API and IP Newsletter
Contents
ANDA approvals in April 2024
We follow ANDA approvals. In April 2024, there were about 91 ANDA approvals and eight tentative approvals.
The below companies received 2 or more than 2 ANDA approvals in April 2024.
Some of our other observations are as follows.
General information
US FDA approves high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable* biosimilar to Humira
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company's interchangeable* biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases.
News here.
Sandoz reached an agreement with Amgen to resolve all patent litigation related to its denosumab biosimilars
Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti and Wyost, on March 5, 2024.
News here
Intellectual Property
Natco Pharma Vs Novartis AG
The Delhi High Court earlier granted an interlocutory injunction to Novartis against Natco’s use of Eltrombopag Olamine (ELT-O) on 13 December 2021. The decision was handed down by a single Judge in the application filed by Novartis (respondent) seeking interim relief. The application for interim relief was allowed then by the single Judge (impugned judgment).
The appeal was filed by Natco, against the impugned judgment dated 13 December 2021.
Novartis had filed the suit earlier, inter alia, seeking a decree of permanent injunction restraining Natco from using, manufacturing, importing, selling, offering for sale, exporting, or dealing in Active Pharmaceutical Ingredient (API), or formulations containing Eltrombopag bis (monoethanolamine). This may amount to infringement of its suit patent IN 233161 (IN 233161)’161).
Novartis also sought rendition of account of profits earned by manufacture and sale of infringing products; damages based on profits earned by Natco through its infringing activities; and a decree for delivery of stocks of products that infringe IN 161. Please note IN 161 has also expired in May 2023.
In terms of the impugned judgment of December 2021, the learned Single Judge has restrained Natco from manufacturing, using, selling, distributing, advertising, marketing, exporting, offering for sale, importing or dealing in any manner in API, pharmaceutical products, or formulation containing Eltrombopag bis (monoethanolamine) (ELT-O) either separately or in combination with any other compound. This infringes IN 161, of Novartis AG, either under the brand “Trombopag” or any other brand.
This is a classic case of debates in Indian Courts about coverage vs. disclosure—a Markush claim vs. a species patent.
There is a prior patent IN’176, which was expired in 2021. There is no dispute that IN’176 covers the product ELT-O. However, Novartis claims that IN’176 is a Markush claim and discloses Eltrombopag free acid (ELT); it does not disclose ELT-O, the subject matter of rights under IN’161.
It is not seriously contested that ELT, which is covered under IN’176 is the API in the formulations marketed by Novartis under the brand names PROMACTATM and REVOLADETM. REVOLADETM received marketing approval in India on 05.01.2011. Admittedly, REVOLADETM was covered in IN’ 176.
Novartis had filed the suit alleging infringement of the suit patent, IN’ 161, granted on 27.03.2009 (species patent) The patent application for `161 was filed by SmithKline Beecham Corporation had finally assigned `161 patent rights to Novartis AG.
Novartis claimed that it was constrained to file the suit as it had become aware through the field force and medical practitioners that Natco had announced the launch of a pharmaceutical drug product containing ELT-O, which was covered by the suit patent.
ELT is also the API of Tromobopag (the formulation launched by Natco) and is the subject matter of the interim injunction issued in terms of the impugned judgement. The suit patent ie IN’ 161 covers the substance, ELT-O which is a salt form of ELT.
The principal controversy that falls for consideration is whether Natco has presented a credible challenge to the validity of IN’161.
Natco argued,
there is no evidence or material on record to establish that ELT-O has a higher therapeutic efficacy than ELT, which is admittedly disclosed and covered by IN’176.
ELT-O is a new (salt) of a known substance (ELT) and, therefore, is not patentable on the anvil of Section 3(d) of the Act.
ELT-O is not an invention and therefore its patent, IN’161 is invalid.
Eltrombopag free acid, along with pharmaceutically acceptable salts, was expressly claimed in IN’176.
Since, ELT-O is a pharmaceutically acceptable salt of ELT, the same was covered in the claims under IN’176 a patent in respect of which the patentee had enjoyed a monopoly for the full term of twenty years.
Novartis did not dispute that ELT-O is covered under IN’176; Novartis counterargued that it is covered, but not disclosed.
The learned Single Judge in December 2021, to some extent accepted the contention that a patent may cover a substance and yet not disclose the same and held that there may be a gap between the coverage of a patent and its disclosure.
Natco’s challenge to the validity of IN’161 on the ground of prior claiming and lack of novelty was rejected on the ground that ELT-O was not specifically disclosed in the complete specifications of IN’176.
In this appeal, Natco contended, we cannot concur with the reasoning of the learned Single Judge to the extent that it accepts that there is a gap between coverage and disclosure.
The learned Single Judge also referred to Novartis v. UoI, supporting the said view. However, a plain reading of the said judgment indicates to the contrary. The relevant extract of the said decision is set out below:
“The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange for the invention being made public. At the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents.”
Natco had also asserted that the predecessor-in-interest of Novartis had specifically claimed that ELT-O, which was being sold under the brand name PROMACTATM was covered under Claim 1 of US Patent 7160870 (US’870). Undisputedly, Claim No.1 of US’870 is Claim No.6 of IN’176. It was contended on behalf of Natco and not controverted by Novartis that the predecessor-in-interest of Novartis had applied for a Patent Term Extension (PTE) for US’870 to compensate for the time spent in obtaining regulatory approvals.
The US Food and Drug Administration (USFDA) had also sent a communication dated 22 February 2011 to the US Patent Office confirming that US’870 (which is the counterpart of IN’176) claims PROMACTATM (Eltromopobag Olamine).
Given the above, Delhi HC opined that Natco did satisfy the standard of raising a credible challenge to the validity of IN’161. The impugned judgement to the extent it holds otherwise is set aside. The Court doesn't need to dilate in other issues as the term of IN’161 has expired, and this Court doesn't need to pass any further orders.
The appeal is disposed of in the aforesaid terms
Decision here
