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 ...
A recent ruling by the Court of Justice of the European Union (CJEU) could mean trouble for many Community trade marks. There is now a heightened risk that national courts will invalidate these trade marks if they have not been used extensively enough in the European Union. Is broader protection better? A Community trade mark (CTM) confers protection in all 27 EU member states ...
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 ...
As Panama became part of a number of industrial property related treaties, our internal laws have become more territorial; the use of a trademark is territorial again and registration becomes imperative for protection. In Panama, as happens in most of the countries around the world, the right to register a trademark is acquired by its first use in commerce ...
Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer. These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
PrefaceThis guide is written as an introduction to Ukrainian legal system from the viewpoint of foreign investors, in particular Chinese ones, and will help you in deciding whether to do a deal in Ukraine and what strategy should be chosen when investing in this country. The digest of key legal issues may be found helpful both at the stage of initial investment research and in the course of a particular investment project ...
In Wyeth and Cordis Corp. v. Abbott Laboratories, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants, holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope. (Slip op. at 3) ...
At the end of May, the U.S. District Court for the Southern District of Florida sentenced a Florida import company president to 22 months in federal prison for violating consumer product safety and other laws. His wife, an executive of a related company, was sentenced to a year of probation. The case is significant because it involves a criminal prosecution of importers of unsafe children’s products ...
I OVERVIEWChile continues to offer an attractive business environment. Chile was the first Latin American economy to join the Organization for Economic Cooperation and Development, and is party to dozens of free trade agreements (including with the United States, the European Union, Mexico, South Korea and Brazil) ...
On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...
Purchases of shares or assets of the target companyPurchases of shares are relatively free of restrictions unless the target company is a public corporation (namely, a company that has its shares registered with the Chilean securities and insurance regulator, the SVS), one of the parties to the transaction participates in a regulated industry or the entity resulting from a business combination raises competition issues ...
The Supreme Court has unanimously upheld an arbitrator’s ruling that a contract that required arbitration of "any dispute" constituted an agreement to class-wide arbitration. The Court’s narrow ruling turns on the parties’ express agreement to allow the arbitrator to decide whether their contract, which contained an arbitration provision but did not mention class proceedings, authorized class arbitration ...
As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
The Libyan Trade Mark Office (“LTMO”) has resumed the process of trade mark searching since April 2013 and will reportedly be accepting new applications for the registration of trade marks in May 2013. This after the LTMO had ceased its operations in January 2011 due to civil unrest in the country. There has, however, been some uncertainty with regard to the LTMO’s acceptance of new trade mark applications ...
The Comoro Islands, situated off the south-east coast of Africa, has ratified the Bangui Agreement, thereby becoming one of the 17 member countries of The African Intellectual Property Organisation (OAPI). The Bangui Agreement, once consented to, requires that the member states accede to the international treaties and conventions listed in the Agreement ...
The Budget. The 83rd Texas Legislative Session convened on January 8th with news of a better-than-anticipated revenue estimate, an unusually high number of new and second-term legislators, and less controversy and fanfare than observers have come to expect at the start of the biennial, 140-day process. In mid-March, only days before the bill became due, lawmakers passed and the Governor signed legislation to fill the $4 ...
Earlier this month, the United States Department of Justice (“DOJ”) filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities (“Vitas”) alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill ...
