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IPPro Magazine Quotes Brinks Shareholder Mark Remus
Published By IPPro Magazine
December 05, 2018

On December 5, 2018, Mark Remus was quoted in the IPPro Magazine  article, "SCOTUS Hears Oral Arguments in Helsinn v. Teva."

The US Supreme Court has heard oral arguments from the Helsinn v Teva Pharmaceuticals case.

In its first patent case of the year, the Supreme Court heard arguments from both parties on a case that questioned whether, under the America Invents Act (AIA), an inventor’s sale of an invention to a third party under a confidentiality agreement qualifies as prior art for determining patentability.

Helsinn filed three of its patents before the AIA came into effect and the fourth after it was implemented.

Teva had sought US Food and Drug Administration approval for a generic version of Helsinn’s drug. Helsinn responded with a patent infringement lawsuit.

Teva claimed that Helsinn’s patents had become under the AIA’s on sale bar following licence and supply agreements between Helsinn and MGI.

Both parties agreed that only the fourth patent, (8,598,219) was subject to the post-AIA definition.

The US District Court for the District of New Jersey ruled in favour of Helsinn and enjoined Teva from manufacturing or selling the generic drug until 2024, when Helsinn’s patent expires.

Teva appealed to the US Court of Appeals for the Federal Circuit, arguing that under the AIA, the phrase “or otherwise available to the public” does not inform the meaning of the preceding phrase “on sale”.

The Federal Circuit reversed the lower court’s decision, concluding that the contrast between “or otherwise available to the public”, “in public use”, and “on sale” showed an intent to reverse certain cases finding a public use. The court said that because Helsinn was not a “public use” case, legislative comments were inapplicable.

During oral arguments at the Supreme Court, most of the justices seemed to take the view that the case has been settled and that Congress’ revision of the statute in 2011 could be thought sufficient to overturn that understanding.

The newest Supreme Court justice, Brett Kavanaugh, said: “It’s pretty hard to say something that has been sold was not on sale.”

He seemed persuaded that “it’s always been the case that if you offer it to even one person or to a small group of people, it’s on sale.”

Kavanaugh responded to Helsinn’s representative's claims that Congress intended the AIA to clarify that an invention is “on sale” only if it is “available to the public”. He said: “If that was a clarification, it was a terrible clarification because there were a lot of efforts, as you well know, to actually change the ‘on sale’ language, and those all failed.”

Justice Elena Kagan took a different approach to analyse the case, suggesting that the language written was at least ambiguous as to whether a private sale like Helsinn’s should be enough to bar a patent. Like Kavanaugh, Kagan found that the revision of the statute in 2011 was specific enough to change the settled meaning.

Justice Sonia Sotomayor settled on the traditional conception of the on-sale bar and suggested that the historical understanding of the on-sale bar posed a real problem for the patent holder.

Justice Stephen Breyer agreed with Sotomayor, suggesting that the purpose of the on-sale rule was to prevent people from benefiting from their invention prior to and beyond the 20 years that they’re allowed.

Mark Remus, shareholder at law firm Brinks, Gilson and Lione said that following the oral hearing, he believes that there is a possibility that the court may affirm the Federal Circuit.

Remus said: “On the other hand, some justices appear prepared to reverse the Federal Circuit. In particular, justice Samuel Alito commented that it would be ‘nonsense’ for Congress to include private sales in a list of public activities and follow it with the ‘otherwise available to the public’ catch-all. Justice Elena Kagan appeared to agree with justice Alito’s concerns.”

“In view of the above, I expect a split decision. Predicting the outcome of an appellate decision is always fraught with uncertainty, but based on yesterday’s oral argument, it appears that the court may be headed toward an affirmance of the Federal Circuit’s holding that ‘on sale’ covers secret sales.”

Michael Pomianek, shareholder at Wolf Greenfield, who was present at the hearing, said that the arguments were “punctuated with laughter and filled with increasingly strange hypotheticals but did not provide much definitive insight into how the Court will decide the question of whether the changes made by the AIA to the on-sale bar encompass ‘secret sales’”.

Pomianek said that the justices “appeared sceptical” over Teva’s interpretation that ‘otherwise available to the public’ does not inform the meaning of the preceding categories but instead simply provides an additional category of prior art.

This article was originally published in IPPRo Magazine.  Click here to read more.

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