09.09.19

Gemini version available ♊︎

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

Posted in Europe, Patents at 10:10 pm by Dr. Roy Schestowitz

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.

Share in other sites/networks: These icons link to social bookmarking sites where readers can share and discover new web pages.
  • Reddit
  • email

Decor ᶃ Gemini Space

Below is a Web proxy. We recommend getting a Gemini client/browser.

Black/white/grey bullet button This post is also available in Gemini over at this address (requires a Gemini client/browser to open).

Decor ✐ Cross-references

Black/white/grey bullet button Pages that cross-reference this one, if any exist, are listed below or will be listed below over time.

Decor ▢ Respond and Discuss

Black/white/grey bullet button If you liked this post, consider subscribing to the RSS feed or join us now at the IRC channels.

DecorWhat Else is New


  1. Gemini Gone Mainstream: German Media Now in Geminispace

    With the likes of TAZ embracing Geminispace/Gemini Protocol we seem to have reached some sort of inflection point; taz.de did in fact add official presence to Geminispace



  2. Links 28/1/2022: LSFMM 2022 and 2021 UI Study Results From Elementary's Distro

    Links for the day



  3. IRC Proceedings: Thursday, January 27, 2022

    IRC logs for Thursday, January 27, 2022



  4. Links 28/1/2022: GNU Poke 2.0 and OPNsense 22.1 Released

    Links for the day



  5. Links 27/1/2022: Archinstall 2.3.1 and Nix 2.6.0

    Links for the day



  6. On the Internet, Trust Should Not Become Centralised

    “Trust” is a word that lost its meaning in the era of “TPM” and fancier names for 'Palladium'; we need to reject this idea that computers need to check with Microsoft if the operating system is trusted (not just Windows!), check with Gulag/Chrome if a Web site is trusted, and whether it's OK to run some application/s on one's own computer (as if Jim Zemlin et al get to decide what is trusted)



  7. Microsoft-Connected Publishers Suffer and Perish With Microsoft (While Peddling 'Fake News' for Their Beloved Sponsor)

    IDG and other fake news outlets/networks/sites (selling to companies flattering articles about themselves or renting out 'news space' to them, not just ad space) want us to think Microsoft is doing very well, but it's just that same old Ponzi scheme



  8. Links 27/1/2022: Mabox Linux 21.11 Herbolth and PipeWire 0.3.44

    Links for the day



  9. IRC Proceedings: Wednesday, January 26, 2022

    IRC logs for Wednesday, January 26, 2022



  10. [Meme] EPO: Pursuing an Eastern and Western District of Europe (for Patent Trolls and Software Patents)

    With the EPO so flagrantly lying and paying for misinformation maybe we should expect Benoît Battistelli and António Campinos to have delusions of grandeur… such as presiding over the Eastern and Western District of Europe, just like Mr. Gilstrap and Mr. Albright (political appointment by Donald Trump, ushering in “the swamp”)



  11. Gemini at 2,000: 86% of Capsules Use Self-Signed Certificate, Just Like the Techrights Web Site (WWW)

    As shown in the charts above (updated an hour ago), the relative share of ‘Linux’ Foundation (LE/LF; same thing, same office) in the capsules’ certificates has decreased over time; more and more (in terms of proportion) capsules choose to sign their own certificate/s; the concept of ‘fake security’ (centralisation and consolidation) should be rejected universally because it leaves nobody safe except plutocrats



  12. [Meme] UPC: Many Lies as Headlines, Almost Exclusively in Publishers Sponsored by EPO and Team UPC to Produce Fake News (Lobbying Through Misinformation)

    Lest we forget that EPO dictators, like Pinky and the Brainless Benoît Battistelli and António Campinos, have long littered the EPO's official Web site as well as publishers not directly connected to the EPO (but funded by it) with disinformation about the UPC



  13. EPO as the 'Ministry of Truth' of Team UPC and Special Interests

    The 'Ministry of Truth' of the patent world is turning the EPO's Web site into a propaganda mill, a misinformation farm, and a laughing stock with stock photography



  14. Microsoft 'Delighted' by Windows 11 (Vista 11) Usage, Which is Only 1% Three Months After Official Launch and Six Months After Release Online

    Microsoft boosters such as Bogdan Popa and Mark Hachman work overtime on distraction from the failure Vista 11 has been (the share of Windows continues to fall relative to other platforms)



  15. Links 27/1/2022: Preinstalled GNU/Linux (Ubuntu) and Arch Linux-Powered Steam Deck 30 Days Away

    Links for the day



  16. Don't Fall for Microsoft's Spin That Says Everything is Not Secure and Cannot be Secured

    Microsoft keeps promoting the utterly false concept that everything is not secure and there's nothing that can be done about it (hence, might as well stay with Windows, whose insecurity is even intentional)



  17. At Long Last: 2,000 Known Gemini Capsules!

    The corporate media, looking to appease its major sponsors (such as Web/advertising giants), won't tell you that Gemini Protocol is rising very rapidly; its userbase and the tools available for users are rapidly improving while more and more groups, institutions and individuals set up their own capsule (equivalent of a Web site)



  18. Links 26/1/2022: Gamebuntu 1.0, PiGear Nano, and Much More

    Links for the day



  19. IRC Proceedings: Tuesday, January 25, 2022

    IRC logs for Tuesday, January 25, 2022



  20. Links 26/1/2022: No ARM for Nvidia, End of EasyArch, and WordPress 5.9 is Out

    Links for the day



  21. Why the Unified Patent Court (UPC) is Still Just a Fantasy and the UPC's Fake News Mill Merely Discredits the Whole Patent 'Profession'

    Patents and science used to be connected; but now that the patent litigation 'sector' is hijacking patent offices (and even courts in places like Texas) it's trying to shove a Unified Patent Court (UPC) down the EU's throat under the disingenuous cover of "community" or "unity"



  22. Links 25/1/2022: Vulkan 1.3 Released, Kiwi TCMS 11.0, and antiX 19.5

    Links for the day



  23. Gemini Milestones and Growth (Almost 2,000 Known Gemini Servers Now, 39,000 Pages in Ours)

    The diaspora to Gemini Protocol or the transition to alternative 'webs' is underway; a linearly growing curve suggests that inertia/momentum is still there and we reap the benefits of early adoption of Gemini



  24. [Meme] Get Ready for Unified Patent Court (UPC) to be Taken to Court

    The Unified Patent Court (UPC) and Unitary Patent system that’s crafted to empower EPO thugs isn’t legal and isn’t constitutional either; even a thousand fake news 'articles' (deliberate misinformation or disinformation) cannot change the simple facts because CJEU isn’t “trial by media”



  25. The EPO Needs High-Calibre Examiners, Not Politicians Who Pretend to Understand Patents and Science

    Examiners are meant to obstruct fake patents or reject meritless patent applications; why is it that working conditions deteriorate for those who are intellectually equipped to do the job?



  26. Free Software is Greener

    Software Freedom is the only way to properly tackle environmental perils through reuse and recycling; the mainstream media never talks about it because it wants people to "consume" more and more products



  27. Links 25/1/2022: Git 2.35 and New openSUSE Hardware

    Links for the day



  28. IRC Proceedings: Monday, January 24, 2022

    IRC logs for Monday, January 24, 2022



  29. Links 25/1/2022: GPL Settlement With Patrick McHardy, Godot 4.0 Alpha 1, and DXVK 1.9.4 Released

    Links for the day



  30. Proprietary Software is Pollution

    "My daughter asked me about why are we throwing away some bits of technology," Dr. Andy Farnell says. "This is my attempt to put into words for "ordinary" people what I tried to explain to a 6 year old."


RSS 64x64RSS Feed: subscribe to the RSS feed for regular updates

Home iconSite Wiki: You can improve this site by helping the extension of the site's content

Home iconSite Home: Background about the site and some key features in the front page

Chat iconIRC Channel: Come and chat with us in real time

Recent Posts