The Real Reason Why Salk Refused to Patent the Polio Vaccine


A guest writer in a recent article in the Wall Street Journal repeated the oft quoted Jonas Salk statement about his Polio vaccine: “There is no patent.  Could you patent the sun?”  Many use this statement as the moral impetus for refusing patents on medically important innovations (see Michael Moore’s Capitalism: A Love Story).  Unfortunately, Jonas Salk created a myth that day by leaving out several crucial details.

As pointed out by Robert Cook-Deegan at Duke University, “When Jonas Salk asked rhetorically “Would you patent the sun?” during his famous television interview with Edward R. Murrow, he did not mention that the lawyers from the National Foundation for Infantile Paralysis had looked into patenting the Salk Vaccine and concluded that it could not be patented because of prior art – that it would not be considered a patentable invention by standards of the day. Salk implied that the decision was a moral one, but Jane Smith, in her history of the Salk Vaccine, Patenting the Sun, notes that whether or not Salk himself believed what he said to Murrow, the idea of patenting the vaccine had been directly analyzed and the decision was made not to apply for a patent mainly because it would not result in one. We will never know whether the National Foundation on Infantile Paralysis or the University of Pittsburgh would have patented the vaccine if they could, but the simple moral interpretation often applied to this case is simply wrong.”

While the debate on whether patents are the best way to incentivize medical innovation and commercialization continues, that debate should proceed without reliance on this myth regarding the history of the Polio vaccine.

UPDATED: Pfizer nabs FDA nod for another targeted cancer drug

The FDA had stamped an approval on Pfizer's ($PFE) new kidney cancer drug axitinib, which the drug giant plans to market as Inlyta. And the approval marks another win on the targeted cancer drug front for Pfizer, which last year nabbed an FDA OK for its non-small cell lung cancer treatment Xalkori for a subset of patients whose tumors express ALK mutations.

The approval for Inlyta, a selective VEGF inhibitor, comes after Pfizer showed in a 723-patient trial that the drug could provide 6.7 months of median progression-free survival, topping the 4.7 months among patients who took Onyx Pharmaceuticals' ($ONXX) Nexavar (sorafenib).

Pfizer has a new horse in what is becoming a crowded race in the market for advanced kidney cancer drugs. According to the FDA, there have now been 7 drugs for kidney cancer approved in the U.S. since the agency's nod for sorafenib in 2005. Pfizer also markets two other drugs for advanced kidney cancer, Sutent and Torisel.

Aveo Pharmaceuticals ($AVEO) plans to seek an approval for its own VEGF inhibitor against kidney cancer, tivozanib. Both Pfizer's and Aveo's horses in this race target multiple VEGF receptors. The FDA is letting Pfizer market its drug for treating patients who have already failed one prior systemic therapy, according to Pfizer's relase. Cambridge, MA-based Aveo has ambitious plans to win an FDA approval for tivozanib as a first-line therapy for advanced renal cell carcinoma.

Despite the competition in this market, the FDA nod supports Pfizer CEO Ian Read's plan to focus the drugmaker's R&D efforts on targeted medicines that serve the needs of specific patients and, of course, adds another commercial product to the company's roster as it battles to replace revenue lost to generic drugs.

- here's the FDA release

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BREAKING: FDA (finally) stamps an approval on Amylin’s Bydureon

After being rejected twice by regulatory officials, Amylin has finally won FDA approval to sell Bydureon, it's once weekly diabetes jab.

The weekly diabetes injection is intended to replace standard twice-a-day injections, and the NHS has already issued its approval in the UK, with NICE officials stamping an OK on the price earlier this week. In the U.S. the focus will now shift from the regulatory decision to the market reaction as Amylin rolls out a drug that has earned a wide range of peak sales forecasts. Most analysts now expect the drug to earn a blockbuster billion a year, about half of what they had projected before the latest rejection in October, 2010.

Those forecasts weren't improved for Amylin after a head-to-head study with Novo Nordisk's Victoza earlier this year showed Victoza had a superior result. Now analysts will want to inspect Amylin's pricing and marketing plan for the drug.

Repeatedly stiff-armed with one disappointing delay after the other, with the two primary partners on the exenatide franchise--Amylin and Eli Lilly--breaking up under the accumulated stress of a difficult relationship, the U.S. development program and long-running regulatory campaign has been one of the longest running sagas on the R&D side of the biopharma business.

Eli Lilly had some boasting rights based on the approval. In their breakup, Lilly gained $1.2 billion as their part of the sales cut - provided an approval arrived in a timely fashion. Alkermes - which wins a royalty stream on sales, got a bump from the news as well. At the very least an approval finally ended the periodic hits it stock took every time Bydureon experienced a fresh setback.

- here's the approval letter

Special Report:  Bydureon - 15 top blockbuster contenders

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Biogen’s lead dealmaker makes case against corporate VC

Biogen Idec's ($BIIB) lead dealmaker, Steve Holtzman, recently sat down with Xconomy's Luke Timmerman to outline just why the big biotech is exiting the corporate VC side of the business. And he did it by shooting holes in some popular concepts that helped drive the trend toward more corporate investing.

First, there's the idea that corporate VC opens a window onto novel technologies. Not so, says Holtzman, the former CEO at Infinity. That's something you should look to your in-house scientists to provide, as they're supposed to be out there scouting the field all the time.

Second, you get to see the other VC players all the time, who have their fingers on the pulse of new tech. But with three experienced players like CEO George Scangos, R&D chief Doug Williams and longtime dealmaker Holtzman on hand, who needs to do rounds with the VCs? They're dropping by practically every day anyway to share opinions and probe on Biogen's interests.

Third, there's the "myth" about gaining some sort of first right of refusal on a technology or a company. False, says Holtzman. Every company has to do the best deal they can get. "Therefore, there are no preferred seats at the table."

Fourth, you're doing right by the business, where the ecosystem needs your support. As you may have guessed by now, though, Holtzman feels that there are better ways to support the R&D ecosystem, and few are better than university discovery deals and biotech partnerships, where the money should go.

- here's the full article from Xconomy

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Biogen Idec taps two ex-CEOs to head R&D, corporate development