This week, the U.S. Supreme Court rejected Swiss pharmaceutical company Helsinn Healthcare S.A.’s claim that Teva Pharmaceutical violated patent rights when the Israel-based company released a generic version of its anti-nausea medicine, Aloxi.
This week, the U.S. Supreme Court rejected Swiss pharmaceutical company Helsinn Healthcare SA’s claim that Teva Pharmaceutical violated patent rights when the Israel-based company released a generic version of its anti-nausea medicine, Aloxi.
The Supreme Court unanimously upheld a lower court’s ruling that had canceled the Switzerland-based company’s patent on Aloxi, a medicine used with chemotherapy patients. The Aloxi patent had been canceled due to a violation of a provision in U.S. patent law that “forbids sales of an invention before applying for a patent,” Reuters reported. Teva first began to sell its version of the anti-nausea medicine last year after the company had argued that Helsinn invalidated its patent, according to the report.
In 2001, Helsinn, which is a small company, struck a deal with another company to distribute Aloxi in the United States in order to defray its costs. The deal had been publicly announced in regulatory filings and press releases, Reuters said. For Helsinn, Aloxi was the company’s primary revenue generator. The drug provided hundreds of millions of dollars for the company annually, Reuters said.
Teva argued that the patent was invalid because the 2001 deal was struck two years before Helsinn first applied for a patent. That constituted a sale, Teva argued, according to the report. Helsinn argued that it had never disclosed its formula dosage or proof-of-concept details about Aloxi, which the court rejected. According to the America Invents Act of 2011, a company or inventor must file a patent application within one year of disclosing the products in a publication or other means available to the public.
In March 2018, Teva released its palonosetron hydrochloride injection to prevent nausea and vomiting that may occur as a result of receiving cancer chemotherapy with a moderate or high risk of causing nausea and vomiting.
The unanimous ruling by the Supreme Court could have some wide-ranging implications. As Reuters noted in its coverage, the ruling “could make it easier to cancel key patents, especially among smaller drugmakers.” The ruling could also widen the patent law provision “prohibiting the patenting of an invention if it has been on sale or offered to the public more than a year before the patent application was filed,” Reuters said.
With the ruling, larger companies could take advantage of the product lines of smaller companies. As the Boston Business Journal reported, many smaller companies do not have the capital to file patents on every new invention within that time frame and “often rely on partnerships and other deals with larger companies to advance their research pipelines.” The ruling has certainly gained its fair share of detractors. The Journal said MassBio, a trade organization in Massachusetts, said the ruling could hinder startups and innovation.
