checks and balances

Regulating the regulators: Candy giant Nestlé enters the medical patent game despite shady allegations

Regulating the regulators: Candy giant Nestlé enters the medical patent game despite shady allegations

Sky Canyon, Stephan Pyles
Chef Stephan Pyles outside Love Field restaurant Sky Canyon. Courtesy Photo
Sky Canyon, Love Field, interior
Sky Canyon at Dallas Love Field features a few Stephan Pyles trademarks, including a Western mural on the wall. Photo by Teresa Gubbins
Sky Canyon, Stephan Pyles, Gina Puente
Stephan Pyles and Gina Puente opened Sky Canyon at Dallas Love Field in April 2013. Photo by Teresa Gubbins
Sky Canyon tacos
The menu at Sky Canyon includes tacos with fillings such as pork, brisket and fried chicken. Photo by Teresa Gubbins
Sky Canyon fried chicken
Sky Canyon has a honey fried chicken with biscuits, French fries and pickles that's similar to the fried chicken served at Pyles' Stampede 66. Photo by Teresa Gubbins
Sky Canyon shrimp and grits
Sky Canyon's menu includes shrimp and grits. Photo by Teresa Gubbins
Sky Canyon, desserts
Desserts at Sky Canyon include butterscotch pudding, black-bottom pecan pie and banana-walnut bread pudding with rum caramel. Photo by Teresa Gubbins
Sky Canyon, pudding
Sky Canyon's butterscotch pudding comes topped with vanilla whipped cream and a sugared mint leaf. Photo by Teresa Gubbins
Love Field
Dallas Love Field has almost finished a stunning renovation. Photo by Teresa Gubbins
Sky Canyon, Stephan Pyles
Sky Canyon, Love Field, interior
Sky Canyon, Stephan Pyles, Gina Puente
Sky Canyon tacos
Sky Canyon fried chicken
Sky Canyon shrimp and grits
Sky Canyon, desserts
Sky Canyon, pudding
Love Field

This week, the Supreme Court began hearing oral arguments in a patent lawsuit between Prometheus Labs and the Mayo Clinic. The two parties were duking it out over a medical test used to calibrate a person’s dosage of the drug Thiopurine. The drug, which has been out of patent for years, is used to treat patients with autoimmune conditions and Prometheus Labs developed a test to monitor metabolite levels in the blood:

"Until the Prometheus method was available, Mr. Bress said, 'doctors had no way to tailor for each individual based on their metabolism the right dosage of these powerful but potentially toxic drugs.'"

...which the Mayo Clinic used for years before deciding to develop their own test. This has been just another legal battle between faceless corporations — who cares, right? 

You care. When you win a case in the Supreme Court you create precedent. You create case law that other lawyers can draw on to strengthen their arguments in future legal battles, and judges tend to rely heavily on precedent to make their decisions. Prometheus is claiming that doctors infringe on their patent if they are even aware of the correlation between metabolite levels and a patient’s dosage. This sets the precedent that if a company can prove a doctor or individual researcher used patented information, not even patented equipment or a patented process, but patented knowledge to influence their decision-making, they could be sued.

Too often patents fail to perform the function they were intended to in Article 1, Section 8, Clause 8 of the constitution ("To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries") and instead allow rich people to get richer by exploiting their legal advantage over those who cannot possibly fight back. Shadowy holding companies buy up bundles of vague software patents that often overlap or conflict with other patents and then search the internet for new start-ups who cannot afford a legal battle and will settle out of court quickly.

It is legalized extortion, plain and simple. These entities are known as “Patent Trolls” and they are killing innovation in the software industry.

I can very easily see a General Practitioner leaving a patient on a slightly elevated dosage of a relatively mild drug rather than get sued. But what happens when it stops being an hypothetical pill in a courtroom and starts being heart medication? Is a doctor expected to ignore medically relevant information because she can’t afford to license it?

 Children in developing nations were being fed formula mixed with contaminated water because their parents had been convinced the formula would make their children healthier.

I imagine you’re thinking, “What company would be unethical enough to abuse patent law to the detriment of the health of patients?” Perhaps the same company that triggered an ongoing worldwide boycott in 1977 over its promotion of infant formula over breast milk — breast milk that provides newborn babies with nutrients and immunities against disease. Children in developing nations were being fed formula mixed with contaminated water because their parents had been convinced the formula would make their children healthier. Instead it made them sick and a lot of them died. The Swiss Food Giant Nestlé, the same company that demanded six million dollars worth of debt repayment from Ethiopia in 2002 when they were in the middle of a famine. 

Nestlé did not acquire an ownership stake in Prometheus Labs until after litigation started. Businessweek did a story on Supreme Court Justice Stephen Breyer’s wife being forced to sell a few thousand dollars in Nestlé stock so he didn’t have to recuse himself. Though the purchase took place in July, it wasn’t revealed to the court until this week that Nestlé was the new owner. Which is chilling, because if there is any company I do not trust with the care and enrichment of human lives, it is Nestlé. 

Medicine does not need additional levels of complication to drive up prices and lower access — and to allow such a thing would be nothing less than a crisis. I do not know why Nestlé was interested in owning this company that may soon have standing to sue medical entities to slow the progress of medical science, but I’m not hopeful. 

Medical professionals are nervous, too. The American Medical Association warned in an amicus brief, a document submitted by interested parties to a trial proceeding that the court can consider during oral arguments and deliberations: “If claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.”

We may not be able stop the Supreme Court from ruling in favor of Prometheus; they have a good case apart from their legal overreach. And companies most certainly need to be able to fund their research and development and receive a return on their investment. But patenting medical knowledge immediately relevant to patient care is sinister and represents an unnecessary impediment to the course of medical science.