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« USPTO News Briefs | Main | FDA Biosimilar Approval Recap – 2021 »

January 04, 2022


Looking in from Europe, I hope this split Decision will stimulate much debate about the WD requirement under First to File. There are nearly 50 members of this one patent family but, as yet, no patent issued by the EPO. Applicant is now on its third generation divisional there, unable to satisfy the EPC's WD requirements. Kevin, I looked for, but didn't find, in the above any opinion from you who has the better view, O'Malley or the Chief Judge.

Prosecution at the EPO in this case is enriched by numerous third party observations on patentability. Under FtF, rival filers slug it out on the exclusive basis of what each disclosed to the PTO, and on what date. The WD requirement is of decisive importance to the outcome. And then there are the ultra-high value evergreening cases too. It is inevitable that in the USA WD requirements will become progressively more onerous. Uncertain though, is how long it will take, to adjust to the exigencies of FtF patent law. See, it took the EPO decades to develop its notoriously strict "Gold Standard".

Thanks for the European perspective, Max, and Happy New Year.

You are correct that I did not opine on which opinion was best; I think Judges O'Malley and Moore set out the pros and cons of their positions very well, and believe it depends very much on what end of the telescope provides your perspective. If I had to choose I think Judge O'Malley's view is more flexible and capable of being applied more evenhandedly; the Chief Judge's position is very doctrinaire and rigid (which would nor fare well with our Supreme Court if they ever considered it which they won't; the issues are much to fact specific). And I also think that if the Chief believed this case smacked of the purported shenanigans associated with the Biogen v Mylan case that this likely colored her view.

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