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    Home > Medical News > Latest Medical News > The business strategy of patent challenge in American generic drugs (5)

    The business strategy of patent challenge in American generic drugs (5)

    • Last Update: 2017-11-14
    • Source: Internet
    • Author: User
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    9、 Challenge patent risk analysis 1 The principle of compensation for losing a lawsuit challenges that if a patent does not go to "venture listing", it will not be judged as "intentional infringement", and the court's punishment for the challenge losing lawsuit is "Prohibition", that is, it is not allowed to sell or the patent expires And the cost of litigation is half of that of generic drugs and half of that of patent drugs 2 The principle of intentional and unintentional is very important The court attaches great importance to whether there is intentional infringement The general practice is to find a lawyer outside the enterprise to do a third-party patent search and issue a patent non infringement or patent invalidation certificate when the generic drug project is approved To prepare for patent litigation is to issue "unintentional" evidence If the court thinks that "intentional" infringement, as mentioned below "venture listing", the losing party should pay three times of the economic loss! Sometimes, when a PIV challenge certificate is withdrawn or modified, the judge will also investigate whether the challenger has "intention" 3 The challenge patent in non Orange Book patent litigation is based on the patent registered in FDA orange book Infringement of patents other than orange peel books could also be prosecuted However, patents other than orange peel book do not have the patent efficacy stipulated by FDA regulations such as "30-month containment period" However, since 1984, many scholars have studied the impact of non Orange Book patents on patent challenges, which is statistically insignificant Because patent drugs generally try to register their patents in orange peel books One more patent will bring more resistance to the challenge The number of patents will also act as a deterrent to challengers It is a success to keep a challenger out of the door! 4 Advantages and disadvantages of venture listing the definition of "at risk launch": 1) FDA has approved anda listing due to various reasons (for example, the 30-month containment period has passed); 2) after FDA approved anda listing, anda will be directly listed without final litigation results After venture listing, if the subsequent judgment of Anda infringement, anda shall compensate the other party's economic losses However, after the completion of the first trial, anda will "risk listing" if it obtains favorable judgment The first reason is that the temptation of 180 day exclusive profit is too great, and the second reason is that the probability of general second instance overturning the first trial decision is relatively low (20%) (Martin voet 2014) If it is not exclusive for 180 days, it will not be "venture listed" No listing, no "intentional", generally there will not be too much loss Teva also has a nickname of "shark of venture listing" in the US generic drug market In order to obtain 180 days of high profits, Teva often takes the risk of huge compensation and grabs profits by listing generic drugs ahead of time before the patent lawsuit is closed In 2007, Teva challenged protonix of Wyeth The 30-month containment period has come FDA has approved Teva's generic drugs However, the lawsuit between Teva and Wyeth is not over In order not to lose high profits, Teva ventured to launch protonix's generic drugs in 2010 In 2013, the court of Appeal ruled that Teva lost the lawsuit At that time, Wyeth had been acquired by Pfizer, so Teva and sun paid Pfizer a total of $2.1 billion However, Teva did not change the nature of "risk-taking sharks" After 2013, Teva's generic strategy remained aggressive Moreover, we are more unscrupulous in the generic drug challenge patent and enterprise merger Last year, Elgin's generic business was pocketed for $40.5 billion 【2】 The risk control and risk analysis of patent litigation is a very complex and professional work Due to the fact that the subject is beyond my knowledge, I'm sorry that I can't give a very accurate discussion 10、 Case analysis of challenge patent case 1, Mova case 1998 1994, Mova pharmaceutical Corp submitted the Anda application of "excellent hypoglycemic", and submitted the PIV challenge certificate Patent holder Upjohn sued Mova for infringement and held a court session in Puerto Rico in 1995 In 1995, mylan also submitted anda (PIII) to FDA, later changed it to PIV, and sent a challenge notification letter to Upjohn Surprisingly, Upjohn did not sue mylan within 45 days Therefore, on December 19, 1996, the lawsuit between Mova and Upjohn was still in progress, and FDA approved the Anda listing of mylan Mova sued the FDA to DC court in Washington, DC, saying the FDA was illegal and should not approve other andas for listing 180 days before Mova failed to perform The FDA countered that Mova was not successfully defended, so according to the rules, there were no 180 days In 1998, the Washington Court ruled in favor of Mova, and the FDA's "winning" provision for generic drugs was invalid, requiring the FDA to suspend the approval of mylan's aDNA listing Subsequently, the Puerto Rican court ruled that Upjohn's patent for "hypoglycemic" was invalid and Mova was granted a 180 day exclusive right So far, the FDA has amended the regulations: the first challenger of generic drugs, whether winning the lawsuit, settling the settlement, or not suing the patentee, can get 180 days of exclusive rights This is the famous "Mova case" (140 F.3d 1060 (1998)) it can also be said that the year 1998, 14 years after the enactment of the drug price competition and patent period compensation act in 1984, was a turning year of patent challenge Case study 2 (creativity): examples of metabolite patent litigation: Geneva pharmaceuticals, (fed Cir., 2003) - "716" is a secondary patent with "233" as the prior technology Schering plough sued: '233' is the prior technology of '716' After the authorization of '233', Schering plough proved that DCL (DES carboethoxyloratadine) in patent '716' is the metabolite of loratadine in vivo through preclinical animal experiment and later human body experiment, and has similar pharmacological effect with loratadine The generic drug of Geneva pharmaceutical produces DCL in use, so claims 1, 3 and 6 in patent '716' are violated Defence of generics Geneva: generics Geneva took note of PIV evidence against - '716' when submitting anda Prior to patent 716, Geneva pharmaceutical had studied the metabolism of loratadine in vivo In 21, 864 human studies, all subjects detected the presence of DCL after taking loratadine Therefore, Geneva pharmaceutical believes that DCL is the natural metabolite of loratadine in vivo, rather than produced by the "synthesis" and "purification" described in -'716 ', so -'716' is not creative The District Court of New Jersey held that: claims 1-3 of '716' do cover DCL, that is, "measured within the human body", and "comprehensively produced in a purified and isolated form" The district court also admitted that: - 233 does not include DCL However, DCL is an inevitable substance produced by the patent method - "233", so the patent itself already covers the invention content - "716" Therefore - '716' belongs to - '233' inherently inhibition, and the patent '716' is invalid Schering plough lost Schering plough appealed to the court, claiming that: to confirm that "DCL" generated by - '233' patent method was not recognized by ordinary technicians in the field when - '233' patent was formed, and that '716' patent method was obtained by Schering's staff after animal and human experiments, so - '716' was creative That is to say, it is also "creation" to "predict" and "prove" the existence of a compound by prior technology The court of appeal rejected Schering plough's claim that when loratadine was absorbed and digested by human body, DCL did not occur accidentally or under some abnormal conditions DCL is an inevitable product of loratadine in the body In other words, even if a person skilled in the art does not understand the content implied in the patent method -'233 ', even if -'233' does not disclose DCL, the results described in '716' will occur as long as loratadine is taken So, '716' is not creative Schering v Geneva pharmaceuticals, (fed Cir., 2003) according to the patent law, it is not creative to predict or confirm the prediction of an existing substance Case study 3 (creativity): patent litigation on the separation of isomers: Aventis v luipn (fed Cir 2007) patent background: - '886', - '258', - '944' are Schering's patents on the separation, purification and action as ACE inhibitors of various stereoisomers of ramipril Later, Aventis and Schering carried out a series of patent licenses Among them, '722', - '886', - '258', - '944' belong to Aventis as a technical patent of limitril In 2004, Lupin submitted anda and proposed a patent challenge (PIV) to -'722 ' Lupin's challenge: - '722' is only a method of separating an isomer from a mixture of stereoisomers According to the common chemical knowledge, it is "obvious" for those skilled in the art to extract the separation and purification of a certain isomer from the prior art, so -'722 does not possess inventiveness Aventis argued that: the inhibition effect of sssss or 5 (s) isomer obtained by '722' method on ace was 18 times stronger than that of other isomers (such as rrsss, rssss), so - '722' method achieved "unexpected results", so - '722' was creative The Virginia District Court found lupin guilty of intentional infringement, and lupin lost the case Lupin appealed to the court of appeal, which dismissed Aventis's defence -The inhibitory effect of 5 (s) obtained by '722' method on ACE should not be compared among the 32 enantiomers of ramipril However, it should be compared with the reference substance for clinical use: for example, the mixture (sch31925) described in patent '258' containing 1 / 3 5 (s) ramipiral and the 5 (s) ramipiral of 10mg - '722' have the same effect, which means that '722' has not achieved "unexpected result", so it has no creativity [18,19] in the same court, six days later, in the case of a dispute over another chemical isomer (loxaprol, estitalopram forest v ivax fed Cir 2007), it was decided that the resolution of isomer was creative and forest won the case The court's reason was that loxaprol split received unexpected results 【20】 Case analysis 4 (small 8): in 2011, Caraco submitted prandin generic application of Novo Nordisk to FDA, and proposed PIV challenge patent - "358" Prandin is approved by FDA for three purposes: 1) use of repaglinide alone; 2) use of repaglinide in combination with Metformin; 3) use of repaglinide in combination with TZD At that time, there was only one patent listed in the FDA orange peel book, namely - '358' The main claim of the patent is "a method for reducing blood sugar in human blood by using retaglinide in combination with metformin" Novo sued Caraco for patent infringement before the New Jersey district court Caraco withdrew the PIV challenge and applied to FDA to change it into 8 small anda applications: only use 1) and 3) are required to be reserved in its own anda instructions, and patent use 2) is deleted In response, Novo changed the orange book's usage code to read: "a treatment for type 2 diabetes in adults." FDA covered the patent method with Caraco's request and rejected eight small applications of Caraco The New Jersey court upheld Caraco and dismissed novo's lawsuit Novo appealed to the Federal Circuit Court of appeals, which rejected the New Jersey court's decision The reasons are as follows: 1) the "an approved method" mentioned by FDA refers to "any approved method" FDA does not need to modify the patent registration of orange peel book 2) "Patent information" only refers to "patent number and patent validity date", excluding "patent use", so Caraco does not have counter claim Due to appeal
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