It is a neoliberal solution that is dependent on the charitable whims of corporations not freedom. Equitable outcomes will never be possible under such a system. The only path forward is systemic transformation that places the right to access medicines as a justice issue not an economic one.

The truth is, voluntary licensing deals paper over the reality that our global health system gives drug companies like Gilead the power to decide who must be sacrificed at the altar of corporate profit so that others may live.

As I told @vox.com's Pratik Pawar, these deals carve the world into low-value markets—where generics can operate because Gilead has deemed them unprofitable—and high-value ones, where Gilead maintains its monopoly grip.

Algeria, Argentina, Brazil, Colombia, Mexico, Peru, and many other upper-middle-income countries are excluded from the agreements.

Genuine questions: At what point does a well-known, industry-wide practice become obvious? Is the obviousness test just lip-service these days?

Using hyaluronidase to enable subcutaneous delivery would be the obvious go-to solution for a scientist skilled in biologic drug development given how many times it has been done to date.

Bristol Myers Squibb used it to create an injectable version of Opdivo (nivolumab, also an immune PD-1 checkpoint inhibitor). Roche also used it to create injectable versions of Herceptin over a decade ago.

Hyaluronidase, and variations of it, is a well-understood ingredient that companies have long used to enable subcutaneous delivery of biologic drugs.

In an interview with CNBC, Merck CEO Robert M. Davis described Keytruda Qlex as an “invention”. That characterization suggests novelty and a technique that someone skilled in the field would not deem obvious to try—and, therefore, patent-worthy.

Merck created Keytruda Qlex by combining Keytruda’s known immune PD-1 checkpoint inhibitor (pembrolizumab) with a form of the enzyme hyaluronidase (berahyaluronidase alfa-pmph) licensed from the South Korean company Alteogen.

...they’d be better equipped to determine whether a company’s follow-on claims represent novel and non-obvious inventions or just trivial tweaks intended to expand a drug’s patent thicket.

Drug companies submit their clinical trial data to the FDA when seeking approval but the data is confidential and inaccessible to the USPTO. If patent examiners had access to it...