Ending Patent Monopoly: J&J Relinquishes Control Over Key TB Drug
J&J Announces Decision to Stop Enforcing Secondary J&J Patents for Bedaquiline
After years of pressure from TB activists and countries with high burdens of drug resistant TB, J&J agreed to not enforce secondary patents for the key new TB drug bedaquiline. The company’s primary patent for the medicine expires this year.
The agreement should enable generic versions of the lifesaving TB drug to enter low and middle-income countries. However, there is much more to do.
Patents for Stelara
J&J’s Stelara (ustekinumab) is poised to face its first biosimilar competition this fall as the originator drug’s patents expire. But it could be a long road for ustekinumab rivals.
In its complaint against Momenta, J&J claims that the generics maker’s manufacturing process infringes two patents relating to the cell culture processes used to make monoclonal antibodies like Stelara. The company argues that these patents, which were granted years after the approval of the original drug, provide monopoly protection for the product.
But in an order passed Thursday, the Indian Patent Office dismissed J&J’s patent extensions, saying that the method of preparing water-soluble compounds through salt formation was not a new invention and thus not patentable under Section 3(d) of the Patent Act. Moreover, the method is well-known to pharmaceutical manufacturers and is also cited in textbooks on pharmacy. The decision paves the way for unfettered access to generic Bedaquiline for people suffering from TB in low- and middle-income countries.
Patents for Bedaquiline
After mounting pressure from global health advocates, J&J has agreed to stop enforcing its patents on the life-saving tuberculosis (TB) medicine bedaquiline in 134 low- and middle-income countries. The move will help reduce costs and expand access to the medicine, which is a key part of treatment for drug resistant TB (MDR-TB).
The agreement was spurred by public outcry over high prices for the drug, which is included in WHO’s model list of essential medicines. The company’s decision not to enforce the secondary patents on bedaquiline in low- and middle-income countries will allow generic manufacturers to produce and sell the drug at a much more affordable price.
But critics say the agreement falls short of what is needed to end the world’s worst infectious disease crisis. They want Japanese pharma giant Otsuka to follow suit with its other critical new TB drug Delamanid and end its use of “patent evergreening” to extend monopoly rights over publicly funded innovations.
Patents for Nipocalimab
Nipocalimab is being studied for a range of autoantibody-driven rare conditions, including Sjogren’s syndrome and warm autoimmune hemolytic anemia. It’s a top reason J&J spent $6.5 billion to buy the drug’s developer, Momenta Pharmaceuticals, in 2020. The New Brunswick, NJ-based company rakes in $18 million every day that it holds exclusive rights to the psoriasis drug in the U.S. Each additional day that it can keep Stelara’s patent protection is a boon to its long-term goals for above-market growth.
Momenta’s core patents involve manufacturing methods that control chemical changes to antibody-based drugs such as Stelara and others in its portfolio. When it bought Momenta, J&J acquired these patents as well as the drug’s clinical and pre-clinical pipeline. It’s a strategy that critics of Big Pharma claim chills competition and drives up health care costs. J&J is asserting these patents in a legal battle with Amgen, which wants to market a biosimilar version of Stelara.
Patents for Dexamethasone
Dexamethasone is an excellent anti-inflammatory that can be used to treat various conditions. Its benefits are widespread, ranging from allergies to brain swelling and tuberculosis. It also treats autoimmune diseases and lung conditions. Its versatility prompted the World Health Organization to include it in its Model List of Essential Medicines. It has twenty-two patents that protect it.
One embodiment of the invention provides a process for preparing a pharmaceutical granulation of dexamethasone. The method comprises combining the compound with water and a viscosity-building excipient to form a spray solution. The spray solution is then sprayed onto base ingredients to form a granulation. The resulting granulation is then compressed into a tablet dosage form.
A sustained campaign targeting J&J by groups such as Partners in Health and Doctors Without Borders finally gained momentum this summer when novelist and social media influencer John Green released a video criticizing the company for placing untold numbers of patients at risk. The campaign forced the company to announce that it would not enforce its secondary patents in low- and middle-income countries for the critical new TB drug Bedaquiline and other drugs like dexamethasone.
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