Generic drug development: Bolar exception to the patent system

Patent rights and generic drug approval procedures

From the perspective of patent rights, drugs can be roughly divided into patented drugs and generic drugs

The generic drug should have the same active ingredients, route of administration, dosage form, specifications and the same therapeutic effect as the generic drug

Therefore, if the generic drug manufacturer can only start the development and registration application of the generic drug after the expiration of the patent right protection period, the generic drug can be truly introduced to the market after a lengthy approval process

Therefore, many countries have introduced Bolar exception clauses in their patent law systems

The origin of the Bolar exception

The Bolar exception originated from the U.

In this case, the plaintiff Roche had a patent for fluazepam hydrochloride, the active ingredient of a sleeping pill, and the patent expired in 1984

Roche refused to accept the first-instance judgment and appealed to the U.

The verdict in this case prompted generic drug manufacturers to carry out a series of activities and pushed the US Congress to take action

The impact of the Bolar exception

In recent years, the sales of generic drugs have continued to rise, and their share in drug sales has also increased year by year.

The system established by the "Drug Price Competition and Patent Term Recovery Act" in the United States not only promotes the accelerated listing of generic drugs, but also encourages generic drug companies to challenge patent drug manufacturers' related patents.

The continuous development of the generic drug industry has given birth to a number of international generic drug giants, and pharmaceutical companies that have advantages in the patented drug industry have also developed their own generic drug departments

In 1997, the patent for ranitidine, one of Glaxo Wellcome’s best-selling drugs, expired.

Pfizer's patented blood lipid-lowering drug Lipitor (atorvastatin) was granted a patent in 1997, and it was the world's first drug with a sales volume of over 100 billion U.

my country's Bolar Exception Clause

China is the world's third largest pharmaceutical market and has deep growth potential

Many international pharmaceutical companies have targeted the Chinese market and have continued to expand their business in China.

Before the current patent law was amended, Article 63 stipulated that the use of relevant patents exclusively for scientific research and experiments does not constitute patent infringement

Known as the "First Bolar Exception Case in China", the Japanese Sankyo Co.
, Ltd.
v.
Beijing Wansheng Pharmaceutical Co.
, Ltd.
was one of the top ten intellectual property cases in Beijing in 2006
.

Japan's Sankyo Co.
, Ltd.
owns the patent right for Olmesartan Lipid Tablets, which was granted on September 24, 2003
.
In July 2005, during the period when Sankyo Pharmaceutical Company applied to the State Food and Drug Administration for the production of the patented drug, Sankyo Pharmaceutical Company discovered that more than a dozen companies in China had applied to the State Food and Drug Administration for clinical approval of a new drug suspected of infringing the plaintiff’s patent.
Beijing Wansheng Pharmaceutical Co.
, Ltd.
has entered the new drug application and approval stage
.
On February 16, 2006, Sankyo Co.
, Ltd.
and Sankyo Pharmaceutical Company sued Wansheng Company for infringement of its patents in Beijing No.
2 Intermediate People's Court
.
The Second Intermediate People’s Court of Beijing held that although Wansheng Company used the patented method to manufacture the drugs involved in the case for the purpose of conducting clinical trials and applying for production licenses, the defendant Wansheng Company’s manufacturing behavior was to satisfy the relevant national authorities’ The need for administrative examination and approval of registration is not directly for the purpose of sales, and does not belong to the act of implementing patents for the purpose of production and operation as stipulated in the Patent Law
.

Regarding this case, although the court ruled that the defendant did not infringe, it is debatable
.
The defendant’s actions in this case had commercial purposes, that is, they had production and business purposes
.
Therefore, in order to avoid this difficulty in the application of the law caused by the lack of direct provisions of the law, in the third revision of China’s "Patent Law," a new paragraph was added that is not considered as a patent infringement, as the sixth patent law.
Article 19, Item 5, namely: manufacture, use, or import of patented drugs or patented medical devices in order to provide information required for administrative examination and approval, as well as those specially manufactured or imported for patented drugs or medical devices, this article is called Bolar in our country is an exception
.
It is worth noting that the Patent Law not only added a fifth Bolar exception clause in Article 69, but also retained the original fourth scientific research experiment exception clause
.
This provides clear legal provisions to resolve similar previous drug patent infringement cases, and avoids falling into the embarrassing situation of vague application of legal provisions
.

Since the revised "Patent Law" was formally implemented on October 1, 2009, generic drug manufacturers have used the Bolar exception clause and the related drug patent link system to apply for drugs in advance within 2 years before the expiration of the drug patent protection period.
Registration, when the drug patent expires, you can immediately enjoy the opportunity to seize the drug sales
.
Although China's Bolar exception clause is not yet complete, with the continuous establishment of related supporting systems, it is believed that the Bolar exception can form a complete system in China, which is more in line with China's national conditions and can better serve us
.

references:

1.
The BOLAR exception to drug patent rights and its impact on the pharmaceutical industry, Yuan Zhongbo, etc.
, Chinese Journal of Pharmaceutical Industry, 2008, 39(1)

2.
Research on the BOLAR Exception Principle of my country's Patent Law, Geng Dandan, master's degree thesis

3.
Bolar exception system and its application research, Ren Jiefang, master's degree thesis

4.
Research on the Principle of Exception in Drug Tests, Xiao Lie, Master's degree thesis