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 ...
While arbitration offers an excellent means for parties to get their disputes settled faster than in traditional courts, how you draft the arbitration clause in a document is critically important for a positive outcome – should a dispute arise. Legal agreements often have a clause indicating that parties agree to settle any disputes arising from the arrangement in arbitration. The text for this clause is frequently supplied by a local arbitration institute ...
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 ...
There were two recent decisions – one in the USA and one in the UK – which dealt with the important but seldom-discussed concept of patent exhaustion. Patent exhaustion in essence means this: the initial authorised sale of a patented item terminates all patent rights to that item, for the reason that the owner of the patent (the patentee) has been rewarded for its ingenuity by that sale ...
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 ...
Legal succession of banksUkrainian legislation prescribes a special reorganisation procedure for banks that, among other things, requires banks to:• develop a reorganisation plan;• obtain approval for internal statute changes from the National Bank of Ukraine; and• conduct an audit to ensure the correctness of transfers (for mergers and acquisitions) or the demerger balance sheet (for spin-offs and transfers) ...
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 ...
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) ...
IntroductionIn the course of implementing the visa liberalisation regime with the European Union, Parliament recently passed several anti-corruption laws, including the Law on Criminal Liability of Legal Entities. The law introduced amendments to the Criminal Code, the Code of Criminal Procedure, the Law on Principles of Prevention and Combating Corruption and the Law on Ensuring the Safety of Those Involved in Criminal Proceedings ...
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 ...
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 ...
Here are select March 2013 rulings of the Philippine Supreme Court on legal and judicial ethics:Attorney; a lawyer shall not assist in the unauthorized practice of law. Atty. Bancolo admitted that the Complaint he filed for a former client before the Office of the Ombudsman was signed in his name by a secretary of his law office ...
1 LegislationWhat legislation is applicable to insolvencies and reorganisations? What criteria are applied in your country to determine if a debtor is insolvent? The applicable law is Republic Act No. 10142, known as the Financial Rehabilitation and Insolvency Act of 2010 (FRIA). The FRIA took effect on 18 July 2010 ...
Important Considerations In Drafting An Arbitration Provision: With the continuing increase in cross-border investments, it bears reminding that companies must plan for the eventuality that parties may not see eye-to-eye in the future – something known but not always implemented ...
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 ...
Here are select February 2013 rulings of the Supreme Court of the Philippines on legal and judicial ethics: Attorney; confidentiality of proceedings against attorneys; exception. Atty. Fortun filed a petition for contempt against respondents for publicizing the disbarment case against him in media. Section 18, Rule 139-B of the Rules of Court states that “proceedings against attorneys shall be private and confidential ...
Here are select March 2013 rulings of the Supreme Court of the Philippines on criminal law and procedure: 1.REVISED PENAL CODE Rape; medical examination of victim not indispensable to prove rape. An inconclusive medical report does not negate the finding that the accused (Penilla) raped AAA ...
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 ...
