Delhi HC restrains Natco from infringing Novartis API containing Eltrombopag Olamine

The court's order came after the drug maker Novartis sought an interlocutory injunction against the perceived infringement, by the Natco Pharma Ltd, of the Novartis' suit patent IN 233161.

The suit patent was originally granted to M/s SmithKline Beecham Corporation (later renamed "GlaxoSmithKline LLC") on 27th March, 2009.

Novartis claimed that the suit patent was first assigned by GlaxoSmithKline LLC to the Glaxo Group Ltd on 5th October, 2015, on which date, by a back-to-back assignment deed, the suit patent was assigned by the Glaxo Group Ltd to Novartis Pharma AG.

The invention patented by the suit patent was titled "3-[(2Z)-[1- (3,4-Dimethylphenyl)-1,5-Dihydro-3-Methyl-5-Oxo-4H-Pyrazol-4- Ylidene] Hydrazino]-2'-Hydroxy-[1,1'-Biphenyl]-3-Carboxylic Acid Bis-(Monoethanolamine)".

Reckoned from 21st May, 2003, being the International Filing Date of the suit patent, the patent would remain alive till 21st May, 2023, by virtue of Section 53(1) of the Patents Act. The invention was granted the non-proprietary United States Adopted Name (USAN) name "Eltrombopag Olamine".

Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.

Eltrombopag is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP).

Novartis said in its submission that Natco Pharma admittedly launched their branded Eltrombopag Olamine (EO) on the market, infringing on the suit patent since Natco Pharma had not received a licence from Novartis.

In response, the Natco Pharma contests the suit by questioning the validity of the suit patent IN 161, invoking, for the purpose, Section 107(1)3, read with clauses (a), (d), (e), (f), (j), (k) and (m)4 of Section 64.

Furthermore, Natco Pharma's advocate, Sai Deepak, argued, "The Active Pharmaceutical Ingredient (API), which provided therapeutic activity against thrombocytopenia, is Eltrombopag, and not EO. EO functioned only as a pro-drug, which enabled delivery of Eltrombopag to the target site. EO does not have any inherent therapeutic activity. Reliance was placed, in this regard, on the leaflet and prescribing information for REVOLADE, which indicated that "(4) Notwithstanding anything contained in any other law for the time being in force, on cessation of the patent right due to non-payment of renewal fee or on expiry of the term of patent, the subject matter covered by the said patent shall not be entitled to any protection."

After hearing the facts of the case, the court noted,

"The infringer Natco Pharma, unable to dispute the charge of infringement on facts, seek to question the validity of the suit patent. While Section 64, undoubtedly, allow them to do so, the challenge has to be credible, not incredible. The defendants, in the present case, neither launched any pre-grant nor any post-grant, opposition to IN161."

The court added,

"They (defendants) have not initiated any proceeding before IPAB or any other authority, for revocation, cancellation or removal of the suit patent from the register of patents. In such circumstances, the holder of the suit patent would ordinarily be entitled to an injunction against continued infringement. Absent any prima facie case of vulnerability of the suit patent to revocation on the ground of invalidity, therefore, injunction cannot be refused, once infringement is established."

Subsequently, the court pronounced its order as;

"The defendant is restrained by itself or through its directors, group companies or sister concerns, associates, divisions, assigns in business, licensees, franchisees, agents, stockist, distributors and dealers from using, manufacturing (either through itself or through third parties), importing, selling, offering for sale either by way of promotion or tender or any other means, exporting, directly or indirectly dealing in Active Pharmaceutical Ingredient (API), pharmaceutical products, or formulation containing Eltrombopag Olamine (Eltrombopag bis(monoethanolamine)) either alone or in combination with any other compound or API or in any other form as may amount to infringement of suit patent IN 233161 of the Plaintiff 1 either under the brand Trombopag or any other brand."

To view the official order, click on the below:

https://indiankanoon.org/doc/104159826/