09.09.19

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

If you liked this post, consider subscribing to the RSS feed or join us now at the IRC channels.

Pages that cross-reference this one

What Else is New


  1. IRC Proceedings: Saturday, January 23, 2021

    IRC logs for Saturday, January 23, 2021



  2. Links 24/1/2021: Nouveau X.Org Driver Release and GhostBSD 21.01.20

    Links for the day



  3. InteLeaks – Part XXX: Harbor Research's Pseudo-scientific 'Research' for Intel, Bizarrely Suggesting a Microsoft Partnership for a Domain Largely Controlled or Dominated by Linux

    The full document that Intel paid for and in turn used to justify cracking down on Free software (obliterating Free software-based workflows inside Intel), instead outsourcing all sorts of things to proprietary software traps of Microsoft



  4. Chromium and Chrome Are Not Free Software But an Example of Microsoft-Fashioned Openwashing Tactics

    It's time to reject Google's Web monopoly (shared with other companies but still an oligopoly); removing its Web browser would be a good start



  5. Links 23/1/2021: Chromium Pains and New Debian Maintainers

    Links for the day



  6. InteLeaks – Part XXIX: Harbor Research Did Not Produce a Study But an Elaborate Hoax for Intel, Suggesting Microsoft Partnership and Outsourcing Based on Zero Evidence and No Solid Rationale

    The pseudo-scientific ‘report’ from Harbor Research is more of the same nonsense we’ve grown accustomed to; unethical if not rogue firms are being paid to lie — or to perpetuate falsehoods which someone stands to gain from



  7. Video: The State of Communities Surrounding GNU/Linux Distributions

    A discussion about the state of volunteer efforts going into the development, maintenance (in the 'maintainership' sense) and support/advocacy of GNU/Linux distros



  8. IRC Proceedings: Friday, January 22, 2021

    IRC logs for Friday, January 22, 2021



  9. InteLeaks – Part XXVIII: Intel Served Report From Microsoft Boosters, Who Provide No Actual Evidence and No Science to Back Their Supposed 'Findings'

    Findings and recommendations from Harbor 'Research' aren't based on any scientific methods, just perceived loyalty, branding, and a bunch of unsourced quotes (from unnamed people with ridiculous job titles like a soup of buzzwords)



  10. Erosion of Communities, Ascent of Corporate-Industrial Fake Communities

    Despite the attempts to manipulate/trick developers (and sometimes users) into becoming unpaid workforce of for-profit companies, there's an exodus back to real communities, which aren't subjected to the fury of wealthy shareholders who utterly dislike or simply don't care for software freedom



  11. The Corporate 'Left' and the Open Source Pseudo 'Movement'

    President Biden may not be as bad as his predecessor, but that hardly means very much; software freedom is still threatened, along with many other things



  12. Links 22/1/2021: pfSense Plus, Endless OS Foundation, and Many Laptops With GNU/Linux

    Links for the day



  13. The Linux Foundation is Trying to Obscure Racism Using Microsoft-Inspired Tactics (Vouchers Disguised as Actual Money)

    The Linux Foundation and its PR stunts don’t help combat racism; one might argue that the Foundation is leveraging racism, which prevails in the US, to paint itself as benevolent and caring (offering immaterial things and self-serving press releases)



  14. InteLeaks – Part XXVII: 'Pulling a Nokia' on Intel (Outsourcing to Microsoft)

    The recommendation of an Intel marriage with Microsoft (even in units that deal mostly with Linux) is an insulting slap across the face of developers employed there; we take a look at recommendations made to IoTG (Intel) by a firm with Microsoft orientation



  15. IRC Proceedings: Thursday, January 21, 2021

    IRC logs for Thursday, January 21, 2021



  16. InteLeaks – Part XXVI: Harbor Research is Horrible 'Research', Lacking Actual Technical Background

    Having looked at the members of staff of Harbor Research (individually), it seems clearer now why they have an affinity for Microsoft and why they're directing Intel to liaise with Microsoft and become a prisoner of Microsoft (even in areas where Microsoft is increasingly irrelevant)



  17. Links 21/1/2021: Raspberry Pi Pico, Ubuntu 21.04 Picks GNOME 3.38, KDE Plasma 5.21 Beta

    Links for the day



  18. How a Newly Inaugurated President Biden Can Advance Software Freedom (If He Actually Wishes to Do So)

    Techrights has 'Four Suggestions' to President Biden, the 46th 'front end' of American plutocracy



  19. InteLeaks – Part XXV: Intel's Brain Drain Leads to Unusual Measures

    As the company once known as 'chipzilla' loses its relevance and dominance in the market it's reaching out to retired people, trying to get them back onboard



  20. Hey Hi (AI) is Just a Trojan Horse for Illegal Software Patents, According to EPO Management and Litigation Firms It's in Bed With

    The longtime pushers or the lobby of patent profiteers just carry on pushing for software patents, nowadays latching onto the inane and unwarranted media hype around Hey Hi (AI) — a hype wave that was co-opted by EPO management to grant unlawful patents



  21. The Central Staff Representatives (CSC) of the EPO Are Petitioning to End the Assault on EPO Staff

    The EPO, just one month after the staff went on strike, is about to receive a compelling petition to stop the assault on EPO staff



  22. InteLeaks – Part XXIV: Love for Microsoft, Not for Free Software or Whatever Replaces Microsoft

    Intel is basing its big decisions on buzzwords and firms that master buzzwords; it's sad that instead of listening to Intel's own (in-house) engineers it's relying on a bunch of clowns who push 'Clown Computing' and 'apps' and 'UX'...



  23. IRC Proceedings: Wednesday, January 20, 2021

    IRC logs for Wednesday, January 20, 2021



  24. Links 21/1/2021: Google Tightens the Screws on Chromium, VideoLAN VLC 3.0.12

    Links for the day



  25. IBM Panics and Resorts to 'Customer Retention' Tactics With Red Hat Enterprise Linux (RHEL)

    IBM 'frees' RHEL but with limitations that can restrict growth of small companies (or subject them to financial barriers, originally unforeseen)



  26. Recent Techrights Articles About President Joe Biden

    Instead of writing yet more stuff about the latest US president, let's look back at what we wrote in recent weeks/months



  27. Links 20/1/2021: LibreOffice 7.1 RC2 and the RHEL Contingency

    Links for the day



  28. InteLeaks – Part XXIII: Intel Paying for Bogus 'Research' 'Insights' Which Merely Seek to Justify Outsourcing to Microsoft and Imposing Microsoft's Proprietary Software on Free Software Developers

    Intel's preference for Microsoft monopoly (an imposed/top-down decision) was seemingly certified by so-called 'consultants' and 'analysts' from the outside rather than the inside, basically manufacturing a false perception of consent after managers had already made up their minds



  29. Suppressed Facts of the Free Software Movement and Its Community of Volunteers – Part V: How FSF Secrecy Ended Up Insulting People, Alienating Trans Developers

    Having just uploaded this introductory video, we delve into the backstory or the real reason the FSF sank into somewhat of a crisis with the trans community almost half a decade ago



  30. InteLeaks – Part XXII: Bubbles and Buzzwords, No Substance at Intel's Internet of Things (IoT) Group (IOTG)

    The video above is continuation of the previous part about a document full of superficial buzzwords (not technical jargon anywhere), in effect recommending to managers that they blindly follow trends and cargo cults (such as Clown Computing) and not what’s most suitable for technical excellence


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