Bonum Certa Men Certa

The European Patent Convention (“EPC”) Does Not Allow Patenting of Life Itself

Wedding Invitation



Summary: Unless the underlying rules are respected and Europe's largest patent office actually follows the laws it's governed by, Europe's patent system won't promote innovation; the European Patent Office's decision on Alexion (patent application 3124029 rejected) is good news

BOTH the European Patent Office (EPO) and the U.S. Patent and Trademark Office (USPTO) still grapple with a question that should not even be asked. Why? Because the answer to it should be obvious. The American 35 U.S.C. ۤ 101 is pretty clear about naturally-recurring phenomena and Europe has already spoken -- many times in fact -- about patents on life. If only Campinos and Battistelli actually obeyed the law...



Today's EPO not only tolerates patents on life and nature; it's also actively promoting software patents in Europe. The EPO is totally out of control!

To our surprise, and for a change, yesterday we saw this article from Phil Taylor (pharmaphorum). When patents are misused not for elevation of the sciences but for monopoly that enables ruinous price hikes in medicines this is what should happen:

The European Patent Office has blocked an attempt by Alexion to extend the patent protection for its blockbuster drug Soliris, setting up biosimilar competition from 2022.

The EPO delivered its verdict late last week but Alexion’s share price remained unscathed by the news, suggesting investors are confident that the company will be able to migrate revenues to its follow-up drug Ultomiris by that date.

In a brief Securities & Exchange Commission filing, Alexion said the EPO had rejected its attempt to extend two patents for Soliris (eculizumab) and it is considering an appeal.

It’s also facing a patent challenge to Soliris in the US from Amgen, which is developing a biosimilar version of the drug called ABP 959 and has petitioned the US Patent and Trademark Office (USPTO) to review Alexion’s intellectual property on the drug. It made the move after Alexion won an extension on its US patent life until 2027.

Soliris – a complement C5 inhibitor used to treat several rare diseases including paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS) – achieved sales of $1.94 billion in the first six months of the year, accounting for more than 80% of the biotech’s total sales in that period.


Kelly Davio (Center for Biosimilars, i.e. patent maximalists and monopolists) responded as follows to the EPO denying antibody patents:

Last week, Alexion disclosed in a filing to the US Securities and Exchange Commission that the European Patent Office (EPO) did not grant Alexion its request for 2 patents on its brand-name eculizumab product, Soliris, a C5 complement inhibitor that treats rare and ultrarare diseases.

The Form 8-K, dated September 5, indicates that the office declined to grant patent application 3124029, which covers a pharmaceutical composition comprising an antibody or antibody fragment binding to C5 for use in treating a patient with paroxysmal nocturnal hemoglobinuria (PNH), and patent application 3167888, which relates to the composition of matter of eculizumab.


This will probably be mentioned by patent maximalists' blogs such as IP Kat and Kluwer Patent Blog in days to come. Both like to promote patents on life/nature, especially in their current composition (they're both run by Big Pharma firms and their lawyers).

Mind this new IP Kat comment from "CRISPR scientist" (profiteer), who defends monopolies on life itself, ignoring health risks: "It would be feasible, but it would require a separate round of gene editing since no one could want to introduce a marker into the functional gene that is the subject of the first round of gene editing. The gene editing process is complicated, time consuming and costly. And every round of editing harbors the risk of additional unwanted modifications. So, can there really be a benefit if one has to perform an additional round of gene editing only for administrative sake? I shall think no. [...] I don't think that reasonable people are actually worried about their own health. Genetic material in the food you consume has very little possibility to influence your body. And I do doubt that it may cause food allergies. As the article correctly points out, the actual risk is what will happen to the ecosystem. I agree that heavy dependence on fertilizer or herbicides is detrimental. However, that is not what CRISPR is about. Gene editing is simply a stunning, secure and reliable technique to modify a plant's genome. Banning gene editing because it may cause harm in certain scenarios is much like banning operations per se simply because people may die if operated wrongly. We can't igonore the benefits that gene editing is bringing a world where we need more nurtrious food and crops that are able to resist climate change."

This is the classic propaganda/talking point from GMO proponents. We spent a lot of time and energy confronting these lies about a decade ago when we wrote a great deal about Monsanto, now part of Bayer in Germany.

Anyway, it's nice to see the EPO rejecting bad patents, probably showing a little bit of respect for the EPC, for a change...

Miquel Montañá has just mentioned the EPC in relation to a case outside the EPO's remit; he ought to take note of the fact that the EPO's management violates the EPC every day, rendering it moot! To quote yesterday's post from Montañá:

As readers are well aware, one of the difficult tasks when applying article 69 of the European Patent Convention (“EPC”) and its Protocol of Interpretation is to strike the right balance between “interpreting” the claims in the context of the specification, while, at the same time, avoiding “importing” features of the specification into the claims. A judgment of 12 February 2019 from the Barcelona Court of Appeal recently published has warned against the risk of using specification for the purpose of unduly restricting the scope of protection of the claims.

[...]

Interestingly, the Court of Appeal relied on the case law from the European Patent Office (“EPO”) Boards of Appeal (for example, T 1018/02, T 1395/07, T-544/89 and T-681/01) noting that, although they do not decide infringement cases, they do have to interpret the scope of protection of the claims when they examine validity.

Finally, the Court of Appeal added that, although in the past the Court had “read” in the claims features mentioned in the specification which were not explicitly mentioned in the claims, this was done in exceptional cases only, when the feature omitted in the claim was essential for the functioning of the invention. The Court of Appeal added that “But this is not the case, because the interpretation of the defendant and its expert relies solely and exclusively on the preferred embodiments disclosed in the drawings.”

All in all, the main teaching of this interesting judgment is that when applying article 69 of the EPC and its Protocol of Interpretation, care must be applied to avoid “importing” features of the specification into the claims.


Readers are well aware, as we've shown many examples lately, that European courts very often deviate from EPO judgments, which sometimes get delivered by the Boards that are afraid of the Office. This lack of independence is, in its own right, a gross violation of the EPC.

Recent Techrights' Posts

Comparing U.E.F.I. to B.I.O.S. (Bloat and Insecurity to K.I.S.S.)
By Sami Tikkanen
New 'Slides' From Stallman Support (stallmansupport.org) Site
"In celebration of RMS's birthday, we've been playing a bit. We extracted some quotes from the various articles, comments, letters, writings, etc. and put them in the form of a slideshow in the home page."
Thailand: GNU/Linux Up to 6% of Desktops/Laptops, According to statCounter
Desktop Operating System Market Share Thailand
António Campinos is Still 'The Fucking President' (in His Own Words) After a Fake 'Election' in 2022 (He Bribed All the Voters to Keep His Seat)
António Campinos and the Administrative Council, whose delegates he clearly bribed with EPO budget in exchange for votes
Adrian von Bidder, homeworking & Debian unexplained deaths
Reprinted with permission from Daniel Pocock
 
GNOME GUADEC 2022 & Debian Albanian women trafficked to Mexico?
Reprinted with permission from the Free Software Fellowship
Sainsbury's: It Takes Us Up to Two Days to Respond to Customers Upon Escalation (and Sometimes Even More Than Two Days)
It not only does groceries but also many other things, even banking
People Don't Just Kill Themselves (Same for Other Animals)
And recent reports about Boeing whistleblower John Barnett
Over at Tux Machines...
GNU/Linux news for the past day
IRC Proceedings: Monday, March 18, 2024
IRC logs for Monday, March 18, 2024
Suicide Cluster Cover-up tactics & Debian exposed
Reprinted with permission from Daniel Pocock
Gemini Links 19/03/2024: A Society That Lost Focus and Abandoning Social Control Media
Links for the day
Matthias Kirschner, FSFE: Plagiarism & Child labour in YH4F
Reprinted with permission from Daniel Pocock
Linux Foundation Boasting About Being Connected to Bill Gates
Examples of boasting about the association
Alexandre Oliva's Article on Monstering Cults
"I'm told an earlier draft version of this post got published elsewhere. Please consider this IMHO improved version instead."
[Meme] 'Russian' Elections in Munich (Bavaria, Germany)
fake elections
Sainsbury's to Techrights: Yes, Our Web Site Broke Down, But We Cannot Say Which Part or Why
Windows TCO?
Plagiarism: Axel Beckert (ETH Zurich) & Debian Developer list hacking
Reprinted with permission from Daniel Pocock
Links 18/03/2024: Putin Cements Power
Links for the day
Flashback 2003: Debian has always had a toxic culture
Reprinted with permission from Daniel Pocock
Sainsbury’s Epic Downtime Seems to be Microsoft's Fault and Might Even Constitute a Data Breach (Legal Liability)
one of Britain's largest groceries (and beyond) chains
[Meme] You Know You're Winning the Argument When...
EPO management starts cursing at everybody (which is what's happening)
Catspaw With Attitude
The posts "they" complain about merely point out the facts about this harassment and doxing
'Clown Computing' Businesses Are Waning and the Same Will Happen to 'G.A.I.' Businesses (the 'Hey Hi' Fame)
decrease in "HEY HI" (AI) hype
Free Software Needs Watchdogs, Too
Gentle lapdogs prevent self-regulation and transparency
Matthias Kirschner, FSFE analogous to identity fraud
Reprinted with permission from Daniel Pocock
Gemini Links 18/03/2024: LLM Inference and Can We Survive Technology?
Links for the day
Over at Tux Machines...
GNU/Linux news for the past day
IRC Proceedings: Sunday, March 17, 2024
IRC logs for Sunday, March 17, 2024
Links 17/03/2024: Microsoft Windows Shoves Ads Into Third-Party Software, More Countries Explore TikTok Ban
Links for the day
Molly Russell suicide & Debian Frans Pop, Lucy Wayland, social media deaths
Reprinted with permission from Daniel Pocock
Our Plans for Spring
Later this year we turn 18 and a few months from now our IRC community turns 16
Open Invention Network (OIN) Fails to Explain If Linux is Safe From Microsoft's Software Patent Royalties (Charges)
Keith Bergelt has not replied to queries on this very important matter
RedHat.com, Brought to You by Microsoft Staff
This is totally normal, right?
USPTO Corruption: People Who Don't Use Microsoft Will Be Penalised ~$400 for Each Patent Filing
Not joking!
The Hobbyists of Mozilla, Where the CEO is a Bigger Liability Than All Liabilities Combined
the hobbyist in chief earns much more than colleagues, to say the least; the number quadrupled in a matter of years
Jim Zemlin Says Linux Foundation Should Combat Fraud Together With the Gates Foundation. Maybe They Should Start With Jim's Wife.
There's a class action lawsuit for securities fraud
Not About Linux at All!
nobody bothers with the site anymore; it's marketing, and now even Linux
Links 17/03/2024: Abuses Against Human Rights, Tesla Settlement (and Crash)
Links for the day
Over at Tux Machines...
GNU/Linux news for the past day
IRC Proceedings: Saturday, March 16, 2024
IRC logs for Saturday, March 16, 2024
Under Taliban, GNU/Linux Share Nearly Doubled in Afghanistan, Windows Sank From About 90% to 68.5%
Suffice to say, we're not meaning to imply Taliban is "good"
Debian aggression: woman asked about her profession
Reprinted with permission from Daniel Pocock
Gemini Links 17/03/2024: Winter Can't Hurt Us Anymore and Playstation Plus
Links for the day