A Delaware federal court upheld four patents related to AbbVie's and Johnson & Johnson's Imbruvica. Specifically, AbbVie’s Pharmacyclics and Johnson & Johnson’s Janssen Biotech fended off a proposed generic version of the drug in an infringement case against Alvogen Pine Brook and Natco Pharma.
Imbruvica (ibrutinib) is approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma, previously treated mantle cell lymphoma, Waldenstrom’s macroglobulinemia, previously treated marginal zone lymphoma, and previously treated chronic graft versus host disease. It is a Bruton tyrosine kinase (BTK) inhibitor, which inhibits B-cell proliferation and survival.
In 2020, Imbruvica brought in $8.43 billion, which was split between the two companies ($5.31 billion for AbbVie and $4.13 billion for J&J). J&J paid less than $1 billion in 2011 to pick up a 50% stake in the drug. A yearly regimen of the medication runs about $148,000.
According to Reuters, Pharmacyclics holds the patents to Imbruvica, with the last one to expire in 2036. In 2019, Pharmacyclics sued Pine Brook, NJ-based Alvogen and India-based Natco for patent infringement after the U.S. Food and Drug Administration (FDA) approved a generic version of the drug.
Alvogen and Natco admitted that their generic product infringed three of the patents. U.S. District Judge Colm Connolly ruled in October 2020 that they had violated the fourth patent during a bench trial. Yesterday, August 19, Connolly rejected Alvogen and Natco’s “numerous” theories that any of the four patents were invalid.
For example, Connolly defended arguments that Pharmacyclics’ patent related to the method for treating lymphoma was invalid, “finding among other things that an ordinary artisan wouldn’t have been motivated to combine prior art references to create the treatment with a reasonable expectation that it would succeed.”
Other aspects included a patent covering a crystalline formulation of the drug, a patent over ibrutinib, the drug’s active ingredient, and others.
Imbruvica’s patents come with some controversy, as do many drugs, particularly blockbuster drugs. To extend their patent protection, drug companies have been accused of creating “patent thickets,” a broad range of patents for new indications and formulations.
A July 2020 report on Imbruvica patents by I-MAK (Initiative for Medicines, Access & Knowledge), a nonprofit that advocates for health equity in drug development and access, noted, “Our analysis of Imbruvica reveals a ‘drip feed’ patenting strategy. The initial patent applications on Imbruvica cast a wide net of scientific knowledge and protection, including potential indications and formulations."
"This knowledge is then disaggregated and patented in phases with more specificity. Because the current patent system is one-size-fits-all — all patents are rewarded with the same 20-year period of exclusivity — the additional granted patents on Imbruvica to date have lengthened its patent protection by nine years. This raises important questions about patent standards, rewards, and incentives.”
I-MAK further estimates that the additional patent life will cost payers $41 billion or more. AbbVie reportedly filed more than 165 patents on Imbruvica, with 88 of them being approved. More than half, 55%, were filed after FDA approval.
AbbVie’s blockbuster drug Humira is even better known for its use of patent protection. The drug is protected by 130 patents. In a February 2019 Senate Finance Committee hearing with several pharma executives, Senator John Cornyn (R-Texas) attacked AbbVie, saying, “I support drug companies recovering a profit based on their research and development of innovative drugs. But at some point, that patent has to end, that exclusivity has to end, to be able to get it at a much cheaper cost.”
Gonzalez responded at the time, “That patent portfolio evolved as we discovered and learned new things about Humira.”