Science & technology together with law now exist in a symbiotic relationship, where both facilitate each other striving for a common goal.
References:
[2] https://www.biospace.com/article/federal-court-overturns-gilead-sciences-and-merck-patent-dispute/
[4] https://www.fiercepharma.com/legal/gilead-wins-reversal-2-54b-verdict-merck-hep-c-patent-case
[6] https://www.fiercepharma.com/pharma/merck-snags-record-2-54b-hep-c-patent-verdict-against-gilead
[8] United States District Court, Case no 13-cv-04057-BLF, Gilead Sciences Inc. (Plaintiff) vs Merck & Co Inc. et al (Defendant)
[9] United States District Court For the District of Delaware, case no 14-846-LPS, Idenix Pharmaceuticals LLC Universita Degli Studi DI Cagliari,(Plaintiff) vs gilead Sciences Inc. (Defendant)
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
