Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology & Hematology

Posts from the ‘Intellectual Property’ category

Readers don’t need Biotech Strategy Blog to tell them that Chimeric Antigen Receptor (CAR) T cell therapy (CAR-T), along with Checkpoint blockade, is one of the hottest areas of cancer drug development.

The last two days have seen pre #JPM15 deal activity with Kite Pharmaceuticals ($KITE) announcing a commercial collaboration with Amgen ($AMGN), which is not surprising given several of the Kite senior management team previously worked at the company.

Meanwhile, both Seattle based Juno Therapeutics ($JUNO) and Houston based Bellicum Pharmaceuticals ($BLCM) had successful IPO’s at the end of 2014. Interestingly, Bellicum are initially focusing most of their IPO funds, not on bringing their CAR-T to market, but on a novel cell therapy post stem cell transplant that aims to lower graft versus host disease (GvHD). GvHD is something we’ve been writing about regularly here!

Just this morning we’ve seen yet more CAR-T activity, with European Cardio3Biosciences (Euronext Brussels and Paris: CARD) acquiring the CAR-T technology of Oncyte (the oncology division of privately-held U.S. biotechnology company Celdara Medical).

There’s certainly a lot of activity in the CAR-T space and I expect we will hear more at next week’s JP Morgan Healthcare conference in San Francisco (#JPM15). One player in the CAR-T space who has not been gaining as much attention, and one that I think should not be dismissed, is Paris based Cellectis (Alternext: ALCLS.PA), who struck deals with both Servier and Pfizer last year. In June, BSB went to Paris and interviewed Chairman and CEO André Choulika, PhD and CSO Philippe Duchateau, PhD. At the recent American Society of Hematology (ASH) annual meeting in San Francisco, Julianne Smith, PhD (pictured below), Vice President CART Development at Cellectis, gave an in-depth interview to BSB. Dr Julianne Smith Cellectis ASH 2014 Interview Some key questions to address here are what are some of the important milestones for Cellectis in 2015 and and what makes the Cellectis CAR-T approach different from other companies in this space? Update Nov 7: This post now has two updates relating to the important news that came out after this post was published concerning the issuance by the USPTO of a gene editing patent that covers Cellectis’ intellectual property.  Subscribers can login to read more or you can purchase access by clicking on the blue icon below.

One of the benefits of attending the American Society of Hematology (ASH) annual meeting that finished earlier this week in New Orleans is the opportunity to talk to experts who are at the forefront of their field.

Picture of Dr Renier Brentjens, Director of Cell Therapeutics, Memorial Sloan-Kettering Cancer Center

Picture Credit: MSKCC

Renier Brentjens, MD PhD,  is Director of Cell Therapeutics at Memorial Sloan-Kettering Cancer Center (MSKCC) and one of the scientific founders of Juno Therapeutics (Juno), a start-up company that recently raised $120M in Series A financing.

Luke Timmerman wrote about the company launch on Xconomy and you can read the Dec 4 press release from Juno here.

juno-therapeuticsLike a modern day David versus Goliath, Juno Therapeutics has set itself up to compete with Novartis in the exciting world of chimeric antigen receptor (CAR) modified T cell therapy that has already shown dramatic results in pediatric and adult acute lymphoblastic leukemia (ALL).

A lot of media attention has focused on the Novartis collaboration with the University of Pennsylvania to develop a novel therapy using CAR modified T cells (CART-19/CTL019) that can be directed against tumor cells that express the CD19 antigen.

The potential promise of CAR modified T cell therapies has already led to a flurry of law suits between the St Jude Children’s Hospital (St Jude) and University of Pennyslvania (U Penn).

According to the Daily Pennsylvanian, U Penn are seeking to invalidate a St Jude patent while St Jude have claimed violations of the terms of a material transfer agreement that allowed access by Carl June (U Penn) to work done by Dario Campana (St Jude).

It will be interesting to see what intellectual property Novartis actually owns and whether they did a thorough enough due diligence prior to licensing the rights to CTL019 from U Penn.

Subscribers to premium content can login to read my interview with Renier Brentjens and listen to audio excerpts from what was a fascinating conversation about a new immunotherapy that has the potential to revolutionize hematology.

Today is the first “Innovation Day” at Children’s Hospital Boston. For those, like me, who can’t be in Boston for it, you can follow on Twitter using the hashtag #iday or watch online via live streaming.

Children's Hospital Boston Innovation Acceleration ProgramI’m impressed that the hospital has an Innovation Acceleration Program focused on supporting “clinical care that impacts patients around the world.

I think this event is a really great way to showcase some of the interesting research and collaboration that is taking place in the hospital in the field of device development, healthcare IT and process innovation.

The program starts at 1.00pm EST. On the Agenda are a few talks that caught my imagination:

Does my baby have a “flat head”? Using the web and digital photos to triage visits to the doctor’s office,  Joseph R. Madsen, MD

Pediatric Vision Scanner: A handheld device that diagnoses vision problems in preschoolers,  David Hunter, MD, PhD

New directions in drug delivery: A contact lens that dispenses medication, Dan Kohane, MD, PhD

The Children’s Hospital Boston science and innovation blog (Vector), which is well worth reading, also has a preview of their Innovation Day.

Given the ease and low cost with which events can be webcast or live streamed, and the potential to reach a global audience, I hope that other institutions will follow Children’s Hospital Boston and showcase their innovation in this way.

Good luck to all at Children’s with your first Innovation Day!

Richard Hsu (@hsutubeesq), a Silicon Vally technology lawyer and partner at King & Spalding has a new blog that I’d like to recommend.

Named “The One Page Blog”, it aims to showcase Richard’s knowledge of IP and technology law using one page posts. Most of the posts have a downloadable PDF with a useful framework or summary. A picture tells a thousand words.

I particularly like Richard’s recent post on how to analyze a confidentiality agreement. The model Richard proposes will be useful to lawyers who are not IP-experts or those who need to talk to their lawyers about some of the issues that should be considered.

The challenge I find with a non-disclosure or confidentiality agreement is always one of negotiating an agreement that is fair and reasonable to both parties. Typically the boilerplate I receive from biotechnology and pharmaceutical companies is far too much in their favor. Redlining and negotiation then follows!

Richard’s blog also has a 48 second video entitled “making my own magnetic rubik’s cube.” It is excellent and a standard I aspire to as I seek to do more video blog posts:

I look forward to more posts and video from the “The One Page Blog.”


I am excited to be attending, for the first time, the Biotechnology Industry Organization (BIO) international convention that takes place in Washington DC in just over a week’s time from Monday June 27 to Thursday, June 30th.

This meeting has something for everyone interested in the biotechnology industry whether it be deal making, partnering, licensing, drug discovery or personalized medicine. There are 16 specialized tracks where industry experts provide insight and best practices.

In addition, there are numerous networking and social events plus an exhibit hall that showcases the world’s biotech regions and how they are promoting innovation.

At meetings where there are parallel sessions, I apply “the law of two feet” (thanks to Podcamp for this) that says if you are not getting what you want from the session, it’s OK to walk out and go to another one.

My top 10 sessions at BIO reflect my personal interests in innovation, science and new product development:

Tuesday June 28

  • How will we afford Personalized Medicines?
  • The Biomarkers Consortium: Facilitating the Development and Qualification of Biological Markers
  • Personalized Oncology: The emergence of Personalized Medicine Strategies in Oncology Clinical Development and Deal Making
  • Navigating the New Law on Licensing Biosimilars

Wednesday June 29

  • Lessons from a Mature Public-Private Partnership. The Alzheimer’s Disease Neuroimaging Initiative
  • Emerging Markets. The Future of Growth for Biologics?
  • The Role of Imaging Biomarkers in Early Phase CNS Drug Development
  • The Promise of MicroRNA-based Therapeutics in Cancer

Thursday Jun 30

  • After the Fall. Venture Capital and the Biotech Funding Landscape
  • Regulatory Issues for Tissue Engineered Products

If you have plans to be at BIO 2011 do say hello after one of the sessions or receptions. You can reach me at the meeting via twitter (@3NT).  See you in DC!

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That is the interesting question that struck me after reading Sam Kean’s informative article in the February 4 edition of Science.  Ten years on from the sequencing of the Human Genome, the patenting of human genetic information presents unique challenges at the interface of science, law and innovation.

Researchers have obtained patents for isolating different sections of DNA that occur naturally in our bodies.  Whether this should be permitted is still open to debate. Currently, diagnostic companies who want to launch a new cancer test face the challenge that patents now cover many genes.

The Science article cites start-up Foundation Medicine in Cambridge, MA who estimated the cost of investigating possible patent infringement for a new diagnostic test at $35M, a cost that exceeded the company’s $25M of VC funding.

Add in the costs of any royalties or licensing fees and the issue of prior patents is now a nightmare for any diagnostics company.  It is simply not practical to license every gene that may be implicated in a multifactorial disease such as diabetes.  Pre-existing patents have become a barrier to market entry.

As the Science article reports, gene patents cover not only very small snips of DNA, as short as 15 nucleotides, but can prohibit the sequencing of associated DNA. Companies such as 23andMe that sequence an individual’s genome to test for the presence of certain genes may be violating patent rights of others.

What’s more so called “method” patents cover the linking of a gene sequence with a specific medical condition.

As advances in personalized medicine continue, there is a need to balance the competing interests of protecting scientific discovery and rewarding innovation, while at the same time allowing access to human genetic information that many think should be “free to all men and reserved exclusively to none.” Quotation from Bilski v. Kappos, 130 S.Ct. 3218, 3225 (2010)

A law suit currently on appeal to the US Court of Appeals for the Federal Circuit may lead to a change in the current practices of the US Patent & Trademark Office.  The American Association of Pathologists and others have challenged several patents relating to the breast cancer genes BRCA1 and BRAC2 held by Myriad Genetics and the University of Utah Research Foundation.

BRCA1 and BRCA2 genes are associated with an increased risk of breast and ovarian cancer.  The US district court for the Southern District of New York in a surprise decision by Judge Robert Sweet, invalidated Myriad’s patents.  The New York Times article about the case has a link to the Judge’s 156 page opinion.  The decision that isolated but otherwise unaltered DNA should not be patentable is now being appealed by Myriad.

In their legal brief, arguing for the decision to be upheld, the United States Government states:

“The fact that a particular segment of the human genome codes for the BRCA1 protein in a human cell, for example, rather than for adrenaline or insulin or nothing at all, is not within the power of science to alter. Such basic natural relationships may not be the subject of a patent.”

If the District Court’s decision is upheld on appeal, it would represent a fundamental policy shift on what patents can be obtained for human genetic information. Such a decision would prevent Myriad from charging royalties and exclusivity for the genetic testing of BRCA1 and potentially invalidate similar types of patents. Depending on your point of view this will either harm the biotechnology industry or increase the market opportunities.

Given the stakes involved, it is likely the Myriad case will end up being considered by the United States Supreme Court, and what they may decide is anyone’s guess.

To read more in-depth analysis about the Myriad case and the legal issues involved with the patenting of genomic information, I strongly recommend the “Genomics Law Report”, a blog written by Dan Vorhaus and others.

Ten years after the human genome was sequenced we are still working out the intellectual property rights. The question as to whether companies should be allowed to patent unaltered human genes is one that will be answered in the not too distant future.

I will be at WordCamp Phoenix tomorrow, along with 650 other attendees, for what is set to be an exciting meeting. Not only is it a great opportunity to escape the lousy New Jersey weather, but the meeting program is awesome.

I’m looking forward to learning from WordPress experts and enthusiasts about how I can improve this blog, its design, marketing and functionality. Saturday’s session schedule can be found here.  I have to say the volunteers who set up this meeting have done a great job!!

What’s more, I will be giving a lightning talk (20 slides in 5 minutes) on how to submit a takedown notice under the Digital Millennium Copyright Act (DMCA).  This is my first time doing an Ignite style lightning talk, and the first time speaking before 650 people, so I’m a bit nervous, but life is about new challenges and opportunities.  Should be fun, and if all fails there’s the after party to look forward to!!

I’m looking forward to meeting new people and having a good time at WordCamp Phoenix this weekend.

World Intellectual Property Organization LogoIntellectual property (IP) rights are important in the biotechnology industry; one only has to look at a licensing, consulting or service agreement to appreciate this.

If you are a non-lawyer new to the area, and wish to gain a basic understanding of the different types of intellectual property protection such as copyright, trademarks, industrial design, patents and unfair competition, then the World Intellectual Property Organization (WIPO) Academy offers a free general course (DL-101).

The course is delivered online, twice a year, over 6 weeks.  If you are a native English speaker, it takes far less time to complete than the 50 hours suggested.  What makes the course work well is you can download the study material as PDF files. These can then be read anywhere – I used my kindle.

An additional benefit, if you have an ego wall in your den or office, is that WIPO send you a certificate after you pass a final exam.  When I lived in the UK, I put all my certificates on the wall in the downstairs toilet,  an idea I “borrowed” from Mrs Thatcher’s eye surgeon when I had dinner at his home. British understatement at its best.

Although the WIPO general course is not focused on biotechnology or the life sciences industry, it does provide a useful overview of international treaties and IP regulation to build upon.  It is worth considering if you are new to the area.

With best wishes for the New Year, may it bring you good health, happiness and prosperity.

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