The government is worried about the generic exclusivity

Pharmaceutical industry argues that ‘14 days rule’ should be improved

What is the initial request for trial,

The generic exclusivity system is about to change in the fifth year of its introduction.

 

Until now, the industry has been criticized for 'free ride' over this system.

 

The core of the system is the grant of monopoly rights, and the contradictory situation in which monopoly was impossible was repeated.

 

The discrimination power was lowered by the process of acquiring the generic exclusivity by anyone, which led to a reduction in substantial benefits.

 

As a result of the Dailypharm analysis, the average benefit per item that has acquired the right so far has reached an average of ₩400 million.

 

For the pharmaceutical company that led the patent challenge and generic development, it was a collapse.

 

It is said that the MFDS, the main ministry in charge, agrees to such criticism from the pharmaceutical industry.

 

It is from the same reason that they have come up with improvements one after another in the fifth year of the generic exclusivity system.

 

However, in the pharmaceutical industry, there is no change in ‘the requirements for first trial', which is the core cause of the problem.

 

In this regard, it is reported that the government intends to separate this part and promote it in the form of legislative legislation.

 

◆The first improvement plan by the MFDS excluding the right of consignment items

Let's take a look at the proposals made by the MFDS.

 

First of all, this is the result of the 'Public-Private Council for Reinforcing International Competitiveness of Generic Drugs' announced on July 16th.

 

As one of the measures to strengthen the competitiveness of generics, the MFDS has decided to ``exclude consignment generics from the generic exclusivity''.

 

The permission of the right for consigned items was another reason for the scattering of right along with the initial request for trial.

 

In fact, there were frequent cases of receiving only the right without developing generics.

 

As many as dozens of companies boarded the train for the generic exclusivity at the same time.

 

For example, in the case of “Sarpogrelate SR,” 23 companies received the generic exclusivity, but manufacturers are only Sinil and Kukje.

 

22 companies entrusted the production of generics to Sinil.

 

Generic for ‘Alitoc (Alitretinoin)’ is more biased.

 

Thirteen companies received the right for the generic exclusivity, all of which are produced by Donkko.

 

The same is true of Stillen 2X and Layla.

 

For generics for Stillen 2X, all 14 companies that received the generic exclusivity were assigned to Richwood (Poonglim), and for generics for Layla, all 10 companies left to Mothers Pharmaceuticals.

 

Most of the major large items had similar circumstances.

 

10 companies each entrusted the production of Januvia (Sitagliptin) and Janumet (Sitagliptin + Metformin) to three consignors.

 

Excluding Chong Kun Dang, Hanmi Pharm, and Dasan Pharm, Kyungdong Pharm, SCD Pharm, Samjin Pharm, Jeil Pharm, Youngjin Pharm, Yuyu Pharm, and Korea Prime Pharm received the right without direct production of generics.

 

Generic production from 21 pharmaceutical companies for Amosartan (Amlodipine + Losartan) was concentrated in three consignment companies, and production of 'Viread (Tenofovir)' from 13 companies was concentrated in five consignment companies.

 

These are the cases in which a pharmaceutical company recruits dozens of Consignment companies to file a patent lawsuit when they devise a formulation development and patent strategy.

 

From the consignee's point of view, it is a strategy that can maximize consignment production income while reducing the risk of patent litigation.

 

This is the reason why some point out that pharmaceutical companies have invited free rides for generic exclusivity by sharing patent strategies.

 

 

▲ The number of companies that acquired the right for major items and the number of consignment manufacturers The number of companies that acquired the right copyright for major items and the number of consignment manufacturers This resulted in a feeling of relative deprivation.

 

This was because the efforts for product development and patent overcoming were in vain.

 

Criticism came out that it did not fit the purpose of the generic exclusivity system.

 

Additionally, it was pointed out that the excessive number of unnecessary lawsuits increased social costs, and that the burden of complaints on the original company, the patent holder, was increased.

 

The improvement plan requires revision of the Pharmaceutical Affairs Act.

 

Currently, the published proposal is the opinion of the public-private council.

 

Even if an amendment to the Pharmaceutical Affairs Act containing these contents is legislated, the gateway to the passage of the National Assembly remains.

 

Taking this into account, it is an observation that at least one year remains before this alternative is actually applied to the field.

 

◆The MFDS Improvement Proposal Second'Unable to delete trick patents The second is the content contained in the 'Partial Amendment to the Pharmaceutical Affairs Act', which was announced on August 20th.

 

The key is to prevent the 'trick' of the patent holder (original company) in advance.

 

The main point is to restrict the deletion of patents in the case of medicines that have received the generic exclusivity.

 

Under the current regulations, the patent right registered in the patent list can be deleted upon request by the patent holder.

 

In this case, the company that received the generic exclusivity cannot exercise the right.

 

It is possible to enter the market without restrictions, not only for items that have received the right, but also for other generics.

 

This is because the right qualification automatically disappears as the patent right is deleted.

 

It is reported that after the actual generic exclusivity system was implemented, several original companies made such an attempt to check the items of right .

 

However, it is explained by the MFDS that there has been no instance of a patent right being deleted after acquiring the right.

 

The industry explanation is a little different.

 

It is explained that there have been no cases of deleting a patent since the right was acquired, but there were often cases where a patent was deleted during the patent evasion process before the right was obtained.

 

Accordingly, there is an opinion in the industry that the timing of the patentee's discretionary restriction of deletion of patents should be set to “the point of filing a patent trial” rather than “after obtaining the right”.

 

◆What is the improvement of the'initial request for trial requirements? Although there are some disagreements, the domestic pharmaceutical industry is generally welcoming the two institutional changes.

 

With regard to the exclusion of generic exclusivity for consignment items, most of them agree to the purpose of the fact that free rides are greatly reduced.

 

Many of the positions that the patentee's discretionary measures not to delete a patent are also welcomed in that it protects the rights of generics.

 

However, there are many opinions that it is unfortunate when it comes to the entire system.

 

This is because the 'initial request for trial', which can be said to be the cause of the abuse of right.

 

Taking generic for Amosartan as an example, if only the measures to exclude the rights of consignment items are applied, the number of pharmaceutical companies that can acquire rights will be reduced from 21 to 3.

 

On the other hand, if the requirements for the initial request for trial are improved, only one place can receive the right copyright.

 

The case of 'Trajenta' is similar.

 

When only consignment items are limited as specified by the MFDS, 12 companies receive the right, but if the initial request for a trial is improved, one will receive the right.

 

▲ Trajenta's copyright holders An official from a domestic pharmaceutical company said, "As long as the requirements for the initial request for trial stipulated on 14days, we cannot fundamentally prevent the abuse of right." A patent attorney in the pharmaceutical and bio field also said, "There is a requirement for an initial request for a trial in the background that the generic exclusivity system has fallen to the level of a generic ticket.

 

The exclusion of the generic exclusivity for consignment items will have some effect, but it is more active in order to properly recognize the price of the effort.

 

Institutional change is necessary." ◆"First request for trial, promoting legislative legislation rather than government legislation, In this regard, according to the results of Dailypharm, it is reported that the MFDS is trying to improve the requirements for initial request for trial through the legislation rather than the government legislation.

 

Several officials from the pharmaceutical industry and the National Assembly gathered saying, "We know that the MFDS is pursuing the government legislation to exclude the right of generic exclusivity of consignment items, and the improvement of the initial request for trial in the form of a legislative legislation." Government legislation and legislative legislation are customarily clear in their strengths and weaknesses.

 

In the case of government legislation, it takes a long time for the legislation to pass, but the passing rate is high.

 

The bill is thoroughly reviewed in the process of pre-evaluation, legislative notice, public hearing, consultation with related ministries, and deliberation by the city council.

 

On the contrary, the time for legislative legislation to be initiated is short.

 

A joint motion of 10 or more members of the National Assembly is a prerequisite.

 

However, the passing rate tends to be slightly lower than that of government legislation.

 

In view of this, the MFDS is pursuing a more conservative and reliable method, the exclusion of the generic exclusivity of consignment items, while the improvement of the initial request for adjudication is undertaken by a two-track strategy that speedily promotes through the legislative legislation.

 

It is not yet known exactly what the bill will contain in relation to the improvement of the initial request for trial.

 

However, instead of deleting the 14-day rule in question, it is effective to eliminate the requirement for the initial request for trial.

 

In this case, the requirements for obtaining the right are reduced from three to two.

 

An official in the pharmaceutical industry said, "If only the 14 days rule is deleted, there is a possibility that the number of requests for trials will increase.

 

By allowing applications to be made, transparency is secured and free rides are also expected to decrease.”