UNITED STATES
SCOTUS invites govt comment on Teva clash
The US Supreme Court has asked the US government to weigh in on whether the court should hear the ‘skinny-label’ dispute between Teva and GSK.
Back in July, Teva petitioned the Supreme Court to overturn a US Court of Appeals for the Federal Circuit decision which Teva claimed had ”blown a hole in the carefully calibrated regime governing the modern prescription-drug marketplace”.
The dispute centres on the common practice of ‘skinny labelling’ where generic drug makers exclude patent-protected indications from generic labels, in a process called “carving-out”.
GSK’s heart drug Coreg (Carvedilol)—which has been approved for treating hypertension, congestive heart failure (CHF), and left ventricular dysfunction (LVD)—is at the centre of the clash.
In 2007, GSK’s patents on the use of Coreg for treating hypertension and LVC had expired. But GSK’s patent on Coreg for the treatment of CHF remained valid, requiring Teva to issue a skinny label and carve out the use of its generic product.
The US Food and Drug Administration (FDA), in 2010, ordered Teva to update its label so it could be “identical in content to the approved [GSK Coreg] labelling” and include the indication for treatment of heart failure, after GSK patents covering other uses of Coreg were delisted from the Orange Book.
Then, in 2014, GSK sued Teva over its generic version of heart drug Coreg (Carvedilol). Coreg has been approved for treating hypertension, congestive heart failure (CHF), and left ventricular dysfunction (LVD).
“In February this year, a split Federal Circuit declined to rehear the dispute. Teva subsequently appealed against the decision to the Supreme Court.”
The Federal Circuit has since twice ruled that Teva’s label on a generic version of Coreg (Carvedilol) led doctors to prescribe the generic for an infringing use.
In August last year, the Federal Circuit reinstated the $235 million verdict against Teva. A 2-1 majority found that Teva had induced infringement by failing to carve-out a patent-protected use of the drug on its generic label.
In February this year, a split Federal Circuit declined to rehear the dispute. Teva subsequently appealed against the decision to the Supreme Court.
In response to Teva’s petition, GSK urged the Supreme Court to reject the petition, claiming that Supreme Court has considered the issue of induced infringement “at least four times over the last approximately 15 years”.
“This fact-bound case presents no new issues in those areas of law, and was properly decided by the appellate court under those authorities,” argued GSK’s defence lawyers. “Certiorari should be denied.”
In early October, the US solicitor general was invited to file a brief in this case expressing the views of the US.
Image: Shutterstock.com / Andrea Izzotti
ENGLAND AND WALES
Big pharma firm hits back in COVID-19 tech dispute
Pfizer and its German partner BioNTec have filed proceedings at the High Court of England and Wales, in a bid to revoke two patents owned by CureVac.
In early July, CureVac accused BioNTech of infringing four patents related to messenger ribonucleic acid (mRNA) technology through Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty.
Filing its suit in the German Regional Court in Düsseldorf, CureVac claimed that it doesn’t intend to seek an injunction or to take legal action that would impede the production, sale or distribution of Comirnaty, but wants its IP rights to be acknowledged and respected in the form of a “fair compensation”.
Pfizer and BioNTech hit back in late July with a filing at the US District Court for the District of Massachusetts. The complaint sought a ruling that they didn’t infringe patents owned by Germany-based CureVac and claimed that CureVac’s US patents are equivalent to the German patents invoked by CureVac in its own suit.
“CureVac claimed that it doesn’t intend to seek an injunction or to take legal action that would impede the production, sale or distribution of Comirnaty, but wants its IP rights to be acknowledged and respected.”
The pair alleged that CureVac had failed to develop a COVID-19 vaccine product so had “turned its attention to an attempt to profit from the success of BioNTech and Pfizer through threats of patent infringement”.
In a September regulatory filing, the duo confirmed that they had filed proceedings in the English High Court, seeking judgment that two of CureVac’s European (UK) patents are not infringed by Comirnaty and/or are invalid and should be revoked.
According to the filing: “The COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and Pfizer.”
Pfizer and BioNTech are also facing a patent suit filed by Moderna, which is alleging that the pair copied its technology when developing their COVID-19 vaccine.
Image: Shutterstock.com / Gorodenkoff
SWITZERLAND
Swiss watchdog investigates Novartis over patent use
The Swiss Competition Commission (COMCO) has initiated an investigation of Novartis over its possible unlawful use of a patent to reduce competitive pressure.
While COMCO did not name the company under investigation in its announcement, Novartis itself confirmed that it was under investigation.
According to COMCO, Novartis has “allegedly attempted to protect its drug for the treatment of skin diseases against competing products by using one of its patents to initiate litigation proceedings”.
COMCO’s investigation aims to determine whether the alleged behaviour constitutes the use of a so-called blocking patent. Under the Swiss Cartel Act, use of a blocking patent might amount to an unlawful abuse of an allegedly dominant position.
As part of the investigation, COMCO conducted a dawn raid at Novartis’ premises on September 13.
“Novartis is fully cooperating with the authorities and is confident to clarify the legitimacy of its position.”
Novartis confirmed that COMCO, in collaboration with the European Commission, had begun an investigation into the assertion of a patent in the field of dermatology treatments.
“The opening of an investigation does not imply any finding of wrongdoing or any financial impact. Novartis is fully cooperating with the authorities and is confident to clarify the legitimacy of its position. As this is an ongoing investigation in its early stages, we will not comment further at this point in time,” said Novartis.
In October 2021, Novartis’ generics unit Sandoz agreed to pay $185 million—alongside generic makers Taro Pharmaceuticals and Apotex Corporation—to resolve alleged violations of the US False Claims Act arising from conspiracies to fix the price of various generic drugs.
At the time, the US government alleged that between 2013 and 2015, all three companies paid and received compensation through arrangements on price, supply and allocation of customers with other pharmaceutical manufacturers for certain generic drugs.
Image: Shutterstock.com / Fedor Selivanov
UNITED STATES
US company secures genetically modified rice ban against Chinese rival
The US International Trade Commission (ITC) issued a blocking order in September, halting the importation of a Chinese company’s genetically-engineered rice seeds.
Earlier that month, the ITC banned Wuhan Healthgen Biotechnology Corp from importing its infringing plant-based albumins into the US.
Kansas-based Ventria Bioscience develops genetically programmed rice to express recombinant human proteins. The proteins, known as albumin, are then extracted for use in medicines such immunotherapy drugs, gene therapies and vaccines, including those used for COVID-19.
Ventria filed its complaint with the ITC back in December 2020, alleging that the imports were infringing US patent numbers 10,618,951 and 8,609,416. The ITC agreed to investigate the allegations in January 2021.
In addition to Wuhan Healthgen, the ITC also investigated California-based companies, ScienCell Research Laboratories and Aspira Scientific, alongside Maryland-based biotech eEnzyme.
The ITC has also issued a limited exclusion order and cease-and-desist order against the three US companies.
“The China-based company is barred from importing unlicensed and infringing plant-derived albumins’.”
According to the notice, Wuhan Healthgen was the only company to participate in the investigation.
The China-based company is barred from importing unlicensed and infringing plant-derived albumins, alongside plant-derived albumins that fail to accurately designate the country of origin.
According to Ventria, a former employee had founded Wuhan Healthgen to make a plant-based albumin using techniques covered by the two patents.
In recent years, Ventria has been involved in a number of legal battles to protect its patented technology.
In an earlier connected case, two Chinese nationals were charged with conspiracy to steal rice technology from Ventria in 2018. At the time, the US Department of Justice said that Ventria had invested approximately $75 million in developing the seeds.
A former Ventria employee and Chinese scientist faced more than ten years in prison after being found guilty of conspiring to steal samples of genetically modified rice from Ventria.
Image: Shutterstock.com / Daniel Western
UNITED STATES
USPTO unveils tool to access key FDA data
The US Patent and Trademark Office (USPTO) has launched a webpage offering the public a new way to access information relating to applications for patent term extensions filed at the Food and Drug Administration (FDA).
A patent term extension is available for pharmaceutical and medical devices under the Hatch-Waxman Act and allows additional time to be added to a patent to compensate for delays in the FDA approval process.
The website provides access to information on applications that have been filed within the past five years. It includes the application number, patent number, and trade name identified in the application, and provides a link to the electronic file containing the relevant papers.
The move has been driven by feedback from stakeholders requesting readily available information about patent term extension applications.
“The move has been driven by feedback from stakeholders requesting readily available information about patent term extension applications.”
Kathi Vidal, director of the USPTO, also committed to exploring ways to facilitate public access to information on these applications and grants in her letter to the FDA earlier this year.
The USPTO and FDA have partnered to facilitate access to affordable drugs, after being called on by US President Biden to collaborate.
As part of the efforts, the office will provide new tools for patent examiners to search global databases of technical information—including publicly available sources maintained by the FDA—to determine whether similar innovations already exist.
The FDA will assist by providing patent examiners with training on the state of the art in the pharmaceutical and biologics fields.
Image: Shutterstock.com / Gorodenkoff
