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This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Susan Kling FinstonBack when I wrote ISO A Scientific Revolution in Cancer Research in April of 2013, I truly did not expect to be able to greet the revolution by year’s end. By December 2013, though, Science magazine anointed cancer immunotherapy as the “breakthrough of the year”, and pharmaceutical R&D for oncology immunotherapy has been surging ever since. This is really good news for cancer patients and their families.

But first, the backstory: Cancer remains the leading cause of death in OECD countries and second leading cause of death in the developing world. Despite the investment of over $100 billion dollars and increased understanding of the genetics of cancer tumors, the vast majority of patients still receive highly toxic chemotherapy – either on its own or combined with radiation and/or surgery. As before, cancers may routinely develop resistance to chemotherapies, and radiation may new cancers, placing additional burdens on patients, families and the healthcare system. So the  availability of funding for cancer immunotherapy represents an important hope for commercialization of safer, more sustainable cancer therapies.

Cancer immunotherapy seeks to stimulate the patient’s immune system to attack malignant tumors, recognizing that the central challenge of the disease is the inability of the body to recognize and confront uncontrolled growth of cancer cells. Bacterial immunotherapy in particular has a long history of nearly 150 years with observation that acute bacterial infections could shrink tumors, often contributing to complete remission of cancer. In the late 19th century, physicians in Germany and the United States observed that cancer patients with coincident bacterial infections experienced tumor regression. German physicians W. Busch and F. Fehleisen separately reported tumor regression in cancer patients with erysipelas infection.

Contemporaneous reports from Dr. William B. Coley, a New York surgeon, noted regression of malignant sarcomas in patients suffering from bacterial infections. Dr. Coley then systematically treated bone and soft tissue cancer with a bacterial vaccine that became known as “Coley’s toxin,” consisting of heat-killed streptococcal organisms combined with heat-killed Serratia marcescens (formerly known as Bacillus prodigiosus). Coley treated over 1000 cancer patients and achieved a high success rate in treatment of sarcomas, carcinomas (e.g. breast and renal cancer), lymphomas and melanomas. Coley’s toxin became the foundation for early cancer immunotherapy, only to be overshadowed by the emergence of radiation and chemotherapies.

Now cancer immunotherapy has come back to the fore, both due to the success of new immunotherapies and recognition of the limits of radiation and chemotherapies, with or without genomics. Science magazine in 2013 cited the first fruits of modern cancer immunotherapy with promising T-cell Receptor therapies, as mentioned. Fast forward two years, and cancer immunotherapy has become perhaps the most important area for experimental cancer therapies and cures.

The current impact and importance of immunotherapy for cancer R&D is perhaps best symbolized by the today’s launch of the Loncar Investments Cancer Immunotherapy Index. The Loncar Immunotherapy fund includes a companies ranging from diversified Fortune-100s to smaller companies focused exclusively on immunotherapy.

At least for now it does not include Amrita Therapeutics Ltd. – an Indian biotech-startup that I co-founded with Ananda Chakrabarty that builds on our increased understanding of the important therapeutic role of bacteria and related peptides in cancer therapy. Ananda has been saying for some time to anyone who will listen that the evolutionary wisdom of bacteria may lead to a new golden age for cancer therapies and broader drug development. For my part, I have learned that the future is a mystery.

Only hindsight is 20/20.

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

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Journal of Commercial Biotechnology

Labels, Lawyers, & Logic
Peter J. Pitts
America deserves access to high-quality health care without avoidable medical errors and complications. This achievable goal begins with harnessing and using the power of information. And that begins with clear, accurate, and usable labeling.The American health care system is undermined, underserved, and undervalued when labeling is written more for corporate liability protection than as a valuable tool for health care providers…
Full details at the Journal of Commercial Biotechnology

Improper Handling of Harmful Chemicals by Small Tea Growers of Assam: Challenge to Heath and Local Environment
Dhrubajyoti Gogoi, Abhishek Kumar Yadav, Madhurjya Gogoi, Debajit Borah
After dominating the world tea market since last 170 years, today India became the fourth largest tea exporter. The state Assam, located in the Northeastern end of the country contributes almost 50% of the India’s total tea production and Small tea growers of Assam (STGs) produces around 30% of its total annual production and contributes almost 12% of India’s annual production…
Full details at the Journal of Commercial Biotechnology

Trends in Market Access for Specialty Biologics: Challenges & Promises
Sanjay Kumar Rao
Specialty biologics are the fastest growing class of bio/pharmaceutical products in terms of the number of new brand launches and rates of health care spending in the U.S. and globally. Innovative biologics meant to treat a range of hitherto untreatable conditions in oncology, inflammation, CNS, endocrinology and other chronic conditions seek to offer radical improvements in efficacy and patient well-being…
Full details at the Journal of Commercial Biotechnology

Human Health Biotechnology: Can Brazil Advance?
Carlos Torres Freire, Victor Callil, Denise Golgher
The Brazilian human health biotechnology sector was analyzed according to its spacial and sectorial distribution of the following aspects: (i) the scientific production; (ii) dependence of companies on governmental funding for research and development; (iii) the lack of innovative capacity regarding the discovery and development of new drugs and (iv) a disconnection between the advancement of scientific output and innovation within the private sector…
Full details at the Journal of Commercial Biotechnology

Importance of venture capital investors for the industrial biotechnology industry
Gunter Festel, Christian Rammer
As in the medical biotechnology area some decades ago, the fast technological development within industrial biotechnology (IB) has caused numerous new ventures…
Full details at the Journal of Commercial Biotechnology

Early Commercial Assessments: An Innovative Tactic for Small Biotechs
Anthony Giovinazzo
As a small biotech company embarks on a drug development program, there is a tendency for management to focus on a well-defined set of issues. Is the science behind the drug valid? Does it solve an interesting problem or unmet need? What are the prospects that the medical community and patients will embrace it as a valuable new solution? And what is the range of indications the drug is conceived as addressing? These are all valid questions, but a small biotech can do even more to prepare itself for the drug development process, which is a journey that can take many years and cost a significant amount of money…
Full details at the Journal of Commercial Biotechnology

Accelerating the Growth of Bioeconomy in Malaysia
Nazlee Kamal, Zurina Che Dir
Advances in commercial application of biotechnology worldwide over the past two decades have led to the development of a bioeconomy, whereby substantial economic outputs are from the development and use of biological materials. Bioeconomy encompasses all industries and economic sectors based on the values implicit in biological materials that can be translated into new sources of income, environmental sustainability and social well-being…
Full details at the Journal of Commercial Biotechnology

Lean Start-up: A Comprehensive Case Study in the Establishment of Affordable Laboratory Infrastructure
Kristopher James Grohn, Kelsey Moody, Danique Wortel, Nick LeClair, Alison Traina, Eric Zluhan, Gerold Feuer
Historically, innovation in the biotechnology sector has relied to a large extent on the expensive infrastructure provided by universities or large pharmaceutical companies. This prohibitive start-up expense is the basis of why garage-style biotechnology entrepreneurs are exceedingly rare as compared to their software and high-tech counterparts…
Full details at the Journal of Commercial Biotechnology

The University of Colorado Certificate Program in Bioinnovation and Entrepreneurship: An Update and Current Status
Madhavan Parthasarathy, David Forlani, Arlen Meyers
The purpose of this paper is to provide an update and report the current status of the cross-campus University of Colorado Denver program in bioinnovation and entrepreneurship, details of which were first reported in the Journal of Commercial Biotechnology in 20125.  The paper outlines the joys and challenges of implementing an inter-campus program that attempts to marry cutting-edge biotechnology innovation with a solid business foundation…
Full details at the Journal of Commercial Biotechnology

Which Types of Bioinformatics Inventions Are Eligible for Patent Protection?
Trent Ostler, Michael Gollin
The field of bioinformatics is flourishing, and strong growth is only projected to continue. Like any cutting edge technology, bioinformatics requires an integrated IP strategy involving patent, trade secret, and copyright laws. The patent system in particular can be a powerful protection for commercializing bioinformatics inventions as long as a corresponding patent application meets certain patent law standards…
Full details at the Journal of Commercial Biotechnology

For more information, see the Journal of Commercial Biotechnology

 

This is a guest post from Halina Zakowicz, Marketing Specialist at Biovest International, Inc. Do you have a response to Halina’s post? Respond in the comments section below.

Scaling up cell culture production can be a tricky proposition.halina

Generating large amounts of cell-secreted proteins is labor-intensive when utilizing traditional cell culture methods. Quality and yields can be inconsistent; these methods are also prone to contamination due to multiple aseptic manipulations. Making the jump to large-scale systems isn’t easy either, often requiring capital expenditures that are not feasible.

Have you been using petri dishes, plates, flasks or spinner bottles for small-scale production of cell-secreted proteins? Are you looking to scale up your protein manufacturing using alternatives to traditional mammalian and insect cell culture?

If so, you should consider hollow fiber bioreactors.

Scaling up poses many challenges

Small-scale cell culture typically requires little more than individual bottles of media, a tabletop incubator and 30-60 minutes a day from a lab technician. However, generating cell numbers that are 100-10,000 fold higher catches many labs short-handed. Lab technicians are usually not hired to perform cell culture as their full-time job; furthermore, lab space is always at a premium.

There are a number of challenges involved in scaling up cell culture, including the following:

Different cell dynamics

What is frequently taken for granted is how the dynamics of nutrient delivery and waste removal change as a function of scale. When expanding and supporting large-scale cell culture volumes, the maintenance of proper pH and temperature becomes challenging, as does the delivery of adequate oxygen, nutrients and growth factors.

Increased labor requirements

Not only do increased numbers of cells require additional passaging, but once the cell-derived products are ready to harvest, they must be purified and concentrated from large volumes of supernatant. Both the additional cells and their derived products require additional labor.

Increased lab space requirements

Many laboratories scale up their production capacity by investing in entire rooms filled with spinner flasks or roller bottles; other labs purchase large stirred-tank bioreactors. Both of these options take up valuable laboratory space.

Higher costs

When expanding cell culture operations, expense and capital budgets are used to purchase extra media, sera and specialized equipment. Additional technician hours must be allotted and budgeted for.

Hollow fiber bioreactors offer one solution

To address the challenges posed by large-scale cell culture, researchers and commercial manufacturing operations are increasingly turning to an established, yet not well known, technology called the hollow fiber bioreactor. This technology addresses the problems outlined above by reducing the following:

Media

The hollow fiber bioreactor system consists of thousands of semi-permeable capillary membranes arranged in parallel and bundled into small cylindrical polycarbonate shells that typically take up the volume of a 12-ounce beverage can.

As a result, two distinct and separate compartments are generated: an intracapillary (IC) space enclosed within the hollow fibers, and an extracapillary (EC) space surrounding the hollow fibers.

hollow-fiber-bioreactorFigure 1. A standard hollow fiber bioreactor shown with its enclosed intracapillary (IC) and extracapillary (EC) spaces.

The small size of the hollow fiber bioreactor system means that significantly less media is required compared with stirred-tank bioreactors. Also, growth factors and other high molecular weight nutrients are unnecessary in the IC space, resulting in a reduced need for serum.

Oversight

Hollow fiber bioreactor systems can be automated for media flow, pH, temperature and oxygen control, and EC cycling. The automation of these cell culture parameters means that less oversight is required to grow large numbers of healthy cells (>109 cells/ml) and to generate large quantities of cell-secreted proteins.

Space

Stirred-tank bioreactors require additional laboratory space for housing and maintenance. Animals used for ascites production must be housed in specialized rooms. In contrast, hollow fiber bioreactor systems have a very small footprint and in many cases can be stored on a lab bench or inside an incubator.

Downstream processing

Because cell-secreted proteins such as monoclonal antibodies or vaccines remain with the cells in the EC space of the hollow fiber bioreactor, they automatically concentrate and do not need to undergo time-consuming downstream processing, a required step for most protein manufacturing processes.

Enabling efficient, cost-effective protein production

Due to their technological advantages over traditional cell culture methods, hollow fiber bioreactors are being increasingly used by academic and research laboratories and biotech manufacturing plants for mammalian and insect culture-based protein production. They also have been — for decades — the workhorse of companies that manufacture human and veterinary IVD products worldwide.

In light of the recent influenza outbreaks, for example, there has been particular interest in using hollow fiber technology to rapidly produce viral vaccines not tainted by allergy-inducing animal proteins. Likewise, both price and ethical concerns over using mouse ascites have situated the hollow fiber bioreactor as a more humane method for large-scale in vitro generation of monoclonal antibodies and other cell-secreted proteins.

Because the hollow fiber bioreactor offers a compact, efficient, economical and long-lived method for protein generation, this technology is becoming increasingly employed across laboratories, and especially laboratories that wish to find an easy and cost-effective method for scaling up their production capacities.

About the author:
As marketing specialist at Biovest International, Inc., Halina helps customers understand how hollow fiber bioreactors can be used to scale up traditional cell culture and facilitate novel in vitro applications like vaccine production. Biovest also uses hollow fiber technology in its upstream protein manufacturing and downstream processing services when working with academic, research and pharmaceutical customers.

Global Biotechnology InventorsI was just notified of a fascinating paper citing my research from DrugPatentWatch.com.

Briefly, I found two surprising results: Firstly, pharmaceutical innovation has been essentially immobile — it remains almost completely rooted in the United States and Western Europe. Secondly, there is virtually no innovation coming out of so-called emerging economies such as India and China (i.e. <1% as many patent inventors as the US).

Going further, Hu et al published a social network analysis of pharmaceutical innovation. They found that the network of international collaboration developed from a star-like US-centric network in the late 1990s to a more distributed network with a diminished centrality of the US in the late 2000s. Importantly the decrease is US centrality is due to increase collaboration between European neighbors, rather than due to a rise among emerging economies.

This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Susan Kling FinstonFor the next chapter in this continuing series, let’s turn back to India and the draft National IPR Policy currently under debate in New Delhi. A great deal of digital ink has been spilled on the constitution of the IPR Think Tank that produced the draft Policy, with less attention given to the importance of the detailed recommendations to improve the environment for creation, commercialization and management of IP in India, with particular attention to the IP challenges of Micro-Small & Medium Enterprises or MSMEs.

With regard to the appointments to the IP Think Tank, IPR academics,  NGOs and assorted IP-skeptics are aggrieved by the appointment of actual IP practitioners with experience in corporate affairs, industrial R&D, patent litigation, WIPO and the Courts, preferring that the Centre Government leave IP policy to the PhDs to avoid ‘potential conflict of interest.’ These criticisms are available online here and here.

In the event, the Modi Government chose a broader, gender-diverse range of experts for the IP Think Tank, appointing a venerable former Judge of the Madras high court, Justice Prabha Sridevan as Chairperson, and including two of India’s leading female litigators, Senior Advocate Ms. Pratibha Singh and Advocate Ms Punita Bhargaval. Rounding out the group are Dr. Unnat Pandit of Cadila Pharmaceuticals Ltd., Shri Rajeev Srinivasan, Director, Asian School of Business, Thiruvananthapuram, and Shri Narendra K. Sabharwal, Retired Deputy DG, World Intellectual Property Organization (WIPO) and now Chair of the FICCI-IPR Committee as the final member and Convenor. The Modi Government also provided opportunities for public comment by stakeholders including both before and after the IPR Think Tank’s submission of the draft document, and posted the draft National IPR Policy online.

Apart from persistent ad hominem attacks on IPR Think Tank Members – because only professors can be ‘IP experts’ –  the primary substantive complaint relating the draft IPR Policy is the threadbare assertion that there is no link between IP, innovation and assimilation of novel technologies for creation of economic and social value. This is an issue that also figured prominently in an earlier ill-fated IP Policy Baseline Draft submitted to the Modi Government by Professors Shamnad Basheer and Yogesh Pai.

Before circling back to the linkages between IP protection and enterprise development, it may be helpful to review the origins on the Basheer/Pai Document, where the Modi Government had earlier tasked three Ministry of Human Resource Development (MHRD) IP chairs – Professors Prabuddha Ganguli, Shamnad Basheer and Yogesh Pai – with submitting a draft IP policy. At some point Prabuddha Ganguly, the senior member of the team with perhaps the greatest expertise on the strategic importance of IP for enterprises, left the group. The remaining two like-minded academes Shamnad Basheer and Yogesh Pai apparently did not seek advice from the Government on how to – or even whether to – proceed, and subsequently submitted a beautifully drafted if highly impractical document.
(In full disclosure: I have known Prabuddha Ganguly and Shamnad Basheer for many years. I respect and admire them both. While I do not know Shri Yogesh Pai personally, as he is Shamnad’s close colleague I am sure he is also brilliant.)

The Basheer/Pai draft is a lyrical document, coming close to poetry in parts, with majestic, soaring language, like the following:

“While India will continue to draw on foreign precedent from jurisdictions that have had a longer and more sophisticated history with intellectual property, it will not blindly adopt their norms. Rather it will seek to adapt them to the local conditions in a bid to promote and protect national interest. Much in line with words of wisdom from the father of the nation, Mahatma Gandhi who once said: “I do not want my house to be walled in on all sides and my windows to be stuffed. I want the cultures of all lands to be blown about my house as freely as possible. But I refuse to be blown off my feet by any.’“ (p. 2)

However earnestly felt, the Basheer/Pai document reads like an IP manifesto rather than a national IP policy, lacking specific, detailed policy recommendations needed by Indian Industry for IP administration, adjudication, or training.  Basheer and Pai dispose of IP enforcement issues in the closing paragraph in 4 sentences (and one fragment)(p. 11). While touching on traditional knowledge, the paper makes no recommendations for improving access to IP rights for R&D-intensive MSMEs, despite growing recognition that innovative MSMEs face the greatest challenges in gaining needed IP protection in India.

In the final analysis,  the challenges facing India’s innovative MSMEs may provide the best response to IP-skeptics on the important connection between IP protection and innovation.

Unlike many larger firms, R&D Intensive MSMEs rely to a much greater degree on their innovative capacities and the ability to protect their creations – whether these are copyrighted works, trademarked products or patentable inventions. MSMEs in OECD-member states like Israel and the United States that have a greater ability to protect and commercialize their technologies, have a track record of creating substantial economic and social benefit in the process.

In fact the original third HRD IP Expert, Prabuddha Ganguly, has undertaken critical research in this area in his role as a WIPO consultant.  He has presented compelling data on the importance of IP protection for MSME enterprises at WIPO events around the globe, as in this paper for a 2004 regional WIPO event in Oman.

Beyond any research, my ongoing work as co-founder of emerging Indian biotech Amrita Therapeutics and consulting (transactional) work for innovative MSMEs provides daily reminders of the causal relationship between the ability of MSMEs to protect their creative works, process and/or products through IP protection, and the effective diffusion and assimilation of new technologies for creation of social and economic value.

Comparing the Basheer/Pai manifesto side by side with the Draft National IPR Policy underscores the wisdom of the Modi Government’s reboot, and calls to mind the old saw:  those who can do, those who can’t teach.  However much we may benefit from IP-Skeptics who keep challenging our IP assumptions, it may better for the rest of us if they are not charged with actual policy making in the meantime!

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

This is a guest post from Robert E. Wanerman, a member of Epstein Becker Green’s Health Care and Life Sciences practice. Do you have a response to Robert’s post? Respond in the comments section below.

Wanerman_Robert_4x5For many biotech manufacturers, obtaining Medicare coverage is a significant milestone in commercializing an item or service. Although Medicare coverage for specific items or services that use biotechnology methods for their production, design or delivery can vary in different parts of the United States, a small number of them are guaranteed nationwide coverage if the Centers for Medicare and Medicaid Services (“CMS”) has issued a National Coverage Determination (“NCD”).  Obtaining a NCD is a difficult process for companies in the biotech industry, and depends on factors such as the quantity and quality of clinical data, including outcomes data, and a consensus of professional opinions or practice guidelines.

Since 2006, CMS has carved out a middle ground for covering items and services when it believes that the clinical data is insufficient to justify issuing a NCD, but believes that the item or service shows promise for improving outcomes among Medicare beneficiaries.  In these situations, CMS has the discretion to cover an item or service with conditions under its Coverage with Evidence Development (“CED”) authority.  If CMS agrees that CED coverage is appropriate, the sponsor then has to design a study that CMS will approve.  How CMS makes that second decision whether or not to approve a study design is often poorly understood.  On November 20, 2014, CMS released its latest guidance on CED coverage, which adds some additional clarification for interested biotech parties.

The new CMS guidance builds on its past CED approvals and typically contains several requirements for an approvable CED study:

  • Medicare beneficiaries must be enrolled in a clinical trial approved by CMS;
  • The study design must answer the questions framed by CMS in its approval;
  • The study must comply with all human subject protection regulations;
  • The study must be registered on clinicatrials.gov before any enrollment can occur (registry studies must also be listed in the Agency for Healthcare Research & Quality’s (AHRQ) Registry of Patient Registries (RoPR));
  • The study protocol must specify the method and timing of public release in either a peer-reviewed journal or in a publicly-available registry of all identified outcomes to be measured, including release of outcomes if outcomes are negative or the study is terminated early, which must be made within 12 months of the study’s primary completion date (even if the trial does not achieve its primary aim);
  • The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of the subpopulations; and
  • The study protocol must explicitly discuss how the results are or are not expected to be generalizable to affected beneficiary subpopulations.

What is new about this guidance is CMS’s focus on outcome measurements.  Two new elements stand out: first, it strongly suggests that in order to approve a CED study, there must be a comparator in a control group in order to minimize potential biases and to give CMS a better grounding to evaluate the effectiveness of the new item or service at the end of the study period.  The comparator in the control arm of the study may be a placebo or standard of care treatment.  Although CMS does refer to blinding as a technique to minimize the placebo effect, the Guidance does not address evaluating (1) the risks to Medicare beneficiaries of sham procedures, such as a spine procedure to relieve back pain as discussed in the Guidance, or (2) how to offset the disincentives for a Medicare beneficiary to enroll in a clinical trial if they know that there is a chance of receiving a sham procedure instead of treatment.

The second new element in the Guidance is CMS’s suggestion that the CED study design include interim analyses that would be shared with CMS.  Although this could potentially expedite a final NCD decision if the results are strongly positive, it may increase the burdens on the trial sponsor and could become problematic for the sponsor if the interim data is not promising and CMS in response changes its demands for data in order to make a final determination.

Although the Guidance is something less than a roadmap for biotech manufacturers and other stakeholders seeking Medicare coverage, it does provide a clearer idea of CMS’s expectations when reviewing a request for CED protocol. As in the past, interested parties are encouraged to meet with CMS’s Coverage and Analysis Group and to maintain a dialogue with the agency throughout the process, to exchange ideas and to fine-tune the proposed clinical trial in order to reach a consensus with CMS.

About the author:

Robert E. Wanerman is a member of Epstein Becker Green’s Health Care and Life Sciences practice. His practice concentrates on regulatory, reimbursement, and compliance matters affecting biotech and health care manufacturers, service providers, and investors in biotech and health care organizations. Robert has extensive experience counseling clients in matters arising under the Medicare and Medicaid programs. He can be reached at rwanerman@ebglaw.com.

This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Susan Kling Finston

At the start of a bright and shiny new year in 2015, I am thinking about my own New Years resolutions as well as one that I would wish for the BRICS and Emerging Markets specifically: to strive for an enabling and nurturing environment for R&D-intensive Micro-Small and Medium Enterprises (MSMEs).  In 2014 I was privileged to work with the Wadhwani Foundation, a non-governmental organization active in South Asia and East Asia to promote MSME entrepreneurship and innovation.  The following is adapted from an upcoming Wadhwani Foundation study:  The Innovation Blueprint:  Identifying, Adapting and Assimilating Best Practice for R&D Intensive MSMEs:

R&D-Intensive MSMEs drive innovation across sectors including information and communications technologies, social media and applications, life sciences, and many others. In India there has long been recognition of the importance of MSMEs for livelihood creation, where the MSME sector employs an estimated 80 million people, and accounts for nearly half of all industrial output. The challenges facing India’s innovative MSMEs are also common to small-scale companies in Brazil and China. In fact in some areas India leads its BRICS peers. Brazil has lagged India in developing both a Venture Capital (VC) and start-up culture. While outpacing India in the WIPO Global Innovation Index, China has been unable thus far to translate innovative capacities into successful start-up companies for creation of economic and social value. For example while China has a stronger VC sector, it continues to struggle with issues of financing for innovative SMEs. China figures prominently in the Wall Street Journal’s Billion Dollar Startup Club  though, with 10 Chinese startups now valued at over a billion dollars (USD) as compared to 2 Indian companies out of a total of 71 companies (as of January 2015).  Looking at the BRICS as a whole, we also see continuing challenges to provide adequate capital resources needed for R&D-intensive life sciences start-ups.

In OECD-level countries, by contrast, innovative MSMEs play a leading role in generation of innovative products and services through direct commercialization, co-development and/or out-licensing to larger companies.

The World Intellectual Property Organization (WIPO), has described Micro-Small-Medium Enterprises (MSMEs) as a “deep, broad, fertile forest floor that nourishes, sustains and regenerates the global economic ecosystem,” 

InnovationBlueprintSlides-FINALWithin the OECD, Israel and the United States excel at innovation and job creation through MSMEs, with a strong ‘start-up culture’ that values risk and tolerates failure. The mantra of one well-recognized US technology cluster, Silicon Valley, California, is “Fail fast, fail often.” Israel also places a high premium on individual initiative and a willingness to challenge conventional wisdom, recognizing that the only true failure is not to try something new. In this context, the Weizman institute estimates that up to 24% of leading new biopharmaceuticals include Israeli-developed technologies (see table).  Acceptability of risk increase effective mobilization of capital for MSMEs through angel investors, seed funders and venture capitalists, as well as local and  centralized sources of funding for start-up ventures.

MSMEs are empirically the most productive engines of innovative technologies, products and services, and yet in the BRICS and most emerging markets, government support and funding favors larger, established and less innovative companies. Perhaps the hardest and most important adjustment of all is attitudinal.

For 2015 then, let’s hope that policy-makers will extend MSME support across sectors and regions for inclusive growth and to truly see the innovative potential of vibrant R&D-intensive MSMEs to become the next Facebook, Google, Amgen or Celgene.

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

Patents require regular ‘maintenance’ payments to keep them in force. Because the cost of maintaining large patent portfolios can be substantial, many companies elect to abandon patents that they feel are not worth pursuing. Sometimes these patents are abandoned because they are outside a company’s focus, and in other cases they may represent markets too small for larger companies to justify targeting.

The upside of abandoned patents is that the inventions they describe enter the public domain prematurely, on abandonment rather than 20-years from filing, and they can allow outside parties to leverage the cutting-edge research from leading labs. Accordingly, some of the patents abandoned by large companies may nonetheless be very valuable for smaller enterprises.

Leveraging data I collect for DrugPatentWatch and PatentStat, I have launched a new site at PatentDrop.com that provides regular updates of patents which expired prematurely due to lack of maintenance payments, in 33 different industry sectors.

These abandoned inventions are in the public domain, and may provide opportunities for open-source projects or small and medium-sized companies to leverage the inventions which larger companies abandoned.

Biotechnology patents can be found in the biotechnology category, or by tracking individual companies, such as Agilent, DuPont, or Wyeth.