By:  Mila Federis

November 10, 2014

A recent decision of the Philippine Bureau of Legal Affairs (“BLA”) tackled the issue of distinctiveness in designations for pharmaceutical products.  In Westmont Pharmaceutical, Inc. vs. Platinum Pharmaceuticals (PVT), Ltd. (IPC No. 14-2011-00153), 22 September 2014, the applicant attempted to register “OMEZOLE” as a trademark for  “pharmaceutical preparations for the treatment of duodenal ulcer, gastric ulcer, gastro-esophageal reflex disease (gerd) and management of zollinger Ellison syndrome”.  The application was opposed on grounds that OMEZOLE is confusingly similar to opponent’s registered trademark OMEPRON, which is also used in connection with “pharmaceutical preparations for the treatment of ulcer and gastritis”.  Opponent further alleged that OMEZOLE resembles the generic name OMEPRAZOLE, a pharmaceutical drug used as proton pump inhibitor, and as such, registration is not permitted under Sections 123.1 (j) and 123.a(I) for being generic or descriptive.

In granting the opposition, the BLA ruled that OMEZOLE is confusingly similar to, and is a virtual replication of the generic mark OMEPRAZOLE. The BLA pointed out that OMEZOLE and OMEPRAZOLE are significantly similar in the beginning letters “O”, “M”, and “A”, and in the ending letters ‘“Z”, “O”, “L” and “E”.  The BLA further noted that the middle letters “P”, “R” and “A” of the generic name OMEPRAZOLE,  were merely removed in arriving at the term OMEZOLE and, that both products are used as pharmaceutical products for gastrointestinal diseases.  The “similarities are so obvious”, according to the BLA, such that if  OMEZOLE is registered, applicant obtains the exclusive use of the generic term OMEPRAZOLE. This, according  to the BLA, will mislead the public into believing that OMEZOLE and OMEPRAZOLE are one and the same product. Citing the Supreme Court decision in East Pacific Merchandising Corp. vs. Director of Patents, G.R. No. L-14377, 29 December 1960, the BLA ruled that OMEZOLE is a mere abbreviation of OMEPRAZOLE and therefore not distinctive. As an abbreviation of an International Nonproprietary Name (INN) generic term OMEPRAZOLE, applicant’s proposed designation  is descriptive of the quality and composition of the products described in the application, the BLA concluded.

If this case reflects the current tack which the BLA follows when confronted with the issue of genericness in drug designations, the following appears to be the take away from this case. That a drug designation which uses some letters from an INN generic term will likely be regarded as a mere abbreviation of the INN and will be considered as descriptive.  Also, a designation which uses the beginning and end letters of an INN generic term will be considered confusingly similar to the INN and will be denied registration for being generic.

The decision confuses and disappoints as it fails to instruct the pharmaceutical community on a consistent standard or test for determining the genericness of a proposed designation for pharmaceutical products.  In other countries, jurisprudence has established tests and defined factors or considerations when determining the genericness of proposed drug designations.  For example, the two-part genericness test established in the U.S. case of H. Marvin Ginn Corp. vs. International Ass’n of Fire Chiefs, Inc., 782 F.2d 987 (Fed Cir. 1986) requires one to offer evidence showing the genus of the goods at issue, and an understanding by the relevant public that the term refers primarily to that genus of goods or services.   Evidence of the relevant public’s understanding of a term may be obtained from any competent source, including direct testimony of consumers, consumer surveys, newspapers, magazines, dictionaries, catalogs and other publications. See In re Miller Lynch, Pierce, Fenner, and Smith Inc., 828 F.2d 1567 (Fed. Cir. 1987) and In re Northern Aluminum Products, Inc., 777 F.2d 1556 (Fed. Cir. 1985).

The BLA in this case reached the conclusion that OMEZOLE is generic by first ruling that OMEZOLE is confusingly similar to OMEPRAZOLE on account of these two terms sharing the first two syllables and the last syllable.  But if such conclusion is the only justification for the finding that OMEZOLE is generic, then the trademark owners are once more lost in their quest for clear guidance for determining the genericness of drug names. The question that remains unanswered is whether the relevant consumers understand OMEZOLE as primarily referring to the genus of the goods that is at issue in this proceeding.  The relevant consumers are those suffering from gastrointestinal diseases. The perception experienced by these consumers when they see OMEZOLE, or, the understanding of these consumers of the class or genus of goods involved and their understanding of the term OMEPRAZOLE were never discussed in the decision. Neither party presented evidence of the relevant public’s understanding of OMEZOLE or OMEPRAZOLE.  The BLA also did not comment on applicant’s failure to present evidence showing that it is not possible for the relevant consumers to be misled into thinking that it is buying the generic drug OMEPRAZOLE when it makes a decision to purchase OMEZOLE. The BLA’s statement that the ”similarities are obvious” comes across as somewhat subjective, and in any case without factual basis because of the parties’ failure to present evidence establishing  the relevant public’s understanding of the terms involved here.  For sure, with this decision, litigators will continue to struggle when faced with the issue of genericness in pharmaceutical trademarks cases.  Brand managers will continue to experiment on names derived from INN generic terms in the absence of clear guidelines, and simply hope for the best outcome in the registration process.