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6 June 2024NewsBiotechnologyMarisa Woutersen

Biopharma sues USPTO over rejected shock therapy patent

Complaint sought judicial validation of the company's patent claims for a distributive shock treatment | Disputes the PTAB's decision deeming the invention obvious.

Massachusetts-based biopharma La Jolla has filed a lawsuit against the US Patent and Trademark Office (USPTO) for rejecting the company's patent application for the treatment of distributive shock.

The complaint, filed at the US District Court for the Eastern District of Virginia on June 3, challenges the decision of the USPTO's Patent Trial and Appeal Board (PTAB) to reject the company's patent application on grounds of obviousness.

La Jolla aimed its legal action at Kathi Vidal, under secretary of commerce for IP and director of the USPTO, and sought a judicial declaration that the claims specified in their application for US patent number 16/220,901 are patentable.

The claims, which cover a sterile dosage form of angiotensin II (Ang II) for the treatment of distributive shock, were deemed obvious by the PTAB in a decision dated April 2, 2024.

Case background

The patent application in question involves a formulation of Ang II, a peptide hormone used to regulate blood pressure when treating distributive shock.

This medical condition, characterised by dangerously low blood pressure, requires rapid treatment to prevent severe adverse outcomes.

The claimed invention aims to provide a more efficient and safer method of administering Ang II by offering a higher dosage in a sterile form, which is currently not available in the market.

In the complaint, inventor James Rolke noted significant challenges in developing this dosage form, highlighting that existing practices involved cumbersome processes that increased the risk of contamination and dosing errors.

The PTAB, however, upheld the USPTO examiner's rejection, arguing the claimed invention was an obvious improvement over existing methods.

Legal and procedural arguments

The biopharma disputed the PTAB's decision, arguing that the rejection was based on an improper application of the legal standard for obviousness and did not adequately consider evidence of secondary factors such as commercial success, long-felt need, and failure of others.

The company asserted that the PTAB's decision was arbitrary and failed to recognise the nonobvious nature of their claims.

During the prosecution of the patent, La Jolla provided substantial evidence to counter the examiner's findings, including expert declarations and market analysis demonstrating the innovative aspects and benefits of their invention, said the complaint.

Despite this, the PTAB maintained the rejection based on prior art references, which La Jolla contends were misapplied.

La Jolla Pharma requested the court reverse the PTAB's decision and direct the USPTO to issue a patent for the pending claims.

It argued that their invention meets all statutory and regulatory requirements for patentability and that the PTAB's affirmation of the examiner's rejections was erroneous.

Specifically, La Jolla sought a judgment setting aside the PTAB's conclusions and authorising the USPTO to issue a notice of allowance for their patent application.

The company also requested any further relief deemed necessary by the court to rectify the situation.

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