Pharmacyclics, Johnson & Johnson win patent infringement suit for anti-cancer drug [Read Judgment]

NEW DELHI: The Delhi High Court has ruled in favour of Pharmacyclics LLC and Johnson & Johnson Pvt Ltd (Johnson & Johnson) in a patent infringement suit moved by them for violation of their rights in targeted cancer treatment drug, Ibrutinib, marketed as Imbruvica.

A single-judge bench of Justice C Hari Shankar has granted interim relief to the petitioners restraining 5 other entities from producing drugs violating Pharmacyclis manufacturing and marketing rights with respect to the drug.

Ibrutinib, sold under the brand name Imbruvica among others, is a small molecule drug that inhibits B-cell proliferation and survival. It does so by irreversibly binding a protein called Bruton's Tyrosine Kinase (BTK). Blocking BTK inhibits the B-cell receptor pathway, which is often aberrantly active in cancers of the B-cell.

The Court has restrained Hetero Labs Ltd, Natco Pharma Ltd, BDR Pharmaceuticals International Pvt Ltd, Shilpa Medicare Ltd, and Alkem Laboratories Ltd from manufacturing and selling versions of the drug pending disposal of ongoing suits.

Relying on the fact that the Intellectual Property Appellate Board itself had upheld the validity of the patent granted to Pharmacyclics for the drug, the bench added, Where a granted patent is prima facie found to be infringed, and is being exploited without a license from the patent holder, the balance of convenience is always in favour of restraining further infringement.

Walking the tightrope between public interest and patent-holders rights in drug patent matters, the Court held, I am aware that the drug in question is needed for treating various serious ailments, including cancer. That said, the law sternly prohibits patent infringement, and it may not be possible to argue that considerations of public interest should be allowed to justify infringing drugs to circulate in the market.

However, given the importance of the drug, it permitted the defendant pharmaceutical companies to exhaust the stock available with them. 

It directed that this would be subject to their placing on record the details of the said existing stock, including Batch Numbers and dates of expiry. It added that this would have to be done prior to releasing the said drug stock in the market, failing which this relief would not apply to them.

The Court also refused to pass any interdiction in respect of stocks of Ibrutinib manufactured by the defendants which are already in circulation in the markets.

Not denying that they were manufacturing and marketing the cancer drug without any license from the patent holder,  the defendant companies had challenged the validity of the suit patent on the ground of obviousness.

The defendants were represented by Adv. J Sai Deepak, whereas some plaintiffs were represented by Sr. Adv. Dayan Krishnan.

Cause Title: Pharmacyclics Ltd LLC & Anr v Hetero Labs Limited & Ors; Laurus Labs Limited v Union of India & Ors; Pharmacyclics Ltd LLC & Anr v NATCO Pharma Ltd; Pharmacyclics Ltd LLC & Anr v  BDR Pharmaceuticals International Pvt Ltd & Ors; Pharmacyclics Ltd LLC & Anr v Shipa Medicare Limited & Anr; Pharmacyclics Ltd LLC & Anr v Alkem Laboratories Ltd

[Read Judgment]