What is Intellectual Property?

Disclaimer: None of the information listed below is considered legal advice and is provided for educational purposes only.

Featured image source

Yesterday afternoon the Accelerator for Biosciences in Connecticut (ABCT) hosted a workshop on Intellectual Property. ABCT is a highly competitive educational program designed to teach Connecticut’s academics, inventors, and founders of start-ups how to be successful entrepreneurs. This workshop was part of their continuing education for the accepted start ups that were recently selected for the 2020 program.

Selected start-ups are chosen based on set of parameters that demonstrate the novelty of start-up’s mission and their capacity to transform the life sciences industry. Accepted participants attend sponsored workshops, informational webinars, and interactive exercises to learn necessary business skills to develop their products and services. Eligibility includes residence within the state of CT and expertise in science, medicine, and/or technology.

Yesterday’s workshop consisted of networking and a moderated panel discussion by ABCT alum Patrick O’Neill of Connecticut Innovation featuring, Craig Kenesky Ph.D. J.D., an associate at Wilson Sonsini Goodrich & Rosati, Tom Jarvie Ph.D., CMO and Co-Founder of Shoreline Biome, and Peter Cross M.S., Vice President of Intellectual Property at AON Risk Solutions. The general focus of the workshop was to discuss current topics regarding patents in the life sciences.  

For background there are four major areas of intellectual property

1. Patents– protect inventions. Example: U.S. Patent No. 5,901,666 defines and protects the invention of “Wearable Pet Display” that allows you to carry a small pet (e.g. hamster) on a vest or belt. The wearable habitat consists of transparent passages and pockets for feeding. 

2. Trademarks– “identifies” the source of a commercial good or service. Example: Paris Hilton was approved for the trademark “That’s Hot.” She even won a large lawsuit when Hallmark tried to use this phrase on their products.

3. Copyrights– protects the expression of works of authorship. Example: A German Chef copyrighted their carefully arranged dishes which requires that if an individual at their restaurant wants to photograph their dish before indulging, they must ask permission or be subjected to a potential lawsuit.

4. Trade Secrets– protects the know-how or technology that gives a company a “secret” competitive advantage. Examples: The Google search algorithm, the New York Times Bestseller List, Listerine, WD-40, Twinkies, McDonalds Big Mac Special Sauce, Krispy Kreme Donuts. 

Majority of life science company’s deal with patents so for the scope of this article, and based on what was discussed at yesterday’s event, I will focus on patents. 

A patent is a legal contract, issued by the government, that defines what the invention is, how to make it and how to use it, delineated by what are called “claims.”  This contract protects the invention and gives the inventor certain rights to their invention such as excluding others from making, using, or selling the invention. 

Definition: An invention is a discovery or idea that is made into a machine, product, or process.

In the life sciences this could be a reagent, an assay, or a technical process for measuring a molecule to name a few. 

There are 3 requirements for obtaining a patent for an invention

-The invention must have at least one utility  

-The invention must be novel

-The invention must be nonobvious (over what is already known, referred to as “prior art”)

With regards to “prior art” obtaining patents in the life sciences can be tricky. Prior art refers to publicly available knowledge of the invention such as a published abstract, journal article, or a social media post. Basically, anything searchable by the general public. This does not include a submission to the FDA or grant submission. However, once a grant is awarded and becomes available online then it becomes prior art and a patent cannot be granted (unless you applied for a provisional patent). This is especially tricky when it comes to the Freedom of Information Act (5 U.S.C. § 552) which means that unreleased information or documents controlled by the U.S. government can be disclosed/released upon a request to do so. 

So, you have an idea and you want to file a patent application… before you do that you shuld be aware of 3 exceptions to patent eligibility as defined by the United States Code title 35 section 101 (35 U.S.C. § 101). This is one point of contention in the field of law as well as life science.

The law states that a patent cannot be obtained on a law of nature, natural phenomena, or abstract idea.

The subject of “patent eligibility” has been a hot topic since two instrumental cases challenged and changed the system, the Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2011-2012) and Alice Corp. v. CLS Bank International (2014) court cases. Recall the definition of invention. This classic definition defines criteria of a “thing” and the eligibility for obtaining a patent must not be a natural phenomena or abstract idea. However, this definition can revoke patent eligibility when claims describe a new process for measuring a drug effectiveness or a novel computational strategy for assessing financial risk.

An example of the first is demonstrated profoundly by the Mayo Collaborative Services v. Prometheus Laboratories court case. The Supreme Court denied eligibility to Mayo’s patent (US patent 6355623B2) because it claimed a law of nature. The claims described how to measure a metabolite of a drug based on an individual’s metabolism. In comparison, the Alice corp. court case challenged patents that comprised abstract ideas. Specifically, this patent’s claims described a computational method for mitigating settlement risk. The court determined Alice Corp.’s patent ineligible because the patent’s claims were directed towards an abstract entity: that implementing the calculation through a computer was not sufficient enough to transform the abstract entity into “something more” that could be patented. 

The outcomes of both of these cases established the 2-step Mayo/Alice test process for determining patent eligibility. 

Step 1- Is the patent claim in question directed towards a law of nature, a natural phenomenon, or an abstract idea? If no- pass or if yes- go to step 2

Step 2- Does the claim include additional elements that add “significantly more” or transform the invention into a patented product? If no-claim is ineligible or if yes- pass 

A great example of how a patent of an abstract idea was patented because it included claims that added “significantly more”. In the case, Diamond, Commissioner of Patents and Trademarks v. Diehr et al. (1981), the court ruled in favor of Diamond for their use of the Arrhenius equation to determine an effective and accurate way to process raw uncured synthetic rubber (US patent 4,344,142). Before this invention rubber making required continuous operator self-checking of temperatures and self-determining when the rubber was finished. This technique resulted in poor rubber construction due to the loss of heat every time the rubber container was opened for a temperature reading. Using the Arrhenius equation, Diamond established a revolutionary method for making rubber that was independent of an operator and he protected this process with a patent, not the mathematical equation. His invention revolutionized the field. 

As we work at the bench, we come across many specialized technologies that allow us to achieve our goals in science and our careers as a whole. One day you might come up with an idea that may help the process of scientific discovery, standardize the way we measure biological phenomena, discover a new way of targeting a disease process, or something entirely new and unexpected. If you do, great! You should protect your idea and consider forming a company to develop your product and more in the future. 

If you have an idea you think could be commercialized and you want to get involved with ABCT you should sign up for their newsletter. Visit their website to learn more about their program and look for information regarding the next round of applications  https://abct.co

To learn about the life Science company’s in the area, reach out or attend events hosted by the UConn Technology Incubator Program. BioCT is another great resource for connecting with start-up companies, entrepreneurs, and other professionals in the bioscience field within Connecticut. 

If you are interested in intellectual property or patents refer to the US Patent and Trademark Office https://www.uspto.gov/patent

Other websites with additional information:

https://www.patentdocs.org

https://patentlyo.com

https://www.essentialpatentblog.com

Medical Science Liaison

Do you love being at the front of scientific innovation? Do you love to share and explain science that you are passionate about to people in a digestible manner? Does the idea of traveling to new places and meeting new people appeal to you? 

Perhaps, you should consider becoming a Medical Science Liaison. 

Last week, the Academic and Industry Opportunities Group (AIOG) hosted Dr. Jellerette-Nolan Associate Director, Medical Science Liaison and Training Reproductive/Women’s Health at Ferring Pharmaceuticals. Ferring is a privately-owned biopharmaceutical company that develops drugs and technologies geared towards women’s health.

Dr. Jellerette-Nolan is an accomplished scientist with more than a decade’s worth of experience in clinical research and the field of embryology. She received her Doctor of Philosophy (Ph.D.) in Reproductive Physiology from the University of Massachusetts Amherst. After which, she worked as an Embryologist in the research and development department at GTC Biotherapeutics. With some industry experience, she decided to transition back to academia as an Assistant Professor of Research at the Baystate Medical Center. After several years conducting clinical research she made her way to the University of Connecticut as a Senior Embryologist Clinical Scientist at the Center for Advanced Reproductive Services. However, over the course of her career her dedication to networking eventually landed her an opportunity to change paths and disseminate her expertise as a Medical Science Liaison.  

What is a MSL: Medical Science Liasions (MSL) work within the medical affairs division of a company invested in pharmaceuticals, biotechnology, medical devices, or other health-related technologies (separate from sales and commercial divisions). MSLs are the “external face” of a pharmaceutical company. Typically, MSLs specialize on particular health-related topic (i.e. reproductive health, oncology, neuroscience) associated with the products the company has either acquired or formulated. They provide medical education and technical support for a company’s products. In addition, MSL’s may collaborate on different projects as new products are researched and developed. Depending on the size of a company, there may be several MSLs that cover similar or varying therapeutic topics. 

Today Dr. Jellerette-Nolan travels the United States and is responsible for a small team of MSLs comprised of medical health professionals and scientists that disseminate information about the latest technologies supported by Ferring Pharmaceuticals.

Characteristics of the MSL 

  1. heavy travel/ field work 
  2. Autonomous work environment 
  3. Flexible 
  4. Expert in a field(s) of Biomedical Science 

MSL positions are great for highly organized people with the stellar ability to micromanage their own time and accomplish a lot in an efficient manner. With a large amount of time devoted to working in the field, MSLs must be able to accomplish tasks on the go (i.e. on an airplane between appointments). Typically, MSL positions are advertised by topic (i.e. reproductive medicine) and by region. Which means, if you are interested in a position outside your realm of expertise, you will have to study hard and possibly relocate depending on the position. Don’t worry, if you are hired, the company will probably give you some time to learn the material but there will be a test! And most likely several tests to make sure you’ve mastered the material and can keep up with new information over time. 

If you are interested in becoming a MSL, here is a list of things a recruiter or your future boss might be looking for:

-PhD in Biomedical Sciences or MD

-Experience in clinical research

-Experience in research and development

-Outgoing personality 

-Networking experience (attendance of scientific conferences, participation in professional societies)

-Interpersonal skills (highly stressed)

-Effective oral communication 

-Data dissemination 

-Enthusiasm for science and technology 

-Engaging during group presentation and one-on-one conversations 

Stay tuned for future events including our Annual Networking Event held at UConn Health April 23rd 2020.

AIOG Moving into the Next Decade

My team of post-docs and students at AIOG are so happy to continue to grow our group, and help others figure out what kind of career is right for them. I thought I would reach out and let everybody know what we have coming up in the new year!

In January, we have two spectacular events. The first is with a Massachusetts based Medical Science Liaison who works in reproductive medicine and maternal health at Ferring Pharmaceuticals (stay tuned for our write-up on MSLs). Following that, we have recent Yale double degree graduate Levi Smith who will talk about how you can make yourself marketable to world of biotech.

After that, we plan on bringing more information about careers in medical writing, industry postdocs, teaching, regulatory positions, and science policy. Our local followers should stay tuned for emails regarding upcoming events.

Lastly, I would like to announce our 3rd annual networking event! We are excited to grow our networking event this year, featuring over 30 companies from CT, and students & postdocs from multiple CT universities. We are excited to have Dawn Hocevar, president of BioCT be our keynote speaker for this event!

Stay tuned for more articles! Follow our page and keep in contact with us. We can always be reached at acadindog.ct@gmail.com

Careers in Venture Development

Mostafa Analoui, Ph.D. is the Executive Director of Venture Development and the Technology Innovation Project at UConn. He is also an adjunct professor of Biomedical Engineering. 

On November 18, 2019, Dr. Mostafa Analoui met with students and post-docs during an informational seminar at UConn Heath. His seminar came with a wealth of knowledge and experience which he shared regarding the reality of entrepreneurship and innovation within the field of biomedical science.

Before working in venture development, Dr. Analoui was also a professor, academic entrepreneur, successful startup founder, corporate research and development leader, and an investment manager. This career trajectory led him to experience any facets of biomedical innovation and product development to which he shared some of his insights with UConn Health students. 

Dr. Analoui explained some of the myths and realities of developing a new drug or medical device and the challenges of working in the biomedical sciences field. He spoke on some of the pros and cons of working in the biomedical field such as, identifying investors, understanding the United States healthcare market, and working through the pre-clinical and clinical trial phases of research and development. 

Key take-aways from the seminar:

First, innovation and entrepreneurship is not always a linear journey.

Instead, small steps lead to increased innovation over time. Dr. Annaloui compared biomedical product development to the high jump. Although it might look like the high jump Olympic record gradually increased over time, there were actually new innovations in jump style and approach along the way that made this possible. From the scissors method, to the western roll, to the straddle, and finally the Fosbury flop, each new method allowed for a slightly better high jump. Product development works the same way. Small steps over time lead to innovation and improvement, but this is not a continuous journey. There are plenty of flops and failures along the way that lead to eventual success.

Second, Dr. Analoui mentioned that the first product on the market will not necessarily become the lead.

He brought up the example of statins, a class of drugs used to lower cholesterol. Mevacor, also known as Lovastatin, first entered the market in 1987. However, the statin Lipitor is the best-selling drug of all time and entered the market in ten years later in 1997. Although some believe that being the first to market might give you an advantage, it does not guarantee success. Instead, having a quality product, good investors, and a solid marketing strategy might help you more. 

Third, Dr. Analoui addressed the large time and money expenditure that it takes to bring a product to market, and that there is a high risk of failure.

It is important to find investors and realize that it takes about one billion dollars to develop a new molecular entity for a new target. In comparison, it takes a fraction of that, about $100,000, to develop an app. Another point Dr. Analoui hit on was that even if you invest money and time into a product, there is still a very high risk of failure. First, it takes years of research to develop a new drug target. Then, only 5 in 5000 drugs that enter pre-clinical testing enter human trials. Of that, usually only 1 of these 5 drugs will be approved by the FDA. There is high reward associated with drug or medical device innovation, but having a realistic mindset about product development is crucial. 

On a final note, Dr. Analoui’s said that there are many ways to get a product into development or to become an entrepreneur. To do so takes a diverse team with varied backgrounds to launch a successful product and the best way to enter this field is to be passionate about your work, have an innovative idea, a business plan, and a realistic mindset about the challenges todays biomedical entrepreneurs face. 

This article was written by Dominique Martin

I am currently a first year PhD student in the Biomedical Science program at UConn Health in Farmington, CT. My research involves understanding metabolic changes associated with aging. I originally thought that I wanted to be a veterinarian. However, after getting involved in undergraduate research, I found that I was more drawn to working in a lab and conducting exciting new experiments. Although I just started my PhD, I am interested in learning about the many opportunities within the biomedical science field.

Grit is a predictor of success

Angela Lee Duckworth, UPenn, speaks on her career experiences teaching middle school math in a New York public school and how she learned IQ is not a fair assessment of intelligence. She explains that success can be predicted by a very different factor -grit.

TED: Ideas worth spreading

Angela Duckworth, the psychologist and researcher, defines grit as a passion and perseverance for long term and meaningful goals.  

PhD students most certainly have grit- they choose to dedicate 3+ years to answering a specific question and then possibly several more years developing an individualized research plan.

However, how many students went to college and decided to go to graduate school just to be greeted by the reality of academia and a level of uncertainty for their future?

During graduate school or your postdoctoral fellowship, take the time to consider what goals are meaningful to you. Redefining your path is one step closer to finding the career path for you. Don’t let your future be a jumbled mess of a cookie cutter academic plan just because you have been in school for the majority of your life. Use your grit to give yourself direction and pave your own path towards success. You most certainly have the tools. You can do anything.

Get it done.

Insights to a career in SciComm

Geoff McGrane, MBA and Raeka Ayar Ph.D. from the New York Stem Cell Foundation visit UConn Health to discuss careers in non-profit institutions for Biomedical Ph.D. students.

On Monday November 4th 2019 the Academic-Industry Opportunities Group (AIOG) co-founded by Robert Pijewski and Giulia Vigone Ph.D. hosted a Scientific Communications (aka SciComm) seminar for UConn Biomedical Sciences students. Representatives from the New York Stem Cell Foundation came to give interactive presentations on their career trajectory in SciComm. 

The talk started with some good advice “Why limit yourself to contributing to science in only 1 way.” There are many ways trained scientists can help science progress. With regards to scientific communication, sharing your findings out in the world is part of the package deal. 

Scientific communication takes several forms, from writing manuscripts to presenting in front of various audiences, and finally, writing proposals for science funding. Scientific communication acts as a bridge between the scientific and medical community to the lay audiences which contribute to the funding of research as well as policies that help promote change. 

Scientific communication uses creative measures to inspire collaborations and solve problems. 

Goals of SciComm: Filling the gaps in knowledge and understanding of scientific topics that may exist between scientists within a field as well as between fields. Sci Comm also highlights important works in an easily digestible manner which is important for obtaining funding for disease research or advocating for science policy’s such as drug prescription rates. 

Non-scientists may mischaracterize information which can lead to public mistrust as well as affect funding for scientific research. Scientists are essential to this dialog between audiences. By writing short articles for different venues such as LinkedIn, the conversation.com, and other websites allows experts to share their knowledge on various topics as well as to correct potential inaccurate portrayals of information that may be miscommunicated by untrained individuals. 

One of the goals of SciComm is to be accurate and provide understanding in a clear and concise way without using scientific jargon or data heavy analysis. 

Scientific communication also has an advocacy component which helps increase the visibility of scientific societies such as not for profit institutions, as well as to increase the awareness of various types of research (i.e. rare diseases or breakthroughs in drug treatments). Scientific funding relies on effective communication. Often ideas can be lost to the wind because they were not described in a meaningful or effective manner. You could have the greatest idea in the world but if you cannot describe it and pull it from an abstract entity than your greatest thing since sliced bread will remain a thought in your head. 

As a PhD or graduate student…

Your experience preparing manuscripts, editing, and reviewing papers is excellent training for a career in SciComm. In addition, you’ve essentially been communicating scientific findings within your laboratory, institution, and greater scientific community for majority of your scientific career.

Some ways to improve your current skills in SciComm

-3-minute thesis 

-Elevator pitch competition

-Data Blitzes

-Writing centers/publicity for your academic institution 

-Find a society you feel passionate about and volunteer as an advocate

Ways to showcase SciComm

-newsletters (online or print)

-social media (LinkedIn, the Conversation.com etc.).

-press releases

-personal or professional blogs (example websites).

-websites

Social media can be a bigger asset to your career than you think. For one, social media can help you build a broad audience of viewership. Social media is an outstanding platform for networking or learning about new fields which may lead to collaboration and potential career opportunities. 

Social media also allows members to promote their achievements, policy activities, and journals. It is a go-to source of material for individuals as well as societies for providing useful information. Like most apps, social media sites are trigger-points for accessing hot topics and keeping up to date with various fields with a tap of your finger. 

If you are interested…

Reach out to your public relations officers for your society, or an online newsletter, get active on social media, or start your own blog. First most, choosing one of these mechanisms will enable you to find your voice and identify topics that interest you the most. Second, build your network by attending conferences, joining online communities, or local events. Third, talk to people in the field and conduct “informational interviews.”

Find a career mentor that is not directly connected to your day-job. Everyone loves to talk about their journey. Some people even like to give advice on what to or what not to do. Use them as a soundboard to talk through your career checkpoints and to support you on your journey. 

If you don’t know what you want to do, then try making a list of things you like in your day job and what you don’t like in your day job. With this list start reading job descriptions to identify positions that may fit your needs, your expertise, but more importantly, the kind of job environment you will thrive the most in. Some of us prefer to collaborate and function among a large network whereas other people like to go to work and put their head down and get the pipetting done. Choose introspection and identify what works best for you. 

Take career development courses, there are free ones online and sometimes (New England .. writers…) societies will have them for cheaper for members. 

Take aways from the seminar:

-No 2 people in science have the same journey. 

-The advice your boss gives you about YOUR career may only pertain to the four walls of your laboratory

-Seek additional advice from people who have trod down new and different paths

-Even if a job interview doesn’t pan out for you, keep your communication line open and don’t burn bridges. You never know if your objectives will align one day and you will need each other as a contact. 

-Know when it is time to move on and accept change 

-leaving the lab is not a failure it’s just a different path to progressing science. 

-Be brave, be you. 

-Know your talents, you have more to offer than just standing at the bench. 

Introduce Yourself: Meet Rob: co-founder of AIOG

My name is Robert Pijewski and I am the co-founder of the Academia-Industry Opportunities Group (AIOG). Read more about me below!

Hey all, I’m Rob. I’ve never written a blog post before so let’s give this a try. I am currently a 4th year PhD candidate in Biomedical Science in the Department of Neuroscience at UConn Health in Farmington, CT. My research is on the role of cellular aging in neurodegenerative disease and healthy aging. However, my research is not the reason why I am here. During my studies, I found that there was a lack of education regarding careers beyond the traditional academic setting, i.e. becoming a tenure-track professor at a research institution. I’ve also heard dozens of PhD candidates just sayin “I think I am more of an industry person”, but my question to them is “what kind of industry?”. With that question in mind, I started a group…I did a thing. The sole purpose of the group is to provide education to students about the vast number and types of careers outside of academia. As a group, we are breaking the phrase “alternative careers” because in fact, these are the majority of careers and academia is the minority.

When I am not in the lab or writing blog posts (see what I did there), I find myself exploring new recipes in the kitchen as well as working out (have to stay healthy if I am preaching about cellular aging and disease!). As I continue to grow as a person, I will hopefully continue to update my introduction section. I hope you all read the content that we post!

Translate »