Akebia TherapeuticsPatents for two drugs used to treat anaemia caused by chronic kidney disease have been successfully defended. As a result of the ruling, the biotech company andFibrogenPart of a massive dispute between the two, Both companies are now suing in the UK Patent Court.

As a biotechnology company, AkebiaSucceed in defeatingFibrogenAt the European Patent Office (EPO) Invalid claims against two of his patents. Opposing partyFibrogenandSandozLaunch a challenge, This is a large lawsuit involving several patents on anemia drugs.

EP3277270andEP3357911Patent No. 1 coversVafseo, This is one that uses active ingredientsvadadustatMedicine for. "vadadustat" It is an inhibitor of hypoxic inducible factor prolyl hydroxylase, It can be used to treat chronic kidney disease in adults (CKD) . nowadays, The global market for drugs used to treat anemia is increasing in value. According to expert prediction, to2028years, Its value will be approximately150Hundreds of millions of dollars.

EPOsupportedAkebia

As mentioned above, AkebiawithFibrogenCaught up in a patent dispute over inhibitors of the hypoxic-inducing factor prolyl hydroxylase. The company claims, FibrogenThe patent claims relate to a broader class of compounds (Defined in terms of structure and function) , And therefore violatedAkebiaRight to medicine. The drug is taken orally by the patient, It can also be used to treat dialysis-dependent patients with symptomatic anemia associated with chronic kidney disease.

2month6day, EPOThe dissenting department heard the caseEP3277270Patent No (This is a recipe patent) The case of. AkebiaHave achieved success, The committee completely rejected the objection, And maintained the status quo, No modifications were made. merely, It is unclear who he faces in the lawsuitSandozWill they appeal.

therewith, AkebiaAnd successfully defended his ownEP3357911Product patent. EPOrejectedFibrogenObjections raised, The patent was again found to be valid. Based onAkebiaWritten defense opinion, FibrogenWithdrew his request for dissent, And the dissent division did not proceed with the dissent proceedings. towardsAkebiaAs for, Both patents are of great commercial importance.

Marketed new drug

AkebiaandFibrogenThe patent battle between the two companies has been going on for years. 2018years, AkebiaAnd licensing partnersOtsukaconvenientFibrogenTwo patent families filed an annulment lawsuit, Designed to pave the way for their products to market. Accepted as a family in EnglandFibrogenLicensed enterprise, Astellasinvolved "Patent familyA" Filed a counterclaim for infringement. In addition, The company is the only one involved "Patent familyB" Put forward preventative (quia timet) Infringement charge.

2021years8month, The British Court of Appeal announcedFibrogentheEP1463823, EP2289531andEP2298301Patent No (Patent familyA) andEP1633333, EP2322153andEP2322155Patent No (Patent familyB) Be effective. The High Court of First instance ruled that most of the patents were invalid, The appeal court's decision partially overturned the ruling.

Patent familyAAll of the patent claims relate to a class of compounds defined as being used to treat chronic kidney disease. Patent familyBThe patent covers the same but can be used to treat chronic anemia (ACD) Compound of.

In the same month that the court rendered its second judgment, FibrogenMedicine forEvrenzoObtained the European Medicines Agency (EMA) Approval of. Its active ingredientroxadustatIt is an inhibitor of hypoxia-inducing factor prolyl hydroxylase, It can be used to treat chronic kidney disease.

Waiting for the Supreme Court decision

however, AkebiaAlso plans to launch its own containingvadadustatAnemia treatment drugs. 2023years4month, AkebiaAnnounced that the European Commission has approved the inclusion of active ingredientsvadadustattheVafeseoMarketing authorization was granted. The drug can be used to treat symptomatic anemia associated with chronic kidney disease in adults who have been on dialysis for a long time.

In spite of this, FibrogenStill thinkAkebiaMay infringe on the patent familyBAnd its use in the treatment of chronic anemia by way of marketing its compounds. After the appeals court ruling, AkebiaHe asked for permission to appeal to the Supreme Court, The request was granted. The highest judicial body in England will be2024Trial of the case. (Be compiled fromwww. juve-patent. com)

TRANSLATORS: Liu Peng　proofread: Wu Xian



　　disclaimer: This network reprint or compile the original articles are from the network, Does not represent the views of this website or confirm the authenticity of its content. If the source is mislabeled or the copyright of the article is involved, Please contact us, This website will be corrected in due course, delete, thank you.