INTRODUCTORY COMMENTS RE: BIOTECH/PHARMA EXTENDED PATENT FAMILIES
In complex art areas like biotech/biopharma, patent strategy is about building extended patent families in key jurisdictions throughout the world, and especially in the U.S. This buildout should include numerous issued patents of different claim types and scope, from numerous related patent filings. These related filings typically share a lot of common disclosure, with numerous subsequent filings, typically provisional patent applications and PCT applications claiming priority therefrom, that have additional disclosure in the form of new embodiments, concepts, and supporting data.
The buildout of extended patent families raises prior art issues within the family as earlier-filed family member(s) become prior art against later filings. Thus, building out your key patent families should be a proactive, well thought-out ongoing process starting with the drafting of your earliest priority filing, and continuing for decades, as long as the covered products and/or methods remain high value.
KEY DATES IN EXTENDED FAMLY BUILDOUT REVEAL 3 ZONES OF OPPORTUNITY
An analysis of key dates during this buildout reveals 3 key zones of opportunity:
1 year post-filing provisional application expiry dates
PCT/direct national stage filing deadlines
Multiple provisional application filings can be priority documents for a PCT (or direct national stage) application, as long as they were filed within 1 year before the filing of the PCT application
The same provisional application can be a priority document for multiple PCT applications within an extended family
Publication dates (at least approx. 18 months from earliest priority date)
1-year post-publication dates (1 year after each pub date above)
The bolded dates above are those that directly relate to prior art considerations of prior members of an extended patent family. The 1-year post publication dates are primarily relevant for U.S. filings. These key dates that occur during an extended patent family buildout create 3 zones of opportunity/risk with respect to subsequent patent application filings in an extended family (See figure):
Zone 1: Within 1 year from 1st priority application filing
By far the best opportunity for adding new concepts and supporting data to follow-on provisional applications, since this all can be included in the 1st PCT application.
Zone 2: From the day after the filing date of a non-provisional application (e.g., 1 year + 1 day if PCT filed on 1 yr anniversary of earliest priority app), to the earliest publication date of the application
2nd best opportunity for adding new concepts and supporting data.
In bio/pharma key data can be generated in Zone 2 (e.g., between ~12 and ~18 months after a 1st provisional filing).
Even outside the U.S., minor claim elements can be added in Zone 2 to avoid novelty issues from a prior family filing, to provide an opportunity to get better data into a follow-on 2nd PCT filing.
Zone 3: 1 day after earliest publication to 1 year after the earliest publication date
(Mainly relevant for the U.S.) another opportunity to add new concepts and data.
In our experience, in bio/pharma the period from ~18 to ~30 months after an initial priority patent filing, can be an important time for incorporating key data and new concepts, for example that were conceived to overcome issues that arose during product development.
The 3 key zones of opportunity have different relevance depending on the jurisdiction. Zone 1 is by far the best time to add new concepts, embodiments, and data in all major countries. Zone 2 is relevant to all jurisdictions, but most relevant outside the U.S., where it is the last opportunity to add new concepts and data where, before publication, the 1st non-provisional application (usually a PCT) in the family is only available for novelty purposes. Thus, new inventive concepts can be used to add new claims and/or added to existing claims, even if such claims don’t involve an inventive step over the published PCT in the family. This can provide the opportunity to get more data into the improvement application(s) than was available at the time of filing the original application in the extended family. Zone 3 is only relevant to the U.S. among the major jurisdictions (U.S., EP, CN, and JP) due to the exception in the U.S. to an inventor’s own disclosures made 1 year or less before the effective filing date of a pending patent application (See 35 USC §§ 102(b)(1)(A) and (B)).
Keep in mind that subsequent priority application filings in an extended patent family each create their own Zones 1-3 of opportunity, although the zones are often most important based on the 1st filing of an extended family. And multiple provisional applications can be priority filings for the same PCT application, as long as they are filed within 1 year before the filing of the PCT application. Furthermore, the same provisional application can be a priority filing for multiple PCT applications, as long as the provisional application is still pending (i.e., within 1 year of its filing date) when a subsequent PCT application is filed. Finally, in our experience as U.S. practitioners, the U.S. provides more opportunity for deeper buildout of an extended family than other major jurisdictions: A key biotech patent family, for example, may include 1 or a few patent applications and patents in each of Europe, China, and Japan, and at least 2 or more times as many applications and patents in the U.S. This is probably because certain prior art exceptions in the U.S. give more opportunity for new patent application filings with earlier members in an extended family not available as prior art. Furthermore, the U.S. has very flexible rules with respect to subsequent filings and the ability of a disclosure to support claims. Finally, the U.S. does not require annual annuity payments for each pending patent application/patent, but rather maintenance fees at 3½, 7½, and 11½ years from the date the patent is granted.
WHY ARE EXTENDED PATENT FAMILIES COMMON IN BIOTECH/PHARMA
The above considerations and zones of opportunity are very relevant for private biotech/pharma companies for at least the following reasons:
Often founded on a platform technology
Since data can be time-consuming and expensive to generate, key data and numerous improvements are often conceived in the months/years after the initial platform patent filing
Often involve multiple patent application upgrades with new concepts and data within priority years of provisional applications in an extended family
Much of the value of the company typically relies on strong patents issuing from one or more foundational extended patent families
IS YOUR COMPANY DOING A GOOD JOB OF BUILDING EXTENDED PATENT FAMILIES?
Is there an extended member of your R&D team that is carefully “sensing” R&D activities for new inventions including improvements and data to strengthen and broaden important patent families?
Is your company investing in follow-on R&D to help strengthen its most important IP filings (e.g., generating supporting data for various disclosed embodiments) in addition to its regular product development activities?
Are publication dates and 1-year post publication dates included in your patent docket? And is there a process ahead of these docketed dates to decide whether to file an upgraded patent application based on new concepts/data that has been generated by R&D?
Does your IP team include a patent professional(s) who is responsible for your global claiming and filing strategy, who directs foreign patent associates, and who considers different disclosures and priority dates within an extended family, different legal standards and prior art laws in different countries, and who is aware of key relevant art for the extended family, including your own art from that same extended family?
The above point, ideally includes a disclosure map to assure that the team is keeping track of which applications in an extended family were the first to disclose the various and numerous concepts that are important for that family, and which applications have actual data to support these concepts and combinations thereof.
CONCLUDING REMARKS
Often for important areas of innovation for your company, and especially in unpredictable art areas like biotech/pharma, it is important to build extended patent families that include multiple related patent application filings and patents throughout the world. Such extended families raise issues with respect to family members being prior art against future family members. These considerations reveal 3 zones of opportunity with respect to subsequent patent application filings as new concepts and/or new data are conceived or generated in the months and years after an initial patent application filing. Your patent team should closely monitor your R&D progress and get the support of your R&D team, to continue to add new patent application filings to build out extended patent families in your key areas of innovation to maximize the value of your company and its patent estate.
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Post History:
8/30/24 posted (EJV, VV)
This blog post is not legal advice and does not necessarily represent the viewpoint of any of the clients of Double Helix Law. Please seek the guidance of a registered and licensed patent attorney or patent agent for any patent-related questions you have. Please note, especially regarding statements made for jurisdictions outside the U.S., that the authors of this article are U.S. patent practitioners.
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