As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
Jack Wills, the clothing company that markets itself as “outfitters to the gentry” has enjoyed recent success in its action against House of Fraser regarding the use of its logo. Jack Wills complained that the rights in its logo comprising a silhouette of a pheasant wearing a top hat and holding a cane had been infringed by House of Fraser’s use of a logo on its own Linea brand of casual clothing that comprised a profile of a pigeon wearing a top hat and bow-tie ...
In 2012 the Western Cape High Court handed down a trade mark judgement that raised eyebrows. The facts were that the owner of a farm called Zonquasdrift had a trade mark registration for the mark Zonquasdrift covering wine (but not grapes). The owner of another farm in the area sold wine grapes under its name, Zonquasdrif Vineyards (no ‘t’ at the end) ...
The authorities seem to have gone on the offensive on the issue of counterfeits. In the run-up to Christmas, the Department of Trade and Industry (DTI) has called on South Africans not to buy counterfeit goods, even if they are cheaper than the originals (as they invariably are) ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
Between 2007 and 2009 non-profit association Motor Sports Limes (MSL) hosted motocross races on a piece of land that it owned. It claimed to have taken all necessary safety precautions, including marking and securing circuit, for the races and associated events held there. According to MSL, only accredited photographers had to sign a contract with MSL, which included a clause stating that no commercial use of photos taken at the races could be made without MSL's prior consent ...
In a highly-anticipated and extremely significant pair of decisions for businesses and consumers alike, the Supreme Court of Canada (“SCC”) ruled on Thursday (October 31, 2013) that the ultimate consumers at the end of a supply chain can effectively leap-frog the supply chain by having direct legal recourse in a class action against a manufacturer who illegally overcharged for the product supplied ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
On October 25, 2013, the Standing Committee of the National People’s Congress of the People’s Republic of China passed an amendment to the P.R.C. Law on the Protection of Consumer Rights and Interests (the “Amendment”) ...
SUMMARY: 1. Principles of Belgian Sports justice – 2. The relationship between ordinary justice and Sports justice – 3. The relevant NOC regulations and NOC judicial body – 4. The relevant football regulations and RBFA judicial bodies – 5. Other sports judicial bodies – 6. Clubs’ and players’ rights and obligations – 7. Dispute settlement – 8. ADR and interim relief – Conclusion Abstract:This article aims at providing an overview of sports justice in Belgium ...
With the publication of Law no.74/2013 of 6 September a Court of Arbitration for Sport (CAS) was created in Portugal. The law will come into force 90 days after the setting up of the CAS, which will be based at the Portuguese Olympic Committee (POC). In an official communication dated 13 September the POC has already announced that it will respond positively to the mandate conferred on it to set up the CAS ...
Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
The High Court has ruled in favour of pop star Rihanna against high street clothes retailer Topshop, which used an unauthorised image of her (almost identical to one used on her CD) on some of its T-shirts.Customers had believed it was an approved image, so the High Court confirmed Topshop was guilty of passing off ...
In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...
The Minister of Finance has issued Regulation No. 37/PMK.04/2013 on Duty-Free Shops on 27 February 2013, which implements Article 48 of Government Regulation No. 32 of 2009 on Bonded Storehouses (Tempat Penimbunan Berikat). The Regulation will effectively be applied 90 days since the issuance date ...
Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...
The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...
The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Counterfeiting continues to make the news. Locally, we’ve just had a report of a R10 million bust in the Vereeniging area, during which fake soaps, shampoos, clothing and bags were seized, and seven suspects from Malawi, Mozambique and China (no surprises there), were taken into custody.But we are increasingly getting reports of counterfeiting in product areas that go way beyond the traditional stomping ground of FMCG and luxury goods ...
We recently had a Namibian court decision in a passing off matter, in the case of Mega Power Centre CC t/a Talisman Plant and Tool Hire v Talisman Franchise Operations (Pty) Ltd. The decision is interesting for a number of reasons. First, passing off cases are fairly rare, so any new decision is welcome ...
