James Love's blog

Maryland House of Delegates passes bill on prescription drug price gouging by vote of 137 to 4

On March 20, 2017, the Maryland House of Delegates approved a prescription drug price gouging bill by a vote of 137-4. A copy of the bill, as it passed the House, is attached.

This is a March 20, 2017 Report by Erin Cox, published in the Baltimore Sun:

Maryland's attorney general could sue drug companies for price gouging under a bill approved by the House of Delegates Monday.

Leaked document: March 15, 2017 Note by Switzerland on India EFTA TEPA IP Chapter

Attached is a March 15, 2017 note by Switzerland on the India EFTA TEPA IP Chapter.

The EFTA is the The European Free Trade Association. The EFTA member states are Iceland, Liechtenstein, Norway and Switzerland. The document refers to a proposed "Trade and Economic Partnership Agreement," or TEPA, between India and the four members of the EFTA. The EFTA page on this negotiation is here.

Company disclosures of R&D costs on SEC filings

Today I attended a work session of the Maryland House of Delegates subcommittee on Health Facilitates and Pharmaceuticals of the Health and Government Operations Committee. I was there to testify in support of HB 666, a bill titled: Public Health – Expensive Drugs – Manufacturer Reporting and Drug Price Transparency Advisory Committee. (PDF version here).

All 12 Zhang/Broad Institute CRISPR patents declare US funding and rights in inventions

February 15, 2017, the USPTO ruled that 12 genome-editing CRISPR-Cas9 patents and one patent application assigned to the Broad Institute of Harvard and MIT did not interfere with a patent application from scientists at the University of California. A copy of the ruling is available here.

Following the ruling by the USPTO that the Broad Institute and the University of California both issued statements, as did several firms with an interest in the dispute.

Spinraza: KEI asks DHHS Office of the Inspector General (OIG) to investigate a failure to disclose federal funding in patents

KEI has asked the DHHS Office of Inspector General (OIG) to investigate a failure to disclose federal funding of patents on nusinersen, a drug developed by Ionis Pharmaceuticals (formerly known as Isis Pharmacetuicals) with BioGen, and sold under the trade name Spinraza.

A copy of the 22 page letter to OIG is available here.

Groups Object to Army Proposal to Give Sanofi a Monopoly on Patents for Taxpayer-Funded Zika Vaccine

12 JANUARY 2017

CONTACT: Zack Struver, zack.struver@keionline.org, +1 (202) 332-2670

Groups Object to Army Proposal to Give Sanofi a Monopoly on Patents for Taxpayer-Funded Zika Vaccine

2016: KEI comments to NIST on Bayh-Dole Act Regulations

In November, NIST proposed to amend the regulations implementing the Bayh-Dole Act, 35 U.S.C. 200 et seq., which concerns intellectual property arising from federally-funded research, including 37 CFR sections 401 and 404. There were 15 comments, including a letter from KEI on December 9, 2016. EFF also provided comments. The other 13 comments to NIST were from Universities, associations or individuals taking the side of right-holders.

The KEI comments are available here.

SCCR 33, KEI's intervention on legal protection for technological protection measures

This was our intervention at SCCR 33 on the topics of exceptions to the legal protection for technological protection measures.

TPMs are an legitimate and important measure to protect certain works, data and technologies from unauthorized uses.

The issues raised by libraries and archives concern the legal protection that one gives the technological protection.

SCCR 33: Notes from KEI NGO statement on WIPO broadcast treaty negotiations, November 16, 2016

Today, after two and a half days of negotiations, mostly off the record in informals, NGOs were given a few minutes to make statements on the broadcasters treaty. We were asked to keep things short, and focus on discussions this week. These are the notes from our intervention.

Notes from KEI NGO statement on Broadcast treaty
November 16, 2016

Right to prohibit

India Patent Office denies patent for prostate cancer drug sold under brand name Xtandi, generic name enzalutamide

According to this story, the India Patent Office has denied a patent for the prostate cancer drug sold under the brand name Xtandi (generic name Enzalutamide). Opponents of the patent claimed it was a new form of a known substance, and not eligible in India under Section 3(d) of its patent act.

Lancet Commission on Essential Medicines Policies publishes 74 page report, endorses delinkage of R&D costs from drug prices

Today The Lancet Commission on Essential Medicines Policies published the 74 page report on "Essential Medicines for Universal Health Coverage." A copy is available here.

The report is rich in data, analysis and recommendations. The report endorses the delinking of R&D costs from drug prices:

Delinking R&D costs from the price of medicines

Some measures that a new President and/or Congress can take to lower drug prices in the near term

KEI and others working in the drug pricing space are frequently asked about measures that a new President or Congress can take to lower drug prices, in the relatively near term. The following is a list of such actions, including some that would require legislation and some that would not.

A comprehensive list of possible actions would be much longer, and this is not such a list. Our list does not include suggestions from several other groups working on drug pricing that deserve consideration, and there is nothing at this point on price spikes.

HIV revenues and industry investments in clinical trials for HIV

According to IMS, the global market for HIV antiviral drugs was $24.4 billion in 2015. Over the past three decades, drug companies have registered an average of one new molecular entity HIV ARV per year. This is a lot of money to spend on HIV drugs to induce just one new drug per year.

Today I took a look at data from the NIH clinicaltrials.gov database, to see what the industry was reporting in terms of trials.

Relative prices of brand and generic drugs

Part 1, and the GPhA report on cost savings from generics, and prices of generics relative to brand in 2015.

The US based Generic Pharmaceutical Association (GPhA) has issued its 8th annual survey of cost savings due to generic medicines. (Copy here). The data they present comes from QuintilesIMS Institute.

The leading shout-out from the report is that generic drugs saved U.S. consumers and third party payers $227 billion in 2015.

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