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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 ...

On May 30, 2013, as had long been expected, the staff in the Division of Corporation Finance of the Securities and Exchange Commission released Frequently Asked Questions concerning the SEC’s conflict minerals rules.1 The FAQs do not address some of the thorniest interpretive issues under the conflict minerals rules, but they do reinforce a number of developing practices and provide helpful guidance on a number of topics for SEC reporting companies.2 We summarize some of the key FAQs below ...

In Louisiana Generating LLC v. Illinois Union Ins. Co., No. 12-30651 (5th Cir. May 15, 2013), the United States Court of Appeals for the Fifth Circuit held that a lawsuit brought by the Environmental Protection Agency ("EPA") alleging violations of the Clean Air Act ("CAA") obligated an insurer to defend its insured ...

As anticipated, on May 29, 2013, the Consumer Financial Protection Bureau delivered the final version of amendments to its January 2013 Ability-to-Repay/Qualified Mortgage rules (the bureau released an early draft of the amendments when the original rule was published). For more information about the Ability-to-Pay/Qualified Mortgage rules, see our prior alerts.1 The rules, as well as the amendments, take effect on January 10, 2014 ...

In the last legislative session (2011–12), bills that would have imposed severe restrictions or even an outright moratorium on hydraulic fracturing (HF) were narrowly defeated in the California legislature. Earlier this year, we issued an alert regarding draft regulations that had been issued by the Division of Oil, Gas, and Geothermal Resources ...

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 ...

Another natural disaster has devastated a community. By now, all are aware of the tragedy the tornado inflicted on residents of Moore, Oklahoma, destroying lives and property. We join in offering our condolences to those affected by the storm. Although there is no way to replace lost lives, as with other catastrophes, there are likely to be a myriad of financial issues that will need to be addressed to rebuild and replace property. Maximizing insurance recoveries is one component ...

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 hacker group Anonymous announced that it, in concert with Middle East- and North Africa-based criminal hackers and cyber actors, will conduct a coordinated online attack labeled "OpUSA" against banking and government websites today, May 7. Anonymous stated that OpUSA will be a distributed denial of service (DDoS) in which websites may be defaced and legitimate users may be unable to access websites ...

The hacker group Anonymous announced that it, in concert with Middle East- and North Africa-based criminal hackers and cyber actors, will conduct a coordinated online attack labeled “OpUSA” against banking and government websites today, May 7. Anonymous stated that OpUSA will be a distributed denial of service (DDoS) in which websites may be defaced and legitimate users may be unable to access websites ...

Adopted in 2000, Regulation FD generally prohibits public companies and personnel acting on their behalf from selectively disclosing material, nonpublic information to certain groups, such as brokers, investment advisers, analysts and shareholders who are likely to trade on information, without concurrently making widespread public disclosure ...

On March 28, 2013, the Environmental Protection Agency (EPA) issued the final National Pollutant Discharge Elimination System (NPDES) Vessel General Permit (VGP). The 2013 VGP, issued under the Clean Water Act (CWA), replaces the 2008 VGP and regulates discharges incidental to the normal operation of commercial vessels greater than or equal to 79 feet in length.1 The 2013 VGP will be effective on December 19, 2013, when the current 2008 VGP expires ...

It’s not impossible for nations in conflict to put aside their differences to coordinate the delivery of natural resources, but it’s unusual. For the Democratic Republic of Congo, Rwanda, and Burundi, cooperation is transforming the shared Ruzizi River into a valuable source of hydro power for three peoples ...

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