Patent protection and obstacles behind the screen of "I am not a drug god"

Patent protection and obstacles behind the screen of "I am not a drug god"

The recent hit "I am not the God of Medicine" reflects the helplessness and sorrow of patients in the face of sky-high drugs. Sky-high drugs have always been the most acute among the many problems in the medical system. I believe that the anger and helplessness of leukemia patients in the film can also be realized by the audience through the screen: being able to afford it means being ruined, being unable to afford it means being ruined, and being forced to join the "army of purchasing medicine", to India and other neighboring countries to purchase low-cost generic drugs. The film points the finger at the original research drug companies and the high pricing strategy of the original research drugs. In our country, drugs with too high prices usually cannot be reimbursed by medical insurance, so this contradiction is still prominent.

The purpose of this paper is not to criticize what happened before, but to better see the direction of the pharmaceutical industry and learn from the past. Sometimes, individuals, companies, or national policies will take some detours, but these detours are not for nothing, they can give us a lot of experience and enlightenment, as the old saying goes: there is no white road in life, every step counts. In the past three years, the government has promoted pharmaceutical reforms at a rapid pace, including zero tariffs on imported anti-cancer drugs, as well as policies related to patent compulsory licensing, speeding up drug registration and other policies to shorten the time to market for generic drugs.

The dilemma faced by the transfer of high-priced drugs into health insurance.

When it comes to original research drugs and generic drugs, the most discussed is nothing more than health insurance and the patent system. In China, the original research drug is protected by law during the patent period, and other manufacturers cannot imitate it. If it is not included in the medical insurance, it will all have to be borne at their own expense. The film says that "the house has been eaten and the family has been destroyed". This is the case. At the end of the movie, leukemia patients finally take their medicine with the help of medical insurance, which is a happy ending. Many people lament that Cheng Yong's efforts have not been in vain, and finally attract the attention of the state. At the same time, they naturally ask: why not include other drugs in medical insurance? The answer is simple: medical insurance black hole.

With the increasing incidence and mortality of cancer,2016The total cost of antineoplastic drugs in China in1110Billions of dollars, and still10%The above growth rate continues to rise, in addition, China is entering an aging society (more users of health insurance), health insurance funds are in short supply, will many sky-high original research drugs into health insurance, talk about easy? Therefore, in addition to health insurance negotiations, generic drug substitution is an important solution.

Legal barriers to generic and imported drugs

There are two possible ways to import drugs from abroad: one is to import the original research drugs produced by or licensed by the patentee, and the other is to import generic drugs without the permission of the patentee.

Even if the patentee produces the original research drug by itself or with its permission, the price may vary greatly in different countries and regions.AccordingTRIPSAccording to the agreement, "import" is a power of patent. The patentee has the right to prohibit others from importing products protected by patents without permission. However, this problem can be solved by the principle of "international exhaustion" of patent rights: as long as the patentee puts his products on the market anywhere in the world, he no longer has control over the products in the sense of patent law, and he cannot prohibit others from importing the products.

For the import of generic drugs without the permission of the patentee, the principle of "international exhaustion" does not apply, because the generic drug product is not a product put on the market by the patentee. Many generic drugs produced in India belong to this situation. Because these drugs are not protected by patents in India, the production of generic drugs does not infringe the patent rights of the original drug research enterprises, but once imported into China, it will still infringe the patent rights of the original pharmaceutical company in China.

In any case, according to China's Drug Administration Law, drugs imported and sold without approval are treated as fake drugs, that is to say, regardless of whether the drugs are true or false abroad, they are all "legal fake drugs".

From the perspective of patent layout,The original research company usually applies for the general structure of the basic compound patent protection before the first human test. This patent protects a class of derivatives with the same purpose to the greatest extent. These compounds have a large number and a common structure, which can avoid premature exposure of the target compound and prevent the opponent from following up. Generally speaking, in addition to the basic compound patent, the applicant may also propose a specific compound patent later.(For example, specific salts, isomers, prodrugs, active metabolites)Application; In addition to compound patents, crystal patents are second only to compound patents and are the second line of defense against the listing of generic drugs. In addition to applying for core patents to restrict generic drug developers, the original research company will also apply for peripheral patents, such as composition patents, synthesis method patents, new usage patents, new crystal type patents and new salt patents. On the one hand, it will prevent rivals from developing new technologies to restrict themselves by patent applications, and on the other hand, it will set up technical barriers for generic drug manufacturers through peripheral patent applications to form so-called "patent barriers", the abuse of the legal protection of the patent system and the implementation of various unreasonable obstacles to restrict the development of enterprises in other countries have put developing countries in a very disadvantaged position.

At present, many experts at home and abroad have put into the ranks of patent challenges, with a view to eliminating the unreasonable patents around the original research drugs, so that generic drug manufacturers can produce locally and participate in market competition, and foreign generic drugs can also be imported and registered, thus reducing drug prices and allowing more patients to receive treatment.