patents

Moderna “does not have plans” to advance its chikungunya antibody candidate to Phase 2, the company revealed last week in its third-quarter earnings press release. The Massachusetts-based mRNA specialist said it had completed a Phase 1 study of mRNA-1944 and would publish full results soon. Moderna also deprioritized a chikungunya vaccine candidate (mRNA-1388) in January 2020.

In other news, the New York Times reported Tuesday on an escalating dispute between Moderna and the U.S.…

A leading pharma trade group reacted fiercely to the U.S. government’s Wednesday decision to support a temporary waiver of intellectual property rights for Covid-19 vaccines. The Pharmaceutical Research and Manufacturers of America (PhRMA) said the move would “sow confusion,” “weaken already strained supply chains,” and “foster the proliferation of counterfeit vaccines,” rather than save lives.

Meanwhile, WHO chief Tedros Adhanom Ghebreyesus praised the Biden administration’s decision…

Merck’s four-year, $2.54 billion patent-infringement saga against Gilead finally ended on Tuesday after the U.S. Supreme Court refused to hear an appeal of a lower court’s ruling that Merck’s hepatitis C treatment patent was invalid, Reuters reported.

Bloomberg Law said the decision—based on the claim that the patent was overly broad—could expose more patents to challenges.

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Media reported this week that the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board has denied Gilead’s request to review two government-owned patents for the company’s pre-exposure prophylaxis (PrEP) product, Truvada. The board issued a similar ruling earlier this month after Gilead filed challenges against two other PrEP patents owned by the U.S. Centers for Disease Control and Prevention.

Britain’s Wellcome Trust issued a report last week saying “too many people” lack access to the healthcare interventions they need.

Wellcome attributed the problem to a lack of R&D in areas of unmet need, “varied mechanisms” for intellectual property management and pricing, and diverse regulatory approaches—all of which are exacerbated by weak health systems and inadequate healthcare financing.

The report said specific challenges for itself and other health R&D funders…

The U.S. National Institutes of Health announced this week that it has started a Phase 3b trial in Malawi, South Africa, Uganda and Zimbabwe to examine safety and preferred use of daily oral pre-exposure prophylaxis (PrEP) pills and a monthly dapivirine vaginal ring for HIV prevention in pregnant women.

Gilead is donating the PrEP tenofovir/emtricitabine tablets and the International Partnership for Microbicides is supplying the vaginal ring (currently undergoing review by the European…

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Citing a “pivotal time” in gene therapy, the U.S. FDA yesterday released new policies to “help advance the field” while ensuring safety and effectiveness. The six final guidance documents cover issues including long-term follow-up, retroviral testing, and chemistry, manufacturing and controls—while new draft rules narrow companies’ ability to claim exclusivity over therapies.

The agency has seen more than 900 investigational new drug applications for clinical studies in gene therapy,…

The U.S. Department of Health and Human Services (HHS) launched a no-cost HIV pre-exposure prophylaxis (PrEP) program for uninsured patients yesterday. “Ready, Set, PrEP” will distribute Gilead-donated Truvada PrEP pills through three major pharmacy chains—CVS, Walgreens and Rite Aid, which will donate their dispensing services.

Gilead announced its 2.4 million bottle donation in May amid activist outcry over Truvada’s pricing. But after HHS signed a $6 million contract with the…

The U.S. Department of Health and Human Services (HHS) announced last week that it is suing Gilead for patent infringement related to pre-exposure prophylaxis (PrEP) for HIV prevention. By refusing to obtain a license for HHS patents, Gilead is profiting from taxpayer-funded research used to develop its blockbuster Truvada and Descovy drugs, a press release said. In August, Gilead filed a petition with the U.S. Patent and Trademark Office to re-review HHS PrEP patents granted since 2015. The…

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Merck KGaA announced this week that it is licensing its CRISPR genome-editing technology to fellow German company Evotec. The press release said the deal builds on agreements made in 2016 for Evotec to use Merck KGaA’s genetic reagents (including CRISPR and shRNA libraries) for drug screening. Merck KGaA said Evotec plans to use CRISPR to develop “precisely engineered assays to determine the biology and toxicity for potential drug candidates during the drug development cycle.”

In other…