Remicade was involved in two kinds of legal battles:

  • One owing to personal injuries
  • Another owing to patent infringement.

Patent Infringement:

Abbott and Johnson & Johnson (J&J) Centocor were involved in a patent battle pertaining to the infringement of the same that was used by Abbott to develop its arthritis drug “Humira”. Centocor claimed that Humira was made using the same technology that was developed by New York University exclusively licensed for the J&J unit. Humira also worked by blocking the action of TNF protein which was NYU’s property related to antibodies against tumor necrosis factor.  Abbott’s actions were determined as willful by the US District Court jury in Marshall, a Texan court, in June 2009 and the decision was made in favor of J&J. Johnson and Johnson, as a compensation received $1.7bn as lost profits and $504m as royalties. Post the verdict, Kim Taylor, President of J&J’s Centocor Ortho Biotech unit mentioned that the manufacturer was gratified that the jury recognized their valuable intellectual property, finding their patent both valid and infringed. However Abbott’s spokesperson was confident of the merits of the case and mentioned that their organization will prevail on appeal.

However, in a new decision later made by the Court of Appeals for Federal Circuit in Washington, DC ruled that Centocor’s patent on Remicade was invalid. The appeals court ruled in the favor of Abbott in the patent battle with J&J. While J&J argued that the patent covered fully human antibodies like Humira, Abbott had the opinion that at the time of filing the patent it wasn’t possible to make fully human antibodies against TNF in a laboratory, hence the patent was invalid.

J&J’s Remicade got its approval in the year 1998, while Abbott’s Humira was approved by the end of year 2002. Both the drugs were major blockbusters for their respective manufacturers. Humira brought in about $4.5bn in annual global sales for Abbott whereas global sales of Remicade some of which go to Centocor’s marketing partners, was about $6.2bn. Both the drugs worked by blocking tumor necrosis factor.

Verdicts owing to Personal Injuries:

Remicade was prescribed generally for Crohn’s disease and rheumatoid arthritis. However, it had many serious and fatal side effects like liver failure, exposure of the body to serious infections and even lupus. Patricia Hamilton, aged 47 years, started Remicade treatment in December 2001 for her Crohn’s disease. As a side effect she developed drug induced lupus the following year, and also suffered from increased risk of liver failure. The Texas jury agreed to both the facts:-

FirstlyThe drug could cause lupus

SecondlyThe manufacturers hid the side effects of Remicade.

Ms. Patricia filed a lawsuit against Centocor, claiming that J&J failed to warn doctors of the risks of the drug. Corpus Christi, a Texas jury awarded Ms. Hamilton $19.4 million as compensation, including $3.4 million in actual damages and $16 million in punitive damages. This verdict was the first ever verdict that involved Remicade, Johnson’s and Johnson’s second largest selling drug.