The business strategy of patent challenge in American generic drugs (2)

3、 Challenge patent procedure and judicial structure 1 Orange peel patent registration system (delimitation of patent dispute boundary) before the reform of generic drug legislation in 1984, FDA did not pay attention to the patent dispute in drug application and review process All patent disputes shall be settled by the parties to the patent office and the court As the so-called "FDA PTO connection system" is established in hatch Waxman act, in order to clarify the infringement liability of generic drugs on patent drugs, patent drugs are required to report the patent status of NDA to FDA FDA will register the patent information in orange peel book, and publicize the patent and data exclusive status of drugs FDA reviews and approves corresponding generic drugs according to orange peel patent status and data exclusive If the patent information is not submitted for the patent drug, FDA shall consider that there is no patent dispute (i.e FDA can approve anda) FDA is only responsible for patent registration, not for patent content and / or laws The patents that FDA requires NDA registration include: compound (active ingredient) patent preparation / formula patent method / use patent * different polymers that are the "same" (solution, solution, Bio availability) as brand (37) can not submit patent: preparation method, intermediate, salt, ester, hydrate, solvate, isomer, crystal, etc Due to the establishment of the patent registration system, the procedures for dealing with drug patent disputes are more clear and standardized than before 1984 In the past, generic drugs used to spend a lot of time searching patents to avoid infringement Moreover, the correctness, accuracy and comprehensiveness of search results often cause patent disputes or complicate them Under the patent registration system, generic drugs have clear and direct targets to evade or challenge patents Through patent registration, patent drugs can reasonably and legally prevent the "pre infringement" of generic drugs from outside the market by using the pre blocking function of FDA regulations Through patent registration, generic drugs can more clearly design imitation strategies, avoid patents and challenge patents FDA is responsible for patent registration, which is updated once a month 2 Generic application (anda) and patent status certification (determination of challenge qualification) when submitting anda, generic drugs shall make patent status description for all patents listed in the orange peel book of the corresponding target drug (reference listed drug RLD) Patent status can be divided into four categories: paragraph I: no patent is listed; Paragraph II: there is a patent, but it has expired; paragraph III: there is a patent, but the application does not seek to be listed within the patent validity period; paragraph IV: the registered patent is invalid, or the application has no infringement If I or II is submitted, there is no patent dispute When the patent is submitted to III, FDA can give "temporary approval" and it can be listed after the expiration of the patent Submission of IV certificate shall be deemed as "infringement" 3 After submitting the Anda and PIV certificates, once the applicant receives the FDA's acknowledgement letter, he / she will be qualified for the challenge Within 20 days, the Anda applicant will formally notify the patentee or NDA holder If it is due to "non infringement", rather than invalidation of the patent against the other party, in addition to stating the reasons for non infringement, FDA shall also be notified to give the patentee the right to view the application documents of Anda The patentee or NDA holder shall decide whether to sue within 45 days after receiving the notice of "infringement" If a lawsuit is filed, FDA will be informed, and FDA will automatically stop the review of Anda for 30 months (30-month containment period of Anda) If no lawsuit is filed (45 days without reply), FDA can start the review of Anda and approve the listing of Anda During the 30-month containment period, if the generic drugs win the lawsuit or settle, FDA can start the Anda audit; if the generic drugs lose the lawsuit, the audit will be stopped until the end of the patent period The 30-month containment period is over, patent litigation is not over, and FDA can also approve the listing of Anda 4 Challenge patent process and legal framework Figure 1 Challenge patent process data source: self made 2017 note: due to the layout, the above process only describes the "road to victory" of generic challenge, omitting the path after "losing the lawsuit" In the whole process, once losing the lawsuit, generic drugs will be attributed to "ordinary anda", or wait for the patent to expire and FDA to review and market Legal framework of patent litigation: institutional setting: FDA, USPTO, FTC, ITC, district court / court of appeal, Supreme Court, Congress The regulations are divided into three levels: Congress Act (e.g federal food, drug and Cosmetic Act, hatch Waxman act); federal regulations set (e.g 21cfr (Pharmaceutical part), 35cfr (patent part)); mmaps and guidance of FDA My understanding of the three levels is: the Congress act defines the rules; the code of federal regulations defines the rules; MMAP and guidance (without legal obligation) describe how FDA does and anda does respectively Any dispute involving the above legal issues in drug patent disputes can be subject to patent litigation There is no patent court in the United States, and the invalidity or infringement of a patent is decided by the United States District Court If you are not satisfied with the decision of the district court, you can appeal to the court of appeal (CDFC) of the DC circuit in Washington The decision of the court of appeal is generally final Only the court of appeal can submit a decision to the Supreme Court This is the so-called "single channel" principle of American litigation The Supreme Court can refer it to Congress, which changes the law to solve the problem The Federal Trade Commission (FTC) is a law enforcement and supervision agency under the U.S Congress, which also has the corresponding legislative power The committee reports directly to the U.S Congress and is responsible, a bit like our national development and Reform Commission So the U.S FDA and the U.S patent office gave him three points ITC, an International Trade Commission under FTC, can directly notify the U.S Customs to detain the goods entering the United States, such as drugs and chemical raw materials, and then directly file a patent lawsuit with the court of appeal That is to say, ITC can fight the lawsuit to the "final adjudication" step by step! U.S pharmaceutical companies often use this advantage against foreign rivals 5 Review by both parties of the Patent Reexamination Board of the United States (ptab) - the last section of IPR introduces the "single channel" of patent litigation in the United States, which is a long and expensive journey Often a patent case is three years, five years Lawyers' fees alone will bring down small enterprises with weak strength In 2012, the United States passed the American invention act (AIA), which introduced the inter party review IPR system to deal with patent disputes The characteristics of this system are: fast time (one year, up to 18 months); low cost (about 500000-1 million US dollars); professional judgment: the patent trial and patent board (ptab) judges the case; the judgment result is final under the court of appeal That is to say, if the conclusion of IPR is estoppel, the local court and other law enforcement agencies shall not discuss it again If not, appeal to the court of appeal IPR only accepts patent invalidation cases (no patent infringement litigation), and the litigant must be a third party other than the exclusive owner or NDA holder (the patent drug holder cannot sue in IPR) Once the IPR is opened, the district court will generally adjourn and wait for the decision of IPR If you think there is enough evidence to invalidate the opponent's patent (creativity, novelty, patentability), and you want to save time, close the case as soon as possible, and save a huge amount of attorney fees and litigation fees, IPR is a good choice Different from the local court, IPR is not accepted in all lawsuits It is a regular court session system, with applications screened in advance Whether it is accepted or not is decided by ptab 6 If the patentee does not sue, settle or the Challenger wins the lawsuit after 180 days of obtaining and losing the patent, FDA will approve the first copy of Anda to be listed to obtain the exclusive right of 180 days of generic drug sales Within 180 days, FDA does not approve the listing of other same anda However, 180 days shall be invalidated in the following cases: 1) 75 days after FDA's approval of Anda, 75 days after the court's judgment, 180 days after generic drugs have not been sold; 2) 30 months after anda's application, 180 days shall be invalidated if anda has not been sold; 3) 180 days shall be invalidated if FTC and the Ministry of justice consider that the settlement violates the anti-monopoly law; 4) 180 days shall be invalidated if anda modifies or withdraws the PIV certificate; 5) During this period, all orange peel registration patents expire and become invalid within 180 days; 6) after 75 days of succeeding anda challenge patents, the first Challenger fails to sell and become invalid within 180 days The above briefly introduces the legislative history and the basic process of patent challenge in the United States 4、 In other words, the hall of the U.S patent and Trademark Office engraves President Lincoln's famous saying: "patent system is to pour the oil of interests into the fire of genius." This is the original intention of modern people to create patent system, and the role of patent system in the progress of human technology is undoubted However, if you take generic challenge as a business strategy, you should look at drug patents from a different perspective Patent certificate is not a "scientific certificate" patent, but a limited right granted by the government to the inventor This is just a right, not related to the technical level and practical value of the invention itself, but also not related to "advanced" or "science" The so-called "independent intellectual property right" only refers to the right to a certain intellectual product, not that your intellectual product must be advanced, scientific and valuable The government grants patents in exchange for the inventor to disclose the contents of the invention, and the applicant's application for a patent is more of a commercial means 2 Patent certificate is the product of assembly line operation, so is the specific production process of patent First of all, patent examiners only examine the "patent application", and do not need to "verify" or "prove" whether the patent application is true, feasible or valuable Even "false patent" does not constitute a crime (the legality of virtual patent will be discussed later) At the extreme, patent applications only need to be "written" rather than "done" The basis for the examiner to grant the patent right only includes, but is not limited to, the patent application, the examiner's search results, and the examiner's own cognition If we question: is the patent application untrue, or defective, or plagiarized? What if there is any omission in the examiner's search? Is the examiner's cognition necessarily right? Is it reasonable? Every year, there are about 300000 patent applications in the United States, of which about 60000 are related to drugs The total number of patent examiners is only 4000 According to some scholars, the average time spent on a patent by each patent examiner is 20-30 hours Logically speaking, it is unrealistic to complete the retrieval, examination and evaluation of several, a dozen or even a dozen claims of a patent in such a short time 3 The particularity of drug patents [3,4,5] 1) the "patent for patent" of drug patents political scientists in the United States ridicule the pharmaceutical industry: American pharmaceutical manufacturers only make money through patents, so they will not produce drugs without patents Because there is no patent for the natural existence, in order to obtain the patent, we must do the substances that do not exist in nature, so the substances that exist in nature can not become drugs It's joking Think about it Isn't the current situation of pharmaceutical industry so? As we all know, few drug manufacturers do not take advantage of the "evergreen patent", which is called "frivolous patent" by American judges