Friday, April 17, 2015

What To Read Next

Lately the folks at Way Better Patents been reading a lot about precision medicine and the emerging worlds of molecular medicine, synthetic biology and biotech start-ups.  It's an outgrowth of watching the patent world try to figure out how it will deal with the very specific aspects of developing drugs for people that have a specific genomic profile. Not for the faint of heart or anyone who isn't good at complex thinking.  The level of scientific complexity in precision medicine on top of the intricate dance of protecting and enforcing intellectual property in the pharmaceutical industry will make for a very interesting patent landscape for years to come.  So we embarked upon an effort to get smart.

Our latest read is all about how Vertex Pharmaceuticals brought two important drugs to market.

The Antidote: Inside the World of New Pharma by Barry Werth — How the rugged world of drug innovation really works.

Why Read It?

This choice is timely for a lot of reasons.

It's easy to read despite the deep science and complicated processes it reveals.  Lots of interesting scientists and innovators here.

USPTO is faced with many challenges on what exactly is patentable in the microbiology, molecular medicine, chemistry space.  Is the invention a product of nature or not?  How will patent examiners deal with the avalanche of data that goes along with a new pharma patent application?  At our latest visit to USPTO’s Biotech Partnership it took over an hour and 57 slides just to explain how to upload a sequence listing and another mind exploding 45 minutes and two presenters just to explain how patent term extension works for drug patents.  (We'll be posting both shortly...stay tuned.)  There is a lot going on here.  

There are molecular medicine patents coming from very unusual places as the latest from the Colorado School of Mines shows.  We ignored Captain Renault's advice to "round up the usual suspects" and found 8,968,705 an invention in the nanomedicine space from The Colorado School of Mines (Mines) — gold/lanthanide nanoparticles for use in targeting, treating, and/or imaging disease states in a patient. You read that correctly, The Colorado School of Mines, the folks who focus on Earth, Energy, Environment. The university focused on engineering and applied science in the geoscience arena adds a new contribution to the spectrum of inventions in the nanomedicine space.

The economics of big pharma are in the midst of dramatic change as biotech delivers more customized medicines that address smaller populations of users. This dramatically changes the economics of healthcare.  The complex issues are unfolding before our eyes as people questions what they see as the exorbitant price for SOVALDI® (sofosbuvir) in treating Hepatitic C (it’s cheaper than a liver transplant) or KALYDECO® (ivacaftor) developed to treat cystic fibrosis.  Both drugs and diseases play starring roles in this book.

Back to the patentsphere for a moment.

There is lots of rumblings over the latest business ventures of Erich  Spangenberg in the pharma space. Mr. Spangenberg is working with Kyle Bass, an activist investor, to use the inter partes review process at USPTO to challenge and invalidate pharma patents.  Basically the play is to file an inter partes review to invalidate a patent, short the stock, and wait for the money to roll in.  There are a host of other shareholder fiduciary and due diligence issues here and board room plot twists galore.  What will be interesting here is that the pharma, biotech, chemistry IP crowd tend to play the patent game at a much higher level than our favorite business methods patent monetization letter writers. No going after the easy stuff like healthcare related business methods patents here. And, this is a passion play on what happens when you tinker with the patent system.  Most of the patentistas never envisioned the inter partes review process being used in the way Mr. Spangenberg and others are now using it.  Lots of intrigue.  Understanding the nuances of how a new molecular drug gets to market and the business of making that happen will help you be more informed when watching this latest patent monetization drama unfolds.  

Add the announcement from IBM, Apple, Medtronic and Johnson & Johnson on their new healthcare offering designed to change the information landscape of medicine and pharmaceutical design.  We’re fans of translational R&D. This partnership and others evolving in the space are clearly an important way to use information to move innovation from the bench to the bedside and back to the bench faster.

And then there are all the discussions on fixing the patent system, the Innovation Act, patent cliffs and the fate of big pharma, shorter patent terms for drugs and a host of other issues.  

Check out the Way Better Patents Reading List.  Read this one and Peter Huber’s The Cure Is In the Code and you’ll have a whole new perspective on pharma innovation and intellectual property.