Archive for bioproducts
On October 15, 2015, Appleton, Wisconsin’s Paper Industry International Hall of Fame will be inducting six people into the Hall of Fame. One of them is an innovator and leader from ancient China who can be considered as China’s answer to Gutenberg. Gutenberg is frequently honored in the West as one of the most important inventors ever for giving us the world’s first book printed with movable type, a remarkable achievement from around 1455. As with many inventions long thought to have had European origins, there’s a touch of Eastern flavor in this one, for Gutenberg’s Bible came 142 years after the world’s first mass-produced printed book made with movable type, the large Book of Farming (Nong Shu) from China, printed in 1313 by Wang Zhen.
Wang Zhen was a Chinese official who recognized that vast amounts of agricultural technology scattered across China needed to be preserved to help all of China reduce famine and be more productive. He took a Chinese invention, movable type, and improved upon it to make a practical way to print an entire book. He used carved wooden blocks for each character, and developed a sophisticated way of arranging them on two rotating tables to allow typesetters to quickly find needed characters to place them in his press. The Nong Shu was printed and preserved many notable inventions in China, including an early form of a blast furnace driven with a reciprocating piston attached to water works, something long that to be a later European invention.
Recognizing Wang Zhen for his important role in the advance of printing is a fitting step for the Hall of Fame, and I look forward to many more Asian inventors, scientists, and business leaders being recognized in the Hall of Fame in future years. The historical contributions of China in numerous fields have received far too little attention, and I’m delighted to see folks in Appleton taking the lead in rectifying this problem. Kudos to the Paper Industry International Hall of Fame!
My latest post here at Innovation Fatigue lamented the actions of the USPTO in their apparent war on patents involving natural products. New information makes the story even more troubling than before, indicating that more than just judicial error and bureaucratic blindness was involved. The steps taken appear much more deliberate and political than that, and reflect an increasingly revolutionary attitude toward patent rights holders, where IP is viewed as the problem, not as a vital tool to benefit society.
First, new insight into the actions of the USPTO comes from a leaked USPTO PowerPoint used to train patent examiners on the radical new USPTO guidelines implementing their extreme response to the Myriad decision. A PDF of the PowerPoint slides, coupled with the USPTO guidelines and some vital commentary have been compiled by Hal Wegner and are kindly provided by a great champion of IP (quality IP, that is), Greg Aharonian, Director, Center for Global Innovation/Patent Metrics. Wegner observes that the new guidelines, which require inventions involving natural products to be “significantly different” than what may be found in nature provide no concrete, objective test to determine when a claimed invention is “significantly different” from ineligible subject matter. Is a creative device made out of wood significantly different from naturally occurring wood? Is a new anti-cancer drug extracted from a newly discovered fungus significantly different? Who knows? The uncertainty created by the test can be disastrous for property rights holders. Wegner points out that a much more useful and concrete test already exists: the Papesch test for determining whether the claimed invention as a whole is nonobvious from the prior art. But this was never mentioned by the Supreme Court in the infamous Myriad decision and has been neglected by the USPTO as well.
In a recent email to his subscribers, Greg Aharonian shares an email sent to him by a biotech patent examiner within the USPTO. It helps explain some of the motivation behind the seemingly crazy USPTO action, which isn’t so crazy at all from the perspective of politics:
1610 examiner here again. We examiners in biotech at the PTO also would like to know ourselves who wrote those ridiculous guidelines. We are being told to stretch 101 as much as possible. The guidelines say that, for example, if claim 1 is an assay method, with steps such as centrifugation, column chromatography, mixing reagents in a test tube, spectrophotometric measurements, if each category of technique was known at the time of the invention (is routine/well known/conventional), forget about whether the step was ever done with the molecules in the claim, we have to write how each step is 103-obvious w/o using 103’s word “obvious”. We have to write somehow how the combination is 103-obvious, w/o the using 103 word “obvious”. Then we have to reject the claim under 101. We don’t know if the PTO requires art cited for each step that is obvious.
Now, Funk Bros. v. Kalo Inoculant, one example in the guidelines, is a decision in which the patented composition, which I think is amazingly clever, was considered not to be inventive. The decision involves 103, not 101. How could the PTO so thoroughly confuse 101 with 103?…
Myriad was politically motivated, filed by the ACLU, because poor people can’t afford the BRCA1 gene test. OK, this is the Obama era, max political correctness. Current politics ruled. The test, however, is expensive and difficult to do. It’s not in the test strip category, like a pregnancy test.
But Mayo v. Prometheus takes the cake. The drug and its metabolites are not natural products. So what is the natural phenomenon that the justices never mentioned? And the clever part is looking for a target concentration of one synthetic metabolite in red blood cells.
What seems to be forgotten is that patents are intellectual property and that patented inventions are new and useful. When intellectual activity is maligned rather than rewarded, the economy goes with it. The PTO seems to be under pressure from the White House, because biotech patents don’t jive with Obamacare, which is backfiring.
Yes, it is high time for patent attorneys to fight back (don’t laugh Greg). David Kappos cut our time for examination, but he increased customer service. Time for the customers to demand more service.
The biotech community seems afraid to speak out too loudly on these outrages, but I think savvy investors see a dimmed future and have begun pulling some of their money out of the field (my guess about the recent plunge). The patent community and the business community is remaining far too silent, perhaps afraid of attracting political wrath, but the losses of IP rights could seriously set back innovation in the US and beyond.
China is ramping up its IP system and strengthening protection, while America is declaring IP to be the problem and weakening IP rights. Who’s going to own the future? I’m living in beautiful Shanghai now, where a lot of the future seems to be sprouting in an increasingly pro-IP environment. Meanwhile, I hope America will come to its senses and return to vigorously protecting IP rights and promoting innovation, not innovation fatigue.
The federal government has set bold and challenging goals for future increases in the production of energy from non-fossil fuel sources. Seeking to curb our dependence on foreign oil as well as fossil fuels in general, our nation is encouraging the development of fuels from biological sources. Biofuels, diesel and gasoline made from renewable sources such as agricultural waste, forest sources, and algae, are a top priority and are the subject of extensive government-funded research and tax credits. Biofuels are a rich source of innovation and show an explosion in patent activity in the past 3 years.
Unfortunately, biofuels are also facing daunting challenges from uncertainty in federal regulations and tax policy that threatens to bring many innovations to a halt as industry puts many developments on hold due. The uncertainty in the environment–the regulatory and tax environment created by the government–is actually hindering many biofuel projects aimed aimed at enhancing the environment in the long run. This was the sentiment from several speakers in the midst of biofuels innovation in sessions at BioPro Expo 2011, a major conference on biofuels and forest bioproducts, being held in Atlanta, Georgia, March 14-16. Concern about government barriers to commercialization of biofuels advances was a repeated theme.
One example is federal regarding the definition of “renewable” for those seeking federal incentives for the use of renewable sources of fuels. Municipal solid waste (MSW) has a large component of plant-based materials such as paper and food waste, and is one of the most available and commercially attractive biofuel sources. The technology is proven, the raw material is available and economically feasible, and projects are ready to roll–except they have largely been put on hold until the federal government rules on whether MSW can be counted as “renewable” or not. Then there are strict new rules on boiler operation (the Industrial Boiler Maximum Achievable Technology, or BI MACT, rule) throwing another wrench and major cost burden on the backs of those with boilers generating energy from biomass sources. There are a host of other rules and conflicting definitions and policies adding to uncertainty, risk, and cost in commercializing biofuels. For the innovator, it is a challenging era with the potential of innovation fatigue from external or environmental factors.
Let’s hope that the rich opportunities being uncovered in biofuels can be commercialized rapidly and that the barriers to innovation can be reduced.
I’m back from the week-long Annual Meeting of the American Institute of Chemical Engineers (AIChE) in Salt Lake City, Utah, where over 4,200 engineers from around the country and many other nations were gathered. Hundreds of technical papers were presented from researchers and leaders pursuing advanced in energy, biotech, materials, nanotechnology, chemicals, and related fields. Energy was probably the biggest theme, but bio-related R&D was extremely hot as well.
The Division that I Chair, Forest Bioproducts Division of AIChE, had over 50 papers presented on topics related to biofuels and bioproducts from plant resources such as cellulosic or lignocellulosic biomass. We learned about advanced in biomass gasification, in fermentation of biomass to product fuels, in managing feedstock, in converting syngas or pyrolysis products into value-added chemicals, and many other topics.
I was especially impressed with a keynote speech from Ann Lee, Senior Vice President of Process Research and Development at Genentech, the biotech company that is now part of the Roche Group. Ann outlined Genentech’s pioneering work as the first biotech IPO, the first company to market a recombinant DNA drug, the first company to develop at humanized therapeutic antibody (Xolair), the first company to develop a therapeutic antibody for cancer (Rituxan), and the first in many other areas. They were paving new ground time after time, taking on huge risks and uncertainties, and facing the numerous barriers that innovators continue to face on their way to success. Through it all, Genentech managed to cultivate and maintain a culture of innovation with commitment at the top to drive past or through the barriers to achieve success in so many areas.
The development of personalized antibodies and antibody fragments for very specific and successful cancer treatments has involved visionary efforts that tapped the expertise of thinkers across multiple boundaries, exemplifying what can be done when a country eradicates internal “not invented here” syndrome. Herceptin, the first personalized custom antibody treatment for cancer (HER2+ cancer cells in breast cancer) is a remarkable advance, as is the related Lucentis drug for treating age-related macular degeneration (AMD). Chemists and chemical engineers working together made these innovations possible, and I applaud Genentech for their innovation success.
One innovation-related tidbit I picked up in a session of the meeting that I chaired for the Management Division concerns resources to help start-ups. The Wayne Brown Institute (VentureCapital.org) has developed a screening system based on 15 criteria that have proven remarkably effective in gauging the health of a start-up. In one study, 80% of those that scored high on their assessment were still in business 10 years later – a remarkable statistic. I’ll be looking into this resource in more detail in the future.
Say, do you know which university led the nation last year in terms of high-tech start-ups generated? MIT? Close! It was actually the University of Utah, with 23. Nearby BYU had 11, is remarkable given its much smaller level of funding for R&D (they typically lead or are in the top 3 in terms of start-ups per dollar of research). Interesting. I saw plenty of evidence of active innovation in the Utah area. One of the highlights of the visit for me was a tour of Ceramatec in Salt Lake City, an innovation company developing ionic ceramic membranes that support fuel cells and other advanced products.
Ethanol as a biofuel may soon reach practical limits in the US and frankly is clouded with questions about its economic and environmental utility. However, the fermentation systems for producing ethanol can be adapted to produce much more valuable products using special microbes developed at some of the most promising green energy and biotech companies. The result is enticing, as we read in “Brazil: The Bossa Nova of Biofuels” from Biofuels Digest:
Another wave of next-generation renewable drop-in fuel companies, Amyris, LS9, Gevo and Dupont, are also investing in and partnering with Brazilâ€™s sugarcane fermentation bioreï¬neries. Why? Because their emerging technologies from cellulosic microbes (yeast, algae, fungus and bacteria) can use the same ethanol fermentation facilities in the US corn belt and in Brazilâ€™s sugarcane belt to produce bio-crude, green diesel, petrol and biojet.
The simplicity is astounding. Hereâ€™s the big idea. Take an existing, stranded ethanol factory or conglomerate. Buy it for a substantial discount. Start with cheap sugar. Drop in a new Amyris, LS9, Gevo, or Cobalt microbe/ bug in the same fermentation vat and what do you get? An integrated biorefinery that can use cheap, sustainable sugars to produce renewable diesel, aviation fuel, and biobutanol â€“ fuels that are compatible with existing petroleum pipelines, storage, petrol stations, and vehicle engines today.
In the near future, these fermentation-based bioreï¬neries will be able to convert multiple inputs from cellulosic sugars–bagasse, switchgrass, wood chips, municipal solid waste, and glycerin–into a diverse set Of outputs, including renewable diesel, aviation fuel, bio-crude oil, biochemicals and biopolymers with significant GHG reductions and carbon emissions compared to petrochemical hydrocarbons.
This is an important lesson in innovation. Don’t live with current assumptions. Look at existing technologies, processes, and products as simply a stepping stone to something more valuable, and then ask what is next. If I have raw materials and processing stations that can use microbes to convert sugars into a biofuel, why be satisfied with the least valuable biofuel around? Why not look at the higher-value products that similar technology could produce? That’s the genius behind some of these rising bioproducts companies.
Speaking about bioproducts, let me encourage any chemical engineers out there to join me at the AIChE Annual Meeting, where the Division that I chair, the Forest Bioproducts Division, is hosting numerous sessions dealing with the exciting developments in biorefineries and value-added products from cellulosic biomass. That’s where some of the best potential is: energy and chemical products from something besides the food that people need to eat.
In my ongoing work on analyzing the intellectual property landscape in biofuels, one of the most impressive companies I’ve run across is Amyris, a renewable products company whose clever use of synthetic biology goes far beyond biofuels. Amyris was founded by Kinkead Reiling, Neil Renninger, and Jack D. Newman who met at Berkeley and founded Amyris in 2003, headquartered in Emeryville, California. With a grant from the Bill & Melinda Gates Foundation, they first developed their technology under a non-profit initiative to provide a reliable and affordable source of artemisinin, an anti-malarial therapeutic. It was viewed as a long-shot, but they found success that paved the way for the growth of the company into other areas. They are now developing new microbial strains that can produce other useful molecules from renewable feedstocks. This industrial synthetic biology platform is providing alternatives to a broad range of petroleum-sourced products. he extremely useful molecule farnesene is an important part of their business. It provides a compound that can be used to produce flavors, perfumes, detergents, cosmetics, biodiesel, and other products.
This week Amyris created a stir by announcing a record number of deals and partnerships for a single week (a record among bioenergy companies, according to Biofuels Digest). These partnerships include P&G, Total, Soliance, Cosan, M&G Finanziaria, and Shell:
Amyris has taken it up a notch with a series of stunners surrounding its synthetic farsenene, which it has named Biofene â€“ the first product that Amyris is seeking to produce at commercial scale.
Beyond its success this week with Biofene announcements, which are the basis for the P&G, M&G and Soliance partnerships â€” there are the broader arrangements with Cosan to develop a platform in renewable chemicals, and the equity agreement with Total that will provide needed capital as well as a broader platform for Amyrisâ€™s expansion into hydrocarbon fuels.
The mysterious agreement with Shell, regarding diesel, is one to watch. The decidedly vague disclosure was buried in Amyrisâ€™ amended S-1A registration statement, but not otherwise mentioned in a flurry of press releases from the company as it promotes its expansion in this pre-IPO environment. Shell Western Trading & Supply is one of 17 Shell trading companies that buy and sell to customers within and outside of Shell.
This news shows an interesting example of companies forming partnerships with an innovative start-up with great technology and apparently highly valuable IP. According to my Patbase search, Amyris has 21 patent families, quite a large number for such a young company. They clearly have been active and aggressive in pursuing patent protection, and those patents are critical for the meaningful partnerships they are now forming. It’s a great unfolding story of open innovation and technology transfer.
The story extends beyond the US. They have operations in Brazil, for example, which is one of the world’s hotbeds for bioenergy, bioproducts, and collaborative innovation.
Further information comes from today’s article, “Amyris: farnesene and the pursuit of value, valuations, validation and vroom,” also from Biofuels Digest.