Pharmaceutical manufacturing and R&D jobs may be insecure now, but lawyers won’t be losing job opportunities anytime soon. Not if you look at some of what is being patented in the U.S today (http://totallyabsurd.com/inventions.htm), or some of the copyrights that are being issued. Last week, for example, we learned that one consulting firm has copyrights on the phrases “maintenance excellence” and “reliability excellence.” A practicing lawyer advised one editor colleague that it might not be a good idea to use either phrase in a headline (although mentioning the phrase in passing within text would be OK. Whew!).
If the approval process is this porous, what is to prevent anyone from copyrighting or patenting practically anything? Maybe the patents won’t hold up in court, but they may hold up just long enough to result in unnecessary legal fees, actions and delays. The delays could last just long enough to put a smaller innovator out of business, or to prevent the use of good science by competitors.
Other patents may not be as absurd as the “electronic ear bud anchor,” but they definitely overreach. These patents attempt to protect, as intellectual property, elements of nature, or established ways of doing things. For instance, there have been attempts to patent portions of the electromagnetic spectrum.
Sound far-fetched? Well, in the 1980’s and 90’s, NIR spectroscopist and Contributing Editor Emil Ciurczak says, some of the world’s largest oil companies, including Ashland, BP and Amoco all tried to claim NIR wavelengths as essential parts of their patents for such things as octane number prediction.
Ashland Oil, for instance, patented NIR wavelengths for the t-butyl-methyne band, while BP International tried to patent the entire NIR region for predicting product properties or yield from feedstock spectra of the process. Heinrich Prufer, now Managing Director of Sensologic (Norderstedt, Germany) and formerly with Bran + Luebbe, recalls fights against patents that claimed wavelengths as an essential part of the ‘invention’. He and colleague Heike Bull collaborated on a poster, and article, that asked whether spectra shouldn’t be free as the air.
Katherine Bakeev, Chief Scientist with CAMO Software, Inc., recalls an application from a company called Enigma NV that tried to patent the use of NIR to optimize the process for making urea-formaldehyde and other formaldehyde composite resins. I’m no spectroscopist, but doesn’t that sound a lot like basic process analytical technology (PAT)? The application dated from the early 2000's. By that time, hadn't spectroscopy, process control and optimization been used together, for decades, to improve petrochemical quality?
Which brings me to FDA’s other three-letter acronym. Recently, we read that the U.S. issued a patent Patent WO 2012/059520 A1 (Pub. May 10, 2012), to Hoffman La Roche and Lisbon-based 4TUNE Engineering Ltd. on a method that combines NIR, MIR spectroscopy and 2-D fluorescence with chemometric and other models to characterize culture media for biopharma production. The technique uses these methods to better understand media feed variability and predict fermentation yield based on media quality, allowing for feedforward control (for example, making changes during manufacturing to improve results), or feedback control, making process changes by working with upstream suppliers.
We are hoping to develop an article with 4Tune that will discuss the nonproprietary aspects of this method in greater detail. It is smart science and it certainly sounds interesting.
But on the surface, the fact that the patent was issued in the first place brought some troubling questions: First, what if every pharmaceutical manufacturer patented its own approaches to PAT and QbD? Would that expand the use of these methods, or preserve the status quo? Second, haven't the patent's underpinnings, or something that sounds very much like them, been done before, for both small and large molecules? I can recall plenty of QbD presentations over the past few years at the annual AIChE meeting that discussed some combination of all these elements for process optimization and control. Does the act of patenting this approach prevent others, who might have developed very similar methods, from using techniques they’ve perfected inhouse?
Pharmaceutical companies are in business to protect their own interests and to be profitable. But with PAT and QbD, isn’t the goal inclusivity, with everyone sharing basic methodologies and embracing new methods? The specifics of how Company X develops a Design Space for Product Y should remain strictly guarded trade secrets. But could patent exclusivity prevent more companies from embracing smarter manufacturing, and put future patients at risk?