API and IP Newsletter: Recent 505 (b) (2) approvals (April 2025) and GENERICS (U.K.) LIMITED v. ASTRAZENECA AB

Contents

Recent 505 (b) (2) approvals

General information

Gucci does not infringe Agfa leather printing patent

Navigating The GLP-1 Litigation Landscape

Intellectual Property

GENERICS (U.K.) LIMITED v. ASTRAZENECA AB

Recent 505 (b) (2) approvals

We track 505 (b) (2) approvals. 

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)). More details on 505(b)(2) FDA approvals can be found here. 

The details of April 2025, 505 (b) (2)/NDA  approvals are as follows:

General information

Gucci does not infringe Agfa leather printing patent

Gucci has not infringed Agfa's patent for a technique used in printing on leather, the UPC's local division Hamburg has ruled. However, the court found the patent to be legally valid. The decision provides detailed analysis of patent claim interpretation.

News here 

Navigating The GLP-1 Litigation Landscape

The GLP-1 drug market is booming, fueled by their success in treating diabetes and obesity. Yet, this growth has unleashed a torrent of litigation — patent disputes, regulatory battles, and clashes over compounded drugs. Understanding the legal landscape can help life science professionals rethink strategies, protect intellectual property, and adapt to a shifting regulatory landscape.

News here

Intellectual Property 

GENERICS (U.K.) LIMITED v. ASTRAZENECA AB

Background

In this write-up, we discuss a ruling in a patent case before the High Court of Justice in England and Wales. 

The case involves challenges from Generics (U.K.) Limited, Teva Pharmaceutical Industries Limited (and Teva UK Limited), and Glenmark Pharmaceuticals Europe Limited (collectively, " Generics (U.K.)  and others") against AstraZeneca AB ("AZ") concerning the validity of supplementary protection certificates (SPCs) about the drug dapagliflozin (marketed as Forxiga), a treatment for type 2 diabetes. 

Generics (U.K.) and others seek declarations that the SPCs are invalid and orders for their revocation, arguing primarily that the European Patent (UK) No. 1506211 ("the Patent"), upon which the SPCs were granted, is invalid. The patent expired in May 2023. However, the British SPCs based on the patent remain valid until May 2028.

In European patent practice, a Supplementary Protection Certificate (SPC) is a specialised intellectual property right that extends the term of protection for patented medicinal and plant protection products for a maximum of five years. 

The High Court ultimately finds the patent invalid, thereby invalidating the SPCs.

Background and Claims

• The Patent and SPCs: The Patent, originally belonging to Bristol-Myers Squibb Co. ("BMS") and later assigned to AZ, claims dapagliflozin and its use in treating diabetes. The SPCs extend patent protection for dapagliflozin and its combination with metformin.
• Generics (U.K.)  and others' Arguments: Generics (U.K.) and others contend that the Patent is invalid due to a lack of inventive step and/or insufficiency. They argue:
• The Patent did not make it plausible that dapagliflozin is an SGLT2 inhibitor (a selective inhibitor of sodium-glucose co-transporter 2) or helpful in treating diabetes.
• The Patent merely made an arbitrary selection of dapagliflozin from a class of compounds disclosed in a prior BMS PCT application (WO 01/27128 A1, "WO 128") without disclosing any advantages of dapagliflozin compared to that class.

Legal Principles

The judge reviews key legal principles concerning inventive step and sufficiency, drawing heavily from case law related to "plausibility," particularly the Warner-Lambert line of cases.

• Plausibility: The specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true. This is not a distinct condition of validity but a standard against which validity must be demonstrated. The document emphasises that the plausibility test is relatively undemanding and should not be reduced to little more than a test of good faith. The specification must disclose "reasonable scientific grounds" for expecting the claimed therapeutic effect might well work.
• Arbitrary Selection: The selection of compounds should not be arbitrary; it must be justified by a previously unknown technical effect stemming from the structural features that distinguish the claimed compounds from others.
• Technical Contribution: Patents are granted for technical contributions to the field (or for technical solutions to problems). This technical contribution must justify the claimed monopoly.

Analysis

The judge meticulously analysed the disclosures in the Patent and WO 128, considering the common general knowledge (CGK) of a skilled team, which includes a medicinal chemist and a biologist/pharmacologist specialising in glucose transport proteins and diabetes.

• WO 128: The judge acknowledged that WO 128 discloses a vast number of C-aryl glucosides, including a broad Markush formula. However, WO 128 does not provide any experimental data or results to support the assertion that these compounds are SGLT2 inhibitors.
• The Patent: The Patent (1506211) discloses dapagliflozin, a specific C-aryl glucoside. However, the judge found that the patent failed to provide any experimental data demonstrating that dapagliflozin is an SGLT2 inhibitor or has any activity in reducing blood glucose levels.

Key Findings

1. Lack of Plausibility: The judge concludes that the Patent does not demonstrate that dapagliflozin is an SGLT2 inhibitor or useful for treating diabetes. The Patent's assertion that dapagliflozin is an SGLT2 inhibitor is deemed a "bare assertion" unsupported by any experimental evidence or a priori reasoning based on structural similarities to known SGLT2 inhibitors.
2. Arbitrary Selection: The judge also determines that the Patent constitutes an arbitrary selection of dapagliflozin from the vast genus of compounds disclosed in WO 128. Because the Patent does not plausibly demonstrate that dapagliflozin has any specific advantage over other compounds in WO 128, it fails to make a technical contribution to the art.
3. WO 128 goes on to state that compounds of formula IA are preferred. In formula IA the options for R1, R2, R2a, R3, R4 and A are reduced compared to formula I, but the number of compounds encompassed is still vast.
4. WO 128 then says that “most preferred” are compounds of formula IB:

1. In formula IB, A has been limited to -CH2—at the meta position of the first phenyl ring, and R2, R2a, and R3 have been limited to hydrogen. 
2. Further, the options for R1 are limited to hydrogen, halogen or lower alkyl at the para position of the first phenyl ring and those for R4 are limited to lower alkyl, -OR5a, -OCHF2 or -SR5e (where R5a and R5e are both alkyl) at the para position of the second phenyl ring. However, it was common ground that the number of compounds encompassed by formula IB was still in the millions.
3. In the Patent (1506211), the “Description of the Invention” section explains in [0013] that the invention provides a C-aryl glycoside compound of formula I:

1. The patent EP 1506211 is a selection patent.
2. Like WO 128, it then says that the invention includes a method for treating or delaying the progression or onset of diabetes, including complications of diabetes, and various related diseases, involving the administration of a therapeutically effective amount of compound of formula I to a human patient in need of treatment.
3. It was common ground that when assessing whether a compound has plausible utility in treatment of a disease, it does not matter whether the mechanism relied on as linking the compound’s activity with an effect on the disease state is disclosed in the patent for the first time or was known from the prior art (see Salk and Warner-Lambert). 
4. So, for that purpose, it is immaterial whether most of the paragraphs [0002]-[0010] were CGK (Common General Knowledge). It should also be noted that neither party contended that there was any CGK relevant to SGLT2 inhibitors as potential treatments for diabetes, which was not in paragraphs [0002]-[0010].  
5. The material in paragraphs [0002]-[0010] of the Patent (1506211) is also present in WO 128. So even if those paragraphs brought together material which was not CGK, that is not part of the technical contribution to the art made by the Patent.  
6. No Technical Contribution: Because the Patent (1506211) did not make it plausible that the invention solves any technical problem, the patentee has made no technical contribution, and the invention does not involve an inventive step.
7. The core issue revolves around the plausibility of the invention, specifically whether the patent specification provides sufficient disclosure to make it plausible that dapagliflozin is an effective SGLT2 inhibitor for treating diabetes. Claimants argue the Patent was invalid for lack of inventive step and/or insufficiency, asserting the patent didn't make it plausible that dapagliflozin is an SGLT2 inhibitor or useful for treating diabetes, and that it merely selected dapagliflozin from a class of compounds without disclosing any advantage compared to that class.
8. The judge reviewed case law concerning plausibility, inventive step, and sufficiency of disclosure. Ultimately, the judge concluded that the patent is invalid because it does not disclose enough to make it plausible that dapagliflozin will have an in vivo effect on blood glucose or that it will treat diabetes. 
9. The judge determined that the patent lacks experimental data or structural reasoning to support the claims, thus being considered an arbitrary selection.
10. The judge further concluded that the skilled team, possessing knowledge of glucose transport proteins and existing SGLT2 inhibitors, would not have been able to predict that dapagliflozin would be an effective SGLT2 inhibitor based on the limited information in the Patent. 
11. The argued similarities between dapagliflozin and phlorizin were inadequate to overcome the absence of experimental data.

Conclusion

• Based on these findings, the judge concluded that the Patent is invalid due to a lack of inventive step and insufficiency. Consequently, the SPCs granted based on the Patent are also invalid, and Generics (U.K.)  and others’ claims for revocation are successful. 
• The analysis relies on the absence of experimental data in the Patent to support the assertion that dapagliflozin is an SGLT2 inhibitor and the conclusion that its selection from the compounds disclosed in WO 128 was arbitrary.

Decision here

Though this could provide early launch opportunities for generics in the UK, AstraZeneca will appeal, and it will be interesting to follow the strategies adapted by generics for potential launch opportunities in the UK. 

Updates regarding the appeal are here.