Pharma IP Toolkit

The Orange Book is the starting point for small molecule exclusivity in the US. It lists the patents the originator says cover each approved drug, with regulatory exclusivity dates, so it shows which patents a generic must challenge to launch early. The Purple Book is not a full patent register for biologics. It only shows patents identified in biosimilar litigation, so a missing patent does not mean there is none. In Europe there is no patent linkage, so combine EMA approval dates with national SPC registers to map exclusivity.

Cell and gene therapy is a very fast-moving field, and the regulatory guidance changes often. IP strategy has to keep in step with the latest regulatory guidance and definitions, as these shape how products are characterised and described. WHO and EMA definitions, and the way approved labels describe a product, are also a good source of claim language.

Clinical trial registers are often where information about a new product first appears, sometimes before any paper or patent. A registration is prior art from the day it is published, and ClinicalTrials.gov keeps every version of a record, so you can see exactly what was public on a given date.

An International Nonproprietary Name (INN) is the official generic name for an active ingredient, chosen by WHO and used worldwide, such as adalimumab or tisagenlecleucel. INNs matter for IP because they are how a product is identified in regulatory filings, SPC applications and the literature. Proposed INN lists also publish the structure or sequence of the active ingredient, sometimes before anything else, so check their dates against your priority dates.

Many sequences appear only in patent documents, so search Lens PatSeq as well as BLAST. A short match can still matter for claims to fragments, epitopes or CDRs.

SureChEMBL extracts structures from patent text and images automatically, so it finds compounds that keyword searches miss. Always check a hit against the original document, as automatic extraction can make mistakes.

Preprints and conference abstracts count as prior art. For a web page, a Wayback Machine snapshot is widely used as evidence of when the content was public.

Patent applications are usually published 18 months after the earliest priority date, so the newest filings will not be visible yet. A patent can only be enforced once it is granted, and only where it is in force. When you read a patent, the claims define the scope of protection, but the examples show you the data the applicant actually has.

UPC decisions are published in the language of the proceedings, often German. Search by patent number, then use machine translation for a first read. For UK judgments, Find Case Law holds the official versions.

Never put confidential information about an invention into a public or non-enterprise AI tool. If the provider can see, store or train on what you enter, this could be treated as a disclosure of the invention and put its patentability at risk. Use enterprise tools with contractual confidentiality and no training on your data.