Since June 2018 a number of biosimilar developments – including with regard to approvals, pending submissions, regulatory matters, litigation and market access – have taken place in Canada. For example, Health Canada recently published an updated Biosimilar Biological Drugs in Canada: Fact Sheet, which provides an overview of the regulatory framework for biosimilar drugs in Canada.
A recent Ontario Superior Court ruling highlights how employers can end up with unexpected employment liabilities after an asset purchase deal. It also highlights the importance of careful wording when hiring employees in those situations. In light of this decision, purchasers in an asset deal should be aware of the new employer's fate. In such cases, proper employment offers are key.
A bill amending articles of the Labour Code relating to family leave and professional reclassification was recently tabled in the Chamber of Deputies. The bill intends to provide an exception to the rule that employees with a dependant child of a certain age are entitled to family leave in case of the child's illness only if the child is hospitalised. It also provides details on occupational reclassification.
The government recently published the General Scheme for the Parental Leave and Benefit Bill. The bill provides for a paid parental leave benefit, which must be used within the first 12 months of a child's life or 12 months from the date of adoption. In light of these changes, employers should not only consider whether they should top up the parental leave benefit, but also review their family leave policies more generally to ensure that their business is in line with the latest developments.
The Federal Court of Appeal recently dismissed Pfizer's appeal of its failed motion to dismiss Amgen's action regarding an infringing patent under Section 6 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations. Pfizer argued that Amgen's action ought to be dismissed as an abuse of process on the basis that Amgen had unsuccessfully litigated the same patent under the pre-amended PMNOC Regulations.
A US District Court for the Central District of California judge recently granted a stay and certified two questions for interlocutory appeal in a relator's False Claims Act suit. The case involved allegations that one of the defendants had perpetrated an upcoding scheme whereby it trained its doctors to describe medical conditions with language that would support increasing the severity levels of diagnosis-related groups that the defendant reported to Medicare, leading to inflated Medicare reimbursements.
Israeli employment law is a blend of continental and common law legal systems. Employment protection laws – a set of laws that provide minimum conditions for all employees, irrespective of their wage levels – are at the foundation of employment law in Israel. Failure to comply with these requirements may constitute a criminal offence and further expose an employer to liability for damages.
The Ontario Court of Appeal recently held that an insurer which had defended its insured for 10 months, without a reservation of rights, could not rely on a policy exclusion to withdraw its defence. In this decision, the court did not find it necessary to distinguish between waiver and estoppel. As such, insurers and insureds alike should ensure that they appreciate the potential consequences applicable to both waiver and estoppel and govern themselves accordingly.
An email containing legal advice leaked to a claimant in an employment dispute did not fall foul of the iniquity principle and therefore remained privileged. An overheard conversation, believed to be in relation to the claimant's dismissal, could not be relied on to aid the interpretation of the email as there was no evidence that the individuals engaged in the conversation had seen it.
The Financial Industry Regulatory Authority recently censured and fined a Florida-based broker-dealer, including for failing to reasonably supervise sales of complex securities such as structured products and leveraged, inverse and inverse-leveraged exchange-traded funds. This case illustrates the need for broker-dealers to establish and enforce proper surveillance systems and written procedures to ensure the suitability of their sale recommendations.
Recent case law confirms that the Swedish courts uphold the general principle that awards finalise a dispute between parties. In order to successfully challenge an award, the challenging party must prove not only that the procedural error likely affected the outcome of the award, but also that the error is of essential importance.
English law has traditionally resisted implying the obligation of good faith into commercial contracts, except in limited circumstances. However, in a growing line of authorities (of which two recent cases are particularly significant), the English courts have confirmed that a duty of good faith will be implied into certain types of agreement as a matter of law. This article considers the ramifications of these decisions for parties to this special category of commercial agreement, which includes franchise agreements.
In two recent cases, the English courts considered whether the duty of good faith should be implied into commercial contracts. These cases demonstrate that the issue of good faith is evolving in English law. Parties to relational contracts must therefore monitor developments to ensure that foreseeable risks are mitigated effectively in their contracts and commercial practices.
In July 2019 the Oviedo Court of Appeal confirmed a trial court decision which had found the defendant guilty of copyright infringement, sentenced him to six months' imprisonment and ordered him to pay the plaintiff's court costs and damages of an amount to be determined during the enforcement of the sentence on grounds of civil liability. In reaching its decision, the court highlighted the multiple contradictions in the defendant's allegations and confirmed the value of the evidence.
Drug invention patents protect multiple types of invention, including compounds, crystal forms, dosage forms, preparation methods and uses. Nonetheless, in practice, it is difficult to patent improvement drug inventions in China. In proving the patentability of such an invention, patentees often face difficulties in establishing its non-obviousness (inventiveness).
In order to recover damages following a violation of their rights, industrial property owners must first file an administrative infringement action before the Mexican Institute of Industrial Property in order to obtain a declaration of infringement and then undergo a civil court trial. This process can take up to five years and rights holders often choose not to claim compensation. As such, a recent proposal aims to reform the process for recovering damages caused by a violation of industrial property rights.
Division of Corporate Finance staff recently issued a new Staff Legal Bulletin 14K on shareholder proposals and the 'ordinary business' exclusion. The new bulletin contains an enhanced reminder that it has not been approved by the Securities and Exchange Commission and, like all staff guidance, has no legal force or effect, does not alter or amend applicable law and creates no new or additional obligations for any person.
Canada has now reached the end of its journey to implement the Patent Law Treaty, with new Patent Rules and associated amendments to the Patent Act recently coming into force. To help ease the transition, this article summarises the more significant changes to Canadian patent practice and procedure that are now in effect.
The Constitutional Court recently handed down an important decision regarding freedom of speech and unfair competition claims following the use of a company's trademark in an online domain name. This decision shows how the court handles cases in which fundamental rights such as freedom of speech and IP rights compete, especially in the service industry sector.
The renewable energy sources (RES) sector of the Greek energy market is undergoing continuous and significant reform. Among other changes, the Hellenic Energy Exchange has commenced operations, RES producers now participate in the day-ahead market and the Greek islands' renewables sector has been expanded.