Category: Biotech & Cleantech

DOE Announces $8.8 Million In Funding For Algae Technology Innovation Projects

On September 8, 2017, the U.S. Department of Energy (DOE) selected an additional four Productivity Enhanced Algae and Toolkits (PEAK) projects to receive up to $8.8 million.  The projects aim to develop high-impact tools and techniques that will increase the productivity of algae organisms to reduce the costs of producing algal biofuels and bioproducts.  In total, DOE has awarded over $16 million in funding to the initiative.

The project winners include:

  • Colorado School of Mines, in partnership with Global Algae Innovations, Pacific Northwest National Laboratory, and Colorado State University, which will use advanced directed evolution approaches in combination with high-performance, custom-built, solar simulation bioreactors to improve the productivity of robust wild algal strains;
  • University of California, San Diego, which will work with Triton Health and Nutrition, Algenesis Materials, and Global Algae Innovations on the development of genetic tools, high-throughput screening methods, and breeding strategies for green algae and cyanobacteria, targeting robust production strains;
  • University of Toledo, in partnership with Montana State University and the University of North Carolina, which will cultivate microalgae in high-salinity and high-alkalinity media to achieve productivities without needing to add concentrated carbon dioxide, and deliver molecular toolkits, including metabolic modeling combined with targeted genome editing; and
  • Lawrence Livermore National Laboratory, which will ecologically engineer algae to encourage growth of bacteria that efficiently remineralize dissolved organic matter to improve carbon dioxide uptake and simultaneously remove excess oxygen.
This post was written by  Kathleen M. Roberts of Bergeson & Campbell, P.C. ©2017
For more Environmental & Energy legal analysis go to The National Law Review

Bioplastics Industry Responds To Revised European Parliament Report On Waste Legislation

European Parliament EU BioplasticsOn June 9, 2016, European Bioplastics (EUBP) announced the support of a European Parliament (EP) report emphasizing the role of bioplastics in the creation of a circular bioeconomy. The report, produced by Italian MEP Simona Bonafè¨, outlines legislation that is needed to use waste more efficiently to create bio-based materials. Increasing the value of waste by promoting its use to create other bioproducts will help shift the linear bioeconomy to a circular, more efficient, bioeconomy. The report suggested defining composting and anaerobic digestion of organic waste as recycling, and requiring the collection of biowaste by 2020 in order to increase organic recycling of biowaste to 65 percent by 2025. On June 15, 2016, the EP debated possible new definitions of litter, with the intent of reducing both land and marine based litter by 50 percent by 2030.

ARTICLE BY Kathleen M. Roberts of Bergeson & Campbell, P.C.

©2016 Bergeson & Campbell, P.C.

Swiss Researchers Develop Model to Assess How Nanoparticles “Flow Through the Environment”

Swiss NanoparticlesThe Swiss National Science Foundation issued a May 12, 2016, press release announcing that researchers from the National Research Program “Opportunities and Risks of Nanomaterials” have developed a new model to track the flow of the “most important nanomaterials in the environment.”  To assess how man-made nanoparticles make their way into the air, earth, or water, researchers developed a computer model to determine the environmental accumulation of nanosilver, nanozinc, nano-titanium dioxide, and carbon nanotubes.  The press release notes that knowing the degree of accumulation in the environment is only the first step in the risk assessment of nanomaterials.  This data must be compared with ecotoxicological test results and the statutory thresholds.  According to the press release, in the case of nanozinc, “its concentration in the environment is approaching the critical level.”  The press release states that it “has to be given priority in future ecotoxicological studies — even though nanozinc is produced in smaller quantities than nano-titanium dioxide.”  Furthermore, according to the press release, ecotoxicological tests have until now been carried out primarily with freshwater organisms.  The researchers conclude that complementary investigations using soil-dwelling organisms are a priority.

Article By Lynn L. Bergeson & Carla N. Hutton of Bergeson & Campbell, P.C

©2016 Bergeson & Campbell, P.C.

Biomass Research And Development Initiative Provides Seven Projects With Up To $10 Million In Funding

On May 9, 2016, the U.S. Department of Energy (DOE), the U.S. Department of Agriculture (USDA), and the National Institute of Food and Agriculture (NIFA) announced the recipients of up to $10 million in funding through the Biomass Research and Development Initiative (BRDI). BRDI is a joint program through DOE and USDA that helps develop sustainable sources of biomass and increase the availability of biobased fuels and products. DOE selected two of the grant winners to receive between $1 million and $2 million: the Ohio State University (OSU) project is “Biomass Gasification for Chemicals Production Using Chemical Looping Techniques,” and the Massachusetts Institute of Technology (MIT) project is “Improving Tolerance of Yeast to Lignocellulose-derived Feedstocks and Products.”

USDA then selected five grant winners to receive a total of $7.3 million in funding:

  • University of California-Riverside, to convert poplar to ethanol and polyurethane via pretreatment and lignin polymer synthesis;

  • University of Montana, to quantify ecological and economic opportunities of various forest types and to quantify benefits of replacing fossil fuel with forest-based bioenergy;

  • North Carolina Biotechnology Center, to optimize production of educational resources on biomass sorghum production in the Mid-Atlantic region;

  • Dartmouth College, to overcome the lignocellulosic recalcitrance barrier; and

  • State University of New York College of Environmental Science and Forestry, to provide life cycle understanding for the production of willow and forest biomass to mitigate investment risk.

Article By Kathleen M. Roberts of Bergeson & Campbell, P.C.

©2016 Bergeson & Campbell, P.C.

Six Biofuel Trade Associations Write Congress To Extend Advanced Biofuel Tax Credits

On April 5, 2016, the biofuel trade associations Advanced Biofuels Business Council, Algae Biomass Organization, Biotechnology Innovation Organization (BIO), Growth Energy, National Biodiesel Board, and Renewable Fuels Association sent a letter to House and Senate Leaders asking for a multiyear extension of advanced biofuel tax credits. The six organizations are specifically asking that the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, the Alternative Fuel and Alternative Fuel Mixture Excise Tax Credit, and the Alternative Fuel Vehicle Refueling Property through the Protecting Americans From Tax Hikes Act of 2015 are extended before they expire at the end of 2016. Other energy production tax credits have been extended, and the biofuel trade associations argue that extending certain energy tax provisions and not others creates investment uncertainty across the energy sector, and puts biofuel producers at a disadvantage.

Article By Kathleen M. Roberts of Bergeson & Campbell, P.C.

©2016 Bergeson & Campbell, P.C.

Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

BullmonLast November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption.

The complaint alleges that the FDA failed in its statutory duty to take a “hard look” at how GE salmon will impact the environment. The plaintiffs warn that the FDA did not appreciate the risk that the farmed salmon would inevitably escape, “interbreed with wild endangered salmon, compete with them for food and space, or pass on infectious disease . . . .”

The plaintiffs also take aim at the FDA’s authority to regulate GE animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), arguing that, back in 1938, Congress did not expect the FDA to regulate genetically engineered animals for human consumption: “GE animals present enormously different risks and impacts than drugs, requiring different expertise, analyses, and regulation than were contemplated when Congress enacted the FFDCA.”

Whether additional lawsuits will follow this one remains to be seen. In our November post, we predicted that consumers could sue to challenge the labeling of the GE fish. Although the FDA initially determined that AquaBounty would not need to label its salmon as GE, a provision in December’s 2016 Omnibus Appropriations Bill required the FDA to ban GE salmon imports until it published labeling guidelines for the fish. In February, the FDA issued that ban and announced its plans to establish labeling guidelines.

Even if AquaBounty puts FDA-approved labeling on its product, consumers still may sue under failure to warn and related legal theories. The food industry has had some success defending state law food labeling claims based on federal preemption. But the federal Nutrition Labeling and Education Act exempts claims based on the adequacy of safety warnings unless the FDA has actually considered a risk and determined that no warning is necessary. So, the key question in any consumer personal injury suit involving GE salmon likely will be whether the FDA considered the risk of the alleged harm in implementing its new labeling guidelines.

Article By Amy M. Rubenstein & Katia Asche of Schiff Hardin LLP

© 2016 Schiff Hardin LLP

Solazyme Becomes TerraVia, Shifts Focus To Food And Specialty Ingredients

On March 11, 2016, Solazyme announced a name change to reflect a new focus on food, nutrition, and specialty ingredients instead of biofuels. TerraVia™ (TerraVia), as Solazyme is now known, will create value in plant-based food through a transformational algae innovation platform. TerraVia will focus on developing AlgaVia® Whole Algae ingredients (lipid rich powder and protein) and AlgaWise™ Algae Oils, as well as consumer food products that currently include Thrive® Culinary Algae Oil. The Company will also focus on animal nutrition ingredients and personal care ingredients, including AlgaPur Oils. The fuels, industrial oils, and Encapso™ business previously run by Solazyme have been moved to a unit called Solazyme Industrials, which is likely to be sold off. This shift towards high-value, low volume product areas is not surprising given the current low oil prices that are hurting biofuel profits, and is a key component in the continued success of the biobased industry.

Article By Kathleen M. Roberts of Bergeson & Campbell, P.C.
©2016 Bergeson & Campbell, P.C.

Biotechnology: Case Studies of Hypothetical, Genetically Engineered Organism

Discussed at Second Meeting on Modernizing the Regulatory System for Biotechnology Products to Illustrate Agencies’ Roles and Responsibilities

On March 9, 2016, the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products,” was convened in the U.S. Environmental Protection Agency’s (EPA) Region 6 Office in Dallas, Texas.  Representatives from EPA, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the White House Office of Science and Technology Policy (OSTP) discussed their current roles and responsibilities regarding biotechnology products under the Coordinated Framework for Regulation of Biotechnology (CF) by reviewing case studies of hypothetical products.

Two documents were released prior to the public meeting:  (1) Table of the oversight of biotechnology products and relevant coordination across EPA, FDA, and USDA; and (2) Regulation of Biotechnology Products — Clarifying Roles and Responsibilities through Hypothetical Case Studies.  A copy of the agenda is available here.

According to OSTP’s blog item on the meeting, the table document summarizes current responsibilities and the relevant coordination across USDA, EPA, and FDA for the regulatory oversight of biotechnology products.  OSTP cautions that it should not be interpreted as a guarantee that specific products in any of the product areas described in the table have been in the past, or will be in the future, determined to be safe by the relative regulatory agencies.

The case studies document states that its intention is to provide general information to developers who believe they have, or are uncertain as to whether they may have, a biotechnology product that is subject to regulation under one or more of the federal laws described in the CF.  It also demonstrates how an innovator might navigate the regulatory framework, starting from research activities in the laboratory to full commercialization of the product.  OSTP states that all of the case studies are of hypothetical products, selected because they cover multiple biotechnology product areas with different characteristics and intended uses, and because they illustrate how agencies coordinate their oversight under the CF.  The case studies discussed included the following hypothetical, genetically engineered organisms:

1. Corn, a field crop used for food.  In the first case study, corn with pesticidal properties is engineered with a plant pest component to have pesticidal activity against certain insects.

2. Plum, a fruit tree/crop used as food.  In the second case study, plum with pesticidal properties is genetically engineered without a plant pest component to resist a fungus.

3. Canola, a field crop, used as food.  In the third case study, herbicide-tolerant Canola is genetically engineered with a plant pest component to tolerate an already registered herbicide.

4. Rose, an ornamental plant.  In the fourth case study, a rose is genetically engineered with a plant pest component to increase the production of a pigment in its petals.

5. Microbial Pesticide, a bacterium that is not considered a plant pest.  In the fifth case study, a microbial pesticide is genetically engineered to enhance its pesticidal properties.

6. Microbial Pesticide, a phytopathogenic bacterium.  In the sixth case study, a microbial pesticide that is genetically engineered to express a pesticidal substance that protects against insects.

7. Algae for Biofuels.  In the seventh case study, a unicellular alga is genetically engineered with a plant pest component to produce industrial oils for conversion into biofuels.

8. Rabbit, an animal.  In the eighth case study, a rabbit is genetically engineered to make a therapeutic protein (recombinant insulin) for treatment of humans lacking this protein activity.

The first public engagement session took place on October 30, 2015, at FDA’s White Oak Campus in Silver Spring, Maryland.  A transcript from the meeting is available online.  The third public meeting will be held on March 30, 2016, at the University of California, Davis Conference Center in Davis, California.

Article By

Biobased and Renewable Products Advocacy Practice Group Bergeson & Campbell, P.C.
©2016 Bergeson & Campbell, P.C.

2016’s TechBridge Challenge Focuses on Advanced Surfaces

Are you working on or interested in advanced surface technologies? Look no further than the TechBridge Challenge on Advanced Industrial Surfaces! In collaboration with ExxonMobil Research and Engineering Company, Fraunhofer TechBridge is using this Challenge to accelerate the development of new material formulations, manufacturing methods, deposition techniques, and other innovations to improve energy efficiency in the petroleum and chemical processing industries. Winners will be awarded up to $100,000 in prototyping, demonstration, and/or validation services from the Fraunhofer R&D network. To learn more about TechBridge, the TechBridge Challenge on Advanced Industrial Surfaces, and how to apply, read on!

Founded in 2010 at the Fraunhofer Center for Sustainable Energy Systems CSE, the TechBridge program aims to advance cleantech startups by evaluating and preparing innovative early-stage companies to demonstrate the value of their promising technologies to investors and the industry. Unlike traditional accelerators, TechBridge provides R&D and prototyping services to its clients, thereby helping to de-risk technologies and increase the chance for private investment.

TechBridge oversees several industry and government-sponsored programs each year, focusing on specific cleantech innovation areas and concluding with the selection of top startups to receive Fraunhofer’s services. For this TechBridge Challenge on Advanced Industrial Surfaces, improvement examples include:

– Improved performance of surface-enhanced features (e.g., improved heat exchange, reduced frictional losses, fouling, or adhesion)
– Improved thermal, mechanical, and chemical stability of equipment surfaces
– Improved deployment of surface modifications in retrofit applications and hard-to-reach locations
– Increased affordability and ease of adoption at scale
– Optimization for process fluids other than water

Completed proposals can be submitted at www.FhTechBridgeChallenge.org/surfaces. Applications are due February 17th so get started today!

Article By Katy E. Ward of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

©1994-2016 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Ariosa v. Sequenom: In Search of Yes After a Decade of No

The Federal Circuit this Wednesday declined to reconsider its June decision in Ariosa v. Sequenom, a closely watched medical diagnostics case involving patents on cell-free fetal DNA testing. Biotech companies, investors, and patent lawyers alike should expect a prompt petition for certiorari, and should hope that the Supreme Court grants it.  (Disclosure: I was one of twenty-three law professors who submitted an amicus brief urging the Federal Circuit to grant en banc rehearing.)

In the last decade, the Supreme Court has suggested in case after case that the inventions they were considering were not merely unworthy of patent protection because they were, say, not inventive enough or useful enough or disclosed in enough detail. Rather, the Court in these cases gave us information about the very boundaries of the patent system—by placing the disputed inventions outside those boundaries altogether. But they have not yet told us what is just inside those boundaries.

This legal uncertainty has a significant chilling effect on investment in innovation, one that we are increasingly able to quantify.  As USPTO Chief Economist Alan Marco and I explained in a 2013 paper in the Yale Journal of Law and Technology, when a court issues a decision resolving the legal uncertainty over whether a patent was valid, that newfound certainty actually moves the market as much as the initial patent grant does.  In other words, the unpredictability of courts forces the market to discount—by as much as half—how much trust to put in the legal rights that the Patent Office issues.

Patent holder Sequenom certainly experienced the downside of that uncertainty, as Wednesday’s rehearing denial sent its stock price tumbling over 14% in just two days.  Others have taken a hit as well, such as the large-cap DNA analysis firm Illumina, which has pursued Ariosa in a separate patent litigation and whose stock price fell 7% across the same two-day period.

The reason for this uncertainty is that we are effectively back in the late 1970s, when the Court was prominently rejecting inventions as patent-ineligible subject matter—Gottschalk v. Benson in 1972 and Parker v. Flook in 1978—without saying anything concrete about what was eligible.  Relief would come only after Diamond v. Chakrabarty in 1980 and Diamond v. Diehr in 1981, when the Court finally produced binding precedents going the other way.

The result is that today’s patentees can only try to run away from the settlement risk mitigation patent in Alice Corp. v. CLS Bank (2014), the breast cancer genetic diagnostic patent in AMP v. Myriad (2013), the thiopurine dosage monitoring patent in Mayo v. Prometheus (2012), the energy futures risk hedging patent application in Bilski v. Kappos (2010), and, although they were never definitively adjudicated, the vitamin deficiency diagnostic patents in LabCorp v. Metabolite (2006).  There is no case yet to run toward.

Ariosa v. Sequenom could have been that case and still can be, if the Court grants certiorari.  Certainly the Federal Circuit order has framed the issue well.  The per curiam order denying en banc rehearing was accompanied by three opinions that addressed in different combinations both the reach and the wisdom of the Supreme Court’s recent precedents.

Judge Dyk’s concurrence concluded that the precedents, particularly Mayo and Alice, do apply to the present facts and that those precedents are generally sound.  He invited “further illumination” from the Supreme Court only on whether the all-important inventive concept must come at the second step of the two-step Mayo test (application of the natural law or abstract idea) or may also come at the first step (discovery of the natural law).  Meanwhile, Judge Newman’s dissent concluded that the precedents, particularly Mayo and Myriad, do not apply here, for the facts “diverge significantly.”  She found the Sequenom patent’s subject matter to be eligible and would have proceeded to more specific patentability analysis under §§ 102, 103, 112, etc.

Their midpoint and the best argument for certiorari was Judge Lourie’s concurrence, which agreed that Mayo controls, with “no principled basis to distinguish this case from Mayo”—but which also urged that Mayo and the Supreme Court’s other precedents from Bilski onward are an increasingly unsound basis for differentiating between natural laws and abstract ideas on the one hand, and applications of those laws and ideas on the other hand.  Echoing a previously expressed position of the Patent Office, he favored the “finer filter of § 112” for issues of indefiniteness or undue breadth (rather than what the agency’s post-Bilski Subject Matter Eligibility Guidelines called the “coarse filter” of § 101).

He also pushed back directly against a argument that the Supreme Court frequently invokes to express its preference for flexible standards that foster over predictable rules that can be manipulated: the draftsman’s art.  Decisions from Flook and Diehr to Mayo and Alice have rested in part on the suspicion that patent lawyers may at any time evade substantive doctrinal limitations through clever claim drafting.  To this Judge Lourie’s opinion aptly responded that “a process, composition of matter, article of manufacture, and machine are different implementations of ideas, and differentiating among them in claim drafting is a laudable professional skill, not necessarily a devious device for avoiding prohibitions.”

In these regards, Judge Lourie’s approach may well represent the “center” of the Federal Circuit on subject-matter eligibility.  He was in the en banc majority in Bilski and authored the panel opinion in Mayo.  He authored both panel majority opinions in Myriad (before and after the Supreme Court’s GVR order).  And he authored the five-judge en banc plurality opinion in Alice, whose analysis was ultimately consolidated and endorsed in the Supreme Court’s opinion in that case.

With the issues so well framed and the recent subject-matter eligibility precedents so well synthesized, then, there is reason to be optimistic that a decade of hearing “no” from the Supreme Court may finally give way to a “yes” and better orient us on the true boundaries of our patent system.

Article By Saurabh Vishnubhakat of Texas A&M University School of Law

© Copyright 2015 Texas A&M University School of Law