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Respiratorius’ US patent application reopens

US Patent and Trademark Office's Patent Trial and Appeal Board sides with Respiratorius

Respiratorius’ US patent application reopens

12 April, 2024

After the initial rejection of Respiratorius’ patent application, the US Patent and Trademark Office’s Patent Trial and Appeal Board has now sided with the company. The decision means a reopening of the application regarding the oral formulation of VAL001. BioStock has contacted CEO Johan Drott to gain a better understanding of what this implies for the project.

Lund-based Respiratorius is developing a treatment for diffuse large B-cell lymphoma (DLBCL). The company has developed the drug candidate VAL001 as a pre-treatment to R-CHOP – today’s standard treatment for the disease – that consists of a combination of chemo- and immunotherapy.

In the Q4 report, the company announced having engaged in in-depth discussions with a potential partner for the continued development of VAL001, but that there are still some question marks before an agreement can be reached.

Pursuing two patent applications for VAL001

The company is currently pursuing two patent applications regarding the novel formulation of valproic acid with the patent authorities in intended target markets. The first patent application relates to an oral formulation of valproate and the second concerns the fully developed and more detailed description of the product, where direct release is combined with a sustained release of the active substance.

The patent for the first application was granted in Japan in 2022 and in Canada in 2023. In the US, however, the examiner had objections and chose to reject the company’s patent application.

Successful in their appeal

Respiratorius appealed the examiner’s decision, and the Patent Trial and Appeal Board at the US Patent and Trademark Office (USPTO) has now chosen to rule in favour of the company. The Board annuls all of the examiner’s objections to individual claims. The decision to reject the patent application is overturned, which means that the examiner has to reopen the case.

In connection with the decision, Respiratorius has stated that the Board of Appeal does not see any obstacles to the patent. The company believes that it should therefore be difficult for the reviewer to raise new obstacles to approval. An approved patent would give the candidate protection on the US market until 2036.

The second patent application, relating to the combined release version of the candidate, was filed in the summer of 2023. This process has not come as far, but if the company receives the green light for this patent, it means that the protection of VAL001 will be extended for another 20 years.

Comments from the CEO

BioStock reached out to Johan Drott, CEO of Respiratorius, to get his view on the US Patent Office’s decision.

Johan Drott, CEO Respiratorius
Johan Drott, CEO Respiratorius

Johan, can you elaborate on what the USPTO’s latest ruling means for the protection of VAL001?

– A patent approval in the US naturally strengthens the case. Our US Patent Attorney is monitoring the progress of the proceedings at the US Patent Office closely. To be clear, this does not mean that the patent has been approved in the US, but it means that the application is reopened.

You believe that it should be difficult to raise new obstacles to the patent. When do you a final decision?

– Right now, I cannot comment on when a possible approval of when the patent application may be approved. This depends on how the reviewer decides to act. Our US counsel has attempted to reach the reviewer for a meeting.

You are running another patent application process in parallel, relating to the latest formulation. Does the USPTO’s new decision have any bearing on that application as well?

– The latter application has not yet reached the international stage and is completely independent of the decision of the Patent Trial and Appeal Board.

You are currently conducting an in-depth partnering dialogue. How is that affected by the US Patent Office’s decision?

– We have not specifically discussed patent applications in this dialogue. The painfully long discussion relates to other issues, more specifically the design and implementation of a phase III study. Such a large investment is a major decision-making commitment.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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