Roche v. Celltrion re: Herceptin Patent Infringement Lawsuit over Biosimilar Herzuma
Celltrion, a Korean company developed a biosimilar Herzuma to Herceptin (trastuzumab) and obtained market approval (MA) for a biosimilar Herzuma (trastuzumab) from KFDA on January 16, 2014. It has been approved for treatment of early and advanced (metastatic) HER2-positive metastatic breast cancer as well as advanced (metastatic) stomach cancer.
Roche has marketed Herception for the treatment of HER2-positive metastatic breast cancer in 150 mg in Korea. However, for high strength of 440 mg, Roche obtained MA just January 26, 2014. Celltrion obtained MA of the first trastuzumab biosimilar for two strengths, 150 mg and 440 mg at the same time and will launch them soon.
Roche filed lawsuit against Celltrion alleging that Herzuma infringes Roche’s patents. More details will follow soon after they are available.
Menarini’s Priligy (Dapoxetine HCl) Use Patent held Not Valid as being Obvious
Menarini launched Priligy in Korea. Dapoxetine HCl is the active ingredient in Priligy tablets. Korean patent No. 719, 977 covers the branded products and is listed in Green List of KFDA. The patented invention is “Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for Treating Sexual Dysfunction.” The patent at issue is not for a compound invention but for the second use invention. The Korean patent for the second use invention will expire on June 5, 2021. Several Korean generic companies filed invalidity proceedings to challenge the second use patent. Menarini will face generic companies’ challenges soon.
On August 23, 2013, the IPT of KIPO held that the patent in issue is not valid because the compound and its use have been disclosed in the prior art. There has been no challenge to the compound patent so far. The key issue for the second use patent was a new limitation of “on as as-needed basis” in claim language. The patentee argued that such a new limitation was not found in the prior art and made the claimed use invention being novel and nonobvious over the prior art. However, the IPT rejected the argument on the ground that such limitation is related to a method of administering a drug and thus such limitation may not be regarded as an element for a patent claim under Korean patent law.
The patentee appealed the IPT decision to the Patent Court and the case is pending.
EV Battery Patent Infringement Lawsuits – LG Chem vs. SK Innovation
Two Korean companies, LG Chem and SK Innovation are major suppliers for EV batteries to top 10 global car makers including GM, VW, Renault, etc. In 2012, LG Chem filed a patent infringement lawsuit against SK Innovation at the Seoul Central District Court. The court for the first instance trial held last Friday that LG’s patent was not infringed by SK Innovation.
The patent in issue is directed to the inorganic material-coated separator that is a key part of large rechargeable batteries for EV battery. The court held that SK Innovation’s inorganic material-coated separator has a different structure from the porous structure of the active layer coating the separator of LG Chem’s patented invention.
On the other hand, under the bifurcated system in Korean patent law, SK Innovation challenged the validity of LG Chem’s patent and was successful in invalidity proceedings at the IPT of KIPO and further at the Patent Court. However, the Supreme Court revoked the lower court decision of invalidity and returned the case to the Patent Court. The invalidity case is pending at the Patent Court.
LG Chem announced to appeal the first instance court decision to the Seoul High Court immediately after they received the losing decision.
Low Dose Entecavir Formulation in Korean Patent held as being Obvious by the IPT of KIPO
Entecavir is the active ingredient in Baraclude tablets of BMS. The drug has been sold for the treatment of chronic hepatitis B virus infection in Korea. When Korean generic companies noticed that a US district court found that entecavir would have been obvious in light of the prior art, they filed an invalidity trial to challenge the validity of the corresponding Korean compound patent, too. The invalidity case is pending in the IPT of KIPO.
On the other hand, Baraclude is covered by another patent for low dose formulation of entecavir. Several companies including those want to launch generic versions of Baraclude after expiry of extecavir compound patent, filed separate proceedings to challenge non-obviousness of law dose formulation over the prior art. The subject Korean patent is No. 757,155 that claims low dose entecavir formulations of 0.5mg or 1.0 mg for the treatment of chronic hepatitis B virus infection. The prior art discloses enetcavir compound, its use, a range of doses and animal test data, but did not disclose claimed doses.
On April 30, 2013, the IPT held that low dose entecavir formulations of 0.5mg or 1.0 mg should be regarded being obvious over the prior art. To the IPT decision, the patentee BMS appealed to the Patent Court and argued that a person of ordinary skill could have neither anticipated nor determined the claimed low dose formulations of 0.5mg or 1.0 mg entecavir from the prior art. Oral hearings were held two days for expert witness examination and BMS’s expert argued at the Patent Court that determining specific doses for human required numerous trials. The panel of 3 judges in the Patent Court will decide the case on March 14, 2014.
Canon v. Baiksan OPC – Patent Owner Canon Awarded US$14 million Damage for Patent Infringement in Korea
The patentee Canon filed many lawsuits against Korean companies. Canon alleged that local companies’ manufacturing and marketing of several printer cartridges for use in Canon and other branded printers infringed Canon’s patents. While local companies challenged validities of Canon’s patents, Canon saved their patented claims from invalidity challenges finally.
On June 7, 2013, the district court of Seoul Central District held that Canon’s patents were infringed and ordered that the defendant, Baiksan OPC must stop manufacturing and selling cartridges and further destroy infringing finished or half finished products. Further, the court awarded Canon about US$14 million as damage compensation.
There are 3 ways to compute damage amount under Article 128 of the Korean Patent Act. Among 3 ways of lost profit of the patent owner, infringer’s unjust profit and a reasonable royalty, the court applied the second method based on infringer’s unjust profit for Canon’s damage compensation.
According to Article 128, paragraph 2, it is possible for a patentee to seek damages based on the profit of infringer. The profit of infringer in the provision should be the actual profit that is the amount of money in which all costs are subtracted from the total sales. The cartridges were exported to foreign markets and the customs had records of sales. The patentee may obtain such data or real records through a court order. Accordingly, the only issue for computing damages in canon case is profit ratio of infringing goods.
In principle, a plaintiff can proves the profit with account data of an infringer. However, it is not easy to figure out accurate data because the infringer does not have a single item and thus can reduce the profit by allocating costs to the subject item. Sometimes the data produced by an infringer are not reliable, too.
Usually the patentee has used the balance sheets of infringers. However, the profit computed by such balance sheets cannot be accurate because the balance sheet of a company reflects final outcome of total business activities rather than a single subject product. As an alternative option, a patentee may use an official statistic number of the government. The tax department of the Korean government noticed an official data regarding an average profit ratio per each business area every year.
According to the official notices, average profits for periods of infringements were 10% for computer printer fields. Under the Korean patent law, courts have discretion to determine a moderate amount of damage to prevent non-compensation to a patentee even though the infringement is found but no sufficient evidence to prove an amount of damage exists. It eases the patentee’s burden of proof. Based on the provision, the district court computed damage of Canon’s patent infringement through the total sales of infringement x 10%. The total amount of US$14 million is a quite big number in the history of patent infringement litigation in Korea.