1.) Recent 505 (b) (2) filings 2.) Allergan Vs. Sandoz

Contents

Recent 505 (b) (2) filings

General information

TQ Therapeutics GmbH Enters into Technology Access Agreement with Kytopen

Delhi High Court refuses to restrain Dr Reddy's from manufacturing, exporting Ozempic like drug

Intellectual Property

Allergan Vs. Sandoz

Recent 505 (b) (2) filings

We follow 505 (b) (2) approvals every month.

Generally, 505(b)(2) NDAs pertain to changes in comparison 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)). For more details on 505(b)(2) FDA approvals, please visit this link. 

In November 2025, a tentative approval was granted for the Ruxolitinib NDA (#219660) for Apotex. Ruxolitinib tablets are marketed as ruxolitinib phosphate salt under the brand name Jakafi.

We are trying to understand why Apotex filed an NDA instead of an ANDA. There is one new strength, 2 MG, but other strengths are available under the brand name Jakafi. 

Apotex's NDA is likely for a formulation using Ruxolitinib free base or an alternate salt (like hemifumarate) to legally navigate the patent landscape and obtain tentative approval under the 505(b)(2) NDA pathway.

The OB listed patent US 8722693 specifically covers phosphate salt, and with Paediatric Exclusivity, it would expire in December 2028. With a different salt (or with free base), Apotex could argue non-infringement, which could provide an earlier launch opportunity than competitors using the innovator's phosphate salt. 

As regards DMFs of alternative salts, Changzhou Pharmaceutical and Dr Reddy’s have filed DMFs for Ruxolitinib Hemifumarate. Chongqing Huapont Shengchem Pharmaceutical filed DMF for the mesylate salt.

Dr Reddy’s also filed DMF for Ruxolitinib base. MSN filed DMF for Ruxolitinib Hemifumarate salt. 

Import-Export data shows that Apotex has imported the Ruxolitinib API from MSN. Therefore, it is very likely that Apotex is using either ruxolitinib free base or Ruxolitinib Hemifumarate in their NDA, i.e., 505 (b) (2) application.

General information

TQ Therapeutics GmbH Enters into Technology Access Agreement with Kytopen

• Kytopen continues expanding its partnership footprint in Europe through a new agreement with TQ Therapeutics GmbH, a Martinsried, Germany-based biotechnology company advancing next-generation cellular therapies.
• TQ Therapeutics, dedicated to advancing the field of cellular in vivo therapies, will gain on-site access to Kytopen's non-viral Flowfect Tx® cellular engineering platform, supporting the planned integration of the technology into its innovative CELLfinity platform.
• A key deciding factor for TQ Therapeutics was validated performance of the Flowfect Tx® platform for the engineering of extracorporeally-retained T cells using the FABfinity cell selection method at both clinical and commercial scale.

News here

Delhi High Court refuses to restrain Dr Reddy's from manufacturing, exporting Ozempic like drug

The Delhi High Court on Tuesday dismissed Novo Nordisk's application to restrain Dr. Reddy's Laboratories Limited and OneSource Specialty Pharma Limited from manufacturing and exporting diabetes and weight management drug Semaglutide [Novo Nordisk v. Dr Reddy's].

Semaglutide is marketed under brand names like Ozempic, Wegovy and Rybelsus by Novo Nordisk.

Justice Manmeet Pritam Singh Arora found that Dr. Reddy's (defendant) raised a credible challenge to the validity of the suit patent by Novo Nordisk on grounds of prior claiming and obviousness.

Dr. Reddy's was permitted to continue manufacturing the drug in India for export to non-patented territories, subject to maintaining accounts.

News here

Intellectual Property 

Allergan Vs. Sandoz

In a significant ruling issued on November 18, 2025, the United States Court of Appeals for the Federal Circuit reversed a District Court judgment, holding that Claim 30 of U.S. Patent No. 9,579,270 (the "'270 patent") is invalid for lack of adequate written description. 

The case involved Duke University and Allergan Sales, LLC ("Allergan") as Plaintiffs-Appellees, and Sandoz Inc. as Defendant-Appellant.

Background of the Case: The '270 patent, issued in 2017 with a priority date of 2000, is titled "Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins." It broadly describes methods for treating hair loss by topically applying compositions containing prostaglandin F ("PGF") analogues. Allergan markets Latisse, an FDA-approved topical solution for eyelash hair growth, which contains bimatoprost—a specific PGF analogue with an ethyl amide at the C1 end and phenyl at the omega (Z) end.

Sandoz began manufacturing and selling a generic version of Latisse. In 2018, Allergan sued Sandoz for infringement of claim 30 of the '270 patent. While Sandoz stipulated to infringement, it challenged the validity of claim 30, arguing it lacked adequate written description, among other defences.

Claims:

17. A method of growing hair, wherein the method comprises topically applying to mammalian skin a safe and effective amount of a composition comprising:

A) an active ingredient selected from the group consisting of a prostaglandin F analogue of the following structure:

Z is selected from the group consisting of a carbocyclic group, a heterocyclic group, an aromatic group, a heteroaromatic group, a substituted carbocyclic group, a substituted heterocyclic group, a substituted aromatic group, and a substituted heteroaromatic group.

30. The method of claim 25, wherein R1 is C(O)NHR3.

District Court Proceedings: During a five-day jury trial, Sandoz presented expert testimony that claim 30 was invalid because it described over 4,000 compounds but failed to identify a single specific embodiment or sufficient common structural features. Allergan countered with its own expert, who opined that the patent adequately described the use of amides for hair growth, specifically mentioning three types of prostamides with a phenyl ring. The jury found that Sandoz failed to prove claim 30 invalid for obviousness, lack of enablement, or lack of adequate written description, awarding Allergan $39 million in damages. The District Court subsequently denied Sandoz’s motions for a new trial and judgment as a matter of law (JMOL). Sandoz then appealed to the Federal Circuit.

JMOL

The Judgment as a Matter of Law (JMOL) in a US patent case is a motion filed after a party has fully presented their case on an issue, but before the case is submitted to the jury, or renewed after a jury verdict. It claims that no reasonable jury could legally find for the opposing party on a specific claim or defence, such as patent infringement or invalidity. If granted, the judge essentially rules on the case without the jury's verdict or overturns the existing verdict. In this case, the District Court had denied Sandoz’s motion for JMOL.

Appellate Court's Standard of Review: The Federal Circuit reviewed the District Court's denial of JMOL de novo, applying the standard that a reversal is warranted only if the evidence, without weighing witness credibility, leads to only one reasonable conclusion. The court noted that proving a lack of written description requires clear and convincing evidence, placing a "doubly high" burden on Sandoz on appeal.

Sandoz's Argument on Appeal: Sandoz argued that claim 30 encompasses a specific subgenus of PGF analogues (ranging from 1,620 to 4,230 compounds), but the patent specification fails to describe this subgenus adequately. It contended that the specification does not provide "blaze marks"—sufficient commonalities of structure or representative examples—to guide a skilled artisan to the claimed compounds, particularly bimatoprost. This failure, Sandoz asserted, indicates the inventors did not possess the full scope of the claimed invention at the time of filing.

Federal Circuit's Analysis: The Federal Circuit highlighted the "written description" requirement of patent law, which demands that a patent sufficiently disclose the invention such that a person of ordinary skill in the art (POSA) understands that the inventor possessed the claimed invention. For a genus of chemical compounds, this means describing the genus's outer limits, a representative number of members, or common structural features with enough precision for a POSA to visualise or recognise the members.

The court noted several uncontested facts:

1. Allergan's expert agreed the patent's backbone, with its multiple open positions, broadly encompassed "billions of compounds."
2. Both parties' experts agreed claim 30 was much narrower, covering only 1,620 to 4,230 compounds. Therefore, the core issue was whether the specification provided adequate guidance for a POSA to identify this specific subgenus within the vast number of possibilities.

The court systematically addressed Allergan's arguments regarding the adequacy of the written description:

1. "Characteristic Prostaglandin Hairpin" Structure: The court found this structural feature to be a generic characteristic shared by billions of compounds, not unique to the claimed subgenus. It failed to provide the necessary distinction to guide a POSA to the specific compounds claimed in claim 30.
2. C1 Position (R¹ variable): Allergan contended the specification disclosed "only 13 options" for the C1 action end, including C(O)NHR³ (an amide). The court rejected this, explaining that most of these "13 options" were actually broad categories containing numerous embedded choices. For instance, selecting C(O)NHR³ would necessitate further selections for R³ from 12 additional categories, each with its own choices.  This created a "maze-like path" rather than clear guidance. Crucially, the specification's "preferred" or "more preferred" options for C1 did not include C(O)NHR³, effectively directing a POSA away from the claimed invention. Synthesis examples also did not cure this deficiency.
3. Z Position (Omega End): Claim 30 requires a phenyl group at the Z position. Allergan argued that the specification identified phenyl as a preferred option among eight categories for Z. However, the court found these eight categories were also broad, requiring further embedded choices. The preference for phenyl only became relevant after a POSA had already chosen an "aromatic group," a decision for which the specification offered no initial guidance. Furthermore, other compounds (like fluro-benzene) appeared more frequently in the patent's examples than phenyl, without any reason given for preferring phenyl.

Conclusion: The Federal Circuit concluded that the '270 patent's specification failed to provide sufficient "blaze marks" or structural commonalities to guide a skilled artisan to the specific PGF analogues with an amide at the C1 position and a phenyl at the Z position, as required by claim 30. The court characterised the specification as a "laundry list" disclosure rather than providing adequate direction for a POSA to conclude the inventors possessed the claimed invention.

Consequently, the court determined that no reasonable juror could have found, by clear and convincing evidence, that claim 30 of the '270 patent was valid. The judgment of the District Court was therefore reversed, invalidating claim 30 for lack of adequate written description.

Decision here