Category: Biotech & Cleantech

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

Bracewell & Giuliani Logo

 

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

vonBriesen

 

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.

Reform Opens Door to Private Investment in Mexico’s Energy Sector

Morgan Lewis logo

Mexican Senate presents comprehensive Energy Reform Bill to the House of Representatives with tremendous potential for domestic and foreign energy companies.

In an encouraging move toward energy reform, the Mexican Senate approved today and presented to the House of Representatives a bill—the combined effort of Partido Acción Nacional (PAN) and Partido Revolucionario Institucional (PRI)—with a constitutional reform proposal (the Energy Reform Bill) that paves the way to allow production and profit-sharing arrangements with, and the issuance of risk-sharing licenses to, private parties. The bill further advances the efforts of both parties, detailed in our August 15, 2013 LawFlash,[1] to promote energy reform in Mexico.

If the bill is enacted, these production and profit-sharing arrangements could be entered either directly by private parties or in association withPetróleos Mexicanos (Pemex), the state oil company. It is expected that risk-sharing licenses will mimic a concession-based system that would allow the booking of reserves for accounting purposes. Mexico has struggled with the adoption of a “pure” concession-based system due to a deeply engrained social and political belief that Mexico’s oil and gas reserves are and should remain the exclusive property of the Mexican state.

In addition, the Energy Reform Bill proposes the creation of the Mexican Oil Fund, with Mexico’s central bank, Banco de México, acting as the trustee. The fund would manage, invest, and distribute hydrocarbon revenues.

In the power sector, the Energy Reform Bill reaffirms the state monopoly with respect to the operation of the national grid and transmission and distribution activities. However, if enacted, the bill would break horizontal processes by permitting private parties to participate and contract with the Comisión Nacional de Electricidad (CFE), the state-owned utility company, and by allowing competitive activities with respect to power generation and commercialization.

Details on the reform are expected to be addressed in subsequent legislation that would follow congressional approval of the Energy Reform Bill; however, the bill underlines the reality of the reform and its potential for domestic and foreign private investors. The Energy Reform Bill, if approved, would give Congress a 120-day period to establish the necessary legal framework and regulate the new contracting mechanisms.

In order to pass, the bill will have to be approved by the House of Representatives and by 17 of the 32 state legislatures. It will then be submitted back to Congress for presentment of the final bill to the president, who must sanction and sign the proposed Energy Reform Bill into law, at which point it will be published in the Mexican Federal Official Gazette. Although some adjustments are expected, both PRI and PAN have indicated their intent to complete the congressional approval of the constitutional amendments on or before December 15, 2013.

[1]. View our August 15, 2013 LawFlash, “Mexican Government to Consider Overhaul of Energy Sector,” available here.

Article by:

Of:

Morgan, Lewis & Bockius LLP

Progress on the Western Front in the Solar Net Metering Battle?

 

The ongoing discussion between solar energy stakeholders and utilities concerning the merits of net metering and the best approach to ensure that ratepayers with installed solar power systems contribute appropriately to overall electric transmission and distribution costs spans the nation,  with state utility commissions from Georgia to California considering this issue.  However, nowhere is that discussion presently more heated and more closely watched than in Arizona and Colorado.

After a day of public comments and a full day of discussions with interveners, the Arizona Corporation Commission (A.C.C.) voted 3 – 2 on November 14, 2013 to modify APS’s Net Energy Metering (NEM) program. (A.C.C. Docket No. E-01345A-13-0248)  In brief, the A.C.C. voted to adopt a 70 cent/kW installed monthly charge for ratepayers with rooftop solar.  For the average-sized rooftop installation of 7 kW, this means a monthly charge of $4.90.  The two commissioners who voted against the decision felt that this did not go far enough in addressing the cost shift from NEM.

While the decision is likely to be perceived as a win for the rooftop solar companies, APS and other utilities can take solace in the fact that the Commission recognized that NEM does produce a cost shift and that the grid has value for all customers.  The details of the cost shift, including consideration of the value of the grid, will be the subject of A.C.C. workshops that will take place prior to the next APS rate case.

Prior to the open meeting, it appeared as though the A.C.C. would adopt a solution that would reduce the NEM subsidy based on a formula that took into consideration the lower cost of utility scale solar.  The monthly charge calculated through this formula ranged from $7.00 to $56.00 per month for a 7 kW installation, depending on the individual Commissioner’s proposal.

However, on the morning of the second day of the open meeting, the rooftop solar interveners and the Arizona Residential Utility Consumers Office (RUCO) negotiated a settlement that was the subject of most of the discussion.  This “settlement” proposed a monthly charge of 70 cents per kw installed or $4.90 for a 7 kW system.  While Commissioner Pierce and others mentioned the lower cost of utility scale solar, the final outcome had less to do with addressing the rate-shift and more to do with the amount that the DV industry said that the average customers, who they contend only save $5-10/month, could absorb and still be willing to install a system.  APS opposed the eventual outcome, as did Commissioners Pierce and Brenda Burns.

The following solution was adopted:

Monthly charge.  New rooftop PV customers beginning after December 31, 2014 will be billed a monthly charge of 70 cents per kW installed to help address the rate-shift from solar to non-solar customers.  For the average-sized system of 7 kW, that would mean a charge of $4.90/month.  The charge can be adjusted by the Commission in the future – either up or down – based on the volume of installations.  Reports of rooftop installation volumes will be provided quarterly.  There is no automatic escalation of the charge based on installation volume.  This charge will be added to the rooftop solar customer’s Lost Fixed Cost Recovery (LFCR) fund assessment currently paid by APS customers.  An offsetting reduction will be made to the monthly LFCR assessment currently paid by customers without rooftop solar.

Grandfathering.  Rooftop installations under the current NEM structure will be grandfathered.  There was a long discussion about grandfathering with a general consensus being reached that while any Commission can change any previous decision made, future Commissions were likely to honor grandfathering decisions made by previous Commissions.  Customers who sign up for systems under the new 70 cent charge will be grandfathered if the charge is increased to 80 cents or $1.00, but only until the next rate case in 2015.  Customers who then sign up under any increased charges (e.g., 80 cents or $1.00) will also be grandfathered until the next rate case.  However, all new rooftop customers (post December 2013) will be subject to any changes agreed to in the next rate case.

The NEM issue will be taken up again in the next APS rate case.

While the net metering discussion in Arizona has reached a conclusion – for now, the debate continues in Colorado.

On July 24, 2013, Public Service Company of Colorado (PSCo), Xcel Energy’s Colorado subsidiary, filed with the Colorado Public Utilities Commission (CPUC) its 2014 Renewable Energy Standard Compliance Plan detailing its updated proposal to meet Colorado’s requirement that 30% of PSCo’s retail electric sales come from eligible energy resources by 2020.  (CPUC Docket No. 13A-0836E)  Long recognized for its substantial commitment to wind energy, PSCo’s renewable energy portfolio also includes utility scale solar facilities and various programs designed to facilitate expansion of distributed solar energy installations, including the popular Solar*Rewards® program which has over 15,000 participants and represents more than 160 MW of installed solar capacity.

In its 2014 RES Compliance Plan PSCo proposed adding 42.5 MW of new distributed solar generation, including 36 MW of retail distributed solar generation through the Solar*Rewards® program and 6.5 MW of community solar gardens through the Solar*Rewards® Community program.  At the same time, the company proposed reducing the per kilowatt-hour incentives paid to customers with distributed solar installations.

The more controversial aspect of the utility’s filing related to PSCo’s call for more transparency in the NEM credit paid to customers with installed solar systems and the costs and benefits associated with distributed solar facilities.  PSCo explains that customers with installed solar arrays receive a 10.5 cent credit per kilowatt-hour of electricity they deliver to the grid, however, that electricity only provides 5 cents in benefits to PSCo systems and customers.  While PSCo acknowledges that distributed solar generation allows for some savings associated with fuel costs, energy losses, and the deferral of new generation resources, the utility argues that the NEM incentive paid to solar-owning customers does not adequately consider other costs related to generation, transmission, and distribution, costs that are presently being borne by non-solar customers.  As did APS in the NEM debate in Arizona, PSCo takes the position that the need for and nature of NEM incentives must be reevaluated as the solar industry moves toward becoming self-sustaining.  If the CPUC does not agree with PSCo’s NEM proposals, the utility indicated that it intends to acquire only enough distributed solar generation needed for minimum RES compliance – a total of 12.5 MW.

Solar businesses and trade groups, renewable energy advocates, and environmental groups have strongly opposed PSCo’s analyses and have characterized the utility’s proposal as declaring war on the solar industry.  These stakeholders argue that PSCo’s analyses fail to properly consider distributed solar’s grid, environmental, and job creation benefits.  To that end, the Vote Solar Initiative (VSI) filed a motion requesting that the CPUC sever the NEM issue from PSCo’s RES Compliance docket and conduct a separate, comprehensive NEM cost-benefit analysis.  While VSI’s motion was supported by various other stakeholders, it was opposed by PSCo and CPUC Staff, and was ultimately denied.

An evidentiary hearing on PSCo’s 2014 RES Compliance Plan, including consideration of PSCo’s proposed NEM changes, is scheduled for February 3-7, 2014.  Until then, it is likely that the NEM battle in Colorado will continue both in the CPUC docket and in the public debate concerning the costs and benefits associated with distributed solar generation, how those costs and benefits should be accounted for and allocated, and the continued need for incentives related to this distributed energy resource.

Article by:

Of:

Lewis Roca Rothgerber LLP

Rite Aid to Pay $12.3 Million for Failing to Properly Manage Waste Products from its California Stores

Beveridge Diamond Logo

Rite Aid Corporation has agreed to pay more than $12.3 million to settle a civil lawsuit alleging that Rite Aid improperly managed, transported, and disposed of hazardous waste at hundreds of its California stores and distribution centers.  The hazardous wastes at issue include: pharmaceuticals and over-the-counter medications, bleaches, photo processing chemicals, pool chlorine and acids, pesticides, fertilizers, batteries, electronic devices, mercury containing lamps, paints, lamp oils and other ignitable liquids, aerosol products, oven cleaners and various other cleaning agents, automotive products, and other flammable, reactive, toxic and corrosive materials.

Background

The case against Rite Aid began in 2009 when local environmental health agencies began to investigate Rite Aid facilities’ management of hazardous wastes. Prosecutors, investigators, and environmental regulators statewide conducted a series of waste inspections at Rite Aid stores and local landfills. The inspections revealed that over a six-and-a-half year period, Rite Aid had improperly managed certain hazardous wastes at its facilities, transported hazardous waste without meeting regulatory requirements, and in some cases illegally disposed of hazardous waste in landfills not authorized to accept such waste. On September 17, 2013, fifty-three California district attorneys and two city attorneys filed a joint environmental protection lawsuit against Rite Aid. Pursuant to California Health and Safety Code sections 25516 and 25516.1, the prosecutors brought a civil action in the name of the People of the State of California and sought to enjoin violations of California’s hazardous waste, medical waste, hazardous waste transportation and hazardous materials release response laws and implementing regulations.

The Allegations

The prosecutors asserted that Rite Aid stores engaged in numerous violations of California’s hazardous waste laws and regulations, including:

  • Disposal of hazardous waste at unauthorized points, such a trash compactors, dumpsters, drains, sinks, toilets, Rite Aid facilities, and landfills or transfer stations not authorized to receive hazardous waste, in violation of Health and Safety Code sections 25189 and 25189.2;
  • Failure to determine whether each waste generated at each facility in question as a result of a spill, container break, or other means of rending the product not useable for its intended purpose was a hazardous waste, as required under the California Code of Regulations (“CCR”), Title 22, sections 66262.11 and 66260.200;
  • Transporting or transferring custody of hazardous wastes without a properly licensed and registered transporter, as required by Health and Safety Code section 25163;
  • Failure to dispose of accumulated hazardous wastes from facilities at least once during every 90 day period, as required by CCR Title 22, section 66262.34;
  • Failure to timely file with the Department of Toxic Substances Control (“DTSC”) a hazardous waste manifest for all hazardous waste transported for offsite handling, treatment, storage, disposal or combination thereof, as required by Health and Safety Code section 25160(b)(3) and CCR Title 22, section 66262.23;
  • Failure to contact the transporter or owner/operator of the designated receiving facility to determine the status of hazardous waste in the event of non-receipt of a copy of a manifest with the signature of the owner/operator within 35 days of the date the waste was accepted by the transporter, as required by CCR Title 22, section 66262.42;
  • Treatment, storage, disposal, and transport of hazardous waste without receiving and using a proper EPA or DTSC identification number for the originating facility, as required by CCR Title 22, section 66262.12(a);
  • Failure to maintain a program for the lawful storage, handling and accumulation of hazardous waste, as required by Health and Safety Code section 25123.3 and CCR Title 22, sections 66262.34, 66265.173 and 662165.177;
  • Failure to properly designate hazardous waste storage areas, segregate hazardous wastes, and failure to conduct inspections, as required by CCR Title 22, sections 66262.34 and 66265.174;
  • Failure to comply with employee training obligations for the management of hazardous waste, as required by CCR Title 22, section 66262.34;
  • Failure to have in place at all times a hazardous waste contingency plan and emergency procedures for each facility, as required by CCR Title 22, section 66262.34;
  • Failure to continuously implement, maintain, and submit a complete hazardous materials business plan, as required by Health and Safety Code sections 25503(a), 25504, 25505 and CCR Title 19, sections 2729 et seq.;
  • Failure to immediately report any release or threatened release of a reportable quantity of any hazardous material from any facility into the environment, as required by Health and Safety Code sections 25501 and 25507;
  • Failure to properly manage, mark, and store universal waste in compliance with management standards in CCR Title 22, sections 66273.1 et seq.;
  • Failure to comply with the California Medical Waste Management Act (Health and Safety Code sections 117600 et seq.); and
  • Causing to deposit, without permission of the owner, hazardous substances upon the land of another, in violation of California Penal Code section 374.8(b).

The prosecutors sought civil penalties for each violation and reimbursement of the costs of investigation, enforcement, prosecution, and attorneys’ fees.

The Consent Judgment

On September 24, 2013, Judge Linda L. Lofthus issued an order approving the consent judgment negotiated by the parties. Under the agreement, Rite Aid agreed to fully comply with the Code sections and regulations at issue in the Complaint. Moving forward, stores will be required to retain their hazardous waste in segregated, labeled containers so as to minimize the risk of exposure to employees and to ensure that incompatible wastes do not combine to cause dangerous chemical reactions. The company will continue to designate four full-time employees responsible for environmental, health, regulatory and safety compliance assurance in California. California Rite Aid stores will work with state-registered haulers to document, collect and properly dispose of hazardous waste produced through damage, spills and returns. Moreover, Rite Aid has implemented a computerized scanning system and other environmental training to manage its waste.

Rite Aid agreed to pay $9,500,000.00 in civil penalties pursuant to Health and Safety Code sections 25189 and 25514 and Business and Professions Code section 17206, to the prosecuting and regulatory agencies. Rite Aid also agreed to pay $1,974,000 for certain supplemental environmental projects. Finally, Rite Aid will pay $950,000 for reimbursement of attorneys’ fees, costs of investigation, and other costs of enforcement.

According to the Los Angeles County District Attorney’s Office, Rite Aid was cooperative with prosecutors and investigators throughout the case.

Conclusion

The Rite Aid case reflects continued active enforcement by California’s prosecutors and regulators of the state’s environmental protection laws against retailers related to alleged mismanagement of hazardous wastes. Since 2011, California regulators have secured more than seven multi-million dollar settlements in hazardous waste enforcement actions against large retailers.

Article By:

Of:

Beveridge & Diamond PC

Cloning Decision Could Lead to Copycat Litigation in the World of Racing

Sheppard Mullin 2012

Owners of elite American Quarter Horses may soon be ponying up to create clones of their champions.

On July 31, 2013 a North Texas District Court jury decided that the American Quarter Horse Association’s (“AQHA”) rule prohibiting the registration of cloned American Quarter Horses violates federal and Texas antitrust laws. The AQHA, located in Amarillo, Texas, is the world’s largest equine breed registry and membership organization, with more than 5 million American Quarter Horses registered to nearly 350,000 members.

The American Quarter Horse excels at sprinting short distances and racing of these animals is the third most popular form of horse racing, generating more than $300 million in bets at U.S. racetracks in 2012. American Quarter Horses are bred to run in races of under a quarter-mile and have been clocked at speeds up to 55 mph.

Plaintiffs Jason Abraham and Gregg Veneklasen sued the AQHA for $6 million in damages, arguing that Rule 227(a) of the AQHA, which prohibits the registration of clones, violated both the Sherman Antitrust Act and the Texas Free Enterprise Act, which reflects federal antitrust law.

Plaintiffs alleged that the association’s prohibition of clones violates Section 1 of the Sherman Antitrust Act because the AQHA acted as a conspiracy that unreasonably restrained interstate or foreign trade. In response, the AQHA argued that the association is a single body and that the Board of Directors acted with a single interest, and therefore cannot be a conspiracy. Plaintiffs further alleged that the rule violated Section 2 of the Sherman Antitrust Act because the AQHA acted to maintain its monopoly power in the industry by enacting the rule. In response, the AQHA argued that the rule did not maintain monopoly power, but instead narrowed the association’s reach by reducing the potential universe of its registered horses.

On July 31, the jury found that the AQHA’s Rule 227(a) violated Section 1 and Section 2 of the Sherman Antitrust Act, as well as the equivalent Texas laws. In their decision, the jury awarded no damages, but could lead to the reversal of Rule 227(a) following an order the District Court Judge.

Johne Dobbs, the President of the AQHA’s Executive Committee, is reported as saying that the AQHA will appeal the North Texas District Court decision to the 5th Circuit, though it may be a year before a decision is made on the appeal.

A decision in favor of the AQHA by the 5th Circuit could have a reversing effect on a number of changes to AQHA rules since 2000, while a decision against could further cement the trend toward the AQHA being more inclusive. In 2000, a breeder sued the AQHA regarding the association’s rule that limited one registeredhorse per breeding pair per year, which thereby prohibited the use of embryo transplants to create multiple foals per breeding pair. The court held in an interlocutory order that the rule was an anticompetitive restraint of trade, adopted for the purposes of limiting the supply of registered quarter horses. Before a final order was written, the two parties settled and the AQHA changed its rules to allow for the registration of all embryo transfer foals. Since then, the AQHA has changed its rules to also register horses considered perlinos and cremellos to register, as well as horses deemed to be excessively white. The AQHA may be interested in pursuing a reversal to these changes if the 5th Circuit rules in their favor.

A decision against the AQHA could also lead to other breeder associations, including the American Kennel Club and American Paint Horse Association, to change their rules prohibiting the registration of clones.

An industry able to support quarter horse clones is likely ready to go if the courts side with the plaintiffs. Texas company ViaGen owns the patent that created the infamous cloned sheep, Dolly. The company has already cloned a number of horses, including Royal Blue Boon, the all-time leading dam of cutting horses with personal lifetime earnings of $381,764 and produce earnings of over $2.6 million. Hundreds of American Quarter Horse owners have already gene banked their horses in anticipation of the AQHA changing Rule 227(a).

Article By:

 of

Watt's New? Michigan Energy News – September 2013

Varnum LLP

Still Getting Ready to Make Good Energy Decisions

After reviewing and analyzing the submissions from seven public forums and from the 114 questions posted on the web for feedback, Energy Office Director Steve Bakkal and MPSC Chairman John Quackenbush will be issuing four reports on the following schedule:

■ Renewable Energy: Draft report release for comments – 9/20/13

Due date for public comments – 10/11/13

Release final report – 11/4/13

■ Additional Areas: Draft report release for comments – 10/1/13

Due date for public comments – 10/22/13

Release final report – 11/15/13

■ Electric Choice: Draft report release for comments – 10/15/13

Due date for public comments – 11/1/13

Release final report – 11/20/13

■ Energy Efficiency: Draft report release for comments – 10/22/13

Due date for public comments – 11/6/13

Release final report – 11/26/13

All this material will be posted at: www.michigan.gov/energy

Net Metering Participation Increases

The Michigan Public Service Commission issues an annual report on electric customers participating in the statewide net metering program required under the Clean, Renewable, and Efficient Energy Act of 2008. [Under net metering, when a customer produces electric energy in excess of its needs, energy is provided back to the serving utility and the customer receives a credit.] In 2012 the size of the net metering program increased 55 percent to 9,583 kW. The number of net metering customers has gone from 53 in 2008 to 1,330 in 2012. While most of the recent increase was due to new solar installations, a 535 kW methane digester in Great Lakes Energy Cooperative’s service territory is Michigan’s first Category 3 (methane digester up to 550 kW) modified net metering project.

Methane-to-Methanol Plant Operational

Oil wells also produce natural gas. When there is no way to get the natural gas to market it is usually “flared”. Now Gas Technologies LLC of Walloon Lake has demonstrated its 25-foot, portable, singlestep, gas-to-liquids plant in a Kalkaska County oil field. This first in the industry process can monetize stranded natural gas, biogas, coal mine methane, and landfill gas. www.gastechno.com

Adopt-A-Watt Helps Library

Dearborn’s Henry Ford Centennial Library has installed 25 energy efficient street lights and an electric vehicle charging station under the national Adopt-A-Watt program. Modeled on the AdoptA-Highway program, sponsorships are sold to fund new, energy-efficient equipment, alternative fuel vehicles and other green technologies for financially challenged public agencies. The agencies then realize the cost savings into the future.

Restrictive Wind Zoning Struck Down by Michigan Court

Forest Hill Energy recently won a court order striking down alleged “police power” ordinances passed by townships attempting to regulate the construction and operation of wind turbines. The Clinton County Zoning Ordinance already had extensive wind energy provisions. Nonetheless, three townships passed ordinances that were more restrictive to wind energy development than the county zoning. The additional restrictions related to height, noise, setbacks, and shadow flicker. Forest Hill Energy brought suit seeking a declaration that the townships’ “police power” actions were really zoning ordinances in disguise. The Clinton County Circuit Court ruled that since the townships were subject to the county’s zoning, the township ordinances were invalid because they were inconsistent with the county’s zoning plan—the townships could not get a “second bite at the zoning apple.” Forest Hill Energy had already obtained a special use permit for the construction of a 39 turbine project in January of 2012, and now expects to move forward with construction in late 2013.

More Wind Farms to Commence Construction in 2013

NextEra’s 150 MW Pheasant Run Wind projects are commencing construction this fall, with the energy to be sold to DTE Electric Company. The two projects will be located in Brookfield, Fairhaven, Grant, Oliver, Sebewaing and Winsor townships, all in Huron County. The Michigan Public Service Commission approved a 20 MW power purchase agreement (PPA) for DTE Electric Company with Big Turtle Wind Farm, LLC. The twenty year PPA has estimated pricing of up to 5.3 cents per kilowatt-hour. The project will have more than 50 percent Michigan-sourced content, and brings the DTE renewable energy portfolio to 9.8 percent. Consumers Energy will begin construction on its 105 MW Cross Winds Energy Park in Akron and Columbia townships in Tuscola County before the end of the year.

Michigan Shorts

ΩΩ Bay City Electric, Light & Power has signed a 20-year contract to purchase 4.8 MW of energy from the Beebe Community Wind Farm at a price starting at 4.5¢/kWh and increasing to 7.2¢/kWh Ω Revolution Lighting Technologies has acquired Relume Technologies, a Michigan manufacturer of LED lighting products and control systems Ω The City of Ypsilanti has set a goal to have 1000 solar roofs within the city limits by 2020 Ω DTE Energy is offering its customers the opportunity to buy BioGreenGas derived from the Sauk Trail Hills Landfill in Canton Ω Lansing Board of Water & Light has announced it will purchase energy from eight wind turbines in Gratiot County under a power purchase agreement with Exelon Wind ΩΩ

Virtual Solar Engineering Center Meeting with Success

GreenLancer.com, a Detroit-based solar energy technology company, has announced its initial $500,000 in funding. The company, launched in 2011, combines state-of-the-art cloud computing with a national network of green energy engineering freelancers (“greenlancers”). Their goal is to reduce the soft costs associated with solar energy projects. Initial investors include Bizdom (Detroit), Start Garden (Grand Rapids), Blue Water Angels (Midland), Northern Michigan Angels (Traverse City), and a private investor. The company has projects in 33 states and six foreign countries.

Converting Corn Stalks into Biofuel

Using a fungus and E. coli bacteria, University of Michigan researchers have turned inedible waste plant material into isobutanol. The waste used in the initial work was corn stalks and leaves. Isobutanol has 82 percent of the energy in gasoline, whereas ethanol has only 67 percent. It also has the added advantage over ethanol of not mixing easily (or absorbing) water. So it is a viable candidate to replace ethanol as a gasoline additive. The fungi turns the plant roughage into sugars that are then converted by escherichia coli to isobutanol. Through bioengineering the researchers believe they can produce a variety of petroleum-based chemicals through this same process.

Article By:

of

Who’s GINA and What Should I Know About Her? Re: Genetic Information Nondiscrimination Act

McBrayer NEW logo 1-10-13

GINA is not a who, but rather a what. The Genetic Information Nondiscrimination Act (“GINA”) was passed by Congress in 2008. GINA makes it illegal for employers with 15 or more employees to discriminate against employees or applicants on the basis of genetic information. Employers cannot lawfully inquire about (1) an individual’s genetic tests; (2) the genetic tests of an individual’s family members; or, (3) the manifestation of a disease or disorder in the family members of such an individual.

At the end of 2012, the Equal Employment Opportunity Commission (“EEOC”) announced in its Strategic Enforcement Plan that genetic discrimination would be a top priority over the next four years. The EEOC stuck to their word – in May, 2013, the EEOC settled its first lawsuit alleging GINA violations. The suit involved a fabrics distributor, Fabricut, Inc., who allegedly violated the Act by asking a woman for her family medical history in a post-offer medical examination. The company refused to hire the applicant after assessing that she had carpal tunnel syndrome, which led to Americans with Disabilities Act violations as well. The suit was settled for $50,000.

Shortly thereafter, the EEOC filed its second suit against The Founders Pavilion, Inc., a nursing and rehabilitation center. According to the EEOC suit, Founders conducted post-offer medical exams of applicants, which were repeated annually if the person was hired. As part of this exam, Founders requested family medical history, which is a form of information prohibited by GINA.

Employers should ensure that their policies related to employee medical information and any conducted medical exams comply with GINA. In addition, it would be wise for employers to update employee handbooks to state that discrimination on the basis of genetic information is prohibited.

Article By:

of

Argentina Legal Highlights (Volume II, 2013)

Beveridge Diamond Logo

Latin American Region Enviromental Report, Second Quarter, 2013

Packaging Waste Management Bill Introduced in Chamber of Deputies

On April 11, 2013, a bill (No. 1859-D-2013; the “Bill”) was introduced in the Chamber of Deputies that would create a national, comprehensive packaging-waste management system. The Bill would apply to most packaging and packaging waste, and would regulate most entities that are involved with the packaging of products, the marketing of packaged goods, or the recycling or recovery of packaging waste. (Arts. 2, 7) A covered entity could comply with its responsibilities through one of two methods. (Art. 9) One option would allow it to pay a fee and participate in a provincially or municipally administered Packaging-Waste Management Program (Programa de Gestión de Residuos de Envases), which would set requirements for collection, transportation, temporary storage, processing, and recovery of packaging waste. (Arts. 10-23) Alternatively, a covered entity could administer its own government-approved Deposit and Return System (Sistema de Depósito, Devolución y Retorno). (Arts. 24-26) The Bill was referred to the committees on Industry, Natural Resources and Conservation of the Human Environment, and Budget and Finance.

Reference Sources (in Spanish):

Battery Waste Bill Introduced in Chamber of Deputies

On April 25, 2013, a battery waste management bill (No. 1859-D-2013; the “Bill”) was introduced in the Chamber of Deputies. The Bill would cover nearly all batteries, with the exception of industrial and car batteries. (Art. 2) Most of the obligations established by the Bill would fall on battery producers: i.e., manufacturers, importers, brand owners, and resellers. These companies would be responsible for collection and management of battery waste and required to implement one of the following waste-management options: (a) establishing their own Individual Battery Waste Management System (Sistema de Gestión Individual de Residuos de Pilas y Acumuladores ); (b) participate in an Integrated Battery Waste Management System (Sistema Integrado de Gestión de Residuos de Pilas y Acumuladores); or (c) establish a deposit-and-return system. (Art. 5) Regardless of the option chosen, approval of the Secretariat of Environment and Sustainable Development (Secretaría de Ambiente y Desarrollo Sustentable) would be required. (Arts. 6-8) The Bill would also set standards for battery collection, treatment, recycling, and disposal (Arts. 9-10), impose labeling requirements (Art. 15), and require equipment manufacturers to make battery removal easy (Art. 16). Under the Bill, as under current Argentine law, used batteries would be deemed hazardous by definition, and thereby subject to Argentina’s extensive restrictions on transport, storage and handling of hazardous wastes. (Art. 3)

Reference Sources (in Spanish):

Article By:

 of

Could Your Business Qualify for a 179D Green Building Tax Break?

McBrayer NEW logo 1-10-13

If your company has built a new facility or upgraded an existing one anytime in the past six years, you might find that you qualify — at least partially — for a tax break of up to $1.80 per square foot under federal tax code section 179D, or the energy efficient commercial buildings deduction. This could be the case even if you had no concrete intention to focus on green building standards at the time.

A couple of great features of this deduction are, first, that you might be able to substantially mitigate your tax burden  as far back as six years and, second, it’s very likely that you will qualify if your facility exceeds 50,000 square feet and it meets current state building codes, according to a business tax writer for Forbes, who spent eight years as the U.S. Senate Finance Committee’s tax counsel.

The 179D tax deduction gives the business an immediate deduction in the current year plus a basis reduction for the value of the facility, which can be anything from a warehouses or parking garage to an office park or a multi-family housing unit. For private-sector projects, the building owner, assuming it paid for the construction or improvements, generally gets the deduction. In public projects, the architect, engineer or contractor can obtain it by seeking a certification letter from the government unit. Nonprofits and native American tribes are not eligible.

The green building deduction was created in recognition of the fact that around 70 percent of all electricity used in the U.S. is consumed by commercial buildings. The deduction, which is up for renewal — and possible expansion — this year, has already proven that efforts to mitigate the tax burden of businesses in a technology-neutral way is an effective way to encourage energy efficiency, according to the Forbes writer.

What improvements must be made to qualify for the green building credit? Currently, the new or renovated building merely needs to exceed the 2001 energy efficiency standards developed by the American Society of Heating, Refrigerating and Air Conditioning Engineers, or ASHRAE — and most state building codes already require this. That means the vast majority of new and improved buildings already meet this requirement.

It’s also possible to partially qualify for the deduction by meeting the standards only for the building envelope itself, which includes HVAC, the hot water system, and the interior lighting system. A building could qualify based upon only one of these systems, or all three.

Source: Forbes, “179D Tax Break for Energy Efficient Buildings — Update,” Dean Zerbe, Aug. 19, 2013

 of