API and IP Newsletter 1.) Recent P-IV filings 2.) Thyssenkrupp Fertiliser Technology GmbH Vs Stamicarbon B.V.

 Contents

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

Thyssenkrupp Fertiliser Technology GmbH Vs  Stamicarbon B.V.

Recent P-IV filings

We follow P-IV certificate filings.

The FDA published its last such list on May 12, 2025. Only one ANDA was filed according to the new list. The list can be accessed here. 

Originally, Opvee was approved as the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.

The company (Indivior Inc.) forecasted annual sales of between $150 million and $250 million.

Indivior reported preliminary Q3 2024 results in October 2024, and Opvee was projected to earn USD 15 million for that quarter. Hence, the company must be achieving $50-60 million in sales per annum currently. 

Three Indian companies imported innovator samples: Cipla, Lupin, and Zydus. One of them could have filed an ANDA. Rubicon also imported API from Mallinckrodt, and Rubicon would likely be one of the contenders in ANDA filings. 

There are two OB-listed patents.

US 11458091 must cover Opvee’s marketed formulation. Someone who has filed an ANDA must have either circumvented US 1145091 or should challenge it in court. 

US 12290596 later submitted a patent to the Orange Book for a treatment method. 

There are four active DMFs

Interestingly, all companies that have imported innovator samples are importing API from Mallinckrodt.

This API supply from Mallinckrodt originates from SpecGx, a subsidiary of Mallinckrodt. All companies have imported HCl salt. Although the quantity requirements for the API are low, this is very costly, priced around USD 40,000/KG.

General information

Compounding Of Offences Under Drugs And Cosmetics Laws: A Legal Shift In 2025

The Drugs and Cosmetics Act, 1940 ("Act") is the primary legislation governing the manufacture, sale, distribution and import of drugs and cosmetics in India. Over the years, the Act has undergone several amendments to keep pace with evolving standards in public health and pharmaceutical industry. Prior to 2008, the Act did not contemplate the concept of compounding of offences. It was the Drugs and Cosmetics (Amendment) Act, 2008 that introduced Section 32B, empowering the government to compound certain offences under the Act. However, this section remained dormant for more than a decade due to the absence of corresponding rules. In this regard, the Ministry of Health and Family Welfare has finally notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 ("Rules") which came into force on April 25, 2025.

News here 

Aptar Digital Health Partners with AstraZeneca to License AI Algorithms for Chronic Kidney Disease Detection

Aptar Digital Health has entered into a licensing agreement with AstraZeneca to utilize the pharmaceutical company’s artificial intelligence (AI) algorithms for detecting chronic kidney disease (CKD). The collaboration grants Aptar access to AstraZeneca’s AI-driven screening technology, which is designed to identify CKD in patients more efficiently.

News here

Intellectual Property 

Thyssenkrupp Fertiliser Technology GmbH Vs  Stamicarbon B.V. 

This write-up concerns a decision made by the European Patent Office's (EPO) Boards of Appeal 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. 

Thyssenkrupp Fertiliser Technology GmbH is a well-established company in the fertiliser technology sector. Thyssenkrupp's total sales for the fiscal year 2023/2024 amounted to €35 billion. It is challenging to pinpoint the exact turnover of the "Thyssenkrupp Fertiliser Technology GmbH" segment specifically. The company organises its business activities into five segments: Automotive Technology, Decarbon Technologies, Materials Services, Steel Europe, and Marine Systems. Fertiliser technology falls under the broader "Decarbon Technologies" segment.

The history of thyssenkrupp Uhde Fertilizer Technology dates back to the 70s when the original technology was developed by NSM, which later became Hydro Agri Fertilizer Technology and Yara.

In 2005, thyssenkrupp acquired exclusive worldwide license rights for the fluid bed urea granulation technology from Yara.

The company now invests heavily in R&D, and many new developments have been launched, such as the ultra-low emission scrubbing system, the Ammonia Convert Technology (ACT), which allows ammonium salt to be recycled from the acidic scrubbing into the final product, new plant concepts to optimise investment and operating costs, a formaldehyde-free additive, and production diversification into sulfur-enhanced urea granules.

Patent Details: The contested patent pertains to a urea production plant and its scrubbing system.

The Opposition Division initially revoked the patent, a decision that prompted Thyssenkrupp's appeal. In summary, the opposition division (at the first instance jurisdiction at EPO) opined in favor of Stamicarbon B.V.  

Stamicarbon B.V. is also the world market leader in designing, licensing, and developing urea plants for the fertiliser industry. The company offers solutions, including fertiliser production technologies, emission reduction technologies, and all technologies for urea integration and adjacent processes.

Stamicarbon B.V.'s specific turnover numbers are not publicly available. Stamicarbon is a subsidiary of Maire Tecnimont. Maire Tecnimont's consolidated financial results report a turnover of €3,157.6 million in 2022.

Since Thyssenkrupp Fertiliser Technology GmbH appealed the initial decision, the Technical Board of Appeal convened on March 18, 2025, to review the case.

Claim 1 of the main request (patent as granted) describes a urea production plant comprising:

1. A synthesis and recovery section.
2. A first evaporation section connected to the synthesis and recovery section, and a first condensation section.
3. A granulation section connected to the first evaporation section.
4. A scrubbing section connected to the granulation section.
5. A second evaporation section connected to the scrubbing section, which is also connected to the granulation section.
6. A second condensation section connected to the second evaporation section.
7. A quenching section comprising a liquid inlet for distributing a quenching liquid, located and connected between the granulation section and the scrubbing section, and connected to a quenching liquid providing section and the second condensation section.

 

Opposition (at first instance at EPO) and Decision: 

The Opposition Division revoked the patent based on Article 101(3)(b) EPC, citing a lack of novelty and inventive step. 

The documents cited in the decision under appeal included:

D1: WO2013165245 A1

D2: "Ullmann's Encyclopedia of Industrial Chemistry," vol. A27

D4: WO2015002535 A1

D9: US20110229394 A1

The core of the dispute revolves around whether the patent demonstrates an inventive step over existing prior art, particularly concerning the inclusion of a quenching section and specific scrubbing configurations.

Arguments of the Appellants (Thyssenkrupp):

1. The appellants argued that combining D1 and D4 would not lead to the specific configuration claimed in the patent, particularly the connection of the quenching section with a quenching liquid providing section and the second condensation section.
2. They contended that D4 only disclosed quenching as part of complicated Venturi scrubber systems, which a skilled person would not incorporate into a plant based on D1.
3. The appellants also pointed out that D1 did not include an acid scrubber, which is present in auxiliary requests 1 and 3, and that none of the prior art documents disclosed a cooler scrubber, as present in auxiliary requests 2 and 3.

Arguments of the Respondent (Stamicarbon): 

The respondent's arguments were reflected in the reasons given by the Opposition Division for revoking the patent, asserting that the claimed invention lacked novelty and inventive step in light of the prior art.

Reasons for the Decision (Boards of Appeal):

Main Request (Patent as Granted):

1. The Boards of Appeal agreed with the Opposition Division that D1 did not disclose a quenching section. While the respondent interpreted section D in Figure 2 of D1 as a quenching section (see attached figure) , the Boards found this unacceptable because quenching and scrubbing are distinct processes requiring separate sections in the apparatus.
2. However, the Boards found that D1 does not anticipate the novelty of claim 1 of the main request.
3. Despite this, the Boards determined that the invention lacked an inventive step under Article 56 EPC. The problem to be solved was identified as providing a urea plant with a more efficient dust removal process. The proposed solution, including a quenching section with specific connections, was considered obvious because D4 also relates to urea production and efficient dust removal. D4 explicitly discloses that quenching the off-gas has advantages for energy conservation and urea dust removal.
4. The Boards reasoned that a skilled person would consult D4 when trying to solve the dust removal problem and would have had good reason to include a quenching section in the setup of D1, especially since D4 teaches that quenching occurs prior to scrubbing. (See figure below). The connection with a quenching liquid providing section and a second condensation section was deemed a logical consequence of combining the teachings of D1 and D4.

 

Auxiliary Request 1:

1. Claim 1 of this request included the feature that the scrubbing section comprises a dust scrubber and an acid scrubber.
2. The Boards found that while D1 does not mention an acid scrubber, D4 discloses in claims 9 and 14 that an acid scrubber can be added downstream of the dust scrubbing section for ammonia removal.
3. Given that off-gases from the finishing section may be contaminated with ammonia, and D4 discloses ammonia removal, the Boards concluded that adding an acid scrubber downstream of the dust scrubber in D1 would be an obvious step for a skilled person concerned about ammonia contamination.
4. Consequently, claim 1 of auxiliary request 1 was deemed not to involve an inventive step.

Auxiliary Request 2:

1. Claim 1 of this request included the feature that the scrubbing section comprises a dust scrubber and a cooler scrubber.
2. The Boards noted the absence of any arguments demonstrating how a cooler scrubber could provide a technical effect or a combined effect with other features in the claim, including the quenching section.
3. The Boards found that a cooler scrubber connected to an additional granulation cooler is a known device in a urea plant, as taught in D9. Therefore, equipping the granulation cooler with a cooler scrubber, known from D9 in the urea plant, known from D1, was considered an obvious alternative.
4. As a result, claim 1 of auxiliary request 2 was deemed not to involve an inventive step.

Auxiliary Request 3:

1. Claim 1 of this request included the feature that the scrubbing section comprises a dust scrubber, an acid scrubber, and a cooler scrubber, combining the features of auxiliary requests 1 and 2.
2. Without any synergistic effect, the Boards determined that the distinguishing features (acid scrubber and cooler scrubber) needed to be addressed independently. The same considerations applied as with auxiliary requests 1 and 2.
3. Consequently, claim 1 of auxiliary request 3 was also deemed not to involve an inventive step.

Order: 

For these reasons, the Boards of Appeal decided to dismiss the appeal, upholding the Opposition Division's decision to revoke European Patent No. 3560907 B1.

Decision here