API and IP Newsletter: ANDA approvals in April 2025 and Société des Produits Nestlé S.A. (Nestle) Vs N.V. Nutricia (Nutrica)
Contents
Recent ANDA approvals
General information
Regeneron secures USD 400 million damages in drug competition suit
AI/ML Innovations Seeks FDA Approval for MaxYield Signal Enhancement
Intellectual Property
Société des Produits Nestlé S.A. (Nestle) Vs N.V. Nutricia (Nutrica)
Recent ANDA approvals
We monitor ANDA approvals on a monthly basis.
There are approximately 70 ANDA approvals and 8 tentative approvals for April 2025.
The ANDA approvals sought by the different companies in April 2025 are listed below.
About 60% of ANDA approvals go to Indian companies, with Aurobindo and MSN leading the list. Below are some of our product-specific observations.
General information
Regeneron secures USD 400 million damages in drug competition suit
The verdict, handed down in the US District Court for the District of Delaware on 15 May, will see Amgen pay out a hefty penalty amounting to over USD 405 million in damages for its violations of the Clayton Antitrust Act, the Sherman Antitrust Act, the New York State Donnelly Act, the California Cartwright Act and Delaware tort law.
News here
AI/ML Innovations Seeks FDA Approval for MaxYield Signal Enhancement
AI/ML Innovations Inc. has filed for a 510(k) premarket notification with the U.S. FDA for its MaxYield™ platform. This proprietary technology aims to enhance ECG signal interpretation across clinical environments using a cloud-based neural network to reduce noise and improve clarity.
MaxYield targets ECG signals in adults aged 18 and older. By addressing common signal distortions, the platform seeks to support consistent interpretations in both hospital and mobile settings, advancing AIML's strategy in integrating digital health solutions.
News here
Intellectual Property
Société des Produits Nestlé S.A. (Nestle) Vs N.V. Nutricia (Nutrica)
Case Overview:
The case concerns an appeal against the Opposition Division's decision to maintain European Patent No. EP 2309876 in its amended form. The patent relates to a nutritional composition containing an oligosaccharide mixture designed to reduce the risk of obesity in infants later in life. The appeal was filed by one of the opponents of the patent, N.V. Nutricia (Nutrica), against the patent proprietor, Société des Produits Nestlé S.A. (Nestle)
The Gist of the Contested Patent Claims: (mainly Claim 1 and Claim 5)
The patent claims focus on:
- The use of N-acetylated oligosaccharides, galacto-oligosaccharides, and sialylated oligosaccharides in the manufacture of a nutritional composition for infants to reduce the risk of obesity later in life.
- A nutritional composition comprising a specific mixture of these oligosaccharides within defined weight percentages (2.5 to 15.0 wt% total oligosaccharides, with at least 0.02 wt% N-acetylated, 2.0 wt% galacto-, and 0.04 wt% sialylated).
Nestle includes N-acetylated oligosaccharides such as 2'-fucosyllactose and Lacto-N-neotetraose, galacto-oligosaccharides, and sialylated oligosaccharides in some of its infant formulas, notably in products designed to more closely resemble human milk for its benefits related to brain development and immune support.
For example, certain formulas in the Gerber or NAN lines may contain N-acetylated oligosaccharides, galacto-oligosaccharides, and sialylated oligosaccharides like sialyllactose.
These brands are significant segments within Nestle's infant nutrition division, which is a substantial part of the company's overall health science and nutrition business.
This patent must be significant for Nestle.
Cited Prior art documents
Arguments of the Appellant (N.V. Nutricia):
The appellant's main arguments against the patent were:
- Added Subject-Matter: Claim 5 of the main request (corresponding to auxiliary request 2 considered allowable by the Opposition Division) contained subject-matter extending beyond the content of the application as filed. The specific combination of oligosaccharides and their amounts to induce the claimed effects was not disclosed initially.
- Insufficient Disclosure: The claimed invention was not sufficiently disclosed because the tests described in the patent did not credibly demonstrate that the composition induced the claimed effects, particularly in preventing obesity later in life. The appellant questioned the relevance of the mouse model used, the composition of the diets, and the interpretation of the experimental data.
- Lack of Inventive Step: The claimed subject-matter did not involve an inventive step over the closest prior art (D4), which disclosed the use of oligosaccharides to prevent obesity. The appellant argued that the skilled person would have arrived at the claimed solution by combining D4 with other prior art.
Arguments of the Respondent (Société des Produits Nestlé S.A.):
The respondent defended the patent, arguing:
- No Added Subject-Matter: Claim 5 was based correctly on the original application and did not contain added subject-matter.
- Sufficient Disclosure: The patent and cited documents provided enough information to carry out the invention and made it credible that the claimed composition induced the claimed effects. The respondent addressed the appellant's concerns about the experimental data and the mouse model.
- Inventive Step: The claimed subject-matter involved an inventive step over the prior art. The respondent (Nestle) emphasised that the prior art did not provide incentives to combine the specific oligosaccharides in the claimed amounts to solve the problem of reducing obesity risk.
Board's Reasoning:
The Board of Appeal addressed each of the appellant's (Nutricia) arguments in detail:
- Added Subject-Matter: The Board disagreed with the appellant Nutricia, finding that claim 5 did not contain subject-matter extending beyond the application as filed. The Board reasoned that the skilled person would understand that the invention related to administering a composition containing a combination of N-acetylated, galacto-, and sialylated oligosaccharides in the first six months of an infant's life to induce specific biological effects, including reducing the risk of obesity later in life. The Board stated that these effects are interrelated and that the claimed combination of oligosaccharides, including that comprising the amounts specified in claim 5 and the passage bridging pages 4 and 5, is meant to induce all the aforementioned effects.
- Sufficiency of Disclosure: The Board found the appellant's (Nutricia) arguments unconvincing. It concurred with the respondent (Nestle) that the patent provided sufficient evidence that the claimed oligosaccharide composition reduces triglyceride concentration in the liver, is associated with reduced lipogenic activity, and causes a shift in lipid metabolism. The Board addressed the appellant's (Nutricia) concerns about the experimental data, the mouse model, and the interpretation of the results. The Board noted that lactose and glucose were added to the control diet to compensate for the amount of lactose and glucose brought into the experimental diet by the addition of the non-digestible oligosaccharides, and that the peer-reviewed article D31 confirmed that the mouse model used in the patent is a suitable model of human baby microbiota. The Board also referenced supporting prior art (D15 and D25) to support the credibility of the claimed effect. The Board concluded that the patent makes it credible that the claimed composition induces the claimed effects, specifically reducing the risk of obesity later in life.
- Inventive Step: The Board found that claim 1 did not involve an inventive step, since the prior art document D4 already taught that non-digestible oligosaccharides reduce the risk of obesity later in life. The board noted that D4 discloses galacto-oligosaccharides (page 15, line 12), sialylated oligosaccharides (page 15, line 16) and N-acetylated oligosaccharides (page 15, lines 25-26, referring to LNT, neo-LNT, fucosylated LNT, and fucosylated neo-LNT, all acetylated oligosaccharides) are suitable for reducing obesity later in life. However, the Board found that claim 5 did involve an inventive step because the specific amounts of the oligosaccharides used in the composition were not obvious from the prior art.
The decision of the Board of Appeal:
The Board of Appeal sided with the opponent (Nutricia) on inventive step for claim 1. The Board allowed auxiliary request 4. The Board remitted the case to the Opposition Division with the order to maintain the patent as amended by auxiliary request 4.
Decision here
