Introduction
The EPO Board of Appeal decision T1989/19 relates to the patent for crystalline micronized Tiotropium Bromide (EP 1785422), owned by Boehringer Ingelheim Pharma. The opponents, including Hexal Pharma and others, challenged the patent on grounds of insufficiency of disclosure (Art. 83 EPC), lack of novelty (Art. 54 EPC), and lack of inventive step (Art. 56 EPC). Ultimately, the Board upheld the patent, focusing on the sufficiency of disclosure and novelty of the invention. This decision underscores important legal principles surrounding the evidentiary requirements and technical effects for inventive step and novelty challenges in pharmaceutical patents.
Summary of the Invention
The patented invention pertains to crystalline micronized Tiotropium Bromide, used in inhalation therapies for respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD). The invention is defined by specific parameters such as particle size (X50 between 1.0 µm and 3.5 µm), surface area (2 m²/g to 5 m²/g), solution heat greater than 65 Ws/g, and water content between 1% and 4%. The product ensures a stable formulation for effective drug delivery in dry powder inhalers, optimizing particle size and moisture levels to prevent agglomeration and maintain therapeutic efficacy over time.
Key Points of the Decision
Sufficiency of Disclosure (Art. 83 EPC)
The opponent claimed that the patent failed to provide sufficient information on how to achieve the claimed ranges of particle size, surface area, and other properties. The opponent also argued that the patent did not sufficiently disclose how to achieve the product without the conditioning step described in the patent.
The Board disagreed, noting that the patent provided adequate guidance through the examples and descriptions. It referenced decision T 435/91, distinguishing this case as the patent gave sufficient instructions on how to achieve the claimed properties. The Board concluded that the skilled person could reproduce the invention using the information disclosed.
Novelty (Art. 54 EPC)
The opponent cited prior art (D9 and D6) in an attempt to show that the claimed invention lacked novelty, particularly concerning particle size and water content. The opponent also argued that a water content of 0.9% from the prior art fell within the claimed range of 1% to 4%, using rounding conventions.
The Board rejected these arguments, stating that the water content of 0.9% does not overlap with the claimed range, and the rounding convention applied by the opponent was not applicable in this context. The Board found that the invention was novel as it had distinguishing features, particularly the specific water content and particle size, which were not disclosed in the prior art.
Inventive Step (Art. 56 EPC)
The opponent challenged the inventive step, arguing that the claimed invention did not provide a technical effect beyond what was known in the prior art. However, the Board referred to experimental data (D23 and D65) provided by the patentee, which demonstrated improved stability and performance of the claimed formulation over prior art products.
The opponent attempted to argue that the differences in crystalline forms of Tiotropium Bromide made the comparisons invalid, but the Board found the patentee’s experiments valid and the improvements substantial. The technical effect of improved stability was deemed to be a legitimate basis for inventive step, especially given that no evidence was provided to challenge this conclusion.
Lessons to be Learned
- Evidence Requirements: Parties challenging a patent must provide substantial evidence to refute the patentee's claims, especially regarding technical effects.
- Rounding and Interpretation: Rounding conventions do not apply automatically in patent law, especially where precise technical measurements are required.
- Importance of Technical Effect: Demonstrating a significant technical improvement over prior art can strongly support an inventive step, especially when supported by experimental data.
Contact
If you have any questions concerning intellectual property issuesor need assistance with patent applications, oppositions, or appeals, please do not hesitate to contact us at Novitech IP. Our team of experienced professionals is here to provide you with expert guidance and support. Reach out to us today to discuss how we can help protect your innovations and navigate the complexities of IP law.
To stay informed about the latest reviewsand updates in IP law, subscribe to our blog. Join our community and receive notifications whenever we publish new reviews and insights on important case law and developments in the field of intellectual property.
Legal Disclaimer
The information provided in this blog post is for generalinformational purposes only and does not constitute legal advice. The summary and analysis of the EPO case are based on publicly available information and are intended to offer insights into the decision and its implications. This content should not be used as a substitute for professional legal advice tailored to your specific circumstances. For advice related to any specific legal matters, you should consult a qualified attorney.