Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib). Background Under the 1984 Hatch-Waxman Act , companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the va...

A new bill introduced in the US House of Representatives on 24 March 2014 would grant companies additional patent protections for repurposed biological products. Bill Basics The bill, the Independent Innovator and Repurposing Act (IIRA) , is cosponsored by Reps. Joaquin Castro (D-TX) and Randy Forbes (R-VA) and is intended to provide "appropriate intellectual property protections" for some products. Those products, the bill explains, are any biologicals regulated un...

India's Union Health Ministry is pursuing three more compulsory licenses that would allow generic manufacturers in the country to compete with patent-protected medicines, including Roche's Herceptin and Bristol-Myers Squibb's Sprycel and Ixabepilone, reports PharmaBiz .  The announcement comes just months after the country's Supreme Court issued a landmark compulsory license for Bayer's Nexavar (sorafenib). What made that decision so remarkable to both critics...

The board of Brazil's National Health Surveillance Agency (Anvisa) has approved updated rules for the agency's prior consent assessment of patent applications for medicines. The new rules establish a process for prioritizing patent reviews to ensure that the focus is on pharmaceutical products of interest to the public health policies of the country's Unified Health System (SUS). The list of products of interest to the SUS will be published by the Ministry of Health, ...

A new piece of legislation introduced in the Senate would prohibit so-called "pay-for-delay" deals under the assumption that the deals delay the introduction of cheaper generic pharmaceutical medicines and are thus anti-competitive. Background The deals occur when a branded company and one or more generic companies settle patent litigation in such a way that the generic company agrees to delay introduction of its generic product for a period of time in return for a paym...

Generic versions of Merck's pharmaceutical blockbuster Singulair (montelukast sodium) are now available to consumers, making it the latest product to fall off the so-called 'patent cliff,' the US Food and Drug Administration (FDA) announced on 3 August . The drug is used by asthma and allergy sufferers to reduce inflammation, and was Merck's most lucrative, bringing in sales of up to $5 billion per year . The company is expected to lose much of its market share to its ...

Brazilian regulatory authorities are looking to keep newly-won authority to deny the grant of patents for medical products-authority won in 2012 as the result of patent reforms. Speaking at a 10 July 2012 hearing before the Brazilian House of Representatives, Anvisa's Coordinator for Intellectual Property, Antonio Carlos Bezerra, told legislators that the agency ensures that there is no "undue delay in the arrival of competitors." "An estimated $28 billion economy for t...

Following closely in the footsteps of India , China has announced the release of a new patent system in which it can grant compulsory licenses to generic pharmaceutical manufacturers to allow them to make copies of on-patent branded medicines. Compulsory licenses are used by countries to override patents when a country deems that a health crisis warrants such action. While compulsory licenses have been granted in moderation since the signing of the Doha Declaration ...

As the result of a new patent review process, Brazilian regulatory authority Anvisa is being given the authority to deny the grant of a patent for a medical product. The agency can make deny a decision to grant a patent if it determines the patent would impede universal access to medicines-a Brazilian constitutional right. This so-called right of "prior consent" by Anvisa would be binding on Brazil's Patent and Trademark Office (INPI). Read more: Patent Review Proc...

The US Food and Drug Administration (FDA) announced it has approved eleven generic versions of Bristol-Myers Squibb and Sanofi's blockbuster blood-thinner Plavix (clopidogrel bisulfate), marking the latest product to go off the so-called "patent cliff." Many drugs are scheduled to lose their patent protection in the coming two years, marking huge potential losses to the bottom lines of numerous companies. Both Sanofi and BMS said they expect a "rapid, precipitous and mat...

The Supreme Court of the United States (SCOTUS) ruled Monday (26 March) to send a case by Myriad Genetics Inc. back to a lower court for review in light of its recent decision, Mayo Collaborative Services v. Prometheus Laboratories , in which the court decided Prometheus's patents on methods to determine the proper dosing for a disease were invalid . In Association for Molecular pathology v. Myriad Genetics , SCOTUS was to consider whether patents held by Myriad on t...

The US Food and Drug Administration (FDA) approved the first generics version of Roche Holding AG's blockbuster osteoporosis drug Boniva (ibandronate), marking the next big patent expiry for the pharmaceutical industry this year. The generic ibandronate will be manufactured by Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals, and will be accompanied by an FDA-required Medication Guide (MedGuide) warning patients about the risks associated with the drug. Boniva h...