Unmerited patents protecting profit not patients – protesting & appealing the decisions so far.
50% of Ukraine’s budget for HIV drugs is spent on a monopolized drug. Because of the high prices made possible by this monopoly it means the health budget is over-stretched and cannot provide essential HIV treatment for everyone who needs it. Our partner, the All-Ukrainian Network of People Living with HIV/AIDS, has filed patent oppositions as it believes the patents do not meet the necessary legal requirements.
The Network’s initial patent opposition has been dismissed, and so earlier this month (11 May), activists from the Network gathered outside Kyiv’s Commercial Court of Appeal. Their purpose was to appeal this dismissal and continue to demand the cancellation of these unmerited ‘evergreening’ patents which allow Abbvie Inc. to set the price on lopinavir/ritonavir in Ukraine.
The Network will not stop fighting for these patents to be reviewed and revoked, as the decision determines whether or not tens of thousands Ukrainian patients receive life-saving treatment.
Unfair pricing = a death sentence
Because of the two evergreening patents on this combination drug, cheaper generic versions cannot enter to the local market. The patents granted to Abbvie Inc. relate to heat stability and method of administering. Neither grounds are truly innovative, and instead are aimed at protecting surplus profits and preventing other manufacturers to enter to the local market.
“Those patents allow the manufacturer to establish high prices. In other words, big pharma makes exorbitant profit from other people’s miseries. We must stop it!” says Sergiy Dmitriev, the Network’s director on policy and advocacy.
Currently, Ukraine spends about 50% of all budget allocated for HIV medicines procurements for lopinavir/ritonavir. It costs around $20 million (USD) annually, but only covers 26,000 patients. It is estimated that if the patents are successfully invalidated the price will drop to approximately a third. This would result in savings of around $14 million USD annually which could treat an additional 125,000 people living with HIV in Ukraine.
“If the court keeps these evergreening patents in place, it effectively signs a death sentence for tens of thousands Ukrainians living with HIV,” says Dmytro Sherembey, Head of Coordination Council at Network.
The Network’s activists were the first to establish a precedent in Ukraine by challenging unmerited patents on behalf of a patient organization. In May last year the Network submitted a claim to the Kyiv Commercial Court aimed at invalidating the lopinavir/ritonavir patents.
Grounds for the patent opposition included that the patents do not comply with the novelty and inventive step criteria, set forth by the law, and it allows Abbvie Inc. to set artificially high prices. However, on March 6, 2017 the court dismissed claim without re-examining the patents.
The grounds for dismissing the claims were controversial. The court firstly claimed that a patient organization has no legal standing to present a patent invalidation, and secondly that it didn’t prove that generic manufacturers would enter the market and lower the price if the patent was rejected.
The Network views this dismissal to be groundless and has opposed this decision at the appeal court.
On the May 11 hearing, Abbvie Inc.’s representatives used tactics to delay the appeal hearing. Proceedings are now delayed until November 16, 2017. The Network is outraged by this ruling as it will automatically allow Abbvie Inc. to sell lopinavir/ritonavir throughout 2017 at the same excessive price.
“We are deeply concerned with the court ruling to postpone consideration of the case for such a long term. In our opinion, it contradicts the procedural regulations, as well as existing legal practice and will have a negative impact on public health,” says Mykyta Trofymenko, Intellectual Property Counsel at the Network.
“We will challenge this at the High Commercial Court in order to start examination of lopinavir/ritonavir patents as soon as possible. We are convinced that every additional day of this unmerited monopoly will cost lives of patients.”