Trade marks are essential for distinguishing goods and services. Likewise, branding of the pharmaceutical products is critical to distinguish products for consumers and especially to avoid or mitigate confusion amongst medical practitioners, pharmacists, nurses, and other health professionals who proscribe, dispense, label or control medicines (“pharmacovigilance”).
The global trend, by way of various treaties, is for harmonisation of trade mark laws, so as to inter alia facilitate ease of branding across borders.
There is a systemic problem around branding confusion and lack of legal coherence, best illustrated in the following situation. “Serevant” is a drug used for patients with breathing issues. The etymology of the name is clear: “sere” is derived from “serenity” and “vent” refers to the opening that allows air, gas, or liquid to pass out of or into a confined space. It is a trade mark which is suggestive, without being descriptive.
On the other hand, “Lipitor” is Pfizer’s trade mark for atorvastatin, the world’s bestselling drug. It has generated more than USD$125 billion in sales in 15 years. It is used to regulate lipids, which consequently lower blood cholesterol, and thereby mitigate the risk of cardio vascular disease. Atorvastatin is a type of statin. Statins all limit production of cholesterol in the liver – and there are many of them:
Click here to iew table.
While each of the generic names for the statins have an obvious etymology (for example, atorvastatin is a type of statin), each of the trade marks do not. There is also no obvious connection between each of the generic names and their corresponding trade marks, nor any obvious connection between any of the trade marks owned by different companies. Each are quite different from the other. Yet statins as a group perform broadly the same purpose.
When Pfizer’s US patent on atorvastatin expired on 30 November 2011, other companies began to sell atorvastatin under different trade marks – “LIPVAS”, “ATORLIP”, “TULIP”. These trade marks contain the suffix “lip”. Lipids are a group of molecules which include, as a sub-group, fats. More accurately, the targeted molecules are low density lipoprotein (LDL) cholesterol. So, “Lipitor”, “Lipvas”, “Totalip”, “Tulip” all make oblique reference to their effects on lipids.
But another drug, “Lipidil”, produced by Abbott Laboratories, is a fenofibrate. It also reduces LDL. The drug is also marketed as Tricor, Lipofen, Antara, Fenoglade, Lofibra and Triglide. Fenofibrate is less effective than statins in reducing LDL. But approximately 3%-4% of all patients using a statin experience liver inflammation , and so it is used as a substitute therapy, or sometimes in conjunction with a statin.
“Lipidil” and “Lipitor” both perform the same function, but have different degrees of effectiveness, and have different side effects, and come from different trade sources.
The potential confusion between the two brands is self-evident through common use of the prefix “LIPI”.
Compared to, say fast moving consumer goods, or the automotive industry with its plethora of strong suggestive trade marks, it is fair to say there is relatively little consumer-facing creative effort in pharmaceutical brands.
The concept of market-driven branding came late to the pharmaceutical industry, for four reasons:
- as drugs sales are not a consumer –“want driven”, but are instead a rational patient –“needs driven” purchase, they were perceived as not requiring branding;
- the perception of no consumer audience for market-driven brands. Purchases were made by patients, but for prescription drugs, the purchasing decisions were made by doctors or pharmacists;
- regulators vastly inhibit branding on pharmaceutical goods;
- expenses incurred in brand creation and advertising could not be recouped by increasing prices, because of regulatory pricing controls.
But branding of pharmaceutical products is critical to:
- distinguish products for consumers and especially to avoid or mitigate confusion amongst medical practitioners, pharmacists, nurses, and other health professionals engaged in pharmacovigilance;
- increase awareness and interest in drugs new to the market, or when drugs transition from being prescription only to “over-the-counter” (OTC) medicines. An example of this is when Glaxo Wellcome began OTC sales of 75mg doses of Zantac (ranitidine, a histamine H-2 receptor antagonist used to treat ulcers by inhibiting stomach acid). Large packs are still subject to prescription, but small packs of the drug are marketed directly to patients. Branding increased in importance in competitive advantage to lay consumers/patients for drugs which have made this transition;
- Protect the drug post-patent. Patents last from 20-25 years for pharmaceutical products. However, many brands (for example, Viagra, Prozac and Panadol) can carry goodwill which lasts long beyond that, assisting by the fact that trade marks are essentially a perpetual monopoly by reason of a 10 year renewal cycle . This assists to offset the very significant research, developments and regulatory costs.
These brands listed are protected by trade mark registrations. Trade mark registrations are statutory rights akin to monopoly rights which attach to various jurisdictions, and are granted after an examination process conducted by the trade mark registry.
For pharmaceutical products, examiners are generally required to cross-check the trade mark against the International Non-proprietary Names (“INN”) list. This list is maintained by the World Health Organisation’s International Non-proprietary Names Programme, in operation since 1953. The Programme assigns non-proprietary names, usually word prefix or suffix stems, to active and excipient pharmaceutical ingredients so that each substance is recognised by a unique name to assist in pharmacovigilance.
The principle is to group drugs by nomenclature that are pharmacologically related (or have the same pharmacological activity), using a common stem. INNs can be used freely by any drug manufacturer, because they are in the public domain and not capable of trade mark protection.
In Australia in 2012, the Trade Mark Registrar relaxed its attitude to use “in a meaningful way” an INN stem, and the consequences of this upon the pharmaceutical industry in Australia may be significant. The Trade Mark Registrar’s decision in Boeringer Ingelheim (2012) ATMO 117 set down principles for determining whether a trade mark is likely to lead to deception or cause confusion, and thereby offend section 43 of the Trade Marks Act 1995. Those principles are:
- the suffix is in common use other than in its INN-stem connotation, as evidenced by both:
- the state of the Register; and
- the marketplace;
- the INN-stem is two or three letters long;
- there are other alternative obvious suffixes present in the trade mark; and
- the INN-stem is non-specific – that is, in the context of the trade mark under consideration the INN-stem would not be generally apprehended as indicating only a particular kind of pharmaceutical because the “prefix” does not conform with the usual formulation specific to the INN-stem under consideration.
In Health World Limited (2013) ATMO 43 addition factors were also considered relevant:
- how familiar are health professionals, who are considered most at risk of being deceived (in Australia), with the relevant products that may contain the INN-stem?; and
- does the manner of sale support that deception or confusion is not likely? For example, are there similar non-prescription goods that contain the same INN stem that serve the same purpose?
If only one or two of these principles are applicable, the Registrar will most likely uphold an objection under section 43. However, when three or more of these principles are applicable, the Registrar should withdraw an objection under section 43.
In addition, in Australia, as part of a pre-market regulatory process, the Therapeutical Goods Administration (TGA) evaluates whether a drug product name looks or sounds like another drug already listed in the Australian Register of Therapeutic goods by the TGA for sale in Australia. The TGA regulates prescription, over-the-counter (OTC) drugs, and complementary medicines in Australia. The TGA also considers packaging, colour and design to assist in pharmacovigilance. In 2011 the TGA initiated a review of the regulatory framework for the branding of drugs and in 2012 issued a consultation paper with its key recommendations. Moving in the opposite direction from the Australian Trade Marks Registrar, some of these recommendations have an impact upon trade mark owners’ rights, notably, the emphasis on active ingredient names on packaging and a ban on look-alike packaging and sound-alike packaging.
It is a confusing field. The drift of both the Trade Marks Registrar and the TGA away from each other on a common position is unfortunate. It is worse when you consider the position of exporters: arrangements for branding of pharmaceutical products from jurisdiction to jurisdiction are disparate, jumbled and often counterintuitive to the public policy behind pharmacovigilance. A World Health Organisation model law and treaty would go a long way towards stemming these issues.