By Aobo Dong
As the future of Affordable Care Act (ACA) hangs in the balance amid political deadlock in Washington, more Americans are signing up for Christian health care sharing ministries (HCSMs) – a growing alternative to traditional health insurance. Instead of paying a monthly premium to insurance companies, most members of HCSMs write monthly checks directly to other members in need. If you are on the receiving end, chances are you may be surprised with a wave of letters, flowers, and prayer cards wishing you well. However, not all medical bills are “eligible for sharing.” Most HCSMs exclude pre-existing conditions, as well as any conditions or medical expenses caused by “unbiblical lifestyle” involving using drugs/alcohol or having sex outside of heterosexual marriage. Also, if you are an adopted child with disabilities or an undocumented immigrant, some ministries explicitly exclude you from participating at all. Continue reading
Yesterday, it was announced that Allergan had transferred the ownership of the patents on its billion-dollar drug Restasis, used for the treatment of chronic dry eye, to the Saint Regis Mohawk Tribe. The Tribe then exclusively licensed the drug back to Allergan, in exchange for tens of millions of dollars in both licensing and royalty fees. Although it may not sound like it, this transfer is potentially huge news in the drug pricing world. It is also extremely complex, and its full implications have yet to be determined.
Enormous caveat before we begin: I am by no means an expert on tribal sovereign immunity. I may well be wrong here. (In fact, I would very much like to be wrong here.) There is little (any?) case law on sovereign immunity’s impact in the Hatch-Waxman area, and much of what follows is extrapolated from case law on tribal sovereign immunity both in IP and in other contexts, state sovereign immunity in the IP area, and discussions with other law professors. Please let me know if this is your area of expertise and you believe I’ve gotten the analysis wrong!
In short, if repeated and taken to its logical conclusion, this transfer has the potential to prevent most invalidity challenges to drug patents. Would-be generic competitors could not seek to initiate inter partes review (IPR) actions before the Patent and Trademark Office (PTO). They could not bring declaratory judgment actions in federal court. And – both most importantly and most unclear – they could not bring Paragraph IV invalidity counterclaims under Hatch-Waxman, preventing generic companies from independently challenging patents’ invalidity and potentially requiring us all to wait until the very end of patent expiration to experience generic competition.
By Clíodhna Ní Chéileachair
Last year Médecins Sans Frontières (MSF) refused free vaccinations for pneumonia from Pfizer, who had offered the medicines as a corporate donation to the humanitarian organisation. The explanation MSF provided (available here) makes for an interesting, if uncomfortable read. Looming large is the lengthy history of negotiations between MSF with the only manufacturers of the vaccine, GlaxoSmithKline and Pfizer. MSF claim that the only sustainable solution to a disease that claims the lives of almost a million children each year is an overall reduction in the cost of the vaccine, and not one-off donations that come with restrictions on where MSF may use the medicines, and a constant power disparity between the parties, where Pfizer may release the medication on their own timeline, and revoke access as they see fit.