API and IP Newsletter

Contents

• Recent 505 (b) (2) filings
• General information
• Securities Class Action Lawsuit Filed Against Applied Therapeutics, Inc.
• HCPLive Year in Review: Top 10 FDA Approvals for 2024
• Intellectual Property
• Pfizer Inc. & Ors. vs Everest Pharmaceuticals Limited & Ors. on 13 December 2024

Recent 505 (b) (2) filings

We follow 505 (b) (2) filings.

Generally, 505(b)(2) NDAs relate to changes compared to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). More details 505 (b) (2)  FDA approvals can be found here. 

The details of December 2024, 505 (b) (2) filings are as follows:

 

General information

Securities Class Action Lawsuit Filed Against Applied Therapeutics, Inc.

The lawsuit, filed by the law firm Kessler Topaz Meltzer & Check, LLP, alleges that Applied Therapeutics made false and misleading statements and failed to disclose important information regarding its drug candidate, govorestat.

News here

HCPLive Year in Review: Top 10 FDA Approvals for 2024

• Semaglutide's label expansion marks the first weight loss drug approved for cardiovascular risk reduction, based on the SELECT trial's significant findings.
• Dupilumab's approval for young children with EoE offers the first treatment for this age group, showing high rates of histological remission.

News here

 

Intellectual Property

Pfizer Inc. & Ors. vs Everest Pharmaceuticals Limited & Ors. on 13 December 2024

The present suit sought a permanent injunction restraining the defendants from infringing Indian Patent Numbers 241773 and 218212, which were issued to Pfizer and relate to Tofacitinib mono-citrate salt and its method of use. The suit was filed in the National Company Law Appellate Tribunal.

Tofacitinib was marketed in India with the brand name Xeljanz®.

Xeljanz® has achieved substantial commercial success in India since its launch in 2016.

No pre- or post-grant opposition was filed against the suit patents during their term. As a result of the grant of these patents, Pfizer held the exclusive right to prevent any third party from manufacturing, using, offering for sale, selling, or importing the subject matter of the suit patents for the duration of their validity. 

The defendant no.1, Everest Pharmaceuticals Limited, is a pharmaceutical company with its head office in Bangladesh. According to its website, Everest manufactures a range of general and specialised pharmaceutical products, including those for oncology, nephrology, haematology, virology, and other biotics.

Everest Pharmaceuticals Limited also claims to develop newly invented molecules and make them available in Bangladesh and worldwide. The product list on its website features the generic version of Pfizer’s patented product, Tofaxen.

The second defendant, Kavya International, is based in Chandni Chowk, Delhi. It claims to distribute anti-cancer and speciality drugs. Kavya International has confirmed a dealership arrangement with Everest Pharmaceuticals Limited and has supplied the disputed Tofaxen product along with other products from Everest Pharmaceuticals Limited.

Defendant number 3, SG Overseas, is characterized as an entity based in Surat, Gujarat. Since 2020, SG Overseas has acted as a trader of anti-HIV medicines, eye drops, and skincare products. SG Overseas has been identified as offering for sale and advertising the generic 'Tofaxen' product from Everest Pharmaceuticals on the IndiaMart website. Moreover, SG Overseas was prepared to supply the contested product for ₹5,000 and has confirmed that it exports it to countries outside India.

Defendant No. 4, Life Care Medicos, is identified as a Delhi-based entity. Life Care Medicos has expressed willingness to supply Pfizer’s product’s disputed generic version for ₹6,500.

The defendant no.5, Genius Remedies, is stated to be an entity in Maharashtra.

It is stated that Everest Pharmaceuticals supplied the disputed product to an investigator commissioned by Pfizer through Kavya International. Everest Pharmaceuticals is the common manufacturer and marketer of the generic versions of the drugs covered by the suit patents, which are advertised, offered for sale, and sold by the defendants.

In the third week of January 2020, Pfizer discovered a listing for the infringing product, "Tofaxen," advertised by defendant no.5, Genius Remedies, on the website of IndiaMart Intermesh Ltd. The listing identified Everest Pharmaceuticals as the manufacturer of the infringing product. Subsequently, Pfizer engaged an investigator to verify the product's availability in the Indian market.

On 04 May 2020, the National Company Law Appellate Tribunal granted an ex-parte ad-interim injunction in favour of Pfizer and against all five defendants, restraining them from using, making, selling, distributing, advertising, exporting, importing, or offering for sale, or in any other way, directly or indirectly, dealing with any product, including 'Tofaxen,' that infringes on Indian Patent Nos. 241773 and 218212.

During the pendency of this suit, Indian Patent No. 241773 expired on 23 November 2020, and Indian Patent No. 218212 expired on 25 November 2022.

On 01 December 2022, the injunction favouring the plaintiff Pfizer and against all the defendants was vacated due to the expiration of the suit patents.

Based on the claims made in Pfizer's complaint, it is evident that Everest Pharmaceuticals, while Pfizer's rights in the patent suit were active, engaged in the unauthorized export, sale, supply, and distribution of the infringing product 'Tofaxen' within India. Everest Pharmaceuticals, in collusion with other defendants, particularly defendant no. 2, Kavya International, actively facilitated these infringing activities, showing complete disregard for Pfizer’s exclusive rights.

The defendants' illegal manufacture, sale, distribution, and export of the infringing product 'Tofaxen', a generic version of the plaintiffs' patented drug, presented a significant and immediate risk to public health.

Decision:

In light of the above analysis, the Court issued a decree favouring Pfizer.

For the calculation of actual costs, Pfizer is directed to file their bill of costs within four weeks.

For this purpose, representatives of Pfizer shall appear before the taxation officer on January 14, 2025, who will determine the actual costs incurred by the plaintiff in the current litigation.

Since the patents had expired during the pendency of the suit, Pfizer did not seek relief from a permanent injunction and was therefore directed to file their bill of costs for the calculation of actual expenses.

This is perhaps the first instance in IP Courts where a US company has sued a Bangladeshi company in Indian Courts.

Decision here