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MALAYSIA: MERCK SHARP & DOHME HITS ANOTHER OBSTACLE

20th March, 2019

In January of 2019, the Court of Appeal at Putrajaya delivered a judgment to the matter of Merck Sharp and Dohme Corp (hereinafter referred to as “Appellant 1”) and Merck Sharp and Dohme (Malaysia) Sdn. Bhd. (hereinafter referred to as “Appellant 2”) v Hovid Berhad (hereinafter referred to as “Respondent”), which attracted a lot of interest in the industry and amongst patent practitioners in Malaysia.

This suit at the Court of Appeal followed the Appellants’ defeat after a full trial at the High Court, in which the High Court found that Claim 1 of Patent 194 to be invalid on the ground that it was not inventive and as such, all of its dependent Claims related to Patent 194 were also invalid.

Appellant 1 is a company incorporated in the United States of America and have been granted with Malaysian Patent No. MY-118194-A (hereinafter referred to as “Patent 194”) in which Appellant 1 produced a pharmaceutical product of alendronate acid or a pharmaceutically acceptable salt (hereinafter referred to as “Alendronate 194”) under the trade name “Fosamax” which has the capability of inhibiting bone resorption in humans. Appellant 2 is a Malaysian company that was granted the exclusive license from Appellant 1 to distribute, sell, and offer to sell Fosamax” products in Malaysia. On the other hand, the Respondent, a Malaysian company, has been granted approval by the National Pharmaceutical Bureau to market “Alendronate” 70 mg tablets (hereinafter referred to as “Respondent’s Alendronate 70 mg Tablets”).  

During the suit at the High Court, the Appellants claimed that the Respondent’s acts of importing, manufacturing, offering for sale, and stocking for the purpose of sale or offer for sale of Alendronate 70 mg Tablets have infringed Patent 194.

The Respondent made a counterclaim to declare that Patent 194 was invalid on a several grounds which include (a) Patent 194 was not a patentable invention as it relates to a method of treatment of human or animal body by therapy, (b) invention claimed in claims of Patent 194 was not novel, (c) Patent 194 lacked an inventive step and (d) Patent 194 lacked a sufficient disclosure.

The Respondent continued its challenge the obviousness of Patent 194 by questioning whether or not the invention surrounding Patent 194 was obvious to a person having ordinary skill in the art (POSITA) or whether the process discussed in the relation to the invention is already made available in the public domain in the form of a prior art.

Having heard and evaluated the evidence brought forward by the POSITAS of both the Appellants and the Respondent, High Court had accepted the view of the Respondent’s POSITAS in which evidence that pertained to the prior art where brought forward, where the dosage of even 80 mg of alendronate per day is already made available in the public domain, and was considered a safe dosage regime. As such, the High Court decided that there was no inventive step in view of Patent 194 as a method of dosing regime, whereby alendronate was prescribed to be taken at 70 mg once for a period of seven days. In the evidence brought by the Respondent, dosages of alendronate, as high as 40 mg and 80 mg has been found to be safe. In view of the prevailing prior art, the method of dosage as claimed in Patent 194 would be obvious to a POSITA and that the the invention in Patent 194 was an obvious creation. Therefore, the High Court had decided that the Respondent succeeded to discharge the legal burden to prove that Claim 1 of Patent 194 lacks an inventive step. Therefore, the High Court dismissed the Appellants’ claims and allow one of the Respondent’s counterclaims.

The Appellants filed an appeal against the High Court’s verdict at the Court of Appeal and during the appeal, the Appellants also argued that the High Court erred in law in failing to hold that Patent 194 was inventive, thus, it was a valid patent, and that dependent claims are equally valid. The Appellants also disagreed that to the High Court’s findings that Patent 194 was obvious at the priority date of Patent 194 and gave preference to irrelevant documents/publications over documents which formed the stock of common general knowledge citing that the High Court failed to give weight to secondary evidence submitted by the Appellants in the form of documents published after the priority date.

In regards to the rest of the claims which were independent claims, the Court of Appeal was of the view that having considered the independent Claims 1 and 11 to be invalid, the Court of Appeal was entitled to hold the High Court’s decision that Patent 194 was invalid as the rest of dependent claims being dependent on Claims 1, would also be invalid. In the essence of the above, the Court of Appeal noted that the only way the dependent claims can survive if they were redrafted to incorporate the features of the claim upon which they were dependent and made an independent claim. The Court of Appeal took precedence to E I Cu Pont De Nemours & Co v Imperial Chemical Industries Plc & Anor (2007) in support of the above decision.

The Court of Appeal upheld the decision of the High Court and concluded that the High Court has not erred in law in its decision pertaining to the Appellants’ invention being one that was obvious and does not involve an inventive in the course of its Patent 194, thus does not meet the requirement of patentability. The Court of Appeal was not convinced that the High Court was wrong in its decision in view of the evidence as adduced before the High Court by the Respondent. The Court of Appeal decided that both the appeal was baseless, thus, was unanimously dismissed and upheld the High Court’s decision and ordered each party to bear their own costs.

This case is rather surprising as dependent claims can automatically be considered to be valid if the independent claims from which the dependent claims are dependent upon are not valid. This defeats the purpose of having dependent claims which are always be relied upon as a fall-back if the independent claims are found to be invalid.

The matter is now pending before the Federal Court for the final appeal.