6 Sep
2016

Procedures and strategies for pharmaceutical brands: United States

Kelly IP - USA

Kelly IP

Drug makers face unique challenges when selecting and clearing trademarks for new drugs. Care must be taken to select a name that can be registered at the US Patent and Trademark Office (USPTO) and will meet the Food and Drug Administration’s (FDA) stringent approval process. USPTO registration and FDA approval are independent and typically proceed along different timelines.

Selection, clearance and registration

Drug makers face unique challenges when selecting and clearing trademarks for new drugs. Care must be taken to select a name that can be registered at the US Patent and Trademark Office (USPTO) and will meet the Food and Drug Administration’s (FDA) stringent approval process. USPTO registration and FDA approval are independent and typically proceed along different timelines.

To obtain federal trademark registration, drug makers should ideally select a name that is inherently distinctive, and therefore registrable as a trademark on the Principal Register without evidence that consumers recognise the mark as indicating the source of the product (ie, ‘secondary meaning’). Secondary meaning is required for descriptive marks, single colours, surnames and geographic designations; typically, it is shown through evidence of sales, advertising, market research and other indications that a mark serves a trademark function. Drug makers must also select a mark that is not confusingly similar (in appearance, sound or meaning) to prior trademarks.

Following USPTO approval, any party which believes that it would be damaged by the registration of a mark may challenge it through administrative proceedings at the Trademark Trial and Appeal Board (TTAB). The grounds for challenge include likelihood of confusion with a prior mark. Challenges brought against pending applications – within a specified 30-day window – are known as ‘oppositions’. Challenges to registered marks – which can be done at any time – are known as ‘cancellations’. The only remedies available in TTAB proceedings are prevention of a pending mark from being registered (in oppositions) or removal of a mark from the Federal Register (in cancellations). The TTAB cannot issue injunctions or award damages or attorneys’ fees.

Trademark owners seeking such other remedies must sue in a US court. The TTAB and the courts use variations on the same test for determining whether a second trademark conflicts with a prior mark – that is, whether there is a likelihood of confusion as to the source, affiliation or sponsorship.

Under a recent Supreme Court ruling, in certain circumstances final TTAB decisions can be binding in later court litigation between the parties.

A drug name can be registered as a trademark before it is approved by the FDA. An application for registration at the USPTO can be based on:

  • a bona fide intent to use a trademark on a product in development that is intended for the US market; or
  • actual use of the mark during the drug development process (eg, use in clinical trials).

Non-US companies can also base US registration on applications or registrations in their home countries, but must also have a bona fide intent to use the mark in the United States.

An applicant should maintain documentary evidence supporting its bona fide intent before the filing date, including documents concerning or showing:

  • research efforts;
  • efforts to seek FDA approval for the product and name;
  • clinical trials; and
  • efforts to bring the pharmaceutical to market in the United States.

US trademark law does not permit applicants to cover an entire class or classes of goods. Further, broad statements such as ‘pharmaceuticals’ are unacceptable; applicants must indicate the nature of the pharmaceuticals (eg, ‘pharmaceuticals for treating respiratory diseases’). Applicants must take care not to include goods that they do not intend to sell in the United States.

Timing can be an issue for pharmaceutical trademarks. Pharmaceutical companies typically select marks years before their products receive FDA approval and enter the market. However, an intent-to-use (ITU) applicant must submit a statement of use within three years of the USPTO allowing its application. If the period for submitting evidence of use expires while the FDA review process is ongoing, the drug maker should file a new ITU application before the existing one is abandoned and conduct a search for relevant intervening filings. It is best to file a new application as early as possible, because ITU applicants can claim the filing date as the date for establishing trademark rights, even if actual first use occurs several years later.

Types of mark eligible for registration

In the United States, trademark registrations can be obtained for:

  • names;
  • symbols or logos;
  • product colours;
  • product shapes;
  • sounds;
  • container and packaging trade dress;
  • scents;
  • flavours; and
  • slogans or taglines.

For example, AstraZeneca holds trademarks for:

  • the brand names PRILOSEC and NEXIUM;
  • the colour purple as applied to those products; and
  • the slogan THE PURPLE PILL.

Pfizer holds a registration for the VIAGRA word mark, as well as the diamond shape of the pill. However, no registrations for scents or flavours of pharmaceuticals have successfully been obtained.

Word marks that are not descriptive or generic, as well as most logos and designs, can be registered and enforced as soon as they have been used on goods shipped in interstate commerce. Descriptive word marks and non-traditional marks (eg, colours, flavours, scents and most trade dress) require proof that the mark has acquired secondary meaning.

Slogans and taglines for prescription drugs pose particular challenges. FDA regulations prohibit them on packaging for prescription drugs, so drug makers wishing to register a slogan or tagline must satisfy the use requirement in other ways (eg, displaying the slogan or tagline at trade shows or including it on materials that contain ordering information).

FDA approval versus trademark registration

Trademark registration offers important advantages, but is not mandatory, since US trademark rights arise through use in commerce, not registration. However, FDA approval of drug names is mandatory. Like the USPTO, the FDA considers the similarity of a proposed name to prior drug names. The FDA also considers whether the name may harm the public (eg, creating a risk of mistakes when pharmacists dispense or patients take the drug) or mislead patients (eg, misrepresenting a drug’s characteristics or capabilities).

In May 2014 the FDA released the draft Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs, complementing the FDA’s 2010 final guidance on information required in an application for name approval.

Preventing medication errors

To reduce errors resulting from drug labelling, the FDA Division of Medication Error Prevention and Analysis (DMEPA) reviews drug trademarks both before and after marketing. The DMEPA’s review covers not only a drug’s brand name, but also the generic names of pharmaceuticals. Besides names that resemble prior names, the names that do not meet FDA guidelines include those that:

  • potentially exaggerate a drug’s efficacy (eg, Rogaine, the brand name for hair-growth drug minoxidil in the United States, is called Regaine in other countries. The FDA would not approve Regaine, believing it to be misleading); or
  • could lead to prescription errors (eg, the wrong drug or dosage)
Avoiding misleading names

To reduce the risk that the FDA will not approve a name, a company should avoid names that:

  • refer to an inactive ingredient in a way that suggests effectiveness;
  • incorporate generic stems in the stem position;
  • imply unique effectiveness (eg, ‘special’);
  • imply maximum strength (eg, ‘ultra’);
  • were previously used on discontinued products;
  • contain numbers (which might be misinterpreted); or
  • include letter prefixes, suffixes or abbreviations that signify dosage intervals in the medical field.
Avoiding names confusingly similar to other drug trademarks

The FDA guidelines urge companies to consider:

  • the sound of the name when spoken, to avoid phonetic similarity;
  • the appearance of names as printed (the FDA uses computer technology to detect spelling and phonetic similarities); and
  • the appearance of a name as written by a physician (physicians sometimes write the first few letters more carefully than the rest of the name).

The following factors should also be considered:

  • the status of the two products being compared (prescription drugs are more likely to be confused with other prescription drugs than with over-the-counter (OTC) drugs);
  • marks that draw too heavily on the generic name of another drug; and
  • similarity with a company’s other drug names (many pharmacies arrange drugs by manufacturer, increasing the likelihood that similarities between names may result in a dispensing error).

A different type of error may result when a company uses different trademarks for products with the same active ingredient that are used to treat different conditions. Doing so may increase the risk that a patient may take cumulative doses of the same active ingredient, presenting a risk of overdose. The FDA may make an exception when a drug approved for one indication that carries a stigma later receives approval for other indications. For example, Eli Lilly originally sold the antidepressant fluoxetine as Prozac. Fluoxetine was eventually shown to be effective for pre-menstrual syndrome (PMS). To avoid possible stigma associated with anti-depressants, the FDA allowed Eli Lilly to use the name Sarafem for fluoxetine prescribed for PMS.

FDA review of trademarks for biologics

Trademarks for non-therapeutic biologics (eg, vaccines) are reviewed by the Advertising, Promotion and Labelling Branch of the FDA Centre for Biologics Evaluation and Research (CBER). In general, the CBER process is similar to the DMEPA process, with the additional provision that the CBER discourages multiple trademarks for the same drug used for different indications.

OTC drug products

When a product goes from prescription to OTC status, the prescription brand name may be used for the OTC version if there has been no change in indications, dosing or strength. Otherwise, the FDA states that it “might be appropriate” to market the OTC product under a different or modified trademark.

Many OTC drugs are not subject to the FDA’s name approval process. However, the FDA recommends that manufacturers choose OTC names with safety considerations in mind.

Brand name extensions

For brand name extensions (also known as ‘family marks’ or ‘umbrella names’), the FDA considers whether the products:

  • share at least one common active ingredient;
  • are differentiated by labelling; and
  • have appropriate modifiers.
DMEPA review process

Drug makers must submit two proposed drug names, in order of preference, to the DMEPA for review. If the DMEPA rejects the first name, it will evaluate the second choice. Names that receive tentative approval undergo a second evaluation 90 days before final approval of the drug or biologic. During the second evaluation, the DMEPA compares the proposed name with drug names approved since the initial evaluation.

The FDA’s May 2014 draft guidance describes how drug companies may design and conduct “comprehensive simulation studies” to assess the likelihood of end-user error due to similarities between drug names. Such studies are not mandatory, but the FDA states that it “would be useful” if more companies used this naming tool.

Post-marketing surveillance

The DMEPA can order changes in drug names that it has approved. For example, Pediaprofen was changed to Children’s Motrin after reports of confusion with Pediapred; and Altocor was changed to Altoprev after reports of confusion with Advicor.

Parallel imports and repackaging

Section 381(d) of the Food, Drug and Cosmetic Act states that only a drug’s original manufacturer may re-import prescription drugs (or drugs composed wholly or partly of insulin) made in the United States and exported to a foreign country. Re-imported drugs must be genuine (not counterfeit), properly handled and – if necessary – re-labelled for sale in the United States.

The Food, Drug and Cosmetic Act also prohibits the import of unapproved new drugs. These include drugs approved for sale by foreign counterparts to the FDA that have not received FDA approval. The FDA may refuse to allow the sale of any drug that “appears” to be unapproved, placing the burden on the importer to provide proof of FDA approval.

Anti-counterfeiting and enforcement

Pharmaceutical manufacturers supplying the US market, wholesale drug distributors, repackagers and many dispensers must:

  • report product transaction histories regarding the parties that handle drug packages;
  • quarantine and investigate any drug that has been identified as suspect; and
  • notify the FDA if an illegitimate drug is found in the supply chain.

By 2017 manufacturers will also have to include serial numbers on packaging. The goal is to track and trace drug packages better in order to spot potential counterfeit products.

Advertising

In 2014 the Supreme Court ruled that the FDA’s food labelling laws do not pre-empt the federal Lanham Act. The case in question involved Coca-Cola’s Minute Maid juice product featuring the words ‘Pomegranate Blueberry’. The phrase “flavored blend of 5 juices” appeared below in smaller type. Although this label complied with FDA labelling regulations, POM Wonderful alleged that the label falsely advertised pomegranate and blueberry juices as the primary ingredients, when the product actually consisted mostly of apple and grape juices. Reversing the Ninth Circuit, the Supreme Court held that POM Wonderful’s false advertising claim could proceed, even though Coca-Cola’s label met FDA requirements. By extension, false advertising suits involving drugs that comply with FDA labelling regulations may be asserted following this ruling.

Generic substitution

Biologics and biosimilars

The active ingredient in a typical pharmaceutical product is a chemical molecule that has been synthesised in the laboratory.

However, a ‘biologic’ or ‘biopharmaceutical’ is a therapy that has been manufactured in a living system such as a micro-organism or plant or animal cells. Most biologics are large, complex molecules or mixtures of molecules. Many arise from recombinant DNA technology.

As with conventional small-molecule drugs, biologics are assigned a ‘proper name’ (reflecting characteristics such as chemical structure and pharmacological properties) and given a ‘proprietary’ name (ie, brand) by the innovator.

‘Biosimilars’ are versions of innovator biopharmaceutical products made by a different company. Unlike the active ingredients in generic versions of brand-name drugs, which are chemically identical to the brand, copies of biosimilars are rarely – if ever – identical to the original.

Generic versions of brand-name small-molecule drugs share the same generic names (eg, fluoxetine for both Prozac and its generic equivalents). Makers of follow-on biosimilars would like their products to share the same proper names as the innovator’s products. However, innovators argue that using the same name for a product that is not identical would be misleading and detrimental to public health.

In proposed guidelines, the FDA recommends that innovator products (‘reference products’) and biosimilars share a core drug substance name, but be assigned unique FDA-designated suffixes composed of four arbitrary lower-case letters. For example, the non-proprietary name of a reference product could be ‘replicamab-cznm’ and a biosimilar to that product could be ‘replicamab-hixf’.

Online issues

Online sales of unregulated and counterfeit drugs are a major source of concern. To combat counterfeits, the generic top-level domain name ‘.pharmacy’ has been awarded to the US-based National Association of Boards of Pharmacy (which includes members from Canada, Australia and New Zealand). Pharmacies that operate a ‘.pharmacy’ website have been vetted and monitored for continued compliance with appropriate standards. The goal is to make ‘.pharmacy’ a trusted domain name worldwide.

Earlier efforts to establish a seal of approval for legitimate online pharmacies largely failed, because counterfeiters could easily copy the seals of approval. The hope is that the ‘.pharmacy’ domain obviates that problem.

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Robert D Litowitz
Partner

robert.litowitz@kelly-ip.com

For 25 years, Rob Litowitz has helped pharmaceutical companies to protect and enforce their IP rights. Clients and colleagues value Mr Litowitz as an outstanding strategist, persuasive writer and passionate advocate who distils complex facts and concepts into winning themes and compelling narratives. His expertise in pharmaceutical litigation includes not only trademarks, but also patents for lifesaving medicines and blockbuster drugs. In addition, Mr Litowitz has extensive false advertising litigation and counselling experience. He also counsels legendary and emerging musicians on all aspects of IP law. His Softrights blog displays his unique perspectives on the intersection of IP law, music and popular culture.

Lynn M Jordan
Partner

lynn.jordan@kelly-ip.com

Lynn Jordan is a talented strategist who has devoted herself to representing clients in all aspects of trademark law. With extensive experience in clearing marks for several major pharmaceutical companies, she understands the unique challenges facing marks with safety concerns and the implications of FDA review. Ms Jordan has been named as one of Managing IP’s Top 250 Women in IP (2014) and IP Stars (2014, 2015). She has been recognised as a top Washington DC lawyer for non-contentious work by the WTR 1000 (2014, 2015) and Legal Media Group’s Expert Guides: Guide to the World’s Leading Trademark Lawyers (2014), and as a recommended trademark lawyer by Legal 500 (2014, 2015).