Report structure
Download the «Report structure» (PDF)
Below we explain in detail what the purchased material contains and the terms of access, so it is easier for you to decide on a purchase and understand how to use the information you receive.
These terms are set out in the public offer agreement, which you must read before paying for the information service.
The site hosting the Content: shop.pctguru.ru
1. Format and composition
The Content is an analytical report on a specific INN in PDF format (the file contains the INN name and opens on any device). The length is typically 13–15 pages. The report combines competitive intelligence with a patent clearance analysis for Russia / the EAPO (taking US practice into account) and is prepared by a specialist from open and closed, national and international sources.
Previously the patent data was provided as a separate Excel file of three sheets («Executive summary», «Patent analytics», «Detailed patent table»). That material is now fully included in the PDF report (the «Patent protection» section) and supplemented with commercial and manufacturing analysis.
Every fact in the report is marked with a source reliability status:
- [OFFICIAL] — verified: FDA/EMA, the originator, SEC, patent databases, peer-reviewed publications;
- [ANALYTICAL] — industry analytics and press;
- [ESTIMATED] — an estimate, without official validation;
- [NO DATA] — not publicly confirmed.
2. What the report consists of
| Section | What is inside |
|---|---|
| 00. Summary and methodology | A brief summary of the drug and the methodology: the list of sources and their reliability statuses. |
| 01. Drug overview | An INN profile: trade name, modality, mechanism, originator, first approval, indications, clinical basis, status in Russia. |
| 02. Development history | A chronology: target discovery, key applications, development, clinical programmes, approvals, landmark patent disputes. |
| 03. Market significance | Therapeutic value, indications and dosing, competitive dynamics, position in Russia/CIS, the window for a biosimilar/generic. |
| 04. Competitive landscape | Direct and indirect competitors — by mechanism and by class — and the situation in Russia. |
| 05. Patent protection — Russia/EAPO | The core of the report: a threat summary, an «Executive summary» with safe launch dates, and a card for each intellectual-property asset with the specialist’s assessment. |
| 06. Entry opportunities — patent clearance | Entry and design-around strategies by layer of protection, with an assessment of applicability and prospects; a dual Russia/EAPO and US focus. |
| 07. Routes to obtain the molecule | The manufacturing paradigm: for biologics — expression, production/purification, formulation, raw materials, regulatory path; for small molecules — synthesis. Appendix — amino-acid sequences (for biologics). |
Some attributes may be missing because they do not actually exist — an INN may have no commercial designation, regulatory data, and so on.
3. How to read the patent part (section 05)
The summary and the «Executive summary». At the start of the section there is a visual summary: how many IP assets block entry, how many are conditional (can be worked around or challenged), and how many do not stand in the way. A separate «Executive summary» box gives the dates when a generic/biosimilar may be safely launched (DAY 1 LAUNCH) and the conditions for each date.
An IP asset card contains: the number, the rights holder, the application number, the priority, the term, the substance of protection, the specialist’s assessment, and a colour-coded threat label:
- Blocking — an active IP asset that stands in the way of development or entry: cannot be worked around / challenged, or a high risk;
- Conditional — an asset that can be worked around (excluding indications, a different delivery device) or challenged; or an application that is a risk factor;
- Non-blocking — an asset that does not affect the relevant indications, has expired, or belongs to a third party.
On the number of IP assets. The product description states the number of IP assets recorded during the analysis. The price of the service does not depend on their number: the strength of the assets and the ability to work around or challenge them vary greatly, and in any case the specialist searches, filters and analyses the entire body of data to reach the final result.
4. File access and technical requirements
The file is available via a link once payment reaches the Contractor’s account. The Content may be downloaded once (1) to the Customer’s device. Requirements: a device able to display information obtained from the site, and an internet connection to interact with the site and download the file.
If you have trouble accessing the file, please make sure that: you have internet access; you are logged in to shop.pctguru.ru with your username and password; in your account, under the Orders tab, the order has the status Completed; and under the Downloads tab the file is available for download. If that does not help, contact the administration at work@pctguru.ru, quoting your order number to identify the service.
5. Content updates
The Content is updated every 180 days — the Contractor has determined this period to be the most appropriate for refreshing patent-clearance data. The Contractor may update the information on a specific INN sooner or later than 180 days and takes the Customer’s requests into account.
To access the updated information, the service is paid for again. In doing so, the Contractor takes earlier use of the service into account and provides a Coupon — a discount whose size depends on how long ago the information on a specific INN was updated. The Coupon does not apply to repeat payment made after 180 days or more.
Notes
- The specialist’s comments on the possibility of working around or challenging an IP asset are not a call to action, are of a preliminary nature, do not guarantee a result, and are not a legal opinion. Such comments help to filter and give an initial assessment of the strength of IP assets and to compare the data with the possibility of reproducing a generic or biosimilar.
- Administration hours: daily from 11:00 to 23:00, except public holidays and weekends.
- The maximum response time to a Customer’s message is 24 hours.
- Technical support is available by email at work@pctguru.ru.