Valeant rehearing request raises hopes for drug brands on Hatch-Waxman venue rules
Drug maker Valeant filed a petition for en banc rehearing at the Court of Appeals for the Federal Circuit this week in a bid to reverse its defeat against Mylan on venue rules for abbreviated new drug applications.
In November, the appellate court affirmed a decision from the District Court for the District of New Jersey that the first-instance court was not the proper venue for Mylan. It had departed from its own case law and that of the District Court for the District of Delaware.
The lower court had previously ruled in Celgene v Hetero Labs that the Hatch-Waxman Act’s focus on future patent infringement following approval of a generic drug made it appropriate to include an alleged infringer’s future acts in a venue analysis.
But in this instance, the District of New Jersey decided that in the context of ANDA venue analyses, acts of infringement only occurred in districts where ANDA submission actions happened, not where generic therapeutics were likely to be distributed once launched.
The Federal Circuit has yet to decide whether it will accept the petition, but counsel for innovator drug companies undoubtedly hope that it will so it can overturn the decision and reduce the likelihood of increased risk and unpredictability in that space.
“The Valeant case confirms that generics companies will have a good chance of litigating Hatch-Waxman matters in their choice of venue, and create the real possibility of multiple parallel cases with potentially conflicting results,” says Henry Hadad, senior vice president and deputy general counsel at Bristol-Myers Squibb in New Jersey.
Other Managing IP stories published this week include:
EUIPO report: Marvel and DC Comics films are most pirated in EU
The EUIPO revealed in a report published last Friday, December 4, that Justice League, Wonder Woman, Thor Ragnarok and Spiderman Homecoming – produced by DC Comics and Marvel – were respectively the most pirated films in the EU for 2017.
The study, called Online Copyright Infringement in the European Union, reported that Dunkirk, Jumanji Welcome to the Jungle, It, The Circle, Cars 3 and Blade Runner 2049 also made it into the list of the top 10 most pirated films for that year.
The report, which was based on an analysis of the 30 most frequently pirated creative works in each of the EU member states, also listed the most pirated TV programmes and songs in 2017.
The top five most pirated TV programmes in the EU were The Walking Dead, Star Trek Discovery, Mr Robot, Vikings and the Grand Tour. The top five musical artists were Ed Sheeran, Luis Fonsi, Ricky Martin, Charli Puth and Bruno Mars.
Some of its key findings were that piracy mainly affects creative works recently produced and released, and that TV series were the most frequently pirated creative works.
EPO staff-representative bodies call for strike on December 15
The EPO’s Central Staff Committee and the Staff Union for the EPO called for a strike to take place on Tuesday, December 15, during a meeting of the Administrative Council this week.
In a letter sent to EPO staff on Thursday, December 10, the staff committee encouraged personnel to join the strike and said staff work packages had been consistently eroded.
“All the while, our president maintains that the staff he meets are happy, that social dialogue is working at full speed and that all is going well in EPO-land (our production has not suffered, even today),” the letter read.
“This is in stark contrast to the emails, phone calls and messages we keep receiving by many colleagues who are increasingly suffering from the unabated production pressure and management by spreadsheet, topped up by the social isolation due to the pandemic.”
SUEPO had already called for the strike in a letter to its members last week. Both organisations cited social conflict at the EPO as the main reason for proposing the strike.
The EPO has yet to publicly respond to the call.
Australia regulator to make Google and Facebook pay for news
The Australian government has tabled legislation in parliament that would force Google and Facebook to negotiate fair payments with news organisations for using their content in newsfeeds, it was announced this week.
The new law, which was intended to safeguard independent journalism in Australia by addressing the loss of advertising revenues in the media industry, comes three years after the government asked the country’s competition regulator to look into the state of competition in the media.
In its 18-month-long inquiry, the Australian Competition and Consumer Commission, which looked into the impact of Facebook and Google specifically, found a bargaining power imbalance between news media organisations and the large digital platforms.
It recommended that codes of conduct be negotiated to govern their commercial deals.
The new law is separate to a recent deal Facebook made to pay mainstream UK news outlets millions of pounds a year to license their articles.
Such legislation has long been desired by newspaper publishers, which have argued that users would find Google and Facebook much less helpful if their news did not appear in those companies’ feeds or in their search results.
Global trademark applications rise while Chinese patent filings fall
A report published by WIPO on Monday, December 7, revealed that worldwide trademark and industrial design-creation activity rose in 2019, while the number of global patent applications fell slightly because of a drop in domestic Chinese filings.
WIPO's benchmark World Intellectual Property Indicators (WIPI) report showed that trademark and industrial design filings increased by 5.9% and 1.3% respectively, and that global patent filings fell by 3% – for the first time in a decade.
The report, which was constructed after WIPO collected and analysed IP data from 150 national and regional offices, noted that if you excluded China from the calculations, global patent filings rose by 2.3% in 2019.
In a press statement, WIPO director general Daren Tang said WIPI's 2019 figures, which pre-dated the COVID-19 pandemic, underlined the long-term growth in demand for the IP tools that incentivise an increasingly global and digital-focused economy.
“The robust use of intellectual property tools shows high levels of innovation and creativity at the end of 2019, just at the onset of the COVID-19 pandemic,” he said.
“The pandemic has accelerated long-building trends by fostering the adoption of new technologies and accelerating the digitisation of everyday life. Because IP is so connected to technology, innovation and digitalisation, IP will become even more important to a greater number of countries in the post-COVID world.”
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