How likely is the patent challenge to win? Look at the attack and defense of pharmaceutical companies

side, multinational pharmaceutical companies are accelerating the pace of imported drugs to market, on the other hand, domestic pharmaceutical companies on generic drug projects and development of increasingly fierce competition, more and more attention to intellectual property business. Many pharmaceutical companies in China have set up independent intellectual property departments, and their business focus has shifted from ordinary businesses such as "patent search" to value-added businesses such as "patent challenges".Recently, the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) (Draft for Comments) were issued, "giving the market exclusive access to the first chemical imitation drug that successfully challenged the patent and was approved for market listing". This will undoubtedly be better than the successful patent challenge of generic pharmaceutical enterprises, domestic enterprises patent challenge enthusiasm will be further activated.And the high barriers to patent challenges and the complexity of intellectual property rights determine the uncertainty of the outcome of the challenge, so how likely is the current patent challenge to win? To this end, the author of the 2017-2019 domestic enterprises on the original drug "patent invalidity" request for the examination results of the statistical.

"All invalid" accounts for more than half ofThe author found that in 2017-2019, the Patent Office of the State Intellectual Property Office (formerly the Patent Review Board) has made 60 requests for patent invalidity.These 60 have been reviewed and involve 53 patents for 38 varieties. Of these, 7 were sugar-lowering drugs (Ingredin, Liglitin, Aglitin, Viglitin, Sigredin, Tigredin, Quglitin), and 5 were antiviral drugs (entrutabin/tinofovefumaticate, fumarate Nofovir, Vipatamivir, Sofebwe, efaviron), 5 anti-cancer drugs (Nzaluamine, cytotinib, sorafinib, yew alcohol, lytoxidone), 2 new anticoagulants (Deva Saban, Tigrillo).In addition, a variety of areas are involved, including the antibiotic amoxicillin, gastric ulcer drug aplasty, antihypertensive drug omegaethylate, heart failure drug sakuba quarthan sodium, anti-allergy drug Lupatamine, osteoporosis drug benzodiacyfen, wind-related drug tofatib, analgesics rely on kaoshi, sedative Remimazoleon, anti-anti-Epilepsy drug buvacitan, antidepressant votixytin, psychotic drug aleptide, constipation treatment drug Rubiprostoxone, urine loss banned drug Sofina new, erectile dysfunction drug tamaraf, anti-hyperuricemia drug Tobista, smoking cessation drug van nicotine, sucrose iron, thyroid eye disease drug Teprotumab.Of these, 55 per cent (33) were "all invalid" decisions and 33 per cent (20) were "partially invalid" decisions. The "maintain effective" decision involved only seven patents in six varieties (agritin, quglitin, Nzaluamine, kertini, Vipatamiwe, vodestin).

clear the way for the sale of the first genericIf successful, the patent challenge will clear the way for domestic companies to list generic drugs and sell them normally.Take JAK inhibitor Tofatib, which treats wind-like control. Tofadib was developed by Pfizer, and Zheng Tianqing and Qilu Pharmaceuticals are the two fastest companies in the country to develop Tofatib generics. In 2018-2019, Zhengda Tianqing and Qilu Pharmaceuticals filed invalid requests for two key patents (compound and crystalline patents) of Tofatib. The original Patent Review Board made "all invalid" decisions on compound patents in August 2018 and crystal patents in November 2019. This clears the way for normal sales of generic drugs by both companies in advance. In September 2019, the first generic drug, Zhengtian Qingtian Tofa, was launched, and in October 2019, Qilu Pharmaceuticals followed suit with a second generic drug approval.Heart failure "heavy bomb" product Shakuba quarthan sodium is also a patent challenge hot spot. In 2019, Zhengda Tianqing, Qilu Pharmaceuticals and other domestic enterprises have filed a "patent invalid" request. Novarma's original drug portfolio consists of three patent numbers: "Drug compositions containing pyrothroids and NEP inhibitors" filed on 16 January 2003 (ZL20110029600.7, granted on 6 November 2013), and "Angiotensin antagonists" filed on 8 November 2006 Drug combination product patents for agents and NEP inhibitors (ZL200680001733.0, granted on December 25, 2013), "and divisional applications under the ZL200680001733.0 patent (ZL20121010191052.2). At present, the final review decision has not yet been announced.

"not creative" reasons are most commonly usedThe choice of reasons is important for the success of patent challenges. "Not creative" (article 22, paragraph 3, of the Patent Law) is the most commonly used legal basis for invalid requestors, and 56 "invalid requests" decisions apply to that provision.Take, for example, the patent challenge of Nzaluamine. With regard to the original drug patent, on 13 May 2005, a patent for the compound WO2006124118 was applied for the preparation method and its purpose (treatment of prostate cancer). At present, Enruguruamine has applied for patent protection in the United States, Europe and China (US2007254933, EP2397469, CN200680025545.1).Two companies, Nanjing Haina and Shanghai FusingTai, filed "invalid requests" for the patent.Nanjing Hainer filed an "invalid request" on March 9, 2018, on the grounds that "the claim was not supported and unclear by the instructions". However, on September 28, 2018, the original Patent Review Board made a "maintained valid" review decision after the patente amended the relevant claim.   On December 18, 2017, Shanghai Fusingtai filed an "invalid request" on the grounds that it was "not creative". The original Patent Review Board decided on October 25, 2018 to review "all void".   In November 2019, the import application for the original drug Astella Enzaluamine softgels was approved by the State Drug Administration.   In fact, the original research party also filed a lawsuit for patent infringement, and filed a lawsuit with the Nanjing Intermediate People's Court of Jiangsu Province against Zhengda Tianqing Pharmaceutical Group, Lianyungang Run people's pharmaceutical (defendant) infringement of the invention patent 200680025545.1, filed on March 14, 2017. However, on May 22, 2018, the plaintiff's claim was dismissed by the court.

the original research party counter-attack, there is also a plot reversal   The benefits of patent challenges are obvious and the odds are high. Of course not. Seemingly easy patent invalidity challenge, will inevitably encounter from the original research party's litigation counter-attack, some will be a wave or even reversal.   Take AstraZenecon's heavy anticoagulant drug Tigrillo. AstraZeneta has obtained a number of patents in China for the protection of Tigrello, the most important of which are patent ZL 99815926.3 (due December 2, 2019) and crystal II patent ZL 20061 Patent ZL 01810564.5 (expires May 31, 2021) and the method of preparing intermediate compounds.   In 2017-2018, Shenzhen Xinlitai launched an "invalid challenge" to the above-mentioned patents, and all three patents were "all invalid" after examination by the original Patent Review Board (decision numbers: 33591, 33975, 34725).   However, in January 2018, AstraZeneone filed a formal lawsuit with the Beijing Intellectual Property Court, seeking to revoke the original Patent Review Board's Decision No. 33591 "Patent Invalid" and to order it to review the decision. In July 2018, the Beijing Intellectual Property Court ruled against AstraZeneta's claim. In August 2018, AstraZeneta filed an appeal with the Beijing High Court. In December 2018, the Beijing High Court issued a second-instance judgment, finding that the original judgment and the decision to be sued were partially unsealed, that the applicable law was wrong, that they should be revoked in accordance with the law, and that the Patent Review Board should re-examine the patent's "invalid declaration" request.   In addition, AstraZeneta has appealed to the Supreme People's Court against the decision to review no. 33975. (Medical Economics)