tag:blogger.com,1999:blog-5574479.post2267131409964575096..comments2024-03-28T09:05:22.006+00:00Comments on The IPKat: Substance or device - a distinction without a difference?Verónica Rodríguez Arguijohttp://www.blogger.com/profile/05763207846940036921noreply@blogger.comBlogger9125tag:blogger.com,1999:blog-5574479.post-79207839127790878172019-02-10T21:46:40.128+00:002019-02-10T21:46:40.128+00:00Thanks for the explanation Nixon.
Thanks for the explanation Nixon. <br />Fabriciohttps://www.blogger.com/profile/02876884182682637796noreply@blogger.comtag:blogger.com,1999:blog-5574479.post-81048079850852342662019-02-10T18:57:13.680+00:002019-02-10T18:57:13.680+00:00@Fabricio:
Article 53(c) EPC does not allow the pa...@Fabricio:<br />Article 53(c) EPC does not allow the patenting of methods for treatment, which is what a use claim would be.<br /><br />To compensate, the legislator initially introduced what is now Article 54(4) EPC and, with EPC 2000, added Article 54(5) EPC. These provisions allow the patenting of a known "substance or composition" for a new first or second medical use. In these particular cases (only), a new use does make the product new (and potentially inventive).Nixonnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-32755861409667252962019-01-28T13:29:13.307+00:002019-01-28T13:29:13.307+00:00Question from a junior: Should not the second medi...Question from a junior: Should not the second medical use patents involve only the USE?<br />As said above, a new use does not make the product new. Even if it is a substance/composition. <br />I believe it would be more simple if second medical use just allowed use claims.<br />What am I not understanding from my junior point of view?<br />thanks!Fabriciohttps://www.blogger.com/profile/02876884182682637796noreply@blogger.comtag:blogger.com,1999:blog-5574479.post-77890530815703926322018-12-31T02:01:30.026+00:002018-12-31T02:01:30.026+00:00@123:
No clever drafting is needed to patent a (m...@123:<br /><br />No clever drafting is needed to patent a (medical or non-medical) device which is novel and inventive.<br /><br />As to methods of treatment, if a new and inventive method of treatment involves the administration of a known "substance or composition", then (purpose-limited) protection can be obtained for that substance or composition.<br /><br />If the same method of treatment also involves the use of a known medical device, then no protection can be obtained for that known medical device. This was a deliberate decision by the legislator as can be seen from the wording of Articles 53(c) and 54(4) and (5) EPC.<br /><br />As always, there will be cases in which discussion is possible about whether a particular product is a "substance or composition".<br /><br />Since this was a decision by the legislator, it is irrelevant whether the exclusion of protection for known (or in itself obvious) medical devices is logical. (In my view it is logical: a "substance or composition" with a therapeutic effect is mandatorily sold with a label identifying the purpose, which turns the limitation on purpose into an objective property of the product+label. The situation is different for medical devices.)Nixonnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-2030958965084935882018-12-29T15:13:21.477+00:002018-12-29T15:13:21.477+00:00Dear 123,
You seem to have forgotten that the nov...Dear 123,<br /><br />You seem to have forgotten that the novelty system wished by the legislator and developed by the case law of the BA is an absolute one. <br /><br />A device does not become new because a new use has been devised for it. The only exception is for substances and compositions relating to medical uses. As an exception it should be handled sparingly, and rightly so. <br /><br />A new, medical use use, of a known device cannot be protected due to the prohibition under Art 53, c). <br /><br />You seem also to mix device, use and substance. A coated stent will remain a device. If it is patentable, then question of the protection of its use is moot. On the other hand, the coating might also be patentable, but in any case the use of the coated stent inside veins or arteries will never be patentable. And it is good so. <br /><br />This has nothing to do with clever writing of claims. Interested Observernoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-39534191454348043612018-12-23T13:21:01.142+00:002018-12-23T13:21:01.142+00:00In response to 'Interested Observer':
The...In response to 'Interested Observer':<br /><br />The present exclusion of medical devices from medical use claims is not logical, and essentially prevents certain technologies from patent protection without any good reason. Devices can of course be limiting features in a medical use claim if a therapeutic substance is involved. In such a scenario an improvement in the device which is novel and inventive could give rise to an acceptable novel and inventive medical use claim, even though the same therapeutic substance was involved. <br /><br />This ends up being a situation where clever drafting gets a patent, and not an underlying policy objective123noreply@blogger.comtag:blogger.com,1999:blog-5574479.post-11426361928498831502018-12-20T20:48:36.621+00:002018-12-20T20:48:36.621+00:00Decision T 758/15 is the result of a long line of ...Decision T 758/15 is the result of a long line of decisions in which the BA always concluded that the second medical use claims are only available for substances and compositions and not for devices. The analysis of the BA is very convincing in my view. <br /><br />Rather than to reduce the discussion to a mode of action either of chemical or physical nature, it appears much more appropriate to decide whether the “product” at stake has an effect of the metabolism of the human or animal body. In the broadest sense it can be considered as being chemical, but the chemistry at stake takes place within the human body. Furthermore, through its action on the metabolism, the product=substance=composition disappears during its action. This cannot be said for a device, even if it is biodegradable. In such a case, it disappears, but without any action on the metabolism. <br /><br />Claims to a first or further medical use for a known “product” are a big exception to the novelty concept as it is handled in the Convention and by the EBA/BA. As such it should remain an exception. Any purpose related novelty/inventive step for known products is to be avoided. It would unnecessarily introduce confusion. <br /><br />At the end of the blog, the suggestion is made that “any inventive medical treatment, regardless of whether it is reliant on the chemical or physical mode of action of a product” should be opened to patentability. In other words, the exception under Art 53,c should be removed. I beg to disagree as this would be in clear contradiction to the intention of the legislator, be it in 1973 or in 2000. In 2000, the EPO had proposed the deletion of Art 52(4) EPC1973, but the contracting states disagreed and its content was merely transferred into Art 53, c). <br /><br />There are also further considerations which lead to the conclusion that medical treatment, or a method for treating the human body should not be patentable. <br /><br />Inventions are there to solve a “technical” problem. Can restoring health or alleviating pain merely be a “technical” problem? With a "true" technical process, be it a process of manufacture or a way of using a device, the correct input values always lead to a reproducible result. In the medical field, the expected result does not always occur, the human or animal body has his own laws.<br /><br />When discussing the patentability of medical methods, we should also keep in mind that the doctor is only obliged to practice his “skills” or his “art”. He cannot be made liable for the expected result, i.e. the recovery of the patient.<br /><br />There is no need for a remittal to the EBA as the case law of the BA is very clear and not diverging. OK for substances or compositions but not for devices. <br /><br />By the way there is only one decision in which a BA patented a known device when used in medical method. See T 138/95, where a BA patented a known aerosol producing device when accepting a Swiss-type claim for a new therapeutic way of administering growth factors or cytokines: <br /><br />“Use of a polypeptide selected from growth factors and cytokines for the manufacture of a device for delivering to the blood stream of a patient a therapeutic dose of the peptide by systemic delivery by pulmonary absorption said device comprising reservoir means (8) for storing the polypeptide; a therapeutic dosage form of the polypeptide disposed in the reservoir means; dispersing means (4-7) for forming in a gas a suspension of particles comprising the polypeptide wherein greater than about 15% of the particles have a mean average diameter of about from 0.5. µm to 4 µm; means (1-3) for transporting the polypeptide to the dispersing means and means (9-12) for delivering the particle suspension to the alveoli of the patient's lungs”<br />Interested Observernoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-89255830323654464852018-12-20T10:50:34.556+00:002018-12-20T10:50:34.556+00:00One wonders why if the terms substance or composit...One wonders why if the terms substance or composition were intended only to comprise materials having a therapeutic effect, the law makers did not introduce "therapeutic" into the article. In my opinion, this really needs a G decision to clarify but the chances of a board issuing a contrary opinion seem remote. Kantnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-58182693772828576852018-12-20T10:03:32.204+00:002018-12-20T10:03:32.204+00:00Another interesting example might be a surgical ti...Another interesting example might be a surgical tissue adhesive. Certainly a substance or composition, and bonding would involve a chemical reaction, but I suspect it might struggle with a second medical use claim if it is seen as achieving its therapeutic effect by physically holding tissue together.Frederick Nicollehttp://www.simmons-simmons.com/en/people/contacts/f/frederick-nicollenoreply@blogger.com