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How the BIO IP Conference moved the conversation forward. Also, patient perspectives on diabetes innovation. (761 words, 3 minutes, 48 seconds) |
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BIO IP Conference covers present and future of patent law |
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Experts discussed changes to intellectual property impacting joint inventorship, public perception of patents, and the use of AI to assist patent lawyers at BIO’s IP Council and Committees Conference.
When, where, what: BIO’s IP Conference, running Nov. 17-19 in Southern California, was the latest version of an annual gathering first held in 2004. Offering best-practice sharing and networking, this is the only industry-sponsored conference focused specifically on intellectual property in biotechnology.
Why it matters: Without patents to protect IP, biotech investors have no way to guarantee they will recoup their investments. Without investments, there will be no development of innovative new medicines.
On using AI: AI can help patent attorneys work more efficiently and economically, but care must be taken to abide by ethical standards and be transparent with clients. Practitioners must hone their prompting skills and check results or risk being caught out by opposing counsel, an expert panel said.
On joint inventorship: Collaboration is critical in biotechnology—but can you tell the difference between a scientific collaborator, a co-author, and a co-inventor? After breaking down leading cases to show how courts decide who owns an invention, a panel recommended means to protect ownership and prevent conflict.
BIO’s view: “There has been a lot of talk about new and different approaches to IP questions under the new administration, including some improvements,” said Dr. Hans Sauer, BIO’s Deputy General Counsel and VP for Intellectual Property. “It’s great to have an event where we can prepare and be informed about these developments.”
Read more on Bio.News.
See also: Why and how BIO supports IP. |
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Patient perspectives matter in type 1 diabetes innovation |
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While some may consider type 1 diabetes (T1D) manageable, people with the condition are eager for access to the latest innovations, which offer the promise of a cure.
What patients say: Despite potential risks, 91% of people with T1D would try a new disease modifying therapy (DMT) and 100% would try a new cell therapy, according to a Breakthrough T1D survey that the organization promoted for November Diabetes Awareness Month.
Why it matters: “There is no substitute for consulting people living with or caring for someone with type 1 diabetes when considering new therapies with novel risks and benefits,” say the survey’s authors.
What’s possible: DMTs slow the progression of T1D by preventing the immune system from attacking insulin-producing beta cells in the pancreas. Cell therapies restore the body’s ability to produce insulin by delivering new insulin-producing cells.
The challenges: The first generation of these therapies are available for some patients, but more development is needed to make them safer and more widely available.
What can be done: Breakthrough T1D works to accelerate this innovation through coordinated work that advances funding, research, development, regulatory processes, access, and adoption simultaneously. This includes research at its own Centers of Excellence and the development of clinical care guidelines and treatment protocols.
Read more on Bio.News.
See also: BIO’s Patient Advocacy and Alliances.
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New No. 2 at CDC has criticized past COVID vaccine policies. Dr. Ralph Abraham, who criticized Centers for Disease Control and Prevention (CDC) vaccine policies during COVID and ordered the Louisiana health department to stop promoting vaccination when he was that state’s surgeon general, was named principal deputy director at the CDC, the agency’s No. 2 position, as of Nov. 23, The New York Times reports. Dr. Abraham has reportedly taken stances that contradict accepted scientific evidence, including suggesting pregnant women should avoid taking Tylenol and backing hydroxychloroquine to treat COVID. Read more here.
CMS announces prices set for 15 more prescription drugs. The Centers for Medicare & Medicaid Services (CMS) on Nov. 25 announced the prices for 15 drugs, the latest to have their prices set under the terms of the Inflation Reduction Act (IRA). The prices will take effect in 2027 and will apply to the amount that will be paid by Medicare. According to a statement from BIO:“The Medicare price control provisions of the IRA are already negatively affecting the research and investment decisions of the biotech industry in the US. As we have said many times before, the IRA impacts not just the drugs targeted, but the entirety of the biotech ecosystem, which must make research and funding decisions many years in advance of ever hoping to bring a product to patients. We will continue our efforts to mitigate the harm these provisions have on patient access, innovation, and our continued ability to lead the world in drug development.” Read more here.
Novartis gains FDA approval for gene replacement therapy to treat spinal muscular atrophy. Novartis today announced that the US Food and Drug Administration (FDA) has approved Itvisma® (onasemnogene abeparvovec-brve), a gene replacement therapy, for the treatment of people aged 2 and older living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene. Itvisma® is the first and only gene replacement therapy available for this broad population and works by replacing the SMN1 gene to improve motor function and potentially reduce the need for chronically administered treatments with one dosage, the company said. Read more here.
FDA approves Amgen’s treatment for extensive stage small cell lung cancer. Amgen announced on Nov. 19 that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. Read more here. |
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