Section 71 of the IP Code grants the patent owner the right to restrain, prohibit, or prevent any unauthorized entity from making, using, offering for sale, selling, or importing a product covered by the patent into the Philippines.

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 on Boehringer’s patent No. 1-1992-43878 (‘878’) entitled ‘Benzimidazoles, Pharmaceutical Compositions Containing These Compounds, and Processes for Preparing Them’. The 878 invention’s international non-proprietary name (INN) is telmisartan, a medicine used to treat hypertension.

Facts

In 2011, after learning that Suhitas had filed applications with the Food and Drug Administration for the generic version of telmisartan under the brand names ‘Misar’ and ‘Misar-H,’ Boehringer informed Suhitas of its patent and requested a written undertaking not to import, distribute, market, sell, or offer for sale telmisartan until May 5, 2022, when the patent 878 expires.

Suhitas did not respond and, in 2013, started importing telmisartan with the brand mentioned above names into the Philippines. Suhitas Misar and Misar-H products were accessible in the various Philippines in 2014. Suhitas indicated on its product information booklet that ‘Misar’ is telmisartan, and the Misar tables were available in either 40mg or 80mg formulations. Boehringer filed a patent infringement suit with the IPOPHL in 2015 after receiving no response from Suhitas to its various notices.

In its defense, Suhitas alleged that:

• Boehringer failed to prove that it sold, imported, or distributed anything;
• The 878 patents do not cover telmisartan;
• 878 has lapsed;
• The importation is authorized by the Cheaper Medicine Act (RA 9502); and
• 878 is overly broad and lacking inventive steps and submitted as its lone witness Hitesh Sharma.

Arguments

Boehringer presented five witnesses, including 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 patents;
• Suhitas committed patent infringement. The evidence 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 were admitted by its witness Sharma. Moreover, no controverting evidence was presented by Suhitas;
• The IP Code does not exempt the importation of telmisartan. Suhitas claims that its importation is exempted from patent infringement on account of the Cheaper Medicine Act, which amended the IP Code. This defence 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
• The 878 patents cover telmisartan. Two tests have been developed in determining patent infringement: 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 infringed upon Claims 1, 4(a), and 5 of the 878 patents. Suhitas did not present a rebuttal witness.

Judgment

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 of 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.