Data: Hatch-Waxman cases plummet
Litigation for abbreviated new drug applications dropped significantly last year, according to new data revealed by Managing IP.
In 2020, 265 ANDA (also known as Hatch-Waxman) cases were filed, compared to 324 in 2019, 369 in 2018 and 415 in 2017, continuing a fall over the past three years. Last year saw the fewest ANDA matters filed in the district courts since 2012, when 241 cases were filed.
Sources suspect this drop could be a result of the pandemic. “COVID stopped generics’ ability to launch new products because it slowed down FDA approval of products and everything else the FDA does,” says Kassie Helm, partner at Dechert in New York.
Other stories published by Managing IP this week include:
UKIPO could allow AI tools to be listed as inventors
On Tuesday, March 23, the UKIPO announced it would consider legislative change to address the question of whether artificial intelligence could be listed as an inventor.
The announcement came as part of a three-month consultation on the impact of AI on intellectual property.
“We recognise that AI systems have an increasing impact on the innovation process. We want to ensure the intellectual property systems support and incentivise AI-generated innovation,” said a UKIPO spokesperson.
“We also want to ensure transparency in the innovation process and that inventorship criteria do not present a barrier to protecting investment in AI-generated innovation.”
The question of AI inventorship has divided the IP community in the past, with some claiming that AI is merely a tool that facilitates innovation, and others arguing that prohibiting AI inventorship could create a legal limbo for inventions created by non-humans.
In an interview with Managing IP, AI patent applicant Stephen Thaler said that refusing to name an AI tool on a patent application would lead to “orphaned patents” that had no recognition under the law.
Thaler claimed that his AI tool, named Device for the Autonomous Bootstrapping of Unified Sentience, was like a small child in that it took in information from the outside world and turned it into new ideas and plans of action.
“If I falsely listed myself, I would become a criminal – I have to sign a declaration that I invented something, and that would not be the case,” he said.
Legislative change would reverse a September 2020 ruling from the England and Wales High Court that excluded AI from inventorship and found that only “natural persons” could be classified as inventors.
EPO to continue VICO hearings, despite legality appeal
The EPO has said it will continue to hold hearings by video-conference without parties’ permission, despite the fact that an appeal questioning the legality of that approach is pending.
In a statement on Wednesday, March 24, an EPO spokesperson said that after a “careful weighing up of the impact for legal certainty and access to justice”, president António Campinos had decided oral proceedings would continue under current practice.
At the moment, oral proceedings before examination and opposition divisions, and at appeal level, can be held by VICO without both parties’ consent.
Earlier this month, an EPO Technical Board of Appeal made a referral to the Enlarged Board of Appeal (EBoA) seeking to clarify whether that approach was permissible under the European Patent Convention.
The referral to the EBoA concerns appeal proceedings, but also extends to oral proceedings by VICO before examining and opposition divisions.
According to the EPO, hosting oral proceedings by VICO in examination and opposition was introduced to ensure the functioning of the office during the COVID-19 pandemic.
Before this was introduced, the pandemic had a “significant negative impact” on legal certainty for parties because almost none of the scheduled oral proceedings could take place, an EPO spokesperson said.
The EPO said it would immediately implement the EBoA’s findings once it rules on the matter.
US and UK rank first and second in annual GIPC report
The US and UK ranked first and second among 53 global economies in the latest edition of the International Intellectual Property Index, which was released on Tuesday, March 23.
Germany came in third, France fourth and Japan fifth in the annual report, which evaluates the IP framework in each economy across 50 indicators that industry stakeholders believe represent economies with the most effective IP systems.
The report, which was compiled by the Global Innovation Policy Center (an affiliate of the US Chamber of Commerce), also found that the global IP environment had strengthened over the past year despite the COVID pandemic, with 32 out of 53 economies showing improvement in their scores.
It noted that trade agreements had substantially improved national IP frameworks, including in China and Mexico, and that IP had enabled the development of a pipeline of therapeutics solutions to combat COVID-19 in 2020.
But despite this improvement, the report continued, several countries took steps to undermine IP-enabled innovation by supporting compulsory licensing legislation and a proposed TRIPS waiver for COVID vaccines.
US firm expands diversity scholarship awards
US intellectual property firm Merchant & Gould has expanded a scholarship programme aimed at sponsoring law students from diverse backgrounds who want to pursue a career in IP, it announced on Tuesday, March 23.
A cash gift of $5,000 will be awarded each year to selected students from nine law schools.
The scholarship programme was previously run in conjunction with the University of Minnesota Law School as well as the University of Tennessee College of Law. However, it has now been expanded to seven other institutions located close to the law firm's offices.
Andrew Jagenow, partner and diversity committee chair at Merchant & Gould, said: “As the legal industry continues to grow, Merchant & Gould is thrilled to enable these law schools to recruit and support more students typically underrepresented in IP law.
“Through the scholarships, we are pleased to give resources to students and, by extension, help make our legal communities more diverse, inclusive, and innovative.”
The seven new participants in the scheme are: John Marshall Law School, Georgia State University College of Law, Mitchell Hamline School of Law, University of Colorado Law School, George Washington University Law School, Benjamin N Cardozo School of Law, and University of New Hampshire Franklin Pierce School of Law.
Jagenow added: “We felt it was the right time to expand our existing scholarship programmes to support more students, more schools, and more communities.”
Managing IP recently spoke to several other law firms that were developing and expanding diversity and inclusion initiatives, including Fish & Richardson, Finnegan, Haynes and Boone, and Morrison & Foerster.
USPTO requests comment on patent bar changes
The USPTO published a request for public comment on Tuesday, March 23, on whether it should rework requirements to sit the patent bar exam.
The office asked whether it should add master's and doctoral programmes to its category A list of automatically qualifying degrees. Under the current system, only bachelor's degrees automatically qualify.
It also asked for comment on a proposal to add several new degrees to the list of automatically qualifying majors.
These new qualifications included aerospace engineering, bioengineering, biological science, electronics engineering, genetics, marine engineering, materials science, neuroscience, ocean engineering and textile engineering.
The USPTO also wanted input on a proposal to amend its category B list (for those that did not meet category A’s list of acceptable degrees).
One of the current options for this category involves completing eight semester hours in chemistry or physics in two sequential courses, each with a lab.
The office said it was contemplating changing this requirement to eight semester hours in a combination of chemistry, physics, and/or biology, with at least one course that included a lab.
The possibility of amending these requirements received attention last December when Senators Mazie Hirono, Thom Tillis and Christopher Coons sent a letter to then-USPTO director Andrei Iancu arguing that the patent office should expand the list of necessary qualifications.
In interviews with Managing IP in January, in-house and private practice lawyers agreed that the office should revisit requirements to sit the bar. But they also emphasised that the USPTO should not lower its standards.
Comments can be sent until May 24.
Health Canada warns against counterfeit 3M masks
Health Canada, the department responsible for Canada’s health policy, issued a warning on Friday, March 19, on counterfeit 3M N95 respirators.
The department said it had seized around 330,000 fake respirators from Canadian distributors and detained nearly 365,000 at the border.
It recommended that people call 3M’s anti-fraud hotline, report suspected fakes to Health Canada or look at 3M’s website for tips to avoid counterfeit products.
Counterfeiters that produce fraudulent masks have been a significant problem for 3M since the start of the pandemic.
In a January interview with Managing IP, Colette Durst, chief trademark counsel at 3M, revealed that the company had joined forces with brand protection company Incopro to enforce its trademark against these fake respirators and masks.
As of January, 3M had taken down more than 16,000 false or deceptive social media posts, nearly 15,000 fraudulent e-commerce offerings and around 300 deceptive internet addresses since the start of the pandemic.
In a panel at Incopro’s Insync Virtual Summit on January 28, Durst also recommended using customs to block goods from entering a country and using the shipment data to track down the offenders.
"That has been incredibly helpful,” she said.
YouTube to help users avoid copyright infringement
Last week, YouTube announced a new tool called Checks that will alert users if the material they upload is protected by copyright and complies with advertising guidelines.
The tool relies on Google’s Content ID system, which automatically alerts copyright owners to infringement.
YouTube said the new feature should help users avoid uploading content with the yellow dollar-sign icons, which signal that advertisement revenue is being withheld because of copyright infringement.
If the new tool finds protected material, it sends a notice to help YouTubers find a way to remove infringing parts of the video. The alert tells the user what content is claimed by copyright, and includes a time code for the parts of the video that need to be removed.
YouTube said that Checks should take three minutes to scan the content for copyright violations, and another couple of minutes to check for monetisation.
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