We review contracts daily at BioPharma Law Group. These range from simple CDAs to more complex licensing discussions. Below are some practices that I have encountered over the years that frustrate lawyers and their clients and can result in prolonged negotiations and can sometimes even jeopardize deals.   Make late-stage edits At the beginning of negotiations, it is common for one party to mark up the other party’s contract template and send it back. These mark-ups are typically done through redlining. The other party then reviews the redline and returns it either having accepted the edit ..read more

Intellectual property (“IP”) assignment agreements are thorny subjects for employees at both mature and early stage companies. Many employees are skeptical about entering into these agreements because they want to retain ownership of the ideas they create while they are away from work. These days, the line between work and one’s personal life are increasingly more difficult to distinguish. For those who have been working from home for the last year, the two paradigms might seem to have merged into one entirely. Accordingly, employees who have entered into IP assignment agreements should evalua ..read more

On August 26, 2021, the Federal Circuit revisited the written description requirement in determining patent validity in Juno Therapeutics v. Kite Pharma. In this case, the Federal Circuit’s decision addressed Juno’s patent written description between Juno Therapeutics and Kite Pharma over Kite’s CAR-T anticancer therapy, Yescarta®. Yescarta® is a $373,000 per treatment regimen. Juno does not market a competing product. In general, CAR-T anticancer therapy works by modifying a patent’s T cells to stimulate a patient’s immune response against tumor cells. CAR-T cells involve a Car-T receptor co ..read more

​Joint inventorship presents one of the most challenging situations within patent law. It allows the ownership of a patent to reside with more than one person; and, as a result, it can create uncertainties over the patent’s chain of title when the inventors’ interests diverge. To avoid such problems, it is preferable to address joint inventorship issues upfront—before any discussions with investors or collaborators takes place. The fact pattern below highlights situations that commonly arise with joint inventors and it then proposes some solutions.   Alice and Dwayne are friends in upstat ..read more

For many early stage inventors, the prospect of securing a patent represents a daunting next step. Cost concerns, complexity, insufficient data, or lack of foresight dissuade inventors from securing patent protection. However, delaying the filing of a patent can cost inventors tremendously. The United States has a first-to-file patent system, which means that the first person to file a patent application receives priority to that application.  It logically follows that if you wait to file then you can lose all rights to your invention; however, this is not the only concern. Failing to ti ..read more

Companies generally have two options when deciding what product to pursue and patent: develop a novel product from scratch or find an existing one and repurpose it. Repurposing existing technologies can offer viable opportunities for companies looking to expand their product portfolios since it eliminates many of the costs, time, and risk associated with developing de novo products. There are two main hurdles when it comes to IP issues involving a pre-existing technology: novelty under 35 U.S.C. Section 102 (“Section 102”) and obviousness under 35 U.S.C. Section 103 (“Section 103”). We will ad ..read more

Drafting a provisional application is often the first step in the road to obtaining a patent. However, due to time or budget constraints, provisional applications are often not afforded the attention that they deserve, resulting in applications that lack the necessary disclosure to support the later-filed non provisional or utility application. When this happens, potentially invalidating prior art that otherwise would have been precluded from the prosecution process by the provisional applications’s filing date could all of a sudden be used to impede patentability. This is becoming increasing ..read more

Provisional patent applications can be a valuable tool for inventors. Such an application serves as a “place holder” for a later-filed nonprovisional (or utility) application. While inventors often debate the need to file a provisional application, filing a provisional application rather than going straight to a nonprovisional has several benefits.  1. Provisional applications establish a priority date. While it is not examined by the USPTO, a provisional application allows the researcher to establish a priority date for an invention that predates subsequent prior art from impeding paten ..read more

On May 29, 2020 the World Health Organization (WHO) officially launched the COVID-19 Technology Access Pool (C-TAP), an initiative which is intended to improve access to existing and new medical technologies, such as therapeutics and vaccines, which are developed in response to the global COVID-19 pandemic.    According to the WHO, the technology pool is meant to ensure better access to existing and new COVID-19 health products through five elements:   1.public disclosure of gene sequences and data; 2.transparent clinical trial publications; 3.funding agreement clauses on availa ..read more

​Chimeric antigen receptor, or CAR, T cell therapies use the body’s own T cells to fight off cancers. The development of such cellular immunotherapies is becoming increasingly popular technology for treating cancer. Novartis’ Kymriah and Kite’s Yescarta are currently the only two FDA approved therapies on the market but many other companies are looking to launch products in this highly lucrative and therapeutically promising field.   Despite the promising nature of cellular therapeutics, however, CAR T cell therapeutics present some unique IP challenges that should be resolved early on in ..read more