Guest post by Konstantin Linnik, Ph.D., a partner in the Boston office of Nutter McClennen & Fish LLP and a co-chair or the Legal & Regulatory Working Group at MassBio and Isaac Hubner, Ph.D. a senior associate with the firm.
Whether you are dealing with a “simple” confidentiality agreement, a consulting agreement, or a multi-billion-dollar license, legal provisions are often a source of misunderstanding, confusion and frustration.
Thinking about consulting for a local biotech, starting a new job or even a new venture? Brace yourself for a barrage of legal implications you may not have thought existed.
On January 28, 2016, MassBio will host an expert panel provocatively entitled “Decoding Legal Mumbo-Jumbo.” The MassBio panel is composed of lawyers as well as non-lawyers including a business development executive. The goal of the panel is to help the audience learn to spot legal pitfalls and opportunities that are so often overlooked in real-life business settings.
The story of Dr. Joseph Grocela, a urologist at MGH who moonlighted as a medical device entrepreneur, serves as a good example of how misunderstanding a basic legal provision in your employment contract may lead to dashed dreams and a lengthy legal dispute to boot. Read the rest of this entry
By: Michael Cohen, Founding Partner, Cohen Partners
Imagine preheating the fresh air drawn in on a steamy July afternoon because your smart building thinks it’s below zero outside.
That’s what happened recently at a Genzyme facility in Massachusetts, but the people working in the offices, labs and biomanufacturing suites didn’t realize there was a problem because the air-cooling system went into overdrive and chilled the preheated air before distributing it throughout the building.
“Simultaneous heating and cooling is a big issue,” said Steven P. Driver Ph.D., Energy Program Manager at Genzyme. “Our biggest offenders are green buildings. When things go out of calibration, we go through a lot more energy.”
Driver was a panelist at the MassBio Forum, Selling Sustainability – How You Can Incorporate Efficient Practices Now on October 28, 2015 that focused on sustainability programs and energy efficiency best-practices for life sciences research laboratories and biotech manufacturing companies. Read the rest of this entry
Guest post by Konstantin Linnik, Ph.D., a partner in the Boston office of Nutter McClennen & Fish LLP, and Marc Chateney-LaPointe, Ph.D. a summer associate with the firm.
On July 17, 2014, MassBio will host an expert panel “Best Practices in Protecting and Exploiting Intellectual Property.” Among other topics, the panel will discuss the new US patent system, the first inventor to file (“FITF”) regime that took effect a little over a year ago as part of the patent reform law known as American Invents Act (AIA). Under the new law, the first inventor to file at the Patent Office wins.
Before AIA, our patent system operated under “first-to-invent” rules for well over two centuries. Under the old system the initial inventor had rights to the patent regardless of whether he was the person first to file an application with the Patent Office. If a subsequent inventor happened to submit a patent application before the first inventor, the latter could bring an interference proceeding at the Patent Office. Here, the first inventor must show that he was the first to conceive of the claimed invention and that he worked diligently to reduce the invention to practice. Both of these facts can be proven by evidence from a laboratory. Therefore, it was standard practice for each inventor to keep a laboratory notebook that provides a permanent record of every planned and executed experiment. Notebooks that were regularly dated, reviewed, signed, and then countersigned by a non-inventor witness, served as evidence of prior conception under the old system.
Many scientists assume that recent changes to our patent system rendered the signing of lab notebooks unnecessary. Not so! Even after the AIA lab notebooks remain as important as ever. Here is why.
Where the invention is allegedly disclosed to a third party, for example, in the course of a scientific collaboration, the third party might file a separate patent application on that invention before the original inventor. The inventor may be able to establish that the later filing applicant derived the invention from his disclosure by instituting a so-called derivation proceeding at the Patent Office, as defined in 35 U.S.C. § 135. A petition under this section must “set forth with particularity the basis for finding that an inventor named in an earlier application derived the claimed invention” as well as state that this earlier application was filed without authorization. Additionally, this petition “shall be supported by substantial evidence” showing that the earlier-filed application was derived from the petitioner. (A further limitation is that the derivation petition must be filed within one year from the date of the first publication of a claim to the allegedly derived invention.)
Guest Post by Craig Dunbar, VP, Product Development, Blend Therapeutics
Big-pharma has long realized the unique value of inhaled therapies to treat chronic diseases by local delivery to the lungs. GlaxoSmithKline’s Advair™ Diskus is in a category on its own in the pharmaceutical industry, having lost US patent protection four years ago while increasing worldwide sales to over $8 billion in 2013. Teva and Sandoz have both admitted defeat in bringing a generic Advair™ on to the US market due to technical complexity and insurmountable regulatory barriers.
2006, the same year that Advair™ was approved, saw the first approval of a pulmonary insulin product, Exubera™, developed by Nektar and Pfizer. This marked a pinnacle of a decade long pursuit of new pulmonary drug development technologies to enable systemic delivery of proteins, with Pfizer having invested $2.8 billion in Exubera™, and competitors Lilly/Alkermes and NovoNordisk/Aradigm following suite with alternative technologies. However, Exubera was dogged by safety concerns, FDA recommending regular lung exams, a 6 month launch delay due to manufacturing difficulties, and poor acceptance by patients, physicians and payers. Just one year after launch the product was pulled from the market, marking the collapse of the pulmonary insulin market.
So where does this leave pulmonary drug delivery today? Mannkind recently (Apr 2, 2014) received an approval recommendation by FDAs advisory committee for Afrezza®, a pulmonary insulin product that improves glycemic control in type 1 and 2 diabetics, opening the way to approval in July of 2014. The boom and bust of the 90s decanted the more robust pulmonary technologies based on particle engineering and simple delivery devices, with Civitas continuing to develop Alkermes’ large porous particle technology for the treatment of Parkinson’s disease, and Pulmatrix developing novel particle engineering technologies for asthma. Further, new drugs, technologies, and clinical development strategies continue to emerge from both big pharma and small biotechs, recognizing the unique opportunities, and challenges, associated with inhaled therapeutics.
On April 29th, from 8-10am, MassBio is hosting a Forum on this important topic entitled Innovation & New Opportunities in Pulmonary Drug Delivery for Local & Systemic Treatment of Chronic Diseases.
Guest Post by Maude Tessier, Assistant Director, Business Development and Strategic Initiatives, TIDO of Boston Children’s Hospital
According to Ernst and Young, Europe represents about 30% of the total pharmaceutical sales worldwide, second only to North America which represents 40%. We’ve all read news pieces about how UK’s N.I.C.E. is sometimes not very “nice” to biotech and pharma companies, but how well do you know this territory’s current, as well as future, challenges and opportunities? I believe that the US has a lot to learn about what’s going on in Europe and these trends happening over the ocean affect us here in Boston. As Asian and Emerging markets rise, we seem to hear less about Europe. However, with a strong academic base, highly skilled workforce, and a number of government incentives, Europe continues to be an important territory in any biopharmaceutical company strategy as a market for products and as a venue for collaboration at all stages of drug development.
The second part of the “Around the World in 120 Days” Forum series on April 10th will introduce key concepts of performing business in Europe and will provide an opportunity to reflect on how this market is evolving. We have a stellar lineup of international presenters and panelists (folks are flying in from the U.K. and from Denmark!), led by moderator Mark Leuchtenberger, CEO of Acusphere and member of MassBio’s Board of Directors. We will discuss topics such as:
- What is the intrinsic value of the EU commercial opportunity? How has this relative value increased, decreased, or remained the same over the last ten years?
- What are the greatest potential opportunities and pitfalls that companies face when attempting to extend their operations into the EU?
- What are the factors that influence corporate development decisions to invest in EU at each stage?
- What are the advantages and disadvantages of partnering/collaborating with a European company?
Please join us as knowledgeable executives tackle these subjects and, importantly, share memorable stories from their own experiences. You’ll also get the chance to interact with several foreign delegations that will be in attendance. Kick start your European strategy with MassBio!
About the author: Maude Tessier is Assistant Director, Business Development and Strategic Initiatives, TIDO of Boston Children’s Hospital. Maude joined TIDO of Boston Children’s Hospital in 2008. Maude’s role is to initiate, develop and realize partnerships and alliances between Boston Children’s and industry partners that create value at all stages of development, and including pre-clinical and clinical investigation.