Recent paragraph - IV filings and case at EPO between two urea plant manufacturing companies.

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Recent P-IV filings

General information

Compounding Of Offences Under Drugs And Cosmetics Laws: A Legal Shift In 2025 Aptar Digital Health Partners with AstraZeneca to License AI Algorithms for Chronic Kidney Disease Detection

Intellectual Property

Stamicarbon B.V. Vs Thyssenkrupp Fertiliser Technology GmbH Vs

Recent P-IV filings

We follow P-IV certificate filings. The FDA published its last such list on August 18, 2025. The list can be accessed here.

General information

US FDA proposes new process to accelerate approval of drugs for rare diseases.

The U.S. Food and Drug Administration on proposed a new process to streamline the approval of drugs targeting rare diseases with very small patient populations, including cases supported by data from single-arm clinical trials. The regulator said eligibility will be based on whether the disease affects a small population – fewer than 1,000 individuals in the United States – and is intended to treat a genetic defect. News here

India looking beyond US for pharma exports amid tariff tensions

India is seeking to boost drug exports to semi-regulated markets in Africa, Latin America and Southeast Asia to reduce its dependence on the U.S., where tariff concerns pose risks, officials from a government-backed trade body told Reuters on Thursday. The Pharmaceuticals Export Promotion Council of India (Pharmexcil) also plans to push for sales of finished goods to China to bridge the trade deficit, the officials said. The Indian industry imports more than 60% of its raw materials and active pharmaceutical ingredients from China. News here

Intellectual Property

Stamicarbon B.V. Vs Thyssenkrupp Fertiliser Technology GmbH Vs

This is a decision from the Technical Board of Appeal of the European Patent Office regarding a patent for a urea production plant, specifically patent number EP2844640B1. The core issue is whether the claimed urea production plant involves an inventive step over the prior art, specifically in terms of energy efficiency. Background: The patent proprietor (Stamicarbon B.V) appealed the Opposition Division's decision to revoke the patent. The patent relates to a urea production plant with a modification involving a second evaporator and condenser unit downstream of the dust scrubbing section. This modification is intended to reduce energy consumption. Stamicarbon B.V. is a global leader in urea technology, licensing, engineering, and revamping urea plants worldwide. They provide technology for the entire urea production process, from raw materials like ammonia and carbon dioxide to product finishing, and offer solutions for improving existing plants through their Evolve series. Stamicarbon holds a significant market share, having licensed over 260 urea plants and completed more than 100 revamp projects. Earlier in June, we covered a decision made by the European Patent Office (regarding an appeal against the revocation of EP 3560907 B1. The patent, owned by Thyssenkrupp Fertiliser Technology GmbH and Thyssenkrupp AG, was challenged by Stamicarbon B.V. The patent pertained to a urea production plant and its scrubbing system. The Boards of Appeal decided to uphold the Opposition Division's decision to revoke European Patent No. 3560907 B1. It appears that these two companies continually challenge each other’s patent families related to urea production. Key Documents cited in this case as a prior art: Several documents were cited as prior art, including:

1. D8a: Pothoff, "Jumbo Single-Line Urea Granulation Plants."
2. D9: Uhde, Brochure Urea.
3. D12: Schmitz, "Emission Control in Urea Plants."

Opposition Grounds: The patent was opposed by Thyssenkrupp Fertiliser Technology GmbH on grounds of lack of novelty, inventive step, unallowable amendments, and insufficient disclosure. The Opposition Division considered D8a as the closest prior art and found that the claimed plant lacked inventive step. Appellant's Arguments: The patent proprietor (Stamicarbon B.V) argued that D8a was directed to a different technical problem (granulator size and ammonia emissions) and would not have been considered a starting point for reducing energy consumption. They suggested D9 would be a more appropriate starting point. Respondent's Arguments: The opponent, Thyssenkrupp Fertiliser Technology GmbH, defended the Opposition Division's decision, arguing that D8a had more features in common with the claimed plant and that the claimed plant was obviously derivable from D8a. Board's Analysis and Decision: The Board of Appeal disagreed with the Opposition Division's choice of D8a as the closest prior art. Closest Prior Art: The Board found that D9, which discloses a classical urea production plant, is a more suitable starting point because it represents the process that the disputed patent uses as a base, with a second evaporation/condensation loop added to achieve overall energy efficiency. D8a, on the other hand, discusses problems related to increasing the size and capacity of urea production plants, focusing on the problematic size of granulators and on limiting ammonia in effluents, where urea is mixed with ammonia chloride. Inventive Step: Starting from D9, the Board considered whether adding the second evaporation/condensation loop (as claimed in the patent) would have been obvious to a skilled person. They noted that by using the added evaporation/condensation loop there is a reduction of steam consumption while retaining urea output, or an increase in urea production while maintaining steam consumption constant. The Flaws in Respondent's (Thyssenkrupp Fertiliser Technology GmbH ) Argument: The respondent's argument suggests D8a can be a starting point for an inventive step. However, D8a's teaching improves the "classical process" where an ammonia convert technology is used to reduce emissions, using acid scrubbing and admixing the ammonia salt thus obtained into the final urea product. With this said, the argument would imply starting with the advertised plant in D8a as an improvement over the classical urea production plant, and backtracking later in the process to exclude the added technology (acid scrubbing and admixing to the final urea product). Overall:

• The Board sided with the appellant's argument that D8a is not a suitable starting point for the assessment of the inventive step of the plants and process defined in the patent, confirming that the inventive step starts at D9.
• The Technical effect achieved by introducing a second evaporation/condensation loop results in a reduction of steam consumption while maintaining urea output, or an increase in urea production while keeping steam consumption constant.

Order: The Board concluded that none of the grounds for opposition prejudiced the maintenance of the patent. Therefore, the decision under appeal was set aside, and the patent was maintained as granted.

Decision here