5-year PDRN dispute comes to an end... PharmaResearch wins

PharmaReserach “recognized for our original technology”

Kiseok Kang, Managing Director of PharmaResearch, “will solidify position as the original through active sales and marketing activities” Makes final win at reversed and remanded retrial…BMI Korea takes a blow

Kiseok Kang, Managing Director of PharmaResearch, “will solidify position as the original through active sales and marketing activities”

The long patent dispute between PharmaResearch and BMI Korea over the PDRN manufacturing method has finally come to an end, with the court ruling in favor of the original company, PharmaResearch.

 

The industry expects the trial win to bring momentum to the rise of PDRN-based pharmaceuticals and devices, such as ‘Rejuran’ and ‘Conjuran.’ If the company also wins the patent infringement trial that follows, PharmaResearch will also be able to hold the generics in check, solidifying its position as the original product.

 

◆ Managing Director Kiseok Kang, “Court recognized our original technology" According to industry sources, the Patent Court of Korea ruled in favor of PharmaResearch in the reversed and remanded retrial on the PCRN manufacturing patent invalidation between PharmaResearch and BMI Korea on the 21st.

 

This brought an end to the 5-year long legal dispute that started in 2017.

 

In a phone interview with Dailpharm after the trial, Kiseok Kang, Managing Director of PharmaResearch, said, “After the long struggle, PharmaReserach was able to win the patent litigation and be recognized for our original technology.

 

We plan to actively make this known to the market and solidify our position as an original product.

 

He added, “With the final ruling made in the invalidation trial, the patent infringement suit that had been temporarily suspended due to the invalidation trial will be finalized soon.

 

We are reviewing various strategies from multiple directions on how to proceed in the future.” The remark reflects Kang’s intent to hold generics in check through the patent infringement suit while strengthening the marketing and sales power of the original product while seeking new product development.

 

◆Twist after twist…PharmaResearch finally wins the patent invalidation trial after 5 years PharmaResearch had long been in a legal dispute over the patent for the PDRN manufacturing technology with BMI Korea.

 

When BMI Korea received approval for ‘ HiDr injection,’ a same-ingredient latecomer drug in 2016, PharmaResearch pointed out that the drug’s API and manufacturing method were inappropriate.

 

As a naturally-derived ingredient, PDRN has a more complex manufacturing method than chemical drugs.

 

Therefore, PharmaResearch claimed that the difference in the origin of the raw material or manufacturing method can bring completely different efficacy and safety results, rendering BMI Korea’s drug completely different from its original.

 

Also, the company claimed patent infringement, pointing out that optimizing DNA fragments extracted from fish for human use is PharmaResearch’s proprietary technology that requires demanding quality and manufacturing process control and management.

 

PDRN patent invalidation trial progress

BMI Korea confronted PharmaResearch’s claims with a patent invalidation trial.

 

In January 2017, BMI Korea filed a trial against PharmaResearch to invalidate its PDRN manufacturing method.

 

The legal battle that ensued showed reversal after reversal.

 

PharmaResearch won the first trial with the Korean Intellectual Property Trial and Appeal Board rejecting BMI Korea's claim in January 2018.

 

In January 2019, the Patent Court of Korea overturned the first trial's ruling.

 

The court ruled that the PDRN patent was invalid.

 

Once again, the victorious smile dawned on the other side at the Supreme Court.

 

In January this year, two years after the hearing began, the court overturned the original ruling and decided to reverse and remand the trial.

 

Following the decision, the Patent Court of Korea made the final ruling on the 21st of this month in favor of PharmaReserach.

 

The 5-year long legal dispute has finally come to an end.

 

With the win, PharmaReserach is expected to establish its own area in the market for PDRN-based pharmaceuticals and medical devices market.

 

Currently, PDRN-based polydeoxyribonucleotide ingredient drugs come in two forms – pain treatment injections and eyedrops.

 

26 painkiller injections including PharmaReserach’s Placentex Inj and Rejuvenex Inj, and 10 eyedrops including the company’s Re-an Eye Drops are in competition in the market.

 

PharmaReserach plans to actively use the court’s ruling to market its two market leaders.

 

◆Interest rises for the patent infringement suit…may halt the entry of generics depending on its results Results of the patent infringement suit that is being tried separately against BMI Korea are also gaining much attention.

 

PharmaResearch, which owns the exclusive license for the PDRM manufacturing technology, had separately filed a ‘Damages Claim Based on a Patent Right Infringement (civil case)’ against BMI Korea in 2016, apart from the patent invalidation trial.

 

However, the claim had been turned down by the Seoul Central District Court.

 

Since then, the infringement suit had been temporarily suspended with the original suit continuing to the second and third trials.

 

If PharmaResearch wins this case as well, sales of HiDr will be prohibited.

 

From PharmaResearch’s view, this will allow the company to keep its biggest competition in check.

 

PDRN is a pharmaceutical product extracted from the reproductive cells of salmon or trout and is used for skin regeneration, such as wound healing and tissue repair, etc.

 

It selectively responds to act on damaged skin areas, reduce inflammation and regenerate tissue.

 

The official name of the patent is ‘Polynucleotide fragments complex separated from fish's semen or egg and its manufacture.

 

It is named ‘'DOT™(DNA Optimizing Technology).’ Its patentee is Mastelli in Italy, and PharmaResearch has the exclusive license for the patent in Korea.

 

A product made from polydeoxyribonucleotide sodium, which is extracted from salmon semen, was first released in Korea through PharmaResearrch’s Placentex Inj that was approved in 2008.

 

The company introduced the drug through a strategic partnership with Mastelli.

 

PharmaResearrch, which had been importing and selling Placentex in Korea, set out to localize PDRN.

 

Through joint research with KIST, the company developed a PDRN/PN extraction technology.

 

Since it established the technology to extract-separate-refine the active material from salmon returning to the eastern coast of Korea in 2012, the company has been manufacturing its own PDRN ever since.