FDA and Senate leadership ask U.S. patent officials to change intellectual property strategy

In letters to the U.S. Patent and Trademark Office (USPTO) in September 2021, FDA acting Commissioner Janet Woodcock, MD, as well as Sens. Patrick Leahy, D-Vermont, and Thom Tillis, R-North Carolina, of the Senate Judiciary Subcommittee on Intellectual Property, suggested ways the office could potentially reduce drug monopolies. In an effort to reduce the price of medications, the FDA and Senate are both exploring methods of limiting pharmaceutical companies' abilities to extend drug monopolies by leveraging patent strategies.

In July 2021, President Biden issued an executive order that called for federal agencies to create policies promoting increased competition in the U.S., including the goal of lowering prescription medication costs by increasing competition through better access to generic and biosimilar drugs.

As a result, the patenting process for therapeutics is under examination. Some suggestions from the FDA and Senate on how the USPTO can better screen patent applications include avoiding practices that allow for companies to obtain patents for minor adjustments to therapies, block competition via expensive litigation, or create “patent walls” of hundreds of patents for a drug that's already been approved. Dr. Woodcock also criticized the practice of “product hopping,” which requires patients to use new formulations of newly patented drugs, rather than switch to a generic.

In Dr. Woodcock's communication to the USPTO, she referenced a study showing that 78% of the new patents granted between 2005 and 2015 were issued to existing drugs, rather than new therapies.

Source: asamonitor.pub/3ubNFwB

Scientists detect autoimmune antibodies linked to severe COVID-19

Scientists at New York University's Grossman School of Medicine have learned that autoimmune antibodies that bind to DNA or phosphatidylserine, a fat molecule, may be the source of COVID-19. These antibodies were found twice as frequently at the onset of infection in patients whose condition quickly deteriorated versus patients whose health did not worsen.

The research published in Life Science Alliance may help determine optimal ways to treat patients with the potential to have severe COVID-19 symptoms (Life Sci Alliance September 2021). Patients with the autoimmune antibodies, which attacked their healthy cells, were five to seven times more likely to experience severe disease compared with patients containing stable levels of antibodies.

This information can help health care workers decide which patients are most likely to need intensive care treatment and monitoring.

BioNTech mRNA cocktail achieves cancer treatment success in rodent trials

BioNTech is looking for ways to apply its mRNA technology, which is incorporated in its COVID-19 vaccine created with partner Pfizer, to treatments for cancer. BioNTech researchers have produced an mRNA cocktail designed to lead cells to produce their own cancer-fighting molecules.

As reported in Science Translational Medicine, scientists injected the mRNA cocktail directly into the colon and melanoma tumors in 20 mice and observed halted tumor growth in all subjects as well as a complete cancer regression in 17 of the subjects (Sci Transl Med September 2021). When combined with anti-CTLA-4 or anti-PD-1 checkpoint inhibitors, the mRNA cocktail's effect was strengthened.

Bats' immunity to COVID-19 could inspire new therapies

Since bats function as “reservoir hosts” for several coronaviruses, but never develop disease symptoms, their immune systems could hold the key to fighting SARS-CoV-2.

Researchers at Monash University in Australia compared human and bat responses to COVID-19 at three different stages of the disease. They found that bats produce a “fine-tuned immune response” that yields “only mild and transient inflammation.” This difference in response can be attributed to how inflammasome – a set of proteins in the innate immune system – is activated in bats versus humans.

A report published in Science Immunology theorized that, in bats, receptor genes to natural killer cells have the potential to decrease the inflammatory cascade created by viruses (Sci Immunol September 2021). Researchers say this knowledge could inform new strategies for COVID-19 therapies, such as shifting focus to bolstering type I and type III interferon responses with treatments at an early stage of the disease.

Although vaccines are helping prevent the spread of COVID-19, there is still a need for therapeutics to alleviate severe respiratory distress in some patients with severe symptoms.

Medtronic purchases implanted infusion pump technology for new treatment development

Medtronic has purchased the intellectual property rights to implanted infusion pump technology developed by the Alfred E. Mann Foundation for Scientific Research. The acquisition of technology from the Mann Foundation, a Los Angeles-based medical device incubator, will help Medtronic continue to bring new diabetes technology to patients.

The acquired technology is unique from other implanted pumps already on the market. The Mann Foundation's technology has increased precision in insulin delivery and is compatible with MRIs and can detect occlusions. Medtronic and the Mann Foundation will now partner to innovate a new type of implantable insulin pump aimed at patients with difficult-to-treat Type 1 diabetes.