Philippines: Patent infringement committed in ‘telmisartan’ case
Editha R Hechanova of Hechanova & Co, Inc discusses a patent infringement case regarding the importation and distribution of drugs used for hypertension
Section 71 of the IP Code grants to the owner of a patent the right to restrain, prohibit or prevent any unauthorised entity from making, using offering for sale, selling or importing a product covered by the patent into the Philippines.
In the case of Boehringer Ingelheim Pharma GmbH & Co v Suhitas Pharmaceutical Inc IPV No. 10-2015-00011, the Bureau of Legal Affairs (BLA), the adjudication arm of the Intellectual Property Office of the Philippines (IPOPHL) issued a decision on June 25 2021, finding Suhitas liable for infringing Boehringer’s patent No. 1-1992-43878 (‘878’) entitled ‘Benzimidazoles, Pharmaceutical Compositions Containing These Compounds and Processes for Preparing Them’. The international non-proprietary name (INN) of the 878 invention is telmisartan, a medication used for managing hypertension.
In 2011, upon knowing that Suhitas filed before the Food and Drug Administration, applications for the generic version of telmisartan under the brand names ‘Misar’ and ‘Misar-H’, Boehringer notified Suhitas of its patent and requested for a written undertaking not to import, distribute, market, sell or offer for sale telmisartan until the expiration of 878 on May 5 2022.
Suhitas did not respond and in 2013 started importing telmisartan with the aforementioned brand names into the Philippines. In 2014, Boehringer was able to purchase Suhitas Misar and Misar-H products in various locations in the Philippines, and on its product information leaflet Suhitas indicated that ‘Misar’ is telmisartan and the Misar tables were available in either 40mg or 80mg formulations. Not getting any response from Suhitas on its various notices, Boehringer filed for patent infringement before the IPOPHL in 2015.
In its defence, Suhitas alleged that:
Boehringer failed to prove that it sold, imported or distributed anything;
Telmisartan is not covered by the 878 patent;
878 has lapsed;
The importation is authorised by the Cheaper Medicine Act (RA 9502); and
878 is overly broad and lacking inventive step, and submitted as its lone witness Hitesh Sharma.
Boehringer presented five witnesses among which was Nikko P Quevada who was qualified as an expert witness. The trial ensued after which the BLA Director held:
Boehringer’s 878 patent is valid. 878 was granted under the old law RA 165 which provided that the term of the patent is 17 years from issuance, hence, it is valid and effective until May 10 2022;
878 patent is novel. Suhitas presented only the unsupported bare allegations of its lone witness Hitesh Sharma which failed to satisfy the degree of proof needed to overcome the presumption of regularity of the substantive examination conducted by the IPOPHL examiner in issuing the 878 patent;
Suhitas committed patent infringement. The evidence presented showed that Suhitas imported, distributed and sold Misar and Misar-H branded products containing telmisartan. Its corporate name, logo and business address were on the packaging and foil wraps of said products, and admitted by its witness Sharma. Moreover, no controverting evidence was presented by Suhitas;
The importation of telmisartan is not exempted by the IP Code. Suhitas claims that its importation is exempted from patent infringement on account of the Cheaper Medicine Act which amended the IP Code. This defense is misplaced since Section 72 only exempts importation of a patented product if the latter comes from the patent owner or its licensees, which is a limited exception to the patent holder’s exercise of its patent rights, to ensure access by the public to affordable quality drugs and medicines; and
Telmisartan is covered by the 878 patent. In determining patent infringement, two tests have been developed: literal infringement and the doctrine of equivalents. Boehringer’s expert witness, Nikko Quevada, testified that telmisartan is covered by Patent No. 1-1992-43878 and that Misar and Misar-H literally infringed upon Claims 1, 4(a) and 5 of the 878 patent. Suhitas did not present a rebuttal witness.
The BLA stated that considering the overwhelming evidence presented by Boehringer it found the latter was able to prove that Suhitas had committed patent infringement when it imported and distributed Misar and Misar-H drugs which contain the chemical compound of telmisartan patented in the name of Boehringer.
The BLA awarded temperate damages amounting to PHP 5.0 million ($100,000) and permanently enjoined Suhitas, its stockholders and other persons acting on its behalf from importing, distributing, marketing, selling and offering for sale its pharmaceutical products with the brand names ‘Misar’ and ‘Misar-H’ and carrying the generic name ‘telmisartan’.
Suhitas was also ordered to dispose outside the channels of commerce all goods infringing on Boehringer’s patent including materials and implements used in committing patent infringement. Both parties appealed this decision to the Office of the Director General where it is currently pending.
Editha R Hechanova
President, Hechanova & Co