As we move into July, I’m truly impressed by all that we’ve achieved during the first half of this year. Patent reform has taken its rightful place at the center of conversations about America’s drug pricing crisis, and in many places that talk has been accompanied by legitimate action. In just the last six months, we’ve seen:
- Multiple major Senate hearings that have focused primarily on patent abuse, including the Senate HELP hearing where I testified and the Senate Judiciary hearing where senators from across the political spectrum called out the need to put a stop to patent abuse.
- Congress introduced two bipartisan bills – the Bill to Address Patent Thickets and the Affordable Prescriptions for Patients Act – focused on curbing patent thickets that, if passed, would be helpful in curtailing specific competition-blocking tactics drugmakers rely on.
- The FTC took major action against junk patent listings on the FDA’s Orange Book by opening investigations into serial patent abusing drugmakers.
As expected, these steps forward are being met with industry-backed pushback. There’s proposed legislation – PREVAIL and PERA – that would actually raise drug prices and harm health care access. On top of that, PhRMA, the pharmaceutical industry’s main lobbying arm, launched a seven-figure ad campaign focused solely on stopping the momentum behind patent reform.
While it’s important to take these threats seriously, they’re a testament to how close we are to solving one of the root causes of the drug pricing crisis.
Onwards,
Tahir
USPTO’S NEWLY PROPOSED RULES
The USPTO has proposed new rules that would require a patent owner to agree that where a key patent is invalidated in court or at the Patent Trial and Appeal Board, any subsequent patent that is linked through what is known as a terminal disclaimer would be unenforceable in litigation. The goal is to stop multiple patents that are often frivolous and obvious variants of a key patent from being asserted in litigation. These additional patents are central to how patent thickets block competition from entering the market, as they exponentially increase the cost of litigation.
As all regulatory agencies should do, the PTO invited members of the public to comment on the proposed rules to better understand its impact and limitations. We submitted a public comment commending the PTO for its efforts while explaining why terminal disclaimers are outdated and should be eliminated altogether. A diverse group of other stakeholders also submitted comments including Public Citizen, Niskanen Center, and Sandoz.
RELEVANT NEWS AND USEFUL READING
The FTC has officially opened an investigation into the drugmaker Teva for refusing to take down patents on inhalers it improperly listed on the FDA’s Orange Book. It’s a great sign that the FTC is going to put teeth behind its policing of patent abuse.
Senator Dick Durbin (D-IL) and FTC chair Lina Khan published an op-ed in STAT explaining how the pharmaceutical industry uses junk patents to block competition and keep drug prices high.
In some troubling international news, Médecins Sans Frontières announced it will be dismantling its global MSF Access Campaign, which has been a voice and a beacon for the access-to-medicines movement. We joined over 100 other organizations in calling on MSF to see the danger of its decision and reverse course.
SOMETHING HOPEFUL
Global health advocates secured another major victory against a pharmaceutical industry monopoly. Due to overwhelming pressure from patient advocates, Johnson and Johnson will not enforce its secondary patent on bedaquiline, a life-saving tuberculosis drug, in South Africa. This decision follows J&J’s loss in India last year after the Indian Patent Office rejected the patent, shutting down J&J’s effort to extend its monopoly. Executive Director of the Health Justice Initiative Fatima Hassan summed up the significance of this win: “It is an important beginning and serves as a warning signal to the global pharma industry: there will be consequences to the abuse of the patent system”.