Drug patent linkage originated as an innovation from the 1984 Hatch-Waxman Act in the US. It refers to (1) procedurally linking the approval of the sale of a generic drug and its patent validity review; and (2) functionally linking the US Food and Drug Administration (FDA) and the US Patent and Trademark Office (USPTO). The system effectively provided legal solutions to potential patent infringements before the generic drug launches into the market.
Jumping ahead to 1 October 2017, Chinas general offices of the CPC Central Committee and the State Council called for exploring drug patent linkage and lowering the patent infringement risks of generic drugs with their Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices, aiming to incentivise generic drug development.
In October 2020, the linkage system was formally introduced into the fourth amendment to Patent Law, an upper-tier law in Chinas legislative hierarchy. On such basis, the National Medical Products Administration (NMPA) and China National Intellectual Property Administration issued the Measures for Implementation of the Mechanism for Early Settlement of Drug Patent Disputes (interim) on 4 July 2021. The following day, the Provisions on Several Issues concerning the Application of Law in the Trial of Civil Cases involving Patent Disputes Related to Drugs of which Applications for Registration are Filed and the Administrative Adjudication of the Mechanism for Early Settlement of Drug Patent Disputes were released by the Supreme Peoples Court and CNIPA, respectively. Thus, drug patent linkage was implemented throughout administration, lawsuit and administrative adjudication.
By comparing the drug patent linkage systems in China and the US, this article will hopefully prove insightful to our colleagues in the industry.
Patent classifications
Registered drug patents in the US can be classified into drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method-of-use patents.
In China, a drug can be patented as a chemical drug, traditional Chinese medicine or a biological product. Chemical drugs may be further registered as pharmaceutical active ingredient compound patents, pharmaceutical composition patents containing active ingredients, or patents for medical use. As the matter of stay period and exclusivity period below does not apply to traditional Chinese medicine or biological products, this article will focus on drug linkage differences between China and the US in terms of chemical drugs.
Patent declaration
Paragraph II certification in the US means that a patent has expired in spite of its inclusion in the Orange Book, FDA's Approved Drug Products with Therapeutic Equivalence Evaluations.
Class two declaration, Chinas equivalent of the above, means that the patent relating to the drug which is imitated included in the registration platform has been terminated or declared invalid, or that the generic drug applier has obtained the relevant implementation license from the patentee.
Duty of notification and limitation of action
Paragraph IV certification in the US requires that the generic drug applier must notify the patentee and the marketing authorisation holder within 20 days from the acceptance of application. The patentee and holder may file a lawsuit at the court within 45 days of receiving the notification.
Under class four declaration, Chinas equivalent of the above, the NMPA should make a public announcement within 10 working days after accepting a generic drug application, and the applier should submit the declaration and its basis to the marketing authorisation holder, who is entitled to file a lawsuit at a court or apply for administrative adjudication by the CNIPA within 45 days from the announcement date.
Dispute resolution
Generic drug patent infringement is determined via judicial proceedings in the US, while application for patent invalidation may be submitted to a court or the USPTO.
In China, generic drug patent infringement can be determined by court via judicial proceedings or by the CNIPA via administrative adjudication. Patent invalidation, on the other hand, must be submitted to the CNIPA.
Stay period
In the US, a stay period of 30 months will be imposed by the FDA if the patentee or the marketing authorisation holder files a lawsuit within the limitation of action. Stay period can only be ordered once and may be shortened or prolonged by the court.
In China, after receiving a notification of case initiation from the court or a copy of CNIPAs notice of acceptance, the NMPA will impose a nine-month stay period.
Exclusivity period
In the US, the first generic drug that successfully challenges the patent and launches into the market is entitled to a 180-day exclusivity period, which will be invalidated if the first applicant:
Exclusivity period in China is 12 months, but cannot exceed the patent term of the challenged drug. The conditions for losing exclusivity remains a vacant spot in Chinas regulations pending future complementation.
Our thoughts
Chinas drug patent linkage system mirrors the US framework, but also deviates from it where the national situation calls for such a change. For instance, given that China is currently short in new drugs, first generic drugs are given preferential treatment, such as shorter stay period and longer exclusivity, to encourage their earlier launch.
It should be mentioned that Chinas drug patent linkage system is still in a nascent stage, with more refined and detailed provisions on the way. We look forward to seeing the new system evolve in future practices.
Read more:
Comparing drug patent linkage in China and the US - Lexology
- What Does the Fourth Amendment Mean? | United States Courts - December 30th, 2022 [December 30th, 2022]
- Fourth Amendment EPIC - Electronic Privacy Information Center - December 30th, 2022 [December 30th, 2022]
- With The Onions support, satirist asks court to revive lawsuit against police who arrested him - SCOTUSblog - October 19th, 2022 [October 19th, 2022]
- Twenty-fourth Amendment to the United States Constitution - October 19th, 2022 [October 19th, 2022]
- Trump legal counsel vows 'Fourth Amendment based' challenge to Mar-a ... - October 19th, 2022 [October 19th, 2022]
- Utah Court of Appeals reverses sex offender's conviction, claiming state failed to prosecute case for 2 years - FOX 13 News Utah - October 19th, 2022 [October 19th, 2022]
- Accused killer sent home in Indianapolis triple murder trial; evidence thrown out - WTHR - October 19th, 2022 [October 19th, 2022]
- What is Fog Reveal? A legal scholar explains the app some police forces are using to track people without a warrant - Cobb County Courier - October 19th, 2022 [October 19th, 2022]
- Some Texas Lawyers Think Greg Abbott's Border Initiative Is UnconstitutionalBut They're Afraid to Challenge It - Texas Monthly - October 19th, 2022 [October 19th, 2022]
- West Virginia midterm elections: What to know about voting in Mon County - The Daily Athenaeum - thedaonline - October 19th, 2022 [October 19th, 2022]
- HIGHPEAK ENERGY, INC. : Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance... - October 19th, 2022 [October 19th, 2022]
- WMU Law professor says if federal probe is opened, the 4th and 5th amendments will be key in Lyoya case - FOX 17 West Michigan News - April 28th, 2022 [April 28th, 2022]
- NJ Appeals Court: Lower Court Mixed Up 4th And 5th Amendment And Either Way, Phone Passcodes Can Be Compelled - Techdirt - April 28th, 2022 [April 28th, 2022]
- Department of Justice reaches agreement with Springfield about policing - Reminder Publications - April 28th, 2022 [April 28th, 2022]
- Op-ed: The Constitution in a time of change - Courier & Press - April 28th, 2022 [April 28th, 2022]
- Sinclair Closes Refinancing and Extension of STG Credit Facilities - Business Wire - April 28th, 2022 [April 28th, 2022]
- SP PLUS CORP : Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet... - April 28th, 2022 [April 28th, 2022]
- 'You Have The Right To Remain Silent JUST KIDDING!' Says Biden Administration - Above the Law - April 28th, 2022 [April 28th, 2022]
- In review: key recent IP developments and trends in China - Lexology - April 28th, 2022 [April 28th, 2022]
- Syracuse police had other options for dealing with 8-year-old accused of stealing. They didn't use them. - City & State - April 28th, 2022 [April 28th, 2022]
- Jon Bernthal embedded with Baltimore police to play city's dirtiest cop in HBO's "We Own This City" - Salon - April 28th, 2022 [April 28th, 2022]
- When the government hides spy cameras on your land, fight back in court | Opinion - Tennessean - December 14th, 2021 [December 14th, 2021]
- Rockford Black Lives Matter case over bond hearings is now in hands of US Court of Appeals - Rockford Register Star - December 14th, 2021 [December 14th, 2021]
- Man convicted of raping two lifeguards appeals to Va. Supreme Court over DNA collected from drinking straws - WTOP - December 14th, 2021 [December 14th, 2021]
- We Hear You: Parents Must Fight to Save Public Schools - Daily Signal - December 14th, 2021 [December 14th, 2021]
- Judge Denies Motion to Suppress DNA Evidence on Cup Used by Accused in Police Interview; Defense Claimed Client Denied Water on 6-Hour Trip, then... - November 29th, 2021 [November 29th, 2021]
- European Union: COVID-19 State aid update - State aid Temporary Framework prolonged and additional aid for recovery possible (6th Amendment) -... - November 29th, 2021 [November 29th, 2021]
- Govt That Spies Has Insatiable Appetite - KMJ Now - February 4th, 2021 [February 4th, 2021]
- No-knock search warrants began in Wisconsin, Rep. Myers wants to end them here - Wisconsin Examiner - February 4th, 2021 [February 4th, 2021]
- Close the Gaps - East Bay Express - February 4th, 2021 [February 4th, 2021]
- Is Americas Approach to Cannabis Racist? Study Shows Its Worse Than You Think - GreenState - February 4th, 2021 [February 4th, 2021]
- Federal appeals court allows reporters to sue SWAT officer who tear-gassed them during Ferguson protests - JURIST - February 4th, 2021 [February 4th, 2021]
- Invoking Scalia, Sotomayor Presses for Broad Fourth Amendment Protections - Reason - October 30th, 2020 [October 30th, 2020]
- EFF Files Amicus Brief Arguing That Law Enforcement Access to Wi-Fi Derived Location Data Violates the Fourth Amendment - EFF - October 30th, 2020 [October 30th, 2020]
- Main Points Of The Fourth Amendment To Chinese Patent Law (Approved On October 17, 2020, Effective From June 1, 2021) - Intellectual Property - China... - October 30th, 2020 [October 30th, 2020]
- Column: Michigan can bring privacy into the 21st century - The Oakland Press - October 30th, 2020 [October 30th, 2020]
- IMPD dismissed from Dreasjon Reed lawsuit - WTHR - October 30th, 2020 [October 30th, 2020]
- The Criminal Justice of Amy Coney Barrett - Washington Monthly - October 30th, 2020 [October 30th, 2020]
- A guide to the statewide constitutional amendments on the ballot in November 2020 - Yellowhammer News - October 30th, 2020 [October 30th, 2020]
- RUTHS HOSPITALITY GROUP, INC. : Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an... - October 30th, 2020 [October 30th, 2020]
- Assembly Committee Clears Verrelli & Benson Bill Protecting Employees from Employer Tracking Device Violations - InsiderNJ - October 30th, 2020 [October 30th, 2020]
- The tyranny of the experts - Leader & Times - October 30th, 2020 [October 30th, 2020]
- Mike R. Galli is recognized by Continental Who's Who - PRNewswire - October 30th, 2020 [October 30th, 2020]
- Mail Voting Litigation in 2020, Part II: Submission of Mail-In Ballots - Lawfare - October 30th, 2020 [October 30th, 2020]
- In its 4th revision to the SEC, Palantir tries to explain what the hell is going on - TechCrunch - September 20th, 2020 [September 20th, 2020]
- City of Pierre among South Dakota towns ordered to pay a total of $440000 because of forced catheterizations - Drgnews - September 20th, 2020 [September 20th, 2020]
- Former Torrington officer seeks to have evidence suppressed before trial - Scottsbluff Star Herald - September 20th, 2020 [September 20th, 2020]
- Council To Have One-Day Session To Learn About Police - The Rhino TImes - September 20th, 2020 [September 20th, 2020]
- Things to Know Before Your Neighborhood Installs an Automated License Plate Reader - EFF - September 20th, 2020 [September 20th, 2020]
- Attorney argues Haynes and his brother bribed witness to recant his testimony in 1999 murder case - Kankakee Daily Journal - September 20th, 2020 [September 20th, 2020]
- Justice Ruth Bader Ginsburgs Lasting Impact on U.S. Traffic Laws - The Art of Gears - September 20th, 2020 [September 20th, 2020]
- Editorial, August 10, 2020: Your cellphone might be "Big Brother" - Richmond.com - August 10th, 2020 [August 10th, 2020]
- Legal Brief: Surveillance and the Fourth Amendment - SecurityInfoWatch - August 10th, 2020 [August 10th, 2020]
- Common Ways to Fight Against a Drug Possession Charge - Student Assembly of the State University of New York - August 10th, 2020 [August 10th, 2020]
- Trump Judge Casts Deciding Vote to Grant Qualified Immunity on First Amendment Retaliation Claim: Confirmed Judges, Confirmed Fears - People For the... - August 10th, 2020 [August 10th, 2020]
- Did Judge Reeves Reach the Correct Result in Jamison v. McClendon? - Reason - August 10th, 2020 [August 10th, 2020]
- The Police Lie. All the Time. Can Anything Stop Them? - Slate - August 10th, 2020 [August 10th, 2020]
- The Court of Justice of the European Union in Schrems II: The impact of GDPR on data flows and national security - Brookings Institution - August 10th, 2020 [August 10th, 2020]
- Calls for police reform and racial justice spur a flurry of resolutions before the ABA House - ABA Journal - August 10th, 2020 [August 10th, 2020]
- Reporters Committee amicus brief in Alasaad v. Wolf - Reporters Committee for Freedom of the Press - August 8th, 2020 [August 8th, 2020]
- Meet the Judge Who Thinks a Black Man Walking Around Is a Crime - Rewire.News - August 8th, 2020 [August 8th, 2020]
- Who will police Springfields cops? - The Boston Globe - August 8th, 2020 [August 8th, 2020]
- 'Defund the police' is not a real reform strategy - The Maine Wire - August 8th, 2020 [August 8th, 2020]
- Assessing Indias obsession with data localisation - Deccan Herald - August 8th, 2020 [August 8th, 2020]
- How 9/11 and the US Civil War provided the framework for federal agents in Portland - News@Northeastern - August 7th, 2020 [August 7th, 2020]
- Senators Graham And Blumenthal Can't Even 'Earn' The EARN IT Act: Looking To Sneak Vote Through Without Debate - Techdirt - August 6th, 2020 [August 6th, 2020]
- The Constitutional Case Against Trumps Use of the Department of Homeland Security - The New Yorker - August 6th, 2020 [August 6th, 2020]
- 'Trump's Troops Are Breaking the Law and Creating Chaos' - FAIR - August 6th, 2020 [August 6th, 2020]
- Portland demonstrates that government spying on citizens has become commonplace, and easy - Washington Times - August 6th, 2020 [August 6th, 2020]
- Plainclothes NYC police grab protester and throw her into unmarked car - WSWS - August 6th, 2020 [August 6th, 2020]
- Majority of Kingston aldermen view Kingstonian project tax pact favorably, with conditions - The Daily Freeman - August 4th, 2020 [August 4th, 2020]
- Officers on the street without ID or insignia is dangerous - News-Press Now - August 4th, 2020 [August 4th, 2020]
- "It's the decent thing to do" - News - Fowler Tribune - August 4th, 2020 [August 4th, 2020]
- What would the Founding Fathers do? - Smoky Mountain News - August 4th, 2020 [August 4th, 2020]
- How the president became the deporter in chief. - Slate - August 3rd, 2020 [August 3rd, 2020]
- Want To Reform The Police? Get Rid Of Qualified Immunity - WBUR - August 3rd, 2020 [August 3rd, 2020]
- Who is Zane James, why were his brother and father detained by police in Cottonwood Heights protest? - MEAWW - August 3rd, 2020 [August 3rd, 2020]
- Unpacking DHS's Troubling Explanation of the Portland Van Video - Lawfare - August 1st, 2020 [August 1st, 2020]
- Capitol Hill grilling of tech CEOs highlights expansion of 'geofence warrants' - WRAL.com - August 1st, 2020 [August 1st, 2020]
- R Sikoryaks latest project is a word-for-word adaptation of the U.S. Constitution - Boing Boing - August 1st, 2020 [August 1st, 2020]