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4 March 2016Americas

Helsinn handed patent win against Teva

A US court has brought to a close a patent lawsuit that cancer care company Helsinn Healthcare filed against Teva after determining that Helsinn did not trigger the on-sale bar provision when marketing its anti-cancer drug Aloxi (palonosetron).

In a decision handed down yesterday, March 3, the US District Court for the District of New Jersey released a supplementary opinion in a case that saw Helsinn accuse Teva of infringing four of its patents.

A memorandum opinion had previously been released by the court in November last year but yesterday’s supplementary opinion detailed the reasons behind that decision.

In total, Helsinn had asserted four patents against Teva: US numbers 7,947,724; 7,947,725; 7,960,424; and 8,598,219. It also sued Dr Reddy’s and Sandoz, but both were dismissed from the lawsuit with consent last year.

Helsinn claimed the patents were valid and enforceable and would be infringed by Teva’s proposal to market a generic version of the drug.

Teva counterclaimed that the patents were invalid and asserted further invalidity claims centring on the on-sale bar provision.

The on-sale bar doctrine, which came into force under the America Invents Act (AIA), provides that an invention cannot be patented if it has been sold or offered for sale for more than one year before a patent being filed.

For an on-sale bar to occur, Congress requires that the alleged “sale” or “offer for sale” be a transaction that makes the invention available to the public, or that the public must be able to learn what the invention is through the transaction.

In its preparation of the drug, Helsinn carried out clinical trials, stability studies and developmental work with third parties. It also prepared to market its drug, which Teva claimed should trigger the on-sale bar provision.

But Helsinn argued that its clinical trials didn’t make the invention available to the public and that, as a result, the bar was not triggered.

In yesterday’s supplemental ruling, Judge Mary Cooper agreed with Helsinn.

Joe O’Malley, partner at law firm Paul Hastings and who represented Helsinn, said: “We are gratified that Judge Cooper has affirmed the strength of Helsinn’s intellectual property, holding each of the four patents in suit valid.

“The court has decided issues of first impression including the scope of the on-sale bar post-AIA. In particular, the court held that post-AIA there can be no on-sale bar with respect to a sale that does not make the claimed invention ‘available to the public’,” he said.

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