A role reversal in biotech patenting

EU_backgroundThe difference in the patenting landscape between the United States and Europe used to be characterized as freewheeling versus cautionary; expansive versus patchwork. Think of Diamond v. Chakrabarty‘s “anything under the sun that is made by man” versus the long battle to finally allow the patenting of stem cells in Europe.

However, the conventional wisdom may be turning around in a big way. In the Tuesday IP track session Antibody Therapeutics: May I Have Them All, the four panelists ran through several theoretical scenarios involving the patentability of therapeutic antibody compounds and methods of use before both the US Patent & Trademark Office and the European Patent Office, as well as the courts who may eventually uphold or invalidate the patents.

The audience was invited to cast their vote on several questions using the MyBIO app, to no great success; we quickly reverted to the more low-tech but highly efficient ‘show-of-hands’ method. Two generally agreed-upon propositions were that: (1) the likelihood of getting a US application approved was dependent on the identity of the patent examiner (cue knowing laughter from the audience), and (2) Europe is starting to present a more streamlined application process, focusing more on the method of “using an antibody to antigen X for the treatment of disease Y” compared to the myriad structural and functional characteristics required by the USPTO.

Panelist Robin Silva, a partner at Morgan Lewis, summed up by advising the audience to continue to claim antibodies “six ways from Sunday and see what sticks.” That might be a harder slog, but in the long run may also be more profitable, both for drug developers and their patent attorneys.

Wednesday’s morning session, Inventions Patentable: Evaluating Proposed Amendments to Section 101 merely reinforced the theme, with panelists discussing how recent US court decisions such as Mayo, Myriad and Alice have in essence replaced the well-understood framework for a “patentable invention”- i.e., novelty, utility, inventiveness- with an “enoughness” test that the USPTO, courts and patent bar are struggling to understand and apply. This has left the US standing alone by excluding from patentability isolated natural products and basic diagnostic methods.

Whether the solution is a legislative fix, regulatory guidance or a change in judicial mindset, it cannot come soon enough to clear the atmosphere of confusion and unpredictability now present.

Michael Francisco

BIO2015 Day 1: Ethics

bubblesOn Monday I attended the panel “The BIOethics of drug development: you decide.”

In this session, everything was fake. A mock company, iCures, with BioCentury’s Steve Usdin as the pretend CEO, found itself mired in all sorts of bioethical dilemmas. The audience (myself included) acted as Agony Aunts by casting our votes on what the fledgling biotech ought to do when faced with various problems. In our fake case study, patients have been whipping up a social media frenzy over a pancreatic cancer drug in phase 2 that, it seems, has a welcome side-effect: it banishes wrinkles “better than Botox.”

If it were my company, I’d have been uncorking champagne — the serendipitous discovery of Viagra’s use springs to mind. But the panellists were cautious. They correctly explored how Twitter, chat rooms  and media hyperbole might threaten their drug’s success. This internet chatter, they said, not only unblinds the trial but also propagates false or possibly inflated information. The fake ompany discussed sanctions and how to penalize patients who cannot stop themselves from sharing their experiences.

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Yet I found the outcome of the voting rather shocking. All five panelists — even the patient advocate — and about 80% or the audience voted to ban participants from a trial if they communicated their experience through social media. I found this disappointing. Haven’t these people heard about Obama’s patient-empowered Precision Medicine Initiative, and the NCI’s Match trials that shake up clinical trials and bring them rushing into the 21st century? These and other innovative designs are incorporating next-generation sequencing, -omics of every kind, data algorithms, sensors and digital medicine. Social media is part of the picture, why not embrace it? Get everyone involved, including the FDA, to conjure up novel ways to harness its undoubted power.

After all, RCTs (randomized controlled trials) have been the gold standard for almost 60 years. Maybe it’s time for platinum?

Lisa Melton

BIO 2015 in Philly

LOVE_park

The iconic Love Park in Philadelphia.

The Biotechnology Industry Organization (BIO) International Convention begins next week in Philadelphia. Running from June 15-18 this year, the conference is historically the industry’s largest gathering. The last time Philly played host (2005), the conference was slightly larger than today’s expected version, with more than 18,000 attendees. There were also more protesters than we see today – enough, in fact, for a group to clash with police, leading to, somewhat indirectly, the death of a cop.

Protester activity has declined since then, as has the number of attendees – BIO expects around 15,000 this year. But what about the host city? As we noted in our December 2014 feature on tech transfer, Philadelphia is a becoming a life science town. In 1970, the city had 190,000 manufacturing jobs, but by 2011 manufacturing had dwindled to just 45,000 positions. Jobs in healthcare, education and social services, meanwhile, had risen to 184,000. The three largest employers in Philadelphia now are the Jefferson Health System, the University of Pennsylvania and the University of Pennsylvania Health System, and Temple University.

You could say Philadelphia overall is having something of a resurgence. The city is getting safer – thanks, in part, to a lauded mayor – and there are plans to revitalize more of the city’s downtrodden areas. It has a growing culinary reputation. Perhaps the nickname “Killadelphia” is no longer valid. (To hear former BIO CEO Carl Feldbaum discuss prosecuting corruption in Philadelphia when he was assistant district attorney, click here for our First Rounders podcast.)

And now BIO arrives, with its long list of events. We’ll be posting from the conference this year, and Nature Publishing Group will have a booth in the exhibit hall. Do stop by – ask for a copy of Nature Biotechnology, and grab a piece of whatever candy we’re offering.

Brady Huggett

MinION conference continues

London Calling Samples-121

Thomas Hoenen speaking on Ebola. Image source: Nigel Chapman

I wrote about the first day of the conference here.

The second day of the conference also had an infectious diseases focus, where we learned how the MinION was used to identify the two major Ebola lineages in West Africa. The MinION has environmental applications, too, as Brook Milligan showed that the MinION was used to trace illegally traded timber, which accounts for $100 billion annually in lost revenue, he said.

Non-infectious clinical applications were less frequent at London Calling. However, the MinION’s long reads have an advantage that was reflected in Ron Ammar‘s pharmacogenomics talk.

Ron showed that Haplotyping the Thiopurine S-Methyltransferase (TPMT) gene at two SNPs (rs1142345 and rs1800460) influenced the immunosuppressive Thiopurine drug dosage more precisely than having the SNPs information separately.

After the two pleasantly exhaustive days, I returned to Kuwait with a personalized Fahd Al-Mulla MinION that dazzled staff at my University and Genatak. I am planning to use it, ASAP, and present my personalized vision for the MinION conference next year. However, while at the conference a colleague and I cautioned Oxford Nanopore staff about the need to validate each MinION before use in the clinic. This will be difficult to do if they keep changing the models so frequently. Perhaps clinical validation will be done on the more accurate and enhanced models soon, and I would be glad to be part of the process.

Before the conference, I had heard competitors project a gloomy picture for the MinION, and I wanted to understand why. After the conference, I formed a theory: When Oxford Nanopore management decided to partner directly with scientists to test and enhance their products, these busy scientists did not act quickly and ended up delaying the progress of MinION. More importantly, the first generation MinION’s flow cells, which worked perfectly well at the source, did not work very well after shipment! It turns out that microbubbles were forming in the not-so-well degassed and shipped reagents and flow cells.

This reminded me of my first trip to Kuwait from Glasgow, where I took my engineered cell lines in a flask half-filled with growth media. It appears that the constant shaking and formed bubbles dislodged my attached cells, and they died. I learned, as did Oxford Nanopore Technologies, to de-gas the media well and fill the flask to the rim with media. I’ve now had the cells for many years in Kuwait, living happily ever after, and I am glad to say that the new flow cells appear green on the computer screen indicating that almost all the nanopores are working to full capacity.

The meeting created a tight bond between researchers and Oxford Nanopore, because this time scientists were offered a product that they then can sculpt into their own scientific achievements. One can only imagine the joy we shared when we were handed the keys to a futuristic technology, and we were asked to assist perfecting it!

It made me think how other companies and entrepreneurs should learn from the sharing business model adopted by Oxford Nanopore Technologies.

Fahd Al-Mulla

 

 

 

 

Two Days of MinION

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Audience members inspecting their free MinION. Source: Nigel Chapman

Oxford Nanopore Technologies invented the MinION device – a pocket-sized DNA/RNA sequencer that is based on protein nanopores set in an electrically resistant polymer membrane. It works by passing an ionic current through the nanopores, creating a specific disruption pattern in the current that is used to identify the molecule. This is similar to the antennae of insects, and it fascinated me. So, I wrote to Oxford Nanopore expressing my wish to join its MinION Access Programme (MAP).

MAP is a community-focused access project that started in Spring 2014. Its philosophy is to enable a broad range of scientists to explore different ways MinION may be useful to them, to contribute to developments in analytical tools and applications and to share their experiences and collaborate. This year I received an invitation to submit an abstract to a conference hosted by Oxford Nanopore called “London Calling.” The two-day conference was opened by Dr. Gordon Sanghera, the CEO of Oxford Nanopore Technologies, who explained to the international audience that London Calling is the third studio album by the English punk rock band the Clash.

The first question one might have is, Does the Nanopore technology actually work? The answer is yes. All speakers, who were part of the early group of MAP users, produced sequences using MinION. Nick Loman showed that he could identify Salmonella as the source of food poisoning in just 100 minutes of sequencing. Moreover, Jared Simpson produced a complete Escherichia coli K-12 MG1655 genome assembly having 98.4% nucleotide identity compared to the finished reference genome. This means that the MinION sequencing data can be used to reconstruct bacterial genomes without the need for a reference sequence.

All of the first-wave of MAP winners utilized the first generation application-specific integrated circuit (ASIC), which has 512 channels to prepare and relay the information from each nanopore to the host laptop (read 30 bases/sec). Imagine what they could have done if they had the next generation MkII MinION device with the next generation of ASIC, which has 3,000 channels. The new method of analysis, Fast Mode, plans to increase the speed from 30 bases per second per nanopore to around 500 and the ASIC is capable of going up to 1,000!

I was also interested to see two new additions:  the PromethION, which is expected to contain 144,000 channels across 48 flow cells, each capable of running multiple separate samples yielding up to 6 Terabases per day; and the Voltrax, a device that fits on top of the MinION or the PromethION and automates the 6-12 samples preparation.

That has me thinking about how these products will be suited to sequence whole human genomes, and the applications of this in the field of genomic medicine.

When the day was over, we went to the conference dinner at the Skyloft, which had panoramic views of London. Yet this was overshadowed by the news of MinION going to space. Yes, NASA’s Astromaterials Research and Exploration Science division plans to fly a few MinIONS to the International space station. Given the confined space within the International Space Station and the necessity to conduct experiments within it, the mere size of the MinION makes it an ideal instrument to study the existence of terrestrial nucleic acids and proteins, as well as possible infectious outbreaks in space stations of the future.

Up next: Day 2 of the conference

Fahd Al-Mulla

Events

calendar3Lots of events coming up — you’ll need your passport.

 

 

China Bio Partnering Forum
April 15-16, Kerry Hotel, Pudong, Shanghai, China
https://www.ebdgroup.com/cbpf/index.php

Legislative Day Fly-in 2015
April 14-15, Washington DC
https://www.bio.org/events/conferences/fly-overview

BIO IP Counsels Committee Conference
April 15-17, The Four Seasons, St. Louis, Missouri
https://www.bio.org/events/conferences/fly-overview

2015 Food and Drug Law Institute Annual Conference
April 20-21, Grand Hyatt Washington, Washington DC
https://www.fdli.org/annual2015

BioBasics Biotech for the Non-Scientist
April 23-24, Duane Morris Office, Boston, Massachusetts
https://biotechprimer.com/events/biobasics-boston-ma/

2015 Inaugural Evolve Biomed Conference
April 29-30, Dublin, Ireland
https://www.biospace.com/calendar_event_details

BioTrinity 2015 European BioPartnering and Investment Conference
May 11-13, Novotel London West
https://www.biospace.com/calendar

BioEquity Europ 2015
May 19-20, Vienna, Austria
https://www.biocentury.com/conferences/bioequityeurope/dates

 

Playing in Paris

playground_logo_383x288For two years, Nature Biotechnology has supported Index Ventures with the VC firm’s flagship Playground event in London. On February 11, 2015, the event is moving to Paris.

The event should be of interest to those exploring entrepreneurism in the life sciences. This year’s event will feature discussions on entrepreneurship by David Grainger (E3BIO), Xavier Duportet (PhageX), and Bernard Gilly (this video in French). There will also be a panel discussion on the startup scene in France.

These are well planned, well executed events, and a great chance to mingle with like-minded folks, as well as an opportunity to get the ear of Index Ventures partners. A reminder that while Playground is free, space is limited. Register promptly.

More information (and registration) can be found on the web here, and also through the PDF link below.

INDEX-Playground

 

Events

calendar3Events of interest to bioentrepreneurs, over the coming months. Plan accordingly, and pack light.

 

 

The 3rd International Partnering of the Israeli BioMedTech Industry: Life Science Israel 2015

February 18-19, Dan Panorama Hotel, Tel Aviv

https://www.lifesciencesisrael.com/

 

CalBio 2015

March 2-3, San Francisco Marriott Marquis

https://baybio.org/calbio-2015/

 

BIO-Europe Spring 2015

March 9-11, Mercure Paris Porte De Versailles Expo

https://www.ebdgroup.com/bes/travel/hotel.php

 

University of Florida 2015 A Celebration of Innovation Startup Showcase

March 10, Hilton University of Florida Hotel and Conference Center, Gainesville

https://www.biospace.com/calendar_event_details.aspx?CalendarEventEntityId=694252

 

Future Leaders in the Biotech Industry

March 20, Millennium Broadway, Hotel & Conference Center

https://www.biocentury.com/conferences/futureleaders/dates

 

12th Annual BIO Asia International Conference

March 24-25, Grand Hyatt, Tokyo, Japan

https://www.bio.org/events/conferences/bio-asia-international-conference

Events

calendar3

 

A collection of interational events in September and October potentially of interest for bioentrepreneurs.

 

 

BioPharm America 2014

September 22–24, Boston Marriott Copley Place

Information found here.

 

The 21st Annual Newsmakers in the Biotech Industry

September 26, Millennium Broadway Hotel and Conference Center, New York City

Details.

 

The 13th Annual BIO Investor Forum

October 7–8, The Palace Hotel, San Francisco, California

The link.

 

BIO Patient and Health Advocacy Summit

October 1415, Mayflower Renaissance Hotel, Washington DC

More information.

 

BioJapan 2014 World Business Forum

October 1517, Pacifico Yokohama, Yokohama, Japan

Click here for more.

 

BioPharma Korea Convention 2014


October 21–23, Renaissance Seoul Hotel, Seoul, South Korea

Details can be found here.

 

BioBasics: Biotech for the Non-Scientist

October 23–24, Duane Morris Offices – Boston, MA

Information.

 

Events

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Grab your calendar, plan ahead — biotech events through June, including the annual BIO Convention.

 

 

ChinaBio Partnering Forum 2014

May 7 & 8, Kempinski Hotel Suzhou, China

https://www.ebdgroup.com/cbpf/index.php

 

Ag Biotech Entrepreneurial Showcase 2014

May 20, North Carolina Biotechnology Center, Research Triangle Park, North Carolina

https://www.ncbiotech.org/AgBiotechShowcase

 

BIOtech 2014 in Japan

May 14–16, Tokyo Big Sight

https://www.bio-t.jp/en/

 

2014 American Association of Pharmaceutical Sciences National Biotechnology Conference

May 19–21, Sheraton San Diego Hotel and Marina

https://www.aaps.org/nationalbiotech/

 

BioEquity Europe 2014

May 21 & 22, Hilton Amsterdam Hotel

https://www.biocentury.com/conferences/bioequityeurope/dates

 

15th Annual Drug Discovery Summit

June 2 & 3, InterContinental Geneva

https://www.drugdiscovery-summit1.com/

 

BioEconomía Argentina 2014

June 5 & 6, Intercontinental Hotel of Buenos Aires, Argentina

https://www.bioeconomia.mincyt.gob.ar/

 

Drug Discovery and Therapy World Congress

June 16–19, The Hynes Beacon, Boston

https://www.ddtwc.com/

 

BIO International Convention

June 23–26, San Diego Convention Center

https://convention.bio.org/