Teva targets Indian pharma firm over inhaler patents
Asthma is one of the most common respiratory diseases in the US and the most common chronic disease among children | Israeli pharma giant’s suit comes amid allegations that it keeps life-saving prescriptions treatments artificially high.
Teva Pharmaceuticals and its Irish subsidiary are suing Cipla over its bid to gain approval to manufacture and sell generic versions of an asthma inhaler before the expiration of three patents.
The Israeli pharma giant and Waterford-based Norton filed the complaint on Monday, May 6, at the US District Court for the District of New Jersey, alleging that the Indian generic drug maker is attempting to roll out its versions of QVAR RediHaler (beclomethasone dipropionate, 40 mcg) before the expiration of US patent numbers 11,793,953, 11,865,247, and 11,896,759.
Teva’s Qvar RediHaler inhaler is a prescription medicine used to prevent and control asthma in people aged four and above, which is protected by the trio of patents—all entitled “Inhalers and Related Methods”.
A deadly condition
Asthma is one of the most common respiratory diseases in the US and the most common chronic disease among children—with research suggesting that asthma kills about 10 people every day,
The litigation emerged after Mumbai-based Cipla submitted an abbreviated new drug application (ANDA) (number 219000) to the US Food and Drug Administration, contending that the three patents—alongside a slew of others owned by Teva—were invalid.
Back in 2017, the US Food and Drug Administration (FDA) approved QVAR® RediHaler, and it became commercially available in both 40mcg and 80mcg strengths to patients by prescription during the first quarter of 2018.
A treatment breakthrough
Notably, QVAR RediHaler differs from conventional metered-dose inhalers as it removes the need for hand-breath coordination during inhalation, according to Teva. In addition, the product is designed to be used without shaking or priming.
At the time of its launch, the product was hailed as a breakthrough as Teva pointed to research showing that “approximately 76% of patients still struggle to use their inhalers correctly, thus placing them at increased risk for asthma exacerbations”.
“From a clinical perspective, QVAR RediHaler is a much-needed treatment option for these patients who may be experiencing continued difficulty with hand-breath coordination,” said Teva in its statement at the time of the launch.
The suit against CIPLA this week comes a few months after Senator Bernie Sanders and others wrote a public letter to Richard Francis, Teva’s president and chief executive officer.
The letter outlined Sander’s determination to probe Teva’s inhaler products and the company’s alleged “extensive efforts to keep prices high for patients”.
‘Artificially high’ prices
Sanders and his co-signatories claimed that, in the US alone, more than 4.5 million children have asthma, and almost all need inhalers to help them breathe.
However, the letter accuses Teva of setting the price of each life-saving device as high as $500 a month.
“Over the past five years, the company has made more than $1.7 billion in revenue from inhalers alone in large part because of these anti-competitive practices,” added the letter.
In its latest lawsuit, Teva insists that Cipla be prevented from introducing its generic inhaler as it would face “irreparable harm”.
The court case was filed by Williams & Connolly and Walsh Pizzi O'Reilly Falanga. Counsel have not yet appeared for the defendants.
