Talking about: "Drug Patent Link System" of "Innovation & Imitation Communication Bridge"

Medicine is a very special commodity, no matter how developed the commercial freedom is, medicine is a kind of licensed commodity.

What is the "pharmaceutical patent linkage system"?

Refers to when the drug registration applicant submits the registration application, the innovative drug is registered within the specified scope, and the improved new drug and generic drug applicant should declare the patent of the original drug involved and the ownership status, and notify the relevant drug within the specified time limit Marketing permit holders and patentees.

Where there is a dispute over the patent right, the party concerned may bring a suit in the court, and the review of drug technology shall not be suspended during the period.

What is the role and significance of the drug patent linkage system?

The drug patent link system is the mutual link between the administrative examination and approval of the drug regulatory department and the judicial decision.

Establishing a drug patent link system that suits national conditions usually has the following four important meanings: protecting the patent rights of original research drugs; encouraging generic drug patent challenges; establishing a standardized drug market access order to prevent malicious competition; and resolving patent disputes in established infringements.

Is the link system for all patents involving drugs?

Not all!

The drug regulatory authority only pays attention to the patent ownership that may affect the approval decision, that is, drug patents (active ingredient patents and preparation patents) and use patents, and does not consider other patents.

Generally speaking, the drug regulatory authority is only responsible for administrative approval and not responsible for professional judgments involving patent infringement.

Which document does the domestic drug patent linkage system originate from?

On May 12, 2017, the State Food and Drug Administration (CFDA) announced the solicitation of "Relevant Policies on Encouraging Drug and Medical Device Innovation and Protecting the Rights and Interests of Innovators (Draft for Comment)" (2017 No.

On October 8, 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council jointly issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices".

20171023，CFDA 《()》“”。

？

！

，，、、，，，。

？

！

2002，2005，2007《》“、、，。，”，、，，“”，，“”，，。，《》69: ，、、，、，。，。

？

《》！，《》。，20171228 ，《》 CNDA ，“”。、、、；、、；，。

In short, the catalog has laid a viable foundation for the implementation of the drug patent linkage system, and is an epoch-making catalog collection.

Where did the earliest patent linkage system come from?

Originated in the United States! The United States is also the country that uses this system best.

Therefore, on the one hand, the bill stipulates that brand-name drug manufacturers can extend the patent period, obtain different periods of market exclusivity, and if they sue generic drug manufacturers, they can obtain a 30-month containment period granted by the FDA, which is beneficial to brand-name drugs.

Based on this code, the US "List of Drugs Approved by Therapeutic Equivalence Evaluation", also known as the "Orange Book", was also established.

More importantly, a communication mechanism between the FDA and the United States Patent and Trademark Office (USPTO) has been established.

How does FDA ensure the smooth implementation of the drug patent linkage system?

>>>>

Orange Book System

That is, "Drugs Approved by Therapeutic Equivalence Evaluation", the list of drugs included in it are all drugs approved by the FDA after safety and effectiveness evaluation.

>>>>

Bolar exception

Based on the Hatch-Waxman Act, the U.

>>>>

ANDA system

The Hatch-Waxman Act greatly simplifies the approval process for generic drugs.
Applicants for generic drugs only need to provide the FDA with data to prove that the generic drug is pharmaceutically equivalent to the reference drug, and provide data to prove the biological relationship between the generic drug and the reference drug.
Effectiveness is sufficient, that is, ANDA.

>>>>

Patent period extension

The Hatch-Waxman Act stipulates that new drug applicants can obtain a patent extension period to compensate for the time spent in clinical trials and drug reviews.
That is, the time for patent extension is equal to half of the clinical trial cycle, plus the time for NDA approval, minus the number of days delayed due to the applicant.

>>>>

Patent declaration and challenge system

According to FDA regulations, generic drugs can submit an ANDA application one year before the expiration of the new drug market exclusivity period at the earliest.
Taking the NCE with a market exclusivity period of 5 years as an example, generic drug companies can submit at NCE-1 at the earliest, so the (NCE-1) day is usually regarded as the first imitation day.
The Hatch-Waxman Act provides a mechanism for the generic drug industry to challenge the latter category of patents.
It stipulates that a generic drug application must simultaneously submit one of four declarations on the patent status of the original research drug.
For imitators who raise a patent challenge on the first imitation date, if the patent challenge is successful, the FDA will grant the first generic drug a 180-day market exclusivity period.

What is the process of the US FDA patent linkage system?

The core procedures of patent linking mainly include: innovation authorization; imitation declaration; patent challenge; result announcement

What is the European attitude towards the patent linkage system?

The European Commission believes that the task of the drug regulatory agency is to verify the safety and effectiveness of drugs, and should not consider whether the product infringes patent rights or other factors, otherwise it would violate the patent law on the Bolar exception.
For potential patent infringement disputes that exist in the process of approval of the listing of generic drugs, the patentee can resolve it by applying for a “temporary injunction” to the court.
If a drug patent holder wants to block the approval process for the marketing of generic drugs in Europe, he first needs to obtain a temporary injunction from the court, which is obviously much higher than the threshold in the United States.

What is Japan's attitude towards the patent linkage system?

In order to resolve potential patent disputes before the listing of generic drugs, Japan has adopted another approach: one is to not approve the listing of generic drugs when the patent period of the new drug active ingredient product has not expired; the second is to deal with other than the active ingredient of the new drug.
For generic drugs with other patents, after the marketing license is issued, the original research drug company and the generic drug company may conduct "prior consultation" on whether there is patent infringement, but the negotiation results have no legal effect.
Judging from the implementation of drug patent links, the vast majority of patent disputes are for subsequent improved drug patents, and new active ingredient patents are indeed difficult to bypass.
Therefore, Japan simply stipulates that applications for generic drugs are prohibited before the patents for the active ingredients of new drugs expire.

"summary"

In general, the most direct role of the drug patent linkage system is to resolve disputes between innovative drugs and generic drugs before the patent period expires.
The system is good, but the author believes that from the perspective of the commodity attributes of medicines, as long as there are huge benefits, it is still difficult to control disputes by relying on the system alone.
After so many years in the United States, isn't it still happening? It's just that it's programmed.
However, the drug patent linkage system is good after all.
The most important thing is that it proves the rapid progress of my country's innovative drug research and development from another dimension! At the same time, it also warns us that if there is no protection of intellectual property rights on the road of innovation, the prairie fire caused by the light of genius is very likely to be met with cold water!