API and IP Newsletter
Contents
Patent applications filed by Sun Pharma Advance Research Company Limited
General information
$275 Million Sandoz Settlement Partially Resolves Generic Drug Price-Fixing Litigation
Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement
Intellectual Property
Merck Sharp & Dohme B.V Vs Aurobindo and others
Patent applications filed by Sun Pharma Advance Research Company Limited
We follow patent applications filed by Indian companies, which helps us understand their direction, including the kinds of products, technologies, and licensing activities they focus on.
This week, we analysed Sun Pharma's patent portfolio. We have analysed PCT patent filings by Sun Pharma Advanced Research Company Limited (SPARC).
Some of our comments are as follows.
The list of all PCT filings by Sun Pharma Advanced Research Company Limited is as follows: all patent families are downloaded from Derwent Innovation.
General information
$275 Million Sandoz Settlement Partially Resolves Generic Drug Price-Fixing Litigation
Sandoz Inc. and Fougera Pharmaceuticals Inc. have agreed to pay a $275 million settlement to partially resolve multidistrict litigation that alleged over 30 pharma companies and their affiliates conspired to fix the prices of prescription generic drugs, causing patients, health plans and other “end payers” to overpay for medication.
News here
Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement
On March 3, 2025, Amneal and mAbxience announced the FDA accepted for review its aBLA for two denosumab biosimilars of Prolia® / Xgeva®. Other pending denosumab aBLAs include Fresenius Kabi (FKS518), Teva (TVB-009P), Organon / Shanghai Henlius Biotech (HLX14), Accord / Intas (INTP23), and Gedeon Richter / Hikma (RGB-14).
On March 7, 2025, Amgen and Fresenius Kabi dismissed their BPCIA litigation, Case No. 1:25-cv-01080 (D.N.J.) The details of the settlement have not yet been disclosed.
News here
Intellectual Property
Merck Sharp & Dohme B.V Vs Aurobindo and others
This case concerns patent term extensions (“PTEs”) for reissued patents under the Hatch-Waxman Act.
The Hatch-Waxman Act provides a process for extending patent terms by up to five years to compensate patent owners for time lost during the lengthy regulatory review of new drug applications. This is as per section 35 U.S.C. § 156.
The formula for calculating PTE is outlined in subsection 156(c), which states that the term of a patent shall be extended by a duration equal to the regulatory review period occurring after the patent is issued.
The sole issue on appeal is whether the PTE for a reissued patent should be calculated based on the issue date of the original patent or the reissued patent- in other words, whether the reference to “the patent” in subsection 156(c) refers to the original patent or the reissued patent.
Using the issue date of the reissued patent typically results in a shorter PTE, as any review occurring before the issue date does not impact the PTE.
The material facts of this case are undisputed. Plaintiff-Appellee Merck owned the ’340 patent, which was issued on December 30, 2003.
The ’340 patent pertains to sugammadex or a pharmaceutically acceptable salt of it.
On April 13, 2004, four months after the ’340 patent was issued, Merck applied to the FDA for approval of sugammadex.
Sugammadex is the active ingredient in BRIDION®, a drug that is administered as an intravenous injection to reverse neuromuscular blockade, a form of paralysis induced by rocuronium bromide and vecuronium bromide in certain types of surgery.
While the regulatory review was pending, Merck applied the PTO to reissue the ’340 patent.
The reissue application retained the original claims of the ’340 patent and included narrower claims specifically directed to sugammadex. On January 28, 2014, the ’340 patent was reissued as the RE’733 patent, preserving the original claims of the ’340 patent and adding twelve additional, narrower claims related to sugammadex.
The brief claim is as follows:
A method for reversal of drug-induced neuromuscular block in a subject, which comprises parenterally administering to said subject an effective amount of sugammadex, sodium salt.
The regulatory review process continued until December 15, 2015, when Sugammadex was approved. Merck thus could not market Sugammadex for nearly twelve years of the ’340 patent’s original term, which was set to expire on January 27, 2021.
On February 10, 2016, Merck filed a PTE application for the RE’733 patent, seeking the maximum five-year PTE based on the ’340 patent’s original issue date.
On February 4, 2020, the PTO granted a five-year PTE to the RE’733 patent based on the ’340 patent’s original issue date: “Since the regulatory review period for BRIDION® began on April 13, 2004, which is after the December 30, 2003, date of issuance for the ’340 patent, the entire regulatory review period has been considered in the above determination of the PTE length.
The expiration date of the RE’733 patent was shifted from January 27, 2021, to January 27, 2026.
From January to March 2020, after the RE’733 patent was reissued and around the time the FDA granted Merck’s PTE application, Defendants (Aurobindo and others) filed ANDAs with the FDA to obtain approval to sell generic versions of BRIDION®.
Aurobindo submitted a Paragraph IV regarding the RE’733 patent. Merck treated this filing as an act of infringement and sued Aurobindo.
At trial, Aurobindo argued that the RE’733 patent was not entitled to a five-year PTE and had therefore expired.
It argued that the PTO erred in calculating the RE’733 patent’s PTE based on the ’340 patent’s original issue date, urging that the plain text of subsection 156(c) required the PTO to calculate PTE based on the issue date of “the patent” for which PTE was sought: the RE’733 patent.
According to Aurobindo, the RE’733 patent was only entitled to a 686-day PTE (corresponding to an expiration date of December 14, 2022), since only 686 days of the 4,265day regulatory review period for BRIDION® ‘occurred after the date the RE’733 patent was issued.
The district court disagreed, finding that Aurobindo’s construction of subsection 156(c) would undermine the purpose of the Hatch-Waxman Act.
The district court concluded that section 156 should be read in light of 35 U.S.C. §§ 251, 252, and that “the patent” in subsection 156(c) must refer to the original patent, not the reissued patent. Based on this construction, the district court held that the RE’733 patent was entitled to a five-year PTE.
Aurobindo appealed.
The question on appeal is not, as the parties sometimes suggest, the meaning of the term “issue.” Aurobindo is clearly correct that the date the reissued patent issues is the date of reissue, which is January 28, 2014.
Instead, this case requires the Appeal Court to interpret the term “the patent” as used in subsection 156(c).
The term of a patent eligible for extension under subsection (a) shall be extended by an amount of time equal to the regulatory review period for the approved product, which occurs after the date the patent is issued.
Aurobindo argued that, under the text’s plain meaning, “the patent” refers to the reissued patent, since “the ‘patent eligible for extension’ is the reissued patent.” This is because the reissued patent is distinct from the original patent, and the latter ceases to exist on the date the former is issued.
Merck advocated for a different interpretation, contending that the text of subsection 156(c), along with other patent statutes and the history of patent reissue, illustrates that subsection 156(c) pertains to the original issue date.
The Court concurred with Merck that the mention of “the patent” in subsection 156(c) pertains to the original patent for a drug product.
As the PTO pointed out, the language of subsection 156(c) standing alone is ambiguous. It is unclear whether “the patent” refers to the original or reissued patent. Because the Court could not determine that this language is entirely free of ambiguity, the Court considered the statutory text and context together.
The Appeal Court stated that the Court must interpret the term “the patent” in relation to the specific context in which it is used, as well as the broader context of the statute.
Although Congress seems not to have considered the situation regarding reissued patents when drafting section 156, the section's purpose is clear: to compensate pharmaceutical companies for effectively shortening their patent terms while they await regulatory approval for new drug applications.
The purpose of the PTE is to establish a new incentive for increased spending on research and development. The incentive consists of restoring some of the time lost from patent life while the patent awaits pre-market approval.
The Court recognised that the purpose of the Hatch-Waxman Act is to provide patent holders with limited extensions of patent terms to recover a portion of the market exclusivity lost during the lengthy development and FDA review process.
The Court concluded that in the context of reissued patents, the Hatch-Waxman Act provides for PTE only for those patents with claims directed to drug products whose exclusivity period was delayed by FDA review.
This purpose applies here, interpreting “the patent” in subsection 156(c), as the original patent compensates Merck for the lost exclusivity period due to regulatory delay. Conversely, Aurobindo’s interpretation denies Merck compensation for all but a brief part of that delay. There is no reason to believe that the Hatch-Waxman Act’s purpose would be achieved by disabling extensions of the unexpired term solely based on a patent holder’s choice to pursue reissue.
Aurobindo, however, argued that “the patent” cannot refer to the original patent, as the original patent becomes void upon reissue.
Aurobindo stated that a patent owner cannot rely on the original patent after the reissued patent is declared void, as the original patent is extinguished.
The only construction that aligns with the purpose of the Hatch-Waxman Act extends PTE to patent owners who were genuinely prevented from benefiting from patent protection during the regulatory review Process. Therefore, the appeal Court concluded that, in the context of reissued patents, “the patent” in subsection 156(c) refers to the original patent. A reissued patent is eligible for PTE based on the original patent’s issue date when, as in this case, the original patent included the same claims directed at a drug product undergoing FDA review.
The most natural interpretation of this language is that “the patent” refers to the original patent, as the original expiration date is linked to the filing date of the original patent, not that of the reissued patent. Subsection 154(a)(2) states that a patent’s term begins on the date the patent is issued and ends 20 years from the date the application for the patent was filed. The reference to “the patent” here denotes the original patent, not the reissued patent, which inherits the term of the original patent.
Hence, CAFC concluded that in the context of reissued patents, “the patent” in subsection 156(c) refers to the original patent that includes claims directed to a drug product. Because the ’340 patent included claims directed to sugammadex and was issued before FDA approval of BRIDION®, the Court agreed with the district court that the RE’733 reissue patent was entitled to the five-year PTE based on the ’340 patent’s issue date.
Decision here
