A biopharmaceutical enterprise encountered a time conflict between patent application and academic paper publication in the research and development of "anti HER2 positive breast cancer bispecific antibody". The antibody drug enhances the tumor inhibition rate to 82% through dual target synergistic effect. The research and development team is eager to improve its industry status by publishing preclinical research results in top journals. However, if key data such as core amino acid sequences and mechanisms of action are made public in advance, it will lead to the loss of novelty in subsequent patent applications, directly threatening the hundreds of millions of yuan worth of new drug research and development investment.

After our team's in-depth involvement, we first conducted a graded evaluation of the technological achievements and clarified the protection boundaries: 7 items including antibody variable region sequence, expression vector construction, purification process, etc. were included in patent protection, while 4 items including animal model establishment and pharmacological evaluation methods were used as literature materials. To address the issue of time conflicts, a "patent priority+strategic disclosure" plan is formulated: first submit a patent application containing core technology, utilize the "temporary protection" function of the patent application, and publish a paper after the patent is published. The paper adopts conservative descriptions of the core sequence and hides key active site data.

During the patent writing stage, assisted the company in completing 5 invention patent applications, among which "an anti-HER2 bispecific antibody and its application" adopts a broad claim layout, covering antibody sequences, derivatives, and pharmaceutical uses. The specification is supplemented with a large amount of experimental data to enhance patent stability. During the publication stage of the paper, the guidance team adjusted the wording to focus on the newly discovered mechanism of action based on the publicly available content of the patent. The final paper was successfully published in the Journal of Biochemistry with an impact factor of 4.2.

After the implementation of the plan, the patent application was successfully authorized, and the protection scope fully covered the core technology. The enterprise completed a Series B financing of 250 million yuan based on this patent. After the publication of academic papers, the company gained attention from international pharmaceutical giants, established technical cooperation relationships, and accelerated the process of drugs entering the clinical trial stage. Through the collaborative layout of patents and papers, enterprises not only protect their core technologies but also gain academic recognition, laying a dual guarantee for the subsequent launch of new drugs.