Latest updates

New pharmaceutical patent linkage litigation scheme
Smart & Biggar/Fetherstonhaugh
  • Canada
  • December 13 2017

The recent amendments to the Patented Medicines (Notice of Compliance) Regulations introduced a new scheme for pharmaceutical patent linkage litigation in Canada regarding generic challenges. The scheme is now much closer to the US Hatch-Waxman scheme, but with a number of key differences.

Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine
Smart & Biggar/Fetherstonhaugh
  • Canada
  • December 13 2017

The Federal Court recently found that the Patented Medicine Prices Review Board's assessment that a patent pertained to Galderma Canada's Differin was unreasonable, as it had failed to consider the entire patent. As a result, the court quashed the board's decision requiring Galderma to file pricing information for Differin.

Draft IP Policy Phase 1 – part two: access to medicines, state 'walk-in' rights and parallel import
ENSafrica
  • South Africa
  • December 06 2017

The recently published Draft IP Policy Phase 1 2017 includes a number of provisions relating to parallel import and state 'walk-in' rights for access to affordable medicines. Although there are complex issues surrounding access to affordable medicines, the inclusive process that the government has used in the implementation of the new policy is encouraging.

California passes sweeping prescription drug price transparency law and co-pay coupon ban
Sidley Austin LLP
  • USA
  • December 06 2017

California recently passed two bills with significant implications for pharmaceutical manufacturers: one imposing prescription drug price transparency requirements and another prohibiting certain types of co-pay coupon and other prescription drug discounting programmes that lower patient cost-sharing amounts for prescription drugs.

Court rejects Apotex's application for judicial review of omeprazole magnesium tablet submission
Smart & Biggar/Fetherstonhaugh
  • Canada
  • November 29 2017

The Federal Court recently rejected Apotex's application for judicial review regarding Health Canada's review of its omeprazole magnesium tablet regulatory submission. Apotex had applied for reconsideration, which was cancelled due to disagreement on an eligible question to pose to the reconsideration panel. Apotex had focused the question solely on safety and efficacy, while the minister of health had required that the question consider bioequivalence.

Pharmaceutical companies request Patent and Registration Office to reassess decisions
Advokatfirman Lindahl
  • Sweden
  • November 22 2017

In eight landmark decisions, the Patent and Market Court of Appeal decided that the terms for already granted supplementary protection certificates (SPCs) should be recalculated in order to reflect a 2015 European Court of Justice decision regarding the method for calculating SPC terms under EU Regulation 469/2009. Several pharmaceutical companies that had been granted SPCs noted that the Patent and Registration Office's method of calculating SPC terms was not in line with EU law.

Patented Medicine Prices Review Board update
Smart & Biggar/Fetherstonhaugh
  • Canada
  • November 22 2017

The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.

Ontario bill proposes mandatory disclosure of financial relationships
Smart & Biggar/Fetherstonhaugh
  • Canada
  • November 22 2017

The Ontario legislature recently introduced Bill 160, which – if passed – will enact the Health Sector Payment Transparency Act 2017. The act will require the disclosure of financial relationships between healthcare professionals and pharmaceutical or medical device manufacturers and the reporting of various information. More details, such as the manner and frequency of reporting, will be prescribed by regulation.

Government issues statement of intended actions to implement CETA
Smart & Biggar/Fetherstonhaugh
  • Canada
  • November 15 2017

Global Affairs Canada recently published its statement of intended actions regarding the implementation of the Canada-EU Comprehensive Economic and Trade Agreement, which has been provisionally applied since September 21 2017. The document summarises the Canadian government's position on its obligations and how it intends to implement the treaty. A number of the document's chapters are relevant to the pharmaceutical industry.

Health Canada update
Smart & Biggar/Fetherstonhaugh
  • Canada
  • November 15 2017

Health Canada recently issued a notice of intent soliciting comments on possible changes to the Food and Drug Regulations relating to pharmaceutical equivalence and an updated notice on its interim policy regarding the interpretation of a medicinal ingredient. In addition, it recently solicited online comments regarding proposed pre-market transparency initiatives for human prescription drugs.

Pfizer obtains prohibition orders for polymorphic form patent
Smart & Biggar/Fetherstonhaugh
  • Canada
  • November 08 2017

The Federal Court recently granted prohibition orders preventing Apotex and Teva from marketing their generic o-desmethyl-venlafaxine products (based on Pfizer's Pristiq) until the expiry of Patent 2,436,668. The court held that Apotex's allegations regarding non-infringement and invalidity on the basis of obviousness, inutility, anticipation double patenting and overpromising and Teva's allegations of invalidity on the basis of obviousness and inutility were not justified.

Creating healthcare solutions with blockchain technology
TozziniFreire Advogados
  • Brazil
  • November 08 2017

The continuity of traditional healthcare models seems unlikely with the breakthrough of disruptive technologies. Historically, the healthcare sector has been slow to implement technological tools that have quickly transformed other areas of people's daily lives. However, a promising solution to address the interoperability, integrity and security challenges presented in the healthcare sector seems to be blockchain technology.

Health Canada and Federal Court publish guidance on final regulations on patent linkage and term restoration
Smart & Biggar/Fetherstonhaugh
  • Canada
  • October 18 2017

The government recently published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement. Health Canada has since published guidance regarding the application process under the new regulations. In addition, the Federal Court has published a practice notice regarding actions brought under the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations 2017.

Taking advantage of patient data
  • European Union
  • October 18 2017

Patient treatment and research creates a wealth of data. Given that health data is sensitive, reaping the benefits of data-based medicine brings particular challenges when it comes to data protection requirements. EU data protection law is currently based on the Data Protection Directive, among other things. This directive will shortly be replaced by the General Data Protection Regulation, under which data concerning health is subject to increased protection.

Supreme Court leave sought for decision refusing natural health product licence
Smart & Biggar/Fetherstonhaugh
  • Canada
  • October 18 2017

In May 2017 the Federal Court of Appeal set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination Inc for its natural health product, Resolve, and remitted the matter back to the minister for redetermination. The Winning Combination recently applied to the Supreme Court for leave.

Draft IP Policy Phase 1: access to medicines and compulsory licensing
ENSafrica
  • South Africa
  • October 11 2017

The keenly anticipated draft IP Policy Phase 1 (2017) was recently published for public comment. It constitutes the first phase in the implementation of a comprehensive IP policy for South Africa. One of the key issues to be addressed is the interplay between the constitutional rights relating to property and access to healthcare. According to the policy, the scope of compulsory licences will be strengthened and clarified in an effort to facilitate the process of exporting IP goods, such as medicines.

Fifth Circuit rules for pharmaceutical manufacturer based on relators' failure to establish causation
Sidley Austin LLP
  • USA
  • October 04 2017

The Fifth Circuit recently affirmed summary judgment for a pharmaceuticals manufacturer on allegations that the company had violated the False Claims Act as a result of off-label marketing efforts and kickbacks to physicians. In its decision, the court emphasised the relators' failure to demonstrate a causal link between the alleged improper conduct and any false claims.

Assessing demand for public pharmacies – a never-ending story
Preslmayr Attorneys at Law
  • Austria
  • October 04 2017

Public pharmacies are heavily regulated in Austria. The opening of new (or the relocation of existing) pharmacies is subject to approval by the district authority. Approval will be granted only if there exists a viable need for the new public pharmacy. In a recent case, two courts ignored a 2016 amendment to Section 10 of the Pharmacies Act, which allowed a deviation from the strict 5,500 person limit set out therein.

District court dismisses False Claims Act claims based on no evidence of falsity
Sidley Austin LLP
  • USA
  • September 27 2017

The US District Court for the Northern District of Illinois recently dismissed the False Claims Act claims brought by the federal government and two state governments based on allegations that Par Pharmaceuticals had orchestrated an unlawful prescription-switching scheme. While the judge acknowledged that Par may have conspired to increase its own profits, it rejected the federal and state governments' claims due to their failure to allege the submission of any claims that actually were false.

Publication of final regulations on patent linkage and term restoration relating to CETA
Smart & Biggar/Fetherstonhaugh
  • Canada
  • September 27 2017

The government recently published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement. According to an order in council, the new regulations will come into force on September 21 2017. The amended regulations mark a significant change to the environment for pharmaceutical companies in Canada, with long-lasting consequences for innovators in terms of exclusivity and drug product lifecycle management.

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