Bayer’s Astepro Allergy was approved by the US Food and Drug Administration (FDA) for nonprescription use back in June. Bayer claims it is the first over-the-counter, steroid-free antihistamine allergy spray available in the US. 

The complaint filed on Thursday asks the US District Court for the District of Delaware to delay the FDA’s approval of Apotex’s generic drug until the final Astepro patent expires in 2028. The complaint also requests that Apotex is blocked from producing it before this date, and a 30-month stay of approval process is initiated by the lawsuit under the Hatch-Waxman Act.

FDA approval was granted to Meda for the prescription version of Astepro in 2009. In a statement, Bayer spokesperson Chris Loder said that the company licences the patents from Meda and maintains the right to enforce them against alleged infringers.  

The suit by Bayer and Meda follows Apotex’s filing of an Abbreviated New Drug Application (ANDA) for FDA approval of its generic drug. An ANDA declares that the relevant drug patents are either invalid or would not be infringed by the generic drug. It opens the applicant to infringement claims from the patent owner. 

The complaint claims that Apotex told the FDA that the relevant parts of the patents were not valid. 

The clause at issue was part of a non-disclosure agreement between Samsung and Australian startup Kannuu Pty Ltd which was signed during licensing negotiations. However, the agreement only related to confidentiality and not the patents themselves.

In 2012, South Korea-based Samsung reached out to Kannuu about potentially licensing its remote control search and navigation technology. The companies signed an NDA that said any legal action arising from the licensing or “the transaction contemplated hereby” would be brought in Manhattan. After 2013, the companies stopped negotiating and never agreed to a license. 

In 2019, Kannuu sued Samsung in Manhattan federal court, claiming that Samsung had infringed its patents by incorporating the technology into its Blu-Ray players and smart TVs. 

In 2020, Samsung filed five petitions at the US Patent and Trademark Office’s Patent Trial and Appeal Board. The tech giant asked it to find the patents invalid and the board agreed to review two of the five petitions. 

In a bid to force Samsung to stop the reviews, Kannuu asked the Manhattan court for a preliminary injunction. Kannuu claims that the reviews violated the NDA’s forum-selection clause. In January, US District Judge Edgardo Ramos ruled in favour of Samsung, finding the PTAB proceedings did not implicate the agreement. 

Kannuu then asked the Federal Circuit to reverse the decision. It claims that the district judge had ignored the ways that the patent-validity issues related to the companies’ discussions. 

However, US Circuit Judge Raymond Chen, alongside Circuit Judge Sharon Post, stated that the non-disclosure agreement could not prevent Samsung from challenging the patents at the board.

In a London court, NatWest indicated guilty pleas to three criminal charges of not adequately monitoring customer accounts between 2012 and 2016. 

The Financial Conduct Authority (FCA) prosecuted the case against the UK bank. The FCA’s lawyer, Clare Montgomery, said: "The facts of the case are complex, the likely sentence is a very large fine." 

The FCA claimed NatWest failed to monitor suspect activity by a client who deposited approximately £365 million in its accounts across five years, of which £264 million was in cash. 

Under sentencing guidelines, NatWest could now face a penalty of around £340 million, Montgomery said. However, the level of any fine will be set by a judge later this year. 

In a statement, NatWest said it will take a provision in its third-quarter results next month in anticipation of the fine for money laundering offences. The bank also said it was not expecting any other authority investigating this conduct, while the FCA said it would not be taking any action against former or current employees of the bank.  

Juror No 4 told Judge Edward Davila in the US District Court San Jose that if Holmes were found guilty and sent to prison for a “long, long time” she would feel it was her fault. 

“I’m thinking of all the time she’ll be in jail,” the juror told Davila, according to The Mercury News.

While the judge reminded the juror that her responsibility was only to decide the facts of the case, the juror said she thought about the punishment “every day.” She said she felt she would only be able to remain on the jury if she didn’t have to vote on whether or not Holmes was guilty.  

Meanwhile, the alternate juror chosen to replace Juror No 4 also expressed concerns about reaching a verdict, due to English not being her first language. According to The Mercury News, the woman told the judge that she felt the language barrier could impact the outcome of Holmes' future. Howveer, she said she had understood the proceedings so far. Following this, the judge told the court and the alternate juror that she would replace Juror No 4 for what remains of the trial. 

Holmes is on trial for charges of fraud and conspiracy to commit fraud over allegations that she misled investors, doctors, and patients about the capabilities of Theranos’ blood-testing machines. If convicted, the Theranos founder and former CEO faces up to 20 years in prison. 

Texas-based Profectus sued Google in 2020, claiming that its Nest Hub and Nest Hub Max, which control smart-home functions, play music, and display images digitally, infringe its patent. Profectus’ patent relates to a mountable digital photo frame.  

However, following a four-day trial, the jury found that Mountain View, California-based Google did not infringe the patent or induce others to infringe. The jury also found that five parts of the patent at issue weren’t patentable.  

U.S. District Judge Alan Albright had told the jury that it could find the patent invalid if its innovations had already been disclosed in earlier devices or publications. Several patents were identified by Google and a Sony digital photo frame was identified as relevant “prior art” to the Profectus patent. 

Profectus has also unsuccessfully sued Apple, Dell Inc, and Samsung Electronics America Inc over the patent.

Owen Diaz was a former contract worker employed at Tesla through a staffing agency in 2015. In court, he spoke of the hostile work environment in which his colleagues used epithets to torment and belittle him and other Black employees. Diaz was told to “go back to Africa” and left a racist drawing in his workspace.

According to Diaz’s attorneys, the case was only able to progress because the former employee had not signed one of Tesla’s mandatory arbitration agreements. Tesla uses mandatory arbitration to press employees to resolve disputes privately rather than in a public trial. Consequently, Tesla infrequently faces substantial damages or takes deep corrective actions after arbitrators settle a dispute. However, the electric vehicle company was required to pay out $1 million to another former employee, Melvin Berry,  as the outcome of an arbitration agreement. Berry also endured a racist and hostile work environment at Tesla.  

Following the verdict, Tesla issued a blog post to the general public, in which Tesla VP of People Valerie Capers Workman says:

“The Tesla of 2015 and 2016 (when Mr. Diaz worked in the Fremont factory) is not the same as the Tesla of today. Since then, Tesla has added an Employee Relations team, dedicated to investigating employee complaints. Tesla has added a Diversity, Equity & Inclusion team dedicated to ensuring that employees have the equal opportunity to excel at Tesla. And Tesla now has a comprehensive Employee Handbook (replacing the Anti-Handbook Handbook) where all of our HR policies, employee protections, and ways to report issues are published in one easy-to-find online document. We acknowledge that we still have work to do to ensure that every employee feels that they can bring their whole self to work at Tesla.”

Ericsson claims Apple is using improper methods to lower the royalty rates it has to pay. Apple is also accused of refusing to license the patents under anything besides its proposed terms. 

According to Ericsson, the lawsuit comes as the two tech giants are deadlocked in negotiations over a new license, having previously settled a licensing dispute back in 2015.

An international agreement requires owners of patents covering technology where it is necessary to comply with wireless standards, such as 5G, to offer licenses on fair, reasonable, and non-discriminatory (FRAND) terms. Ericsson said it began licensing its wireless patents to Apple following the release of the first iPhone in 2008. In 2015, Apple sued Ericsson during negotiations for a new license. The case was settled later that same year with a second agreement. 

In Monday’s lawsuit, Ericsson said it began negotiating a new license with Apple towards the end of 2020. It said that Apple has maintained its position that Ericsson’s rates aren’t FRAND and that the only way for them to become FRAND is by adhering to “Apple’s self-declared methodology.” 

Ericsson claims that Apple demands that standard-essential patents owners grant it permission to examine, value, and license each patent in its portfolio at Apple’s discretion. Ericsson also claimed that Apple has asked them to prove that every patent is essential, valid, and infringed. 

The real estate, family law, agriculture, and private client teams at UK premier law firm Lodders have each been awarded the top spot in the latest edition of The Legal 500, the leading guide to law firms in the UK. 

Within the latest Legal 500  guide, published last week,  Lodders’ senior associate in the real estate practice, Dan McLeod,  and associate in the private client team, Jennifer Russell, are named as its “Rising Stars”. Head of the real estate team Mark Miller, head of family law Beverley Morris, and the firm’s charity law expert Mark Lewis are named as the Guide’s “Leading Individuals” this year.

The Legal 500 UK describes Lodders’ real estate practice as providing “excellent service and out-of-the-box thinking’” with regards to land development projects for landowners, landed estates, investment acquisitions and disposals. 

Meanwhile, the Guide praises the family law team at Lodders for providing an “excellent service” with “top-flight performers”. It also recognises the team for consistently seeking “a personal touch with clients” and “to reassure where considerable doubt and concern may exist on the journey ahead.” Team head Beverley Morris was recognised for her “strength in financial remedy work.” 

Lodders’ private client team also retained a top ranking. The Legal 500 guide says the team has a “wealth of experience across a wide spectrum of private client matters”, and goes on to describe Martin Green as “an experienced trustee.”  It also mentions John Rouse’s work with business owners, farmers, and high-net-worth individuals as well as Sofia Tayton’s work on cases involving NHS care funding and mental capacity issues. Ian Flavell is praised for his niche experience in heritage property.

Paul Mourton, managing partner at Lodders, said, “Across the board, this year’s rankings are fantastic. We’re delighted to have retained our tier 1 spot in several areas, as well as have more people named as leading individuals, rising stars, and next-generation partners, and receive some outstanding comments and feedback from so many clients contacted by the Legal 500.”

Niall Hearty of Rahman Ravelli assesses the arguments made and the issues raised regarding reforming the law on corporate criminal liability.

It’s becoming increasingly difficult to remember a time when corporate criminal liability was not on the agenda, or at least up for discussion. The high-profile activities of certain companies and the authorities’ response to them seem to have a way of ensuring the issue holds the attention of the legal and business worlds.

Now we have the Law Commission drawing up options to overhaul fraud laws in a way that could make it easier to prosecute companies in the criminal courts. With the Commission set to produce a paper by the end of the year on its options – now its consultation period is complete – the issue that has prompted much thought and debate now looks set to be tackled once and for all by the powers that be. With seven out of every ten Law Commission reports having been wholly or partly implemented in the last 50 years or so, we are clearly past the point of corporate criminal liability being little more than a debating point.

Corporate criminal liability is an issue that has been focused on the “directing or controlling mind” of a company, and whether that mind (which is usually taken to be a senior company figure) was involved in alleged criminality. As there was never an exact definition of what constitutes a controlling mind, it was thought someone at chief executive level fitted the bill. Come 2019, however, and the Serious Fraud Office’s fraud charges against Barclays over its fundraising in Qatar were thrown out, with the Court of Appeal ruling that the bank’s former chief executive John Varley was not its directing mind. Cue SFO Director Lisa Osofsky saying the narrow scope of the controlling mind test made it hard to hold companies to account, and the Law Commission admitting that its 2010 conclusion that reform was not needed was perhaps out of date. 

“Failure to prevent” offence

The Commission’s current options now include a “failure to prevent” offence, which could see companies prosecuted if they have inadequate measures in place to stop fraud. It is an option that appears to be modelled on failing to prevent bribery, which is found in section 7 of the Bribery Act, and the failure to prevent tax evasion offence contained in the Criminal Finances Act. It also appears to have the support of Osofsky. Yet while there are plenty of people who believe that there is a dire need for such reform to reflect the modern, complex nature of many companies, there are also those who worry about piling further compliance burdens on businesses. And then there is the debate over whether any such failures by companies should be viewed as a criminal or regulatory matter.

A Strong Argument For Reform

One strong argument for reform is that the organisation and structure of most modern companies prevent any single individual from having full discretion to act with no accountability to others. This was the case with the Barclays prosecution. That ruling gave further fuel to the argument that there was a need for a fresh look at the law and the supposed protections currently available to larger companies. Supporters of this argument make the point that the present situation makes it easier for the big boys to escape prosecution, while the smaller companies are seen as easier targets – the “low hanging fruit’’ that can be picked off at will by the authorities.

There is merit in this argument. After all, the first contested failure to prevent bribery case saw the conviction of the far from huge Skansen Interiors – a company that had self-reported its problems and had actually ceased trading by the time it was convicted. But extending failure to prevent and attaching criminal liability to a company could bring its own problems. The idea of punishing a company’s board, its shareholders and other interested parties for the actions of employees who can, after all, be punished as individuals could be seen as a way of beating a business with an unnecessary stick. While it can be argued that the modern, devolved structure of many companies does make it hard to pin corporate responsibility on them, it could also be stated that such structures are in place to improve compliance rather than to act as a means of evading prosecution. Any change in the law will have to be carefully calibrated to reflect this.

With the Law Commission expected to report its findings later this year, it is important to note that any legislative change is not likely until at least 2022 or 2023. The arguments regarding corporate criminal liability, it seems, are set to rumble on for some time, with little likelihood of a quick fix - let alone one that pleases everyone. 

The justices declined to hear an appeal of a lower court’s decision upholding the surcharge by two trade groups representing generic drug makers and drug distributors, and a unit of UK-based pharmaceutical company Mallinckrodt, which filed for bankruptcy protection last year. 

Amongst the law’s challengers were the Association for Accessible Medicines, whose members include Mallinckrodt, Teva Pharmaceutical Industries, and the Healthcare Distribution Alliance.

Three of the largest opioid distributors in the US — McKesson Corp, AmerisourceBergen Corp, and Cardinal Health — were members of the alliance. In July, they proposed paying $21 billion to resolve lawsuits accusing them of fueling the opioid epidemic. 

The payments to New York were owed under the Opioid Stewardship Act, which was signed into law in 2018 to address the rising costs of the opioid crisis imposed on the state. It marks the first time a state has sought to impose a tax on opioid companies over the epidemic. Minnesota, Rhode Island, and Delaware have since adopted their own, similar taxes. 

In separate statements, the Association for Accessible Medicines and the Healthcare Distribution Alliance said they were disappointed in the Supreme Court’s actions. The alliance said it is evaluating its options and is working out what its next steps will be.