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 ...
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 ...
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) ...
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 ...
You’ve seen all the articles about the Supreme Court’s decision in Assoc. for Molecular Pathology v. Myriad Genetics Inc. and the end of DNA patents, but what does this mean outside the biotech world? It means more insight into patent eligibility under 35 U.S.C. § 101. While Myriad does not affect business method and software patents, it is indicative of the general trend of the Supreme Court with respect to the threshold required to obtain a valid patent ...
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 ...
It’s been well reported that the singer Rihanna has sued the UK retail chain Topshop for US$5 million in damages for the unauthorised use of her image on a t-shirt. Rihanna is apparently suing for passing-off, the argument being that people seeing the t-shirt are likely to assume that she has endorsed the brand. This may have got you wondering what the law is in South Africa on the issue of unauthorised endorsement ...
Domain names and trade marks are inextricably linked. The reason for this is simple – when a company needs to decide on a name at which it wants people to find it on the Internet, it generally opts for one of its own trade marks. As a result, the issues that crop up in trade mark disputes often crop up in domain name disputes too ...
The KZN High Court handed down a really interesting judgment in May 2013 in the case of Distell v KZN Wines & Spirits. The decision’s interesting because it not only looks at the issues that need to be considered in a trade mark infringement claim, but it also highlights the differences between trade mark infringement and passing off ...
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 ...
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. Use as a Basis 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 ...
Although we observed a increasingly widespread use of computer-based solutions in the cloud ( cloud computing ) in the information systems of companies and administrations, sometimes the obvious advantages it brings to the customer do not pay the necessary attention to the assessment of corporate risks that can generate its adoption ...
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 Supreme Court’s recent decision has seeded another patent protection feather in Monsanto’s increasingly large cap, in addition to providing guidance on application of the patent exhaustion doctrine in the case of self-replicating technology. In Bowman v ...
The Federal Circuit released the results of its en banc hearing of a case involving the issue of what is patent eligible subject matter under section 101 of the Patent Act. (CLS Bank International v. Alice Corporation Pty. Ltd., F. 3d., Case No. 2011 1301 (May 9, 2013) ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
A survey by the Information Commissioner's Office (ICO) has revealed that 47% of all UK adults now use their personal smart phone, laptop or tablet computer for work purposes - known as 'bring your own device' (BYOD).However, fewer than three in 10 users had received guidance on how to use their devices for work. This raises concerns that users may not understand how to protect the personal information accessed and stored on these devices ...
The first industrial revolution, which began in the 1750s, lasted for between 80 to 100 years. The pace of technological change today encourages us to believe that the second industrial revolution (IR2) will be completed at much greater speed. So if we take the mid-1980s as a starting point, with the emergence of optical disk technologies into consumer markets, you would expect us to be well on the way to completion, 30 years into IR2 ...
