Many pharmaceutical businesses are resolving patent issues out of court as generic drugmakers are being forced into litigation by patent holders and the cost of litigation rises for both generic and inventive pharma companies.
The generic companies frequently agree to postpone their entry into the market in exchange for certain benefits like rights to other patents.
Consider Bristol Myers Squibb's battle for patent protection against Indian generic Eliquis competitors (apixaban).
Due to the patent expiring in a few weeks, BMS and Micro Labs have notified the Delhi High Court that they are prepared to talk about a peaceful resolution.
While the court has ordered Natco Pharma of Hyderabad to maintain the status quo in the patent dispute, BMS is still suing Emcure Pharma, Torrent Pharma, Cipla, Alkem Laboratories, Indoco Remedies, and BDR Pharma for allegedly violating its medication patent.
The Delhi High Court prohibited the companies Indoco, Emcure Pharma, Torrent Pharma, Cipla, and Alkem Laboratories from marketing generic versions of the medication, which BMS claims is patented until September 2022, in December 2019.
Eliquis contributed $9.16 billion in sales to Bristol Myers in 2020, or more than 21% of its overall earnings.
In a recent settlement, Dr Reddy's Laboratories (DRL) also had the underlying lawsuit in a patent dispute for a drug used to treat opioid dependence rejected.
In order to address all disputes between the parties about the generic buprenorphine and naloxone sublingual film made by the Indian company, DRL entered into a settlement agreement with UK-based Indivior and Aquestive Therapeutics.
The agreement also addressed the patent infringement claims made by Indivior and Aquestive as well as DRL's counterclaims regarding antitrust. As per the settlement, Indivior will receive $72 million by March 31, 2024.
In June 2018, Indivior filed a motion to enjoin DRL from releasing its generic suboxone film after learning of DRL's intentions to release the product under an abbreviated new drug application (ANDA).
In the USA, DRL re-launched its buprenorphine and naloxone sublingual film in February 2019 as a therapeutic generic alternative to suboxone.
The re-launch followed a favourable ruling from the US Court of Appeals for the Federal Circuit, which found that Indivior had not demonstrated that its claim that DRL's product violates its US Patent is likely to succeed.
The preliminary injunction preventing DRL from marketing its generic version of suboxone sublingual film, which is typically used to treat opioid dependence, was overturned by the Federal Circuit.
A mutual stipulation of dismissal filed by the parties resulted in a recent dismissal of all claims and counterclaims that were still ongoing in the case by a US court with prejudice.
In a recent severe loss, AstraZeneca had its appeal against low-cost versions of the diabetic medication Forxiga (dapagliflozin), which is sold in India under licences from Sun Pharma and Abbott Healthcare, denied by the Supreme Court of India.
The Delhi High Court was instructed by the supreme court to handle the case and reach a quick decision on the appeal.
In order to stop them from producing and marketing low-cost versions of its diabetes medication, the British pharmaceutical multinational has sued over a dozen Indian generic drug companies to the Delhi High Court in October 2020.
A complaint against West Coast Pharma was resolved last year after the Indian company pledged in court that it would respect AstraZeneca's patent rights and refrain from producing or marketing dapagliflozin.
However, the cases against the others go on, and despite the Delhi High Court's division bench dismissing nine of AstraZeneca's appeals against two separate orders made by a single judge that forbade nine generic drug companies from producing and marketing the drug, the British company appealed the decision.
AstraZeneca was also penalised $56,677 by the division bench for "trying their chances" before various benches, which the British company felt "absolutely inappropriate."
AstraZeneca sued a number of businesses, including Intas, Alkem, Zydus Healthcare, Eris Lifesciences, USV, Torrent Pharma, MSN Labs, Micro Labs, and Ajanta Pharma. Dapagliflozin from AstraZeneca received approval for the treatment of heart failure patients in India in July 2020.
The company obtained the approval of dapagliflozin for CKD in India in February 2021. This drug is already a successful treatment for certain types of heart failure and type 2 diabetes.
Dapagliflozin's basic (genus) patent expired on October 2, 2020; however, it is still covered by a more specific (species) patent in India through May 15, 2023. In 2019, dapagliflozin generated $1.54 billion in global sales under the brand names Farxiga and Forxiga.
The second patent claim is being contested by Indian businesses.
The medicine is protected by two patents: one covering the skeletal structure and issued in 50 nations; the other, covering dapagliflozin alone and granted in 70 nations.
In order to prevent the expiration of five patents on Erleada (apalutide), the Sloan Kettering Institute for Cancer Research and Johnson & Johnson's Janssen division sued India's Aurobindo Pharma.
According to the plaintiffs, Aurobindo informed them that it had submitted an abbreviated new drug application (ANDA) to offer Erleada in generic form back in April.
The Indian company and its subsidiaries Eugia Pharma and AuroMedics claimed in their appeal that the generic did not infringe on J&J's patents because it lacked the active component apalutamide.
Additionally, Aurobindo has been sued over the Novartis and Eisai-created medicine Banzel (rufinamide), which is used to treat epilepsy.
The two pharmaceutical firms have petitioned the US district court, pleading for the court to step in and stop the distribution of Aurobindo's generic version of Banzel.
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