Time to stop the delay in drug patent conflict

Professor Kim Kwan Shik (patent attorney) at Hannam University Department of Law

Professor Kim Kwan Shik

The world bombarded with COVID-19 related news has been disheartening.

 

Even the new coined term ‘Corona Blue’ was trending.

 

But on the lighter side, I came across some good news for myself, who mainly lectures and researches on patent law depicted in news articles.

 

It was from a global pharmaceutical company, AbbVie announcing it would give up on the global patent rights to Kaletra, a potential COVID-19 treatment.

 

In other words, anyone can make a copycat version (generic) of Kaletra.

 

Anyone with a slightest interest in the industry would understand that giving up on a patent right means a tremendous commitment.

 

Considering pharmaceutical companies are spending astronomical expense to protect and extend the pharmaceutical patent right as much as possible, the news actually sounded a little ironic.

 

Global and Korean pharmaceutical companies use various tactics to prolong the market exclusivity period protected by the patent rights.

 

One of the most popular strategies is ‘patent term extension.’ A patent’s term is valid until 20 years after the patent issue date, but in some cases it could be extended up to five years.

 

As for pharmaceutical patent, a drug with listed patent cannot be commercialized immediately as it has to receive marketing approval from Ministry of Food and Drug Safety (MFDS) reviewed based on efficacy and safety data collected from clinical trial.

 

Taking account of the time spent on the administrative procedure, the term can be extended up to five years.

 

Many of Korean pharmaceutical companies tend to manufacture generics that copy original products with expired patent and sell them in inexpensive pricing.

 

And by doing so, conflicts arise frequently due to the possibility of infringing patent rights.

 

A famous case reported recently was on a drug sharing same effect with a patented original drug, but was using an incrementally modified substance uniquely approved by MFDS.

 

The conflict fired up as the original drug company claimed the modified drug maker has infringed its patent right with extended term.

 

In the end, the pharmaceutical industry was disconcerted by a staggering decision of the Supreme Court overruling the lower-instance Court’s conclusion that the patent was not infringed.

 

Another pharmaceutical company has requested negative confirmation of the original’s patent scope to the Intellectual Property Trial and Appeal Board claiming that an item sold with effect and benefit, initially not acknowledged for the original’s patent that based the term extension, is not infringing the extended patent right of the original.

 

However, the legal conflict has been on hold due to the COVID-19 pandemic.

 

The order of strict social distancing has slowed down the court proceedings.

 

Probably the pharmaceutical company pursuing the Court’s decision would be deeply frustrated as it needs to complete all procedures before the product launch.

 

Recently lost in a series of term-extension related patent trials, pharmaceutical companies should not be hindered by the ‘delay in proceedings,’ when they have finally found an alternative strategy.

 

This specific case and its follow-up trials would play a crucial role in the Korean pharmaceutical industry, as it could harmoniously arbitrate the conflict among pharmaceutical sovereignty, financial health of National Health Insurance, patients and stakeholders of the Korean pharmaceutical industry.

 

Sources say the damage taken by pharmaceutical company from the pandemic is resulting in stagnating economic growth.

 

The patent law was found to protect and promote invention and to contribute in industry advancement.

 

The Intellectual Property Trial and Appeal Board and the Court should promptly make a reasonable decision, in accordance with the original objective of the patent law, for the pharmaceutical companies continuing to take challenges amid the difficult times to propel the flourishing industry in Korea.