Adjustment of European intellectual property rules still insufficient

If the monopoly granted by the government in the form of a patent cannot be abolished when the public interest so requires, abuse is coming.Recent EU legislation has the potential to combat such abuse, but currently Only in crisis situations. In order to truly protect public health, Must go further.

The covid-19 pandemic has reignited interest patent compulsory license health technology. A compulsory license is a mechanism that governments can deploy to authorize the use of a patented product or process without the consent of the patent holder. The 2001 World Trade Organization Ministerial Conference adopted a declaration clarifying that Flexibility in Patent Law It complies with global trade rules and can be used to the maximum extent possible to protect public health. Compulsory licensing became popular in global healthcare in the early 2000s to ensure that low-cost HIV drugs could flow in global trade.

Spaniard to lead EUIPO: “Intellectual property crime must intensify”

Erin Cortez

Since 2020, we have taken a number of initiatives Grant of compulsory license covid-19 treatments in nine countries, which resulted in the granting of six compulsory licenses.several countries updated their patent laws Allow fast-track granting of compulsory licenses during the pandemic. For example, in March 2020, Germany passed legislation authorizing the Ministry of Health to directly grant the government compulsory licenses for the use of patents on a wide range of products needed during the pandemic. The U.S. licenses patents without the consent of the patent owner to speed up the development of countermeasures against the pandemic. Research group Knowledge Ecology International reported on 62 government contracts related to the Covid-19 pandemic that authorized the use of patented inventions to ensure that patent litigation does not delay the development of a Covid-19 vaccine.these actions are considered correct essential to protect the public At that time, timely response to the epidemic was a matter of life and death.

Unfortunately, it’s not easy or simple Deploy these tools based on public demand.The European Commission recently found series of questions under the current EU compulsory licensing regime. in: lack of coherence In EU countries compulsory license, limited territory effect Of these licenses, Cumbersome and lengthy administrative proceduresand lack single market For products that require a compulsory license. In addition, compulsory licenses are often applied to patents and “supplementary protection certificates”, which extend patent protection to address longer regulatory approval times.But apart from Spanish legislation, the EU’s compulsory licensing rules transfer not considered Trade secrets, test data or technical know-how that may be required to manufacture a product.

Tolls, taxes, tolls: Government promises to EU have yet to materialize

Javier Jolin

The protection of intellectual property rights in the European Union is increasingly harmonized, but Mechanisms to Protect the Public Interest — an integral part of any balanced intellectual property system — they are not. For example, the new unitary patent system recently entered into force in most of the EU, but it does not provide for compulsory licenses.said license continue to be governed by member state laws participants.Citing the Commission’s report on the topic “A purely state compulsory licensing system and the resulting divergences” Will conflict with growing European integration Patent Law”.

This situation further strengthens the market position of pharmaceutical companies.how is the company harness market forces. A 2020 white paper published by the European generics industry entitled “The Anatomy of Launch Failure” provides a sobering look at a range of issues. monopoly extension strategy The pharmaceutical industry is deployed to keep competitors at bay for as long as possible, no matter the public health cost.

Other obstacles to the effective use of compulsory licenses in the EU are Combined Drug Regulations, which provides data and market exclusivity for medicines registered in the EU.These non-patent-related market monopolies serious hindrance Effective use of compulsory licenses. To register and sell a generic drug in the EU, the manufacturer must demonstrate that the product is equivalent to the registered original product.data exclusivity Delay generic drugs entering the market Demonstrate equivalence by restricting generic drug manufacturers’ access to clinical trial data.

EU freezes 200,000 assets of Russian central bank

LP

no equivalent Monopoly compulsory licenses are granted through the drug regulatory system. In the EU, data and market exclusivity cannot be waived.Therefore, the grant of a compulsory license becomes silent measures Since generic drugs manufactured or imported under a compulsory license cannot be registered, unable to enter the market.

This is not a hypothetical question: the exclusivity of the data is one of the main obstacles In 2015, Romania considered issuing a compulsory license to import generic sofosbuvir, an antiviral drug used to treat hepatitis C.

Even in a public health emergency, regulatory exclusivity unable to legally get up. This phenomenon was first brought to light in 2006. European Generic Medicines Association (hereafter the European Medicines Association) ask for clarification On whether data exclusivity applies to the emergency compulsory authorization in the EU of the flu drug oseltamivir (marketed by Roche under the brand name Tamiflu). Oseltamivir stockpiles accumulated in countries due to H5N1 bird flu outbreak, cause product shortages.However, the European Commission informed generics companies that the European Community’s legislative system on medicines “does not currently contain any provisions allow exceptions Rules for Data Exclusivity and Marketing Protection Periods”.

Why Europe’s key to avoiding recession lies in U.S. pharma

Wall Street Journal.Paul Hannon

Seventeen years later, another pandemic struck, This is finally about to change.European Commission Proposal new legislation EU-wide compulsory licensing mechanisms and exemptions from data exclusivity and marketing.

Commission proposes a regulation Crisis Management Compulsory Licensing If the resolution is passed, it will establish unique program A Union Compulsory License is granted covering the entire European Union and can be granted by filing a single application. EU compulsory licensing will apply to “crisis-related products and processes”. EU Compulsory Licenses can be applied to granted patents, published national and European patent applications and Supplementary Protection Certificates.New proposals for medicines directive provide for suspension of data exclusivity and market protection in case of compulsory licenses to respond to public health emergencies.

These are sensible and long overdue suggestions, but the downside is only in crisis situations. This is a narrow approach.

For example, a compulsory license may be required to guarantee access to the technology. to prevent a crisis.Compulsory licensing should also be an effective remedy Against Anti-Competitive Behavior at EU level. In addition, the development of European health unions will require stronger instruments to deal with the high prices of new treatments.Currently, member states have great difficulty Good price negotiations with monopoly pharmaceutical companies have resulted in delays in access to medicines in the EU and inequalities in access to new medicines.European Commission pledges to help member states in response to high drug prices. An effective compulsory licensing mechanism would provide this support by strengthening the government’s position in price negotiations.

View

EU Anthropology

Juan Gonzalez-Barba Pera

Sometimes governments should be able to sit down and negotiate, but it’s hard to do If the pharmaceutical monopoly can never be dismantled, the health of patients cannot be sacrificed.

it’s important Expansion mechanism Compulsory licensing at EU level outside of crisis situations so you too can For other reasons of public interest when necessary. In order to ensure the effective use of compulsory licenses, data exclusivity and market immunity should be provided in all cases where the Commission or Member States issue compulsory licenses related to medical products. The new rules should also establish obligations, possibly including patent holders, to transfer know-how to beneficiaries of compulsory licenses.

committee Collecting comments With regard to his proposed EU-wide compulsory licensing mechanism, it shows that there is room for improvement. An important step in the right direction is to ensure that this mechanism can be used to protect public health. in all situationsnot just in health emergencies.

*Content licensed from barron’s weekly.

If the monopoly granted by the government in the form of a patent cannot be abolished when the public interest so requires, abuse is coming.Recent EU legislation has the potential to combat such abuse, but currently Only in crisis situations. In order to truly protect public health, Must go further.