Category: Biotech & Cleantech

Reclassification of Hydrocodone Takes Effect This Week

McBrayer NEW logo 1-10-13

The U.S. Drug Enforcement Administration (“DEA”) published a Final Rule on August 22, 2014, which elevates hydrocodone-combination products (“HCPs”) to a Schedule II category of drugs under the Controlled Substances Act. That rule becomes effective this week – on October 6, 2014. While some hydrocodone products are already listed as Schedule II, some combination products (such as Vicodin, Norco, and Tussionex) were previously listed on the less-restrictive Schedule III. In determining whether rescheduling was necessary, the DEA considered multiple factors including the potential for abuse, likelihood of dependence, and the threat to public health posed by the drug.

How does the new rule affect prescribers?

According to DEA, HCPs prescriptions issued prior to October 6, 2014 and authorized to be filled or refilled may be dispensed if such dispensing occurs before April 8, 2015. In some cases, pharmacy dispensing software products may not be able to process existing refills starting on October 6, or pharmacies may simply choose not to dispense refills after the effective date.

Pursuant to the Final Rule, HCPs prescriptions written on or after October 6, may not be refilled. No refills are allowed by any practitioner for Schedule II controlled substances and Schedule II prescriptions may only be given for maximum of a 30-day supply. Commentators to the proposed rule worried that rescheduling would result in more trips to the doctor to receive appropriate pain control. In response to these concerns, the DEA noted in the Final Rule that prescribers may issue multiple prescriptions authorizing patients to receive up to a 90-day supply, provided certain regulatory requirements (established in 21 CFR 1306.12) are met.

Prescription Bottle of Pills Spilled on Table

In addition, in Kentucky, Schedule II controlled substance prescriptions may not be faxed or called in to a pharmacy except as provided for in 902 KAR 55:095. Schedule II controlled substance prescriptions that are electronically prescribed must use a system that has been audited for compliance with the regulations specified in 21 CFR 1311. Further, Schedule II controlled substance prescriptions are valid for 60 days from the date written and controlled substance prescriptions must be signed and dated on the date issued by the prescriber.

Kentucky prescribers should be aware that restrictions on prescribing existing Schedule II pure hydrocodone products remain under current Kentucky statutes and regulations because these products were not rescheduled to Schedule II.

Midlevel providers who operate under collaborative agreements or are limited in their ability to prescribe certain Schedules of medications may be particularly affected by the Final Rule. In Kentucky, KRS 314.011, Section 8 (a) limits APRN prescribing of Schedule II controlled substances to a 72 hour supply with no refills, except certified psychiatric-mental health nurses are permitted to prescribe up to a 30-day supply of a Schedule II psychostimulant with no refills. KRS 314.011, Section 8 (b) limits APRN prescribing of Schedule III controlled substances to a 30-day supply with no refills. Because KRS 314.011, Section 8 (b) was in effect March 19, 2013, all APRNs will continue to be permitted to prescribe a 30-day supply of Schedule II hydrocodone combination products if allowed under their DEA license.

Even if the Final Rule does not specifically affect a prescriber’s abilities, prescribers should be prepared to work with pharmacies in order to minimize dispensing disruptions after the effective date. They should also identify and inform patients who are currently receiving HCPs about the rescheduling and, if necessary, discuss alternative pain management options. And, as prescribers well know, any new regulatory framework also brings with it the expectation of greater scrutiny and oversight in the future from regulatory authorities and law enforcement agencies.

ARTICLE BY

Christopher J. Shaughnessy
OF
McBrayer, McGinnis, Leslie and Kirkland, PLLC

Report on State Preparedness to Implement EPA Clean Power Plan

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States are well positioned to implement the Environmental Protection Agency’s (EPA) Clean Power Plan, according to a new study conducted by Analysis Group Senior Advisor Susan Tierney and Vice Presidents Paul Hibbard and Andrea Okie. The report, “EPA’s Clean Power Plan: States’ Tools for Reducing Costs & Increasing Benefits to Consumers,”is based on a careful analysis of states that already have experience regulating carbon pollution. It finds that those states’ economies have seen net increases in economic output and jobs. “Several states have already put a price on carbon dioxide pollution, and their economies are doing fine. The bottom line: the economy can handle – and actually benefit from – these rules,” said Dr. Tierney.

The EPA’s proposed Clean Power Plan would regulate carbon emissions from existing fossil-fueled power plants using EPA’s existing authority under the Clean Air Act. The draft rules, due to be finalized next year, allow a variety of market-based and other approaches states can choose from to cut greenhouse gas emissions from power plants.

The Analysis Group team analyzed the carbon-control rules already in place in several states to see what insights they might hold for the success of the national rule. The report was based on states’ existing track records, rather than projecting costs and benefits that might be expected under the Clean Power Plan. The report, funded by the Energy Foundation and the Merck Family Fund, was released at the summer conference of the National Association of Regulatory Utility Commissioners (NARUC) in Dallas, Texas.

Read the report

ARTICLE BY

Susan F. Tierney, PhD
Paul J. Hibbard
Andrea Okie
 
OF
Analysis Group, Inc.

Patent Practitioners: Inventions and the Ecosystem of Ideas

Womble Carlyle Law firm

There are some striking parallels between inventions and living organisms, and between technology in a consumer marketplace and an ecosystem.  Insights gained through the comparisons may be beneficial to inventors, companies, consumers and the patent community.  What are the connections?  To review, living organisms exist in an ecosystem, and flourish or perish according to the laws of nature, with survival of the fittest.  Variations among the organisms occur from generation to generation, and are positively or negatively selected over the passage of time and generations, as organisms evolve.  This begets new species, which occupy environmental niches in the ecosystem, and also begets extinction in which species die off.  Ideas, invention and technology exist in a sort of man-made ecosystem, with the consumer marketplace performing a selection process, the whole experiencing a type of guided evolution.

Human beings have ideas.  We brainstorm them, communicate them to each other, and come up with more ideas.  Humans invent, bringing some of these ideas to fruition.  In turn, humans bring some of these ideas to actual products, which are then put up for sale and use in the consumer marketplace.  This is a sort of test in the ecosystem, as to which products will survive.  Consumers then make choices, purchasing the products they like, for various reasons.  Products that are not purchased and used influence manufacturers to stop making those products.  Products that are purchased and used influence manufacturers to continue making those products, and to develop next-generation variations of those products.  New features are added to next-generation products, and some of these new features are popular, and some are not.  The process of selection as to popularity, and sales volume, of products, is made by the consumers.

Next-generation variations of products are rather like offspring with mutations, in the comparison to living organisms in an ecosystem.  A brand-new, never before seen product is rather like a new species that has suddenly emerged.  Entire product types that become obsolete are rather like the dinosaurs that went extinct long ago.  Even the term “dinosaur”, in colloquial usage, is synonymous with outdated technology (and is also sometimes applied to people who still prefer to use such outdated technology).

Ideas, invention, products and technology thus emerge, develop, thrive or perish, beget variations, and evolve over time in the consumer marketplace.  The ever-present interest by, and purchasing power of, consumers drives the selection process that guides the evolution of products and technology.  The ever-present ingenuity of inventors, and desire for companies to succeed in the marketplace, drives the production and mutation (variation) processes that guide the evolution of products and technology.  The history of technology thus parallels the history of living organisms. 

We patent practitioners are privileged to be chroniclers of inventions.  A study through the body of published patent applications and issued patents illuminates the more recent history of invention and key aspects of technology.  A study of the United States Patent Classification System, as developed and used by the United States Patent and Trademark Office, is rather like studying the taxonomy of living organisms.

How might we apply these insights?  Consider a new product without a marketplace.  Is such a product likely to survive?  Perhaps a new marketplace will emerge for the new product, which could then dominate.  How will other products compete with this new product?  How will consumers decide whether to select and use, or deselect the new product?  Consider competition against a product that is well-established in a marketplace.  What new feature or new product could compel consumers to favor it?  If some branch of technology is headed for obsolescence, why is this?  If some new branch of technology is emerging, how might it fare, and why?  And, for the patent practitioners in the audience, how might we best capture the innovative aspects and the inventions in our drawings, descriptions and claims on behalf of the inventors?  This is all part of the art of patenting.

ARTICLE BY

Christopher M. Hall
 
OF 
Womble Carlyle Sandridge & Rice, PLLC

What Does Regulation of Greenhouse Gas Emissions as Described by EPA in the “Tailoring Rule” have to do with the Clean Air Act?

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UARG v. EPA: Tailoring Rule Litigation

On June 23, 2014 Justice Scalia delivered the opinion of the U.S. Supreme Court on the question of whether EPA motor vehicle greenhouse gas regulations necessarily automatically triggers permitting requirements under the CAA for stationary sources that emit greenhouse gases. The statements in the opinion concerning EPA’s assertions of power are quite provoking. If read carefully, this opinion launches a warning to EPA about its future regulatory actions relative to greenhouse gases. The text of the opinion can be found here. The following quotes are offered as examples of that warning.

“EPA’s interpretation is also unreasonable because it would bring about an enormous and transformative expansion in EPA’s regulatory authority without clear congressional authorization. When an agency claims to discover in a long-extant statute an unheralded power to regulate “a significant portion of the American economy,” Brown & Williamson, 529 U.S. at 159, we typically greet its announcement with a measure of skepticism. We expect Congress to speak clearly if it wishes to assign to an agency decisions of vast “economic and political significance.” Id., at 160; See Also MCI Telecommunications Corp. v. American Telephone & Telegraph Co., 512 U.S. 218, 231 (1994); Industrial Union Dept., APL-CIO v. American Petroleum Institute, 448 U.S. 607, 645-646 (1980) (plurality opinion). Slip op at 19.

“. . . in EPA’s assertion of that authority, we confront a singular situation: an agency laying claim to extravagant statutory power over the national economy while at the same time strenuously asserting that the authority claimed would render the statute “unrecognizable to the Congress that designed” it. “ Slip op at 20.

“We are not willing to stand on the dock and wave goodbye as EPA embarks on this multiyear voyage of discovery. We reaffirm the core administrative-law principle that an agency may not rewrite clear statutory terms to suit its own sense of how the statute should operate.” Slip op at 23.

In a step wise fashion the opinion presents and answers the following:

1.  The question before the Court was “. . .whether it was permissible for EPA to determine that it motor-vehicle greenhouse-gas regulations automatically triggered permitting requirements under the Act for stationary sources that emit greenhouse gases.” Slip op at 2.

First we decide whether EPA permissibly interpreted the statute to provide that a source may be required to obtain a PSD or Title V permit on the sole basis of its potential greenhouse-gas emissions. Slip op at 10.

“It is plain as day that the Act does not envision an elaborate, burdensome permitting process for major emitters of steam, oxygen, or other harmless airborne substances. It takes some cheek for EPA to insist that it cannot possibly give “air pollutant” a reasonable, context-appropriate meaning in the PSD and Title V context when it has been doing precisely that for decades.” Slip op at 12.

“Massachusetts does not strip EPA of authority to exclude greenhouse gases from the class of regulable air pollutants under other parts of the Act where their inclusion would be inconsistent with the statutory scheme.” Slip op at 14.

“In sum, there is no insuperable textual barrier to EPA’s interpreting “any air pollutant” in the permitting triggers of PSD and Title V to encompass only pollutants emitted in quantities that enable them to be sensibly regulated at the statutory thresholds, and to exclude those atypical pollutants that, like greenhouse gases, are emitted in such vast quantities that their inclusion would radically transform those programs and render them unworkable as written.” Slip op at 16.

2.  . . . we next consider the Agency’s alternative position that its interpretation was justified as an exercise of its “discretion” to adopt “a reasonable construction of the statute.” Tailoring Rule 31517. We conclude that EPA’s interpretation is not permissible.” Slip op at 16.

“EPA itself has repeatedly acknowledged that applying the PSD and Title V permitting requirements to greenhouse gases would be inconsistent with – in fact, would overthrow – the Act’s structure and design.” Slip op at 17.

“A brief review of the relevant statutory provisions leaves no doubt that the PSD program and Title V are designed to apply to, and cannot rationally be extended beyond, a relative handful of large sources capable of shouldering heavy substantive and procedural burdens.” Slip op at 18.

3.  “We now consider whether EPA reasonably interpreted the Act to require those sources to comply with “best available control technology” emission standards for greenhouse gases.” Slip op at 25.

“EPA argues that carbon capture is reasonably comparable to more traditional, end-of-stack BACT technologies, . . . and petitioners do not dispute that.” Slip op at 26. “. . . it has long been held that BACT cannot be used to order a fundamental redesign of the facility.” “. . . EPA has long interpreted BACT as required only for pollutants that the source itself emits; accordingly, EPA acknowledges that BACT may not be used to require “reductions in a facility’s demand for energy from the electric grid.” Slip op at 27.

“The question before us is whether EPA’s decision to require BACT for greenhouse gases emitted by sources otherwise subject to PSD review is, as a general matter, a permissible interpretation of the statute under Chevron. We conclude that it is.” Slip op at 27.

“We acknowledge the potential for greenhouse-gas BACT to lead to an unreasonable and unanticipated degree of regulation, and our decision should not be taken as an endorsement of all aspects of EPA’s current approach, nor as free rein for any future regulatory application of BACT in this distinct context. Our narrow holding is that nothing in the statute categorically prohibits EPA from interpreting the BACT provision to apply to greenhouse gases emitted by “anyway” sources.” Slip op at 28.

Opinion of Breyer, with whom Ginsburg, Sotomayor and Kagan join, concurring in part and dissenting in part. Rather than exempting certain air pollutants like greenhouse gas emissions from the statute, it makes more sense to read into the statute an exemption for certain sources that were never intended to be subject to PSD.

Opinion of Alito, with whom Thomas joins, comments that Massachusetts v. EPA was wrongly decided at the time, and these cases further expose the flaw with that decision.

 

Federal Circuit Issues Decision Affirming Obviousness of a Molecule Patent Claim

Katten Muchin

On June 12, 2014, the US Court of Appeals for the Federal Circuit issued a precedential opinion affirming the obviousness of a patent claim directed to a drug molecule. Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., ___ F.3d ___ (2014). This is an example of the Federal Circuit holding a molecule patent invalid for obviousness.

The Federal Circuit upheld US District Court for the District of Delaware Magistrate Judge Christopher Burke’s opinion that held claim 8 of U.S. Patent No. 5,206,244 invalid in light of a structurally similar molecule. Claim 8 covers the entecavir molecule, which is the active ingredient in BMS’ Baraclude® tablets, which are designed to treat hepatitis B virus (HBV) infection. Teva successfully argued that one of ordinary skill in the art seeking to make an anti-HBV drug in October 1990 would have selected a prior art compound called 2′-CDG as a “lead compound” and would have modified it by adding a methylene (i.e. carbon-carbon double bond) group as indicated in the diagram to the right, below.

Lead Compound

Relying on testimony from both parties’ experts and prior art publications, the Federal Circuit saw no error in the district court’s finding that 2′-CDG was a proper lead compound. There was sufficient evidence that one of ordinary skill would have studied carbocyclic nucleosides generally, and 2′-CDG specifically, as antiviral drugs, especially because BMS’ expert admitted that “medicinal chemists . . . were actually treating and using 2′-CDG as a lead compound” in the search for new antivirals. Slip. Op. at 9-10. BMS argued that 2′-CDG would not be a lead compound because it was discovered to be toxic after the filing date of the patent. Id. at 10. The Federal Circuit (and the district court) rejected BMS’ argument because in October 1990 (i.e. the date of the proper inquiry), “2′-CDG was not yet known to have high toxicity” and BMS’ expert agreed that researchers thought 2′-CDG was a promising compound at that time. Id. at 10.

Motivation to Modify

The Federal Circuit also found that the record amply supported the district court’s conclusion on motivation to modify 2′-CDG to make the patented compound, entecavir. Slip Op. at 11-14. For example, both parties’ experts agreed that chemists were making changes on the carbocyclic ring in the prior art, and Teva’s expert stated that such changes resulted in greater activity than changes elsewhere on the molecule. Id. at 12. Unrefuted expert testimony also explained that the modification would take place at the 2′ or 5′ position on the carbocyclic ring because small changes could easily be made only at these positions. Id. at 12. The experts also agreed that the skilled artisan would focus on the smallest elements for the substitution, and BMS’ expert stated that he would “rule out everything but the carbon.” Id.The Federal Circuit found no clear error in the district court’s finding that the modification required was a minor one based on the testimony of both parties’ experts and a prior art article teaching improved antiviral activity by addition of a methylene group to a carbocyclic nucleoside. Id. at 12-13.

Reasonable Expectation of Success

Based on the prior art and the structural similarity of 2′-CDG and entecavir, the Federal Circuit found no error in the district court’s finding of “reasonable expectation of success.” Id. at 14. In doing so, the Federal Circuit rejected a bright-line rule regarding reasonable expectation of success in new chemical entities proposed by BMS. Specifically, BMS had argued that the existence of unexpected properties forecloses a finding of a reasonable expectation of success. Id. at 14. Citing its en banc In re Dillon decision, the Federal Circuit held that “unexpected results do not per se defeat, or prevent, the finding that a modification to a lead compound will yield expected, beneficial properties.” Id. at 15. Instead, the court found that unexpected results should be analyzed as secondary considerations of nonobviousness. Id.

Secondary Considerations

The Federal Circuit found no reversible errors in the district court’s analysis of secondary considerations of nonobviousness.[1] The Federal Circuit was deferential to the lower court’s factual findings regarding evidence of secondary considerations, including unexpected results. Id. at 18. The district court found that the results regarding entecavir’s high potency and large therapeutic window were not entirely unexpected because it was known in the prior art that 2′-CDG was effective against HBV and had a good therapeutic window. Id. They were differences of degree, not kind. Id. While the district court credited entecavir’s high barrier to resistance as an unexpected property, the three properties taken together were not sufficient to support nonobviousness. Id. at 17-18.

Article By:

Robert B. Breisblatt
Christopher B. Ferenc
Jeffrey A. Finn
Samson Helfgott
Martin S. Masar III, PhD
Hassan Abbas Shakir
Of:
Katten Muchin Rosenman LLP

[1] The Federal Circuit found that the district court made two legal errors (albeit harmless ones) in assessing unexpected results because it: (1) compared entecavir to another HBV drug on the market and not the closest prior art, 2′-CDG, and (2) looked at what the inventor knew, not a person of ordinary skill in the art. Id. at 18-19. The Federal Circuit also found no error in the lower court’s findings on commercial success and long-felt need. Id. at 19.

Supreme Court Finds that CERCLA Does Not Preempt Statutes of Repose – Comprehensive Environmental Response, Compensation, and Liability Act

GT Law

On June 9th, the Supreme Court issued its opinion in CTS Corp. v. Waldburger et al., No.13-339 (June 9, 2014) (slip op.) [link], in which it held that CERCLA section 309, 42 U.S.C. § 9658, does not preempt statutes of repose, reversing the Fourth Circuit.  Section 9658(a) preempts state law statutes of limitation for personal injury and property damage claims related to the release of a hazardous substance.  Justice Kennedy, writing for the majority, reaffirmed the oft-repeated “presumption against preemption” in reasoning that Section 9658 does not preempt state statutes of repose.  Statutes of limitations bar claims after a specified period of time based on when the claim accrued, whereas statutes of repose bar suits brought after a specified time since the defendant acted, regardless of whether the plaintiff has discovered the resulting injury.

CTS Corporation (“CTS”) operated an electronics plant in Asheville, North Carolina from 1959 to 1985.  CTS, which manufactured and disposed of electronics and electronic parts, contaminated its property with chlorinated solvents.  CTS sold the facility in 1987, and portions of the property were sold off.  Owners of those parcels, and adjacent landowners, brought suit against CTS in 2011, alleging that they discovered contamination on their properties in 2009.

The District Court found that N.C. Gen. Stat. § 1-52(16), North Carolina’s statute of repose, barred the suit.  That section prohibits a “cause of action [from] . . . accru[ing] more than 10 years from the last act or omission of the defendant giving rise to the cause of action.”  The Fourth Circuit reversed on the basis of CERCLA preemption, finding that section 9658 was ambiguous because it did not explicitly list “statutes of repose.”

The main issue at oral argument before the Supreme Court was whether the distinction between statutes of repose and statutes of limitation actually existed when Congress enacted Section 9658.  As Justice Scalia said, “. . . I used to consider them when I was in law school and even as late as 1986 [when section 1958 was added by Congress], I would have considered that a statutes of limitations.  Now, you think Congress is smarter.  They know the law better.”  Although other justices seemed to agree—and the distinction had only begun to be made in the 1980s—a 1982 Senate Superfund Study Group Report made that distinction and recommended that the few states that have statutes of repose repeal them.  Despite the overlap between statutes of repose and statutes of limitation, the Court found the distinctions important—statutes of repose are not related to the accrual of any cause of action and  cannot be tolled.  Because the Study Report made the distinction between the two, and because section 9658 fails to mention “statute of repose” and is not written in a way to suggest that it is intended to include both, the Court reversed.

The Court cited, as additional support for its conclusion the “well-established ‘presumptions about the nature of pre-emption.’”  The presumption against preemption counsels courts, when interpreting the text of a preemption clause susceptible of more than one possible reading, to “ordinarily accept the reading that disfavors pre-emption.”   The Fourth Circuit failed to mention this presumption (although the dissent relied on it).

This opinion follows recent Superfund cases in the Supreme Court in two respects.  First, the Supreme Court attempts to apply the “natural reading” of the statutory text rather than to reach out to interpret the statute broadly to effectuate its “remedial purpose.”  Indeed, Justice Kennedy explicitly derides that rationale for interstitial lawmaking.  Second, the Supreme Court attempts to preserve ordinary state law principles to the greatest extent possible.  So, for example, United States v. Bestfoods, 524 U.S. 51 (1998), was very respectful of state corporation law, and so too Waldburger is respectful of state tort law.  In this way, one might consider today’s decision to be fairly unremarkable.

The majority does not even address Justice Ginsburg’s dissent in which she and Justice Breyer worry that personal injuries with long latencies—like cancers—will go uncompensated.  But some of the long latencies arise not from the progress of some disease but of slow migration of a hazardous substance, in a groundwater plume for example.  Indeed, to the extent that many environmental toxic tort claims rest on allegations of property damage or diminution in value, the cancer model may be misplaced.

EU Sanctions And The International Oil And Gas Industry

Andrews Kurth

The international oil and gas industry is continuously tasked with adapting to an ever evolving sanction-regulated environment. The level of sanction activity and implementation in recent years has been unprecedented, partly as a result of the political events which gave rise to the Arab Spring and the opposition to Iran’s nuclear programme. The recent crisis in the Ukraine, and associated sanctions against Russia, have sparked further debate around the need for effective, targeted punitive measures and the consequences they may have for Europe.

This article considers the EU’s sanction regime, explores the effect it has on international oil and gas companies and addresses the short-comings of the EU’s decentralised system.

What are sanctions?

Sanctions are political policy instruments used to encourage jurisdictions acting in contravention of international law to adopt standards supported by the wider global community. They impose measures designed to cause damage to the targeted government, non-state entity or individual (“Target”) in order to force it to undertake, or prevent it from undertaking, certain behaviour. They may inhibit the Target from accessing foreign markets for trade or deny it from pursuing financial and other forms of commerce. The professed ultimate objective of a sanction is to preserve or restore global peace and security.

What is the source of EU sanctions?

The UN Security Council imposes sanctions through Security Council resolutions which are binding on the EU. The EU implements all sanctions imposed by the UN Security Council through legislation enacted by the European Council. The process typically results in a European Council regulation which has direct effect in EU member states’ separate legal systems, creating rights and obligations for those subject to them, and overrides national law. Additionally, the EU may decide to impose self-directed sanctions or restrictive measures which go further than a UN Security Council resolution in circumstances in which the EU deems such action to be necessary.

Why do EU sanctions affect international oil and gas companies?

Over the past two decades, the EU has engaged in an active use of restrictive measures in the form of economic and financial sanctions, embargoes and restrictions on admission to a country. Economic and financial sanctions typically take the form of asset-freeze measures which involve the use of funds and economic resources by Targets or persons acting for and on behalf of Targets, and the provision of funds and economic resources to designated Targets. Embargoes may prohibit trade in certain goods, and activities relating to such trade, with Targets (including the flow of arms and military equipment). Visa or travel bans can be imposed preventing certain persons from entering the EU or transit through the territory of EU member states. These sanction measures are part of the EU’s strategy to support the specific objectives of the Common Foreign and Security Policy.

At the time of writing, the EU has announced asset freezes and travel bans against around twenty individuals in Russia and the Ukraine. Companies conducting their business in the oil and gas sector should be particularly vigilant to ensure they act in compliance with EU sanctions, as Ukrainian and Russian entities and individuals who operate in this industry may increasingly become sanction targets.

US sanctions are questionable under international law because they apply extra-territorially to third state parties involved in business activities with the Target. Unlike the US, the EU has refrained from adopting legislation with extra-territorial effect. However, the EU’s recent sanctions against Iran displayed a greater resemblance to those levied by the US than had previously been the case. For example, sanctions were imposed prohibiting the provision of key resources to various parts of the Iranian oil and gas industry, as well as the provision of financial services to that sector. As a result of EU financial sanctions most, if not all, banks and other financial institutions have declined from conducting any business relations with the Iranian regime.

It is clear that EU sanctions are wide reaching and their scope has a significant impact on business activities. They will apply to international oil and gas companies in the following situations:

  • within EU territory, including its airspace;
  • on board of aircrafts or vessels under the jurisdiction of an EU member state;
  • to EU nationals, whether or not they are in the EU;
  • to companies and organisations incorporated under the law of a member state, whether or not they are in the EU (this captures branches of EU companies in non-EU countries); and
  • to any business done in whole or in part within the EU.

The corporate behaviour, performance and conduct of international companies are powerful channels through which the objectives of sanctions against Targets are achieved. Since an international oil and gas company has little option but to observe EU sanctions to the extent such company falls within the EU’s jurisdiction, these restrictive measures are likely to play a big part in a company’s commercial decision making processes.

Why are EU sanctions difficult to manage?

A principal reason why EU sanctions are difficult for international oil and gas companies based in various EU member states to manage largely stems from the fact that the European Union lacks a centralised licensing body. Instead, the responsibility for implementing and enforcing EU sanctions is delegated to the relevant competent authorities of the EU member states. The potential for variance and discrepancy is rife in a system where there are twenty-eight EU member states, each with their individual national resource constraints and self-centred policy objectives.

Typically, the competent authorities of EU member states are responsible for:

  • granting exemptions and licences;
  • establishing penalties for sanction violations;
  • coordinating with financial institutions; and
  • reporting upon the implementation of sanctions to the European Commission.

There have been calls for a central EU licensing body which would produce a single licensing and exemption policy for EU member states. Although EU guidelines on sanctions and best practices for the effective implementation of restrictive measures go some way to plug the gap, arguably a more comprehensive regime for implementing sanctions is required to provide a better level of certainty to international businesses operating in the realms of the EU.

Managing the risks

International oil and gas companies have always had to function in politically active climates. As sanctions initiated by multilateral organisations such as the UN and EU become more fashionable, so too does the exposure to political risk that these companies will face. Given the considerable levels of investment that can only be recouped over extended periods of time, and in accordance with pre-determined contractual apportionments, international oil and gas companies need to be able to recognise, assess and manage these political risks effectively.

Oil and gas companies can relieve the risks imposed on them by sanctions through political lobbying, taking pre-emptive measures and by reacting quickly to sanctions once they are implemented. Commercial negotiations will need to focus on the allocation of risk as a result of one party’s failure to perform or withdrawal from the contract on the grounds of applicable sanctions.

International oil and gas companies need to be proactive and consider both the legal solutions and pre-cure safeguards. Time and effort should be spent focusing on drafting and negotiating the relevant contractual documentation, following a careful risk assessment, instead of deferring to dispute resolution provisions. For instance, careful construction of force majeure provisions can allocate each party’s obligations in the circumstance where an event outside of a party’s control causes contractual performance to become impossible. Thus, whilst conventional force majeure clauses relating to physical events afford relief to an affected party from its liabilities under the contract, oil and gas companies should consider expanding such contractual provisions to cover sanctions and other restrictive measures imposed on them by the UN and EU.

To avoid falling foul of existing EU sanctions, oil and gas companies should also consider putting in place comprehensive compliance procedures and systems to implement applicable sanction regimes. Penalties for breach of sanctions can be severe; a person guilty of a sanction-related offence may be liable on conviction to imprisonment and/or a fine. Falling foul of sanctions also means that a transaction can immediately become unlawful.

Conclusion

In view of the economic significance of the EU, the application of economic financial sanctions can be a powerful tool. But like a chain is no stronger than its weakest link, the effectiveness and success of the EU’s sanction regime depends on all EU member states applying, implementing and enforcing EU sanctions in a consistent manner.

The current EU sanction regime warrants a fully integrated approach which would undoubtedly benefit its policy objectives and move some way to reducing the unduly high economic cost that international oil and gas companies face when operating their businesses in the EU.

In voicing the sentiments of Henry Kissinger: “No foreign policy – no matter how ingenious – has any chance of success if it is born in the minds of a few and carried in the hearts of none”, perhaps now, in the dawn of the recent events which have taken place in the EU’s backyard in the Ukraine and Russia, the EU should further global security measures by tightening its ranks and implementing a more centralised, and better monitored, sanction regime.

Article By:

Rebecca Downes
Of:
Andrews Kurth

Colorado’s Cutting Edge Legislation Fosters Clean Fuel Truck Adoption

Lewis Roca Rothgerber

 

The State of Colorado recently passed HB 14-1326, the “Clean Trucks Bill,” catapulting itself into the group of cutting edge states that are on the forefront of the clean fuel issue. Recognizing that trucks represent a huge opportunity for emissions reductions by replacing diesel engine trucks with trucks reliant on clean fuels, the Clean Trucks Bill paves the way for improved air quality, reduction in greenhouse gases, promotion ofdomestic energy sources and ultimately, cost savings for industry and for consumers. The bill, which passed the Colorado Senate unamended from the version previously passed by the House, was sent to Governor Hickenlooper on May 12, 2014. The Governor is expected to sign the bill and pass it into law soon.

The Clean Trucks Bill employs several components to promote clean fuels. The bill recognizes that the expense of clean fuel trucks over their traditional fuel counterparts leaves clean fuel trucks at a competitive disadvantage, with clean fuel trucks costing between 25 and 75 percent more. As such, the bill expands the alternative fuel tax credit targeting trucks. While existing tax credits provided incentives for compressed natural gas and propane trucks, the bill broadens the category of eligible fuels by incorporating hydrogen and liquefied natural gas into the credit-eligible fuels. Electric or hybrid-electric vehicles greater than 8,500 pounds in gross vehicle weight ratio (GVWR) also become eligible for the tax credit. Additionally, the bill introduces tax credits for heavy duty trucks (greater than 26,000 GVWR) and expands tax credit eligibility to light and medium-duty trucks.

By promoting broader adoption of clean fuel trucks, eventually market development and economies of scale will cause clean fuel trucks to become more cost competitive. The bill provides an 8-year period to achieve those economies of scale, paring down the percentage of a clean fuel truck purchase or conversion that is eligible for the tax credit over that time period. However, the maximum amount of the credit remains constant over the life of the legislation; heavy-duty trucks are eligible for up to $20,000 in tax credits per income tax year, medium-duty trucks up to $15,000 per income tax year, and light-duty trucks up to $7,500 per income tax year.

But the Clean Trucks Bill didn’t stop at a package of clean fuel truck purchase or conversion tax credits. Aerodynamic technologies proven to improve fuel efficiency and clean fuel refrigerated trailers also gained eligibility for tax credits. (Previously, tax credits were only available for idling reduction technologies.) The importance of the inclusion of clean fuel trailers cannot be understated, as fleets prefer to use the same fuel for the truck as the trailer, and the tax credit provides an incentive for the purchase or conversion of the clean fuel trailer in companion with the clean fuel truck.

The Clean Trucks Bill also updates the sales tax exemption for low-emitting vehicles over 10,000 GVWR. Today, virtually every vehicle over 10,000 GVWR meets the eligibility requirements for the sales tax exemption. The Clean Trucks Bill limits that sales tax exemption to trucks meeting more stringent standards.

The final element of the Clean Trucks Bill eliminates the specific ownership tax penalty for purchasing a clean fuel truck. Because the specific ownership tax is based on the purchase price of a vehicle, clean fuel trucks with their higher purchase price stand at a disadvantage to traditional fuel trucks with a lower purchase price. The Clean Trucks Bill abrogates that penalty by reducing the price at which clean trucks are valued for purposes of the specific ownership tax to an amount comparable to traditional fuel vehicles. By equalizing the tax value of a clean fuel truck with a traditional fuel truck, local government recipients of specific ownership tax revenues are unaffected from a revenue standpoint.

The benefits of the Clean Trucks Bill are many. First, the bill stimulates Colorado’s economy by promoting trucks using clean fuels, of which Colorado is a major producer. The bill also supports reduced emissions and improved air quality by providing an incentive for cleaner fuel trucks. Finally, the bill encourages energy independence through the promotion of domestically-produced clean fuels like natural gas and propane, as well as hydrogen and liquefied natural gas. It’s not often legislation of this magnitude can be widely perceived as a win-win, but Colorado is on the eve of becoming one of few states to accomplish such a feat.

Article By:

Dave McGimpsey
Of:
Lewis Roca Rothgerber LLP

Clash Of Titans over Biosimilars at Federal Trade Commission (FTC) Workshop

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On Tuesday, February 4, the Federal Trade Commission (FTC) conducted an all-day public workshop at its headquarters in Washington, D.C. on competition issues involving biologics and biosimilars.1 During highly informative presentations and roundtable discussions, the FTC and various stakeholders, including top-level representatives from originators of biologics (Pfizer and Amgen), biosimilars developers (Sandoz, Momenta and Hospira), payors (Aetna), prescribers (CVS and Express Scripts) and academia (Harvard Medical School), analyzed the likely impact of recent state substitution laws and naming conventions on biosimilars.

No one denied nor debated that the future of the drug industry lies in the robust and dynamic area of biologics. In 2010, 4 of the top 10 drugs were biologics and it is anticipated that in 2016 biologics will account for 7 of the top 10 drugs worldwide.2 At the same time, all panelists were concerned that the costs associated with biologics are rising at a staggering rate and are therefore not sustainable for patients nor payors, and that many patients will be unable to afford biologics if competition is not introduced.

According to Harry Travis, Vice President at Aetna, patients currently spend about $1 a day on non-specialty medication (traditional drugs) whereas they spend roughly $100 a day for specialty medication (biologics).3 He stated that only 1% of Aetna’s customers use specialty products, which account for 50% of Aetna’s total drug spending. This trend was confirmed by Steve Miller, Chief Medical Officer at Express Scripts, who underlined that specialty products (biologics) currently account for 30% of total drug spending, but this number will rise to 50% in 5 years.

It is thus not surprising that all participants urged for FDA-approved biosimilars in order to improve access to biologics while at the same time protecting public health and safety. Participants were also virtually unanimous in their recommendations that fostering public confidence in biosimilars will be crucial to their success and that unnecessary obstacles to substitution may restrict competition.4

The following points were discussed, relying on a large amount of data and comparative studies between countries:

  • Competition between originators of biologics and biosimilars developers: Panelists agreed that competition is not expected to have the same effects on the biologics industry as it has had in the small-molecule drugs space when generics penetrated the latter. Because the dynamics are completely different, the entry of biosimilars is unlikely to result in either steep price discounting or rapid acquisition of market share by manufacturers of biosimilars.5
  • Premature state biosimilar substitution laws: 18 states have already decided to introduce bills to regulate biosimilars, and 4 of them have enacted laws, all of which may seem slightly premature given that the FDA has yet to approve a biosimilar. Certain provisions of these substitution laws appear controversial as they place onerous requirements on the substitution of biosimilars for branded biologics. Of particular concern are certain substitutions laws requiring pharmacists to promptly notify patients and/or prescribers when dispensing a biosimilar, and to keep special records. These state-level restrictions not only deter substitution by imposing on pharmacists burdensome recordkeeping and additional communications with the physician, they also contradict federal law, namely the Biologics Price Competition and Innovation Act (BPCIA), which expressly provides for substitution.6 These state laws are arguably inconsistent with the BPCIA and could undermine the attractiveness and access to more affordable biologics.
  • Impact of naming on biosimilars: There was debate as to whether biosimilars should bear different non-proprietary names and whether such a requirement would have anticompetitive effects. Some argued that requiring distinct non-proprietary names is simply an effort to cause doubt and distrust among physicians and patients by making biosimilars appear different from biologics. As noted by Bruce Leicher, General Counsel at Momenta, the Biotechnology Industry Organization opposes GMO labelling on genetically modified foods precisely for the same reason – requiring a different name for biosimilars would communicate a different (and perhaps suspicious) product and would therefore grant a competitive advantage to branded biologics. Other panelists argued that names and other types of identifiers were justified by the need for an effective pharmacovigilance system, while some speakers expressed the need for distinguishable naming or other identifiers for purposes of linking a responsible product to a specific adverse event in the event of product liability.

The FTC did not express its own views on the effect of state-level restrictions and naming conventions on competition in the biosimilars market, but did note that securing more prescribing physicians on the panel might have added to the debate.

We will continue to monitor federal and state activities in the regulation of biosimilars.

1 The Food and Drug Administration defines biologics as medical products made from a variety of natural sources (human, animal or microorganism).  Moreover, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.

2 As presented by Steve Miller, Senior Vice President and Chief Medical Officer at Express Scripts.

3 More alarming to Mr. Travis is that the cost of biologics increased by approximately 15% annually, as compared to the approximately 5% increase in the cost of small molecule drugs.

4 Substitution, by allowing the pharmacist to automatically substitute an interchangeable biosimilar for the branded biologic without the intervention of the physician, provides a strong incentive to use biosimilars.

5 According to Dr. Sumant Ramachandra, Hospira’s Senior Vice President and Chief Scientific Officer, it takes approximately $5 million and 2-3 years for a generic manufacturer to bring a small molecule drug to market, whereas it takes over $100 million and 8-10 years for a biosimilar manufacturer to bring a biosimilar to market.

6 The BPCI provides that “the [interchangeable] biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.”

Article by:

Of:

Bracewell & Giuliani LLP

Wisconsin Supreme Court Upholds Broad Asbestos Exclusion

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In Phillips v. Parmelee, 2013 WI 105 (Dec. 27, 2013), the Wisconsin Supreme Court upheld the validity of a broad asbestos exclusion.

In 2006, Daniel Parmelee and Aquila Group (“Sellers”) sold an apartment building to Michael Phillips, Perry Petta and Walkers Point Marble Arcade, Inc. (“Buyers”) covered by an American Family business owners policy. Prior to selling the building to Buyers, Sellers received a property inspection report noting the probable presence of asbestos. However, Buyers claimed Sellers never put them on notice that the property probably contained asbestos and eventually filed suit.

The trial court granted American Family’s motion for declaratory judgment due to the policy’s broadly worded asbestos exclusion. The court of appeals upheld the trial court’s decision.

The asbestos exclusion at issue stated as follows:

This language does not apply to … “property damage” … with respect to:

a. Any loss arising out of, resulting from, caused by, or contributed to in whole or in part by asbestos, exposure to asbestos, or the use of asbestos. “Property damage” also includes any claim for reduction in value of real estate or personal property due to its contamination with asbestos in any form at any time.

b. Any loss, cost, or expense arising out of or in any way related to any request, demand, order, or statutory or regulatory requirement that any insured or others identify, sample, test for, detect, monitor, clean up, remove, contain, treat, detoxify, neutralize, abate, dispose of, mitigate, destroy, or any way respond to or assess the presence of, or the effects of, asbestos.

….

f. Any supervision, instructions, recommendations, warnings or advice given or which should have been given in connection with any of the paragraphs above.

The only issue presented to the Wisconsin Supreme Court was whether the asbestos exclusion in the American Family policy precluded coverage for the losses claimed by Buyers.

First, Buyers argued the term “asbestos” is ambiguous because it is undefined in the American Family policy and there are various forms and meanings of “asbestos.” The court was unpersuaded and found a reasonable person reading the policy would understand the word “asbestos” to mean any form of asbestos.

Buyers then argued the broad language of the asbestos exclusion invites multiple reasonable interpretations and it should be narrowly construed against American Family. The court found the case law cited by Buyers in support of their position to be factually distinguishable because the exclusion language in that policy was materially different from the broad, comprehensive language in the American Family policy, which included a wider range of asbestos-related losses than the case law cited by Buyers.

Finally, Buyers asserted that the Sellers negligently failed to disclose defective conditions or any other toxic or hazardous substances contained on the property. However, the court found nothing in the record to demonstrate the Buyers sustained any loss related to electrical or plumbing issues. Rather, the loss arose from asbestos.

For the aforementioned reasons, the Wisconsin Supreme Court upheld the court of appeals’ decision giving force to American Family’s broadly worded asbestos exclusion.

Article by:

Of:

von Briesen & Roper, S.C.