Posts Tagged: "life sciences"

Life Sciences Masters Panelists Warn of IRA Impact on Innovation

IPWatchdog’s Life Sciences Masters 2023 concluded today, following three days of panels that tackled some of the most pressing issues facing intellectual property professionals in the life sciences space. In the spotlight was the Biden Administration’s recent passage of the Inflation Reduction Act (IRA) and its potential impact on future drug development in the United States. Prescription drug pricing controls are one aspect of the IRA, a landmark piece of legislation passed by Congress last August that also directs funding to be spent on clean energy projects and increased tax enforcement. The IRA authorizes the Health and Human Services (HHS) Secretary to establish a Drug Price Negotiation Program, codified at 42 U.S.C. § 1320f, to establish maximum fair prices of certain drugs that become eligible for the program because they constitute a large portion of expenditures by Medicare Part B and Part D patients. Pharmaceutical companies who do not agree to the price set during negotiations with HHS will have to pay a new excise tax codified at 26 U.S.C. § 5000D calculated based on daily sales and starting at 65%.

Navigating the Brazilian Regulatory System for Life Sciences and Agribusiness

Regulatory Law in the Life Sciences and Agribusiness sector plays an essential role in balancing scientific innovation and the protection of public interests. In Brazil, a country recognized for its vast biodiversity and potential for scientific research, regulation in this field is crucial to ensuring responsible access to genetic resources and to address emerging issues, such as cannabis regulation. Before commercializing products in the Brazilian market, a company must be able to navigate a vast array of laws and regulations, especially in cases involving pharmaceuticals, seeds, pesticides, food or feed, cosmetics and medical devices. On top of that, when it comes to biotechnology related products involving genetically modified organisms (GMOs), or products derived from access to genetic resources or where traditional knowledge is associated, another layer of rules is applicable.

Patent Eligibility and the Life Sciences Industry – The Impact of Law on Innovation in the Industry

One of the panels at last year’s IPWatchdog’s Life Sciences MastersTM Series addressed the thorny problem of patent eligibility.  I moderated the panel, titled Patent Eligibility and the Life Sciences Industry–What Next?, where the speakers, with input from passionate audience members, discussed the impact of section 101 jurisprudence on innovation in the life sciences industry. Do the limits on what is patent-eligible subject matter created by the courts strike the proper balance or do unpredictable court decisions harm investment and research in the life sciences? While the majority view appeared to be that patent-eligibility reform is necessary, both to provide clarity and to incentivize certain type of inventions, the panel also expressed the idea that some form of section 101 jurisprudence is necessary to prevent “discoveries” from being monopolized, which could also harm innovation.

Claim Drafting Issues for Biotech, Chemical and Pharma Patent Applications, Part II: From Indefiniteness to Negative Claim Limitations, Know Best Practices

In our previous blog post, we covered claim construction, Markush Groups, and dependent claim invalidation. As stated previously, while it is impossible to cover all of the various issues related to claim drafting for biotech, chemical and pharma patent applications, in Part II we will highlight some more of the most common issues that may come up, including changes to the law around indefiniteness; product-by-process and means plus function claims; and negative claim limitations.

Claim Drafting Issues for Biotech, Chemical and Pharma Patent Applications, Part I: Claim Construction, Markush Groups, Dependent Claim Invalidation

The fields of patent prosecution and patent litigation are ever-evolving, and with every new court decision there are lessons for patent practitioners. While it is impossible to cover all of the various issues related to claim drafting for biotech, chemical and pharma patent applications, here, and in future blog posts, we will cover a range of claim drafting topics of interest.