Patent Battle Over Breast Cancer Drug: Roche Withdraws Its SLP Against Delhi High Court’s Approval To Biosimilars

Swiss Pharma major, Roche has withdrawn its Special Leave Petition filed in the Supreme Court against the Delhi High Court’s March 3 decision, rejecting its challenge to the grant of approval to drug companies, Biocon and Mylan, to use product data for Trastuzumab, a generic biosimilar for cancer.

The Supreme Court bench of Justices R.K.Agrawal and Abhay Manohar Sapre, noted in its order, on August 11: “A letter has been circulated by learned counsel for the petitioners seeking permission to withdraw these Special Leave Petitions.  Permission granted. The Special Leave Petitions are dismissed as withdrawn.”

The withdrawal of the petition in the Supreme Court follows other legal setbacks suffered by Roche.

On March 3, the Delhi High Court held that Biocon and Mylan can market cancer drugs for all three indications – early breast cancer, metastatic cancer and gastric cancer.

India does not recognize data exclusivity and data of the innovator company like that of Roche can be relied upon by the drug regulator, while approving a biosimilar drug.

Biosimilars are considered highly similar versions of an approved biological drug.   According to analysts, biosimilars are complx, sensitive and difficult to make.   Like generic drugs, biosimilars are priced less than the innovator drug, although their market share is lower than that of the innovator drug.

The Delhi High C ourt told Roche that it cannot hang on to Trastuzumab, innovated by it, for the rest of its life after having enjoyed the fruits of its patent.

Roche had challenged the approval mechanism adopted by the Drugs Controller General of India, in giving Biocon and Mylan approval for its biosimilar drug and its inserts containing product data before the single Judge of the Delhi High Court.

The single Judge first had allowed Biocon and Mylan to market their product without any reference to Roche’s product or biosimilarity.

The division bench of  Justices Badar Durrez Ahmed and Sanjiv Sachdeva modified the single Judge order and allowed Biocon and Mylan to use the product insert for only metastatic breast cancer, but without product data. Reliance and Cadila also sell this drug with different product inserts.

Product inserts are the slips of paper inside each box of the medicine containing details of the drug.  Biocon and Mylan said their product inserts contained their test data also , and that they were entitled to show the data of Roche.  More important, their claims that the DCGI has approved the inserts were confirmed by the DCGI itself to the Court through the Additional Solicitor General, Sanjay Jain.

Roche had criticized the High Court judgment because it claimed it denies patients and physicians the right to make informed decisions about the treatment of breast cancer.  Roche had contended that Biocon, Mylon and Reliance did not follow the entire protocol of tests and studies, as was done by it.  The Delhi high court’s answer to this was that biosimilarity is an abbreviated process and companies like Biocon and Mylan need not go through the entire “rigmarole” as was done by Roche.

In 2002, Roche launched Trastuzumab under the brand name Herceptin in India, marketing each 440 mg vial at Rs.1,20,000.  Roche subsequently withdrew its Herceptin and launched the drug under the brand name, Herclon and Biceltis, at a slightly lower price of Rs.75000 for a 440 mg vial.  Biocon, which launched its version in 2014, priced it at Rs.57000 a vial, besides offering rebates.  Roche holds 70 per cent market share, and has, according to reports, introduced Trastuzumab for other indications like gastric cancer.  Like generics, biosimilars are considered a critical component of providing affordable access to life-saving biologics for ailments like cancer.

Biocon and Mylan began marketing biosimilars of Trastuzumab under the brand names CANMAb and Hertraz in 2014.  Roche filed a case against the regulators for issuing licenses to these companies for the drug.

Meanwhile, on April 25, the Competition Commission of India directed a probe on whether Roche used its dominant position to maintain its monopoly over the breast cancer drug.  The probe results are awaited.

Estimates suggest that nearly 75000 Indian women die of breast cancer every year.  Early detection and treatment are considered the best way to reduce mortality, due to breast cancer.

Roche’s withdrawal of its SLP from the Supreme Court may be a market strategy, according to analysts.  They cite not only the CCI’s decision to probe Roche’s claims, but Roche’s settlement with US drug maker, Mylan, granting the company a licence for biosimilar Herceptin.

In June, Supreme Court allowed Cipla and Roche to withdraw their appeals, following their disclosure that they had arrived at a settlement to close the patent dispute over lung cancer drug, erlotinib hydrochloride.  In this case, the Delhi High court had ruled that Cipla had infringed Roche’s patent.   It is not clear whether the withdrawal of Roche’s SLP over the breast cancer drug follows a similar settlement with the manufacturers of biosimilars.