SCOTUS urged to remedy ‘threat’ to patent law in sleep drug feud
Biotech company submitted a petition challenging an ‘incorrect’ ruling by the Court of Appeals for the Federal Circuit | Earlier decision invalidated several of Vanda’s patents in its sleep drug dispute against a pair of big pharma firms.
Vanda Pharmaceuticals has filed a petition with the US Supreme Court, seeking a review of an earlier judgment by the US Court of Appeals for the Federal Circuit in its dispute with Teva Pharmaceuticals and Apotex.
The Fed Circuit’s judgment, issued May 10, 2023, affirmed a lower court's finding that several of Vanda's sleep drug patents were invalid.
The petition, filed on January 12, argued that the Federal Circuit's deviation from established standards posed a threat to patent law, particularly in the pharmaceutical sector.
Vanda held that the Federal Circuit's standard for obviousness diverged from the principles articulated by the Supreme Court—stating that the Federal Circuit “has charted its own course”.
“Rather than pegging obviousness to ‘predictable results,’ that court instead holds that a combination of known elements is obvious when an ordinarily skilled artisan would have a ‘reasonable expectation of success’ in the results reached,” said Vanda.
The case concerns the patentability of tasimelteon, marketed under the name Hetlioz, a drug developed by Vanda to treat non-24-hour sleep-wake disorder, which affects blind individuals.
The patents in question are US patent numbers: RE46,604; 9,730,910; 10,149,829 and 10,376,487.
The petition argued that the Federal Circuit's adoption of a “reasonable expectation of success” standard, as opposed to the Supreme Court's “predictable results” criterion, has far-reaching consequences.
The Federal Circuit's standard could cause many drug developments to be unpatentable, according to the petition.
This would have significant implications for rare diseases, where patent-based incentives play a crucial role in encouraging investments for the development of new treatments.
Vanda argued that the court should have applied the Supreme Court's “predictable results” standard, which, it said, would not support a finding of obviousness in this case.
The pharmaceutical company asserted that the Federal Circuit's departure from established standards had led to an incorrect outcome.
In the context of pharmaceutical patents, Vanda argued that the Federal Circuit's standard undermines the incentives for drug development and patent protection.
Vanda also highlighted the financial burden and time-consuming nature of developing pharmaceuticals, meaning that patent protection is essential for recouping investments.
The petition urged the Supreme Court to review the case and “correct” the Federal Circuit's standard for obviousness in patent law.
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