CONTENTS
- 1. Patent Litigation, a Dispute Over a Pneumococcal Vaccine
- - Patent Litigation, the First-Instance Judgment in the Pneumococcal Vaccine Dispute
- 2. Patent Litigation, the Appellate Court's Determination in the Pneumococcal Vaccine Dispute
- - Patent Litigation on Appeal, the Case Falls Within the Exception Under the Patent Act
- - Patent Litigation on Appeal, an Export for Research Purposes Is Excepted From Protection Under the Patent Act
- - Patent Litigation on Appeal, the Determination on Whether the Existing Settlement Was Violated
- 3. Patent Litigation, Daeryun's Strategy?
1. Patent Litigation, a Dispute Over a Pneumococcal Vaccine
This patent litigation originated in 2017.
In 2016, the domestic pharmaceutical company S became the first in the country to develop the 13-valent pneumococcal vaccine "S" and obtained product approval from the Ministry of Food and Drug Safety.
In response, in 2017, a subsidiary of the global pharmaceutical company P (hereinafter "Company P") brought patent litigation claiming that the vaccine infringed the patent for its own 13-valent pneumococcal vaccine "P" and demanding a halt to domestic sales and damages.
At the time, this case proceeded all the way to the Supreme Court and concluded in favor of Company P, and the parties reached a settlement under which Company S would not domestically produce or sell vaccine S until April 2027.
Subsequently, however, in 2018, the dispute reignited when Company S exported 13 individual protein-conjugate drug substances to a Russian pharmaceutical company for research purposes.
Company P regarded this as patent infringement as well and proceeded with additional litigation.
Patent Litigation, the First-Instance Judgment in the Pneumococcal Vaccine Dispute
Company S took the position that supplying a drug substance abroad for research and testing purposes, rather than a finished product, did not constitute infringement of the patent.
The first-instance court, however, relying on Company P's arguments, held that the export violated the conditions of the settlement intended to protect the patent.
On the question of patent infringement, the first instance found that technology similar to that used in vaccine P had been applied to vaccine S.
It also accepted Company P's argument that exporting the drug substance to the Russian pharmaceutical company for research purposes amounted to infringement of the patent.
The court regarded the matter as an infringement of the patent on the basis that the drug substance could be combined to form a finished product and that, even if the purpose was research, Company P's patented technology had been used.
2. Patent Litigation, the Appellate Court's Determination in the Pneumococcal Vaccine Dispute
Having lost at the first instance of the patent litigation, Company S filed an appeal.
The Patent Court reversed the first-instance judgment and ruled in favor of Company S.
The following examines the principal issues in this patent litigation and the appellate court's determination.
Patent Litigation on Appeal, the Case Falls Within the Exception Under the Patent Act
The court handling the appeal in the patent litigation, however, reached a different determination.
It focused on the fact that the research at issue did not pursue commercial profit.
The court determined that Company S's activity constituted an export for research purposes and could not be regarded as patent infringement, and accordingly held that Company S's conduct, which did not pursue commercial profit, did not violate the Patent Act.
Patent Litigation on Appeal, an Export for Research Purposes Is Excepted From Protection Under the Patent Act
On the issue of whether an export for research purposes falls within the research exception under the Patent Act, the appellate court recognized it as an exception.
In particular, the fact that Company S made no commercial use beyond research purposes served as an important basis for the judgment.
Patent Litigation on Appeal, the Determination on Whether the Existing Settlement Was Violated
In 2017, Company S had agreed with Company P to halt domestic production and sales, but it later took a different course and had exported the individual protein conjugates.
Whether Company S's export of the drug substance fell within this settlement, however, became the issue in the litigation.
While the first instance found that the export for research purposes violated the settlement, the appellate court determined that it was not a commercial activity.
The appellate court focused on the point that the settlement was directed at commercial production and sales.
Afterward, Company S stated, in a corporate statement to the press, that it considered the decision "a judgment that appropriately checked global pharmaceutical companies' unfair and unreasonable abuse of patent litigation."
Company P, however, did not accept the judgment and immediately filed a final appeal.
3. Patent Litigation, Daeryun's Strategy?
Patent litigation by domestic pharmaceutical and biotechnology companies is frequently directed against large global pharmaceutical companies.
For example, Company A, which developed technology for converting an intravenous injection into a more easily administered subcutaneous (SC) formulation, was also raised as a candidate that might become entangled in patent litigation with its only competitor, Company H of the United States.
Patent litigation over pharmaceutical and biotechnology IP involves a protracted process because of complex technical issues and the difficulty of gathering evidence.
To secure a favorable position in patent litigation such as this case, one must understand the technical complexity and accurately assess the scope of the patent rights, whether infringement has occurred, and validity.
In addition, because the losing party is likely to file an appeal or a final appeal, it is important to receive the assistance of an experienced attorney and to prepare thoroughly for protracted litigation.
The Intellectual Property Group of Daeryun Law Firm LLP forms teams of Korean Bar Association-registered 🔗intellectual property attorneys, as well as attorneys handling medical matters and patent attorneys with experience at the Patent Court and at large pharmaceutical companies, and it carries out a range of intellectual property work, including patent litigation and patent oppositions in the pharmaceutical and biotechnology industry, thoroughly protecting clients' rights.
