Pendulum Swings Again: Entresto Patent In India Restored, For Now
Executive Summary
Patent pertaining to Novartis’s Entresto re-instated for now in India after a two-judge bench stays a previous order that set aside the grant of the patent. Will that put Indian firms that launched generic versions of the heart failure therapy at risk of infringement in the interim?
Twists and turns around the patent battle pertaining to Novartis’s blockbuster heart-failure therapy Entresto (sacubitril/valsartan) continue to play out in India, this time the pendulum swinging the way of the Swiss multinational.
Days after the Delhi High Court set aside the 14 December 2022 decision by an assistant controller of patents and designs granting a patent (IN414518) pertaining to Entresto, Novartis has secured a stay on the single judge order till the next date of hearing in February. (Also see "Entresto Patent Order Quashed In India, Market Ripe For Action" - Scrip, 16 Jan, 2023.)
A two-judge bench of the Delhi High Court, which heard Novartis’s appeal in the matter against Natco Pharma Limited on 19 January, noted that it is of the prima facie view that issues as to whether once the pre-grant opposition is filed both examination and opposition proceedings “stand merged” and also whether any examination of the application can be undertaken by the patent controller without issuance of a notice to the opponent, need to be considered in the present appeal.
“Till the next date of hearing, there shall be stay of the impugned judgment. However, the appellant shall maintain accounts of its expenses and sales,” Justices Manmohan and Saurabh Banerjee said in an order dated 19 January, now in the public domain.
The single judge order had earlier this month set aside the December 2022 decision by Rajendra Kumar Lohiya, an assistant controller of patents and designs who held that Novartis’s claimed compounds were “novel, inventive and patentable” under the Indian Patents Act.
Justice C Hari Shankar, in his order dated 12 January, had quashed the assistant controller’s decision and remanded the matter back to the Indian patent office for reconsideration, albeit from a specific juncture in the case, after noting certain “disquieting” features of the procedure that was followed in the grant of the patent.
The two-judge bench in the latest order has asked the contesting parties to file their written submissions “not exceeding five pages” before the next date of hearing, with the patent controller being directed to “produce its relevant original record” wherein the order dated 14 December 2022 was passed in a “sealed cover” on the next date of hearing.
One of the judges is believed to have observed that no endeavor was made by the single judge to determine the "practice and procedure" at the patent office pertaining to the examination, and opposition of the patent application, though Scrip could not immediately verify the exact reference made.
The matter has now been listed for hearing and disposal on 1 February.
‘Erroneous Interpretation’
Novartis’s counsel had during the hearing before the bench argued that the single judge’s interpretation of certain rules under the Indian Patent Rules were "erroneous."
“Rule 55 only prescribes procedure for disposal of pre-grant opposition under Section 25(1) of the Patents Act, 1970, whereas the procedure for examination of patent applications is prescribed under Sections 14 and 15 of the Act read with Rules 24B, 28 and 28A,” the counsel asserted as per details in the court order.
Justice C Hari Shankar had in his order observed that proceedings before the patent controller cannot be “analogized to a railway track, where the two paths run on a parallel lines and do not converge, save and except when the patent is ultimately granted or refused.” The judge had, among a string of comments, noted that once a pre-grant opponent objects to the application seeking of a patent, every decision which impacts such grant, or the extent to which the application is granted, results in serious civil consequences, both to the applicant seeking grant as well as to the pre-grant opponent opposing such grant.
“The right to oppose the grant of a patent is just as sacrosanct as the right to seek grant of a patent."
Novartis’s counsel, however, further contended before the bench that the single judge had given a finding of violation of principle of natural justice based on erroneous interpretation of Rule 55. He also underscored that the patent in question had been granted after 16 years of the application being filed, with only three and a half years of the term of the patent being left.
Natco’s counsel, on the other hand, submitted that there had not only been violation of principles of natural justice, but also of the statutory mandate as enshrined in Sections 14 and 15 and Rule 55 of the Patent Acts and Rules. He asserted that that the procedure adopted by the controller of patents is “contrary” to the procedure laid down by the court and cited specific cases to back that claim. It also ran contrary to the directions given by the single judge in a previous inter party writ petition, the counsel claimed.
What Next?
The Delhi High Court bench’s ruling now implies that the IN414518 Entresto patent is alive, at least in the interim until the 1 February hearing, while a fresh hearing on Natco’s pre-grant opposition as suggested in the single judge order will have to wait at least until the hearing next month.
Rajendra Kumar Lohiya's ruling on 14 December 2022 upheld Novartis’s patent application, which essentially disclosed a “dual-acting compound”, i.e. a single compound that has two different modes of action, namely angiotensin receptor blockade (ARB) resulting from valsartan and NEP inhibition resulting from sacubitril, and declared that it is distinct from a mere physical mixture of sodium salts of valsartan and sacubitril.
The bench’s order potentially complicates matters for some Indian firms that launched their cut-price sacubitril/valsartan combinations following the expiry of Novartis’s basic patent [IN 229051] for a combination of valsartan or a pharmaceutically acceptable salt and sacubitril or a pharmaceutically acceptable salt on 16 January 2022. The quashing of the IN414518 patent order by the single judge had then added further momentum to launch efforts.
Glenmark Pharmaceuticals Limited had launched its cut-price generic sacubitril/valsartan combination SacuV on 17 January, while Lupin Limited followed with two brands of the combination – Valentas and Arnipin – the next day. Interestingly, a third Indian player appeared to have decided to hold plans amid all the court goings-on and retracted a statement pertaining to the proposed introduction of its sacubitril combination on 19 January.
Novartis declined to respond to queries on case specifics, including the implications of the court proceeding on generic players. “Novartis remains committed to protecting its patent rights for Entresto/ Vymada and has faith in the Indian judicial system. Given that the legal proceedings are ongoing, we are unable to comment further,” the company told Scrip. Entresto is sold as Vymada in India. (Also see "Galloping India Growth For Sacubitril/Valsartan Under Shadow Of Challenge" - Scrip, 16 Oct, 2019.)
Industry experts envisage a situation where Novartis can potentially seek legal action against the Indian players for allegedly infringing the now restored IN414518 patent, pending the final decision on its appeal. Conversely, Indian companies can now use the post-grant opposition route to challenge the IN414518 patent or perhaps other legal avenues to revoke the patent.
Either way, “it’s messy and perhaps prolonged,” as one industry source put it.
Notably, Vymada already had multiple same-composition second brands, sold as Cidmus by Dr. Reddy's Laboratories Ltd. and Azmarda by JB Chemicals & Pharmaceuticals Ltd. – the two brands were previously marketed by Lupin and Cipla Limited respectively. Further, a third local firm, Mankind Pharma Ltd. licensed the product from Novartis and markets it as Neptaz in India. Dr Reddy’s had on 18 Jan sharply lowered prices of Cidmus across the 50mg,100mg and 200mg strengths. The ongoing legal case and related uncertainty could potentially also see the second brands further cement their market position in the interim.