How can generic drugs break through the patent dilemma for the benefit of public health.

In July 2018, a movie "I am not a drug god" was released in China, which tells the touching story of a poor male health care product vendor who became the exclusive agent of the Indian generic drug "Lenin. The film won the 32nd China Film Golden Rooster Awards andThe 55th Taiwan Film Golden Horse AwardsThe huge price difference between generic and original drugs has aroused widespread public concern on both sides of the strait.

The original research drug is also known as the patent drug, which refers tooriginal research.new drug, generally by large multinational pharmaceuticalCompanyR & D.Drugs fromLayer-by-layer screening of thousands of compoundsAfter andThrough rigorous clinical trials,Approved for listing after registration,aboutTo experience more than 10 years of time,Research costs are even higher.hundreds of millions of dollars,Original drugin the patentLostEffectBeforecannot beImitation.When the original drug has passed the patent protection period, it can be copied by other companies,Copy the main molecular structure of the original drug,Search drugs.YesGenerics.Because generic drugs haveShort investment cycle and low costThe characteristics,It has a dominant position in the pharmaceutical market in various countries, especially in developing countries,InChinaGeneric drug sharefor 90%Above.

Original and generic drugs usually haveSame active ingredient,route of administration,Purpose of treatmentAnd so on, but there is a huge price difference between the two, the price difference reflects the value of the patent. This is not understood to mean that patents lead to higher prices, but that the original drug isR & D,Production not only costs huge research funds, at the same timeAnd often face the risk of failureThe patent can guarantee the right holder to enjoy a certain legal exclusive right, so that it can recover the huge research and development costs and continue to develop new drugs.GenericIs based on the success of the original drug research and development, itsThe cost is mainly reflected inRaw materials and sales channels,far belowOriginal drugcost, so the price of generic drugs is oftenOnly 20%-40% or even 10% of the original drug.

Why can India copy Gleevec?1970ofIndia's Patent Law allows Indian companies to copy at will.The original research drug, after India applied for WTO accession in 1995, set up a 10-year transition period, the Indian government can still refuse to grant patent rights to drug products, while the earliest compound patent of Gleevec was applied for in 1994 and did not obtain patent authorization in India, so India can imitate Gleevec. Gleevec has a patent license in China. Before the patent expires, the relevant generic drugs cannot be legally produced. Even if the imitation Gleevec imported from India will infringe the patent right of Gleevec in China.

GenericCouldsmoothproduction,Sales, not only depends on whether it has obtained a drug marketing authorization, but also depends on other constraints, the most important of which is"PatentDilemma".Even if the relevant patent expires, it does not mean that generic drugs can be produced at will. Two main factors need to be considered, one is that althoughCore patents expire,But...Drug-relatedOtherPatentStill in the period of protection, imitationBehaviorPossible presence invasionTheseRisks of patentsand, therefore,in genericsProject approvalstage,Generic drug companies should search.Original patent of a drugLayoutThe application time span from basic compound patent to preparation patent can reach more than ten years or even more than twenty years, and the protection period is naturally longer. In April 2013, the patent protection of Gleevec compound in China expired. Hausen, Jiangsu Zhengda Tianqing and Shiyao were approved by the State Food and Drug Administration to produce generic imatinib tablets and capsules respectively. NovartisthinkAlthough the patent for Gleevec's compound has expired, the patent for the treatment of gastrointestinal stromal tumors remains.effective, therefore.Will Zhengda Tianqing and Haosen Pharmaceuticals, etc. to court.RecommendationsBusinesses are tracking.CompoundPatents at the same time.retrieval and analysisRelatedcrystal form,Therapeutic use,Process, formula, accessories and other patents,This alsoHelps improve genericsBioequivalence.Second, raising.Patents inChinaDueFailure,may remain under protection in other countries, legitimate generic drugs produced in ChinaSalesThese countriesIt may still constitute infringement. The original drug.GlobalWhen patent layout, it is often proposed in many countries and regions of interest.PatentApply for patent protection.In some countries, the patent protection period for the original drug can be extended, for example, in the United States.Promulgated in 1984It'sDrug Price Competition and Patent Period Compensation Act, dueThe time it takes to obtain marketing approval for regulated products such as pharmaceuticals, medical devices, and agrochemicals significantly reduces the duration of the relevant patents,The ActTo compensate the patent owner for up to five years of patent protection lost when the product is developed and approved by the U.S. Food and Drug Administration (FDA), the mandatory review period used to estimate the extension of the patent protection period should occur after the patent is granted.But...InOriginal drugAfter FDA approval, plus an extended period of effective patent protectionGeneralNo more than 14 years.

The size of China's pharmaceutical marketNearly 2 trillion yuan, the price and quality of drugs are closely linked to the well-being of the people. The year after the release of "I am not a drug god"On August 26,ChinaNew revisionIt'sDrug Administration Act, the ActIt is stipulated that for the unauthorized import of a small amount of drugs that have been legally marketed abroad, if the circumstances are relatively minor, the punishment may be mitigated; if no personal injury is caused or the treatment is delayed, the punishment may be exempted.AsGeneric drug power,of our countryMedical,Pharmaceutical ChemistryThe workers shouldJoint efforts to shorten the gap between generic drugs and original research drugs in China, for the benefit of people's health.On the patent sideOn the other hand, generic drug companies should search and analyze the core patents and peripheral patents of the original drug, and while avoiding design, they should carry out patent layout for peripheral technologies such as new crystal forms, preparation methods and preparations. Finally, we should also pay attention to the patent application and patent authorization disclosed by the original research drug company and the company that produces similar generic drugs in real time. For the patent infringement risk that cannot be avoided, we should prepare for invalid application or negotiate to obtain patent authorization in advance.