— Jessica Gutierrez Alm, Attorney

In an age of rising healthcare costs, pharmaceutical companies can be an easy target in calls for patent reform.  Patent protection helps drug manufacturers recoup their investment in developing the new drug,.  It also prevents generic manufacturers from releasing the same drug formulation at lower cost.  The Hatch-Waxman Act provides

Schering-Plough Healthcare, owner of the MiraLAX brand — the top-selling OTC oral laxative ($360 Million in OTC sales since launching in February 2007) — has pulled out all of the available stops and then some, in a pre-Thanksgiving Day federal district court action brought in the District of Delaware, asserting a variety of intellectual property and unfair competition claims under both federal and state law. Bloomberg.com’s report on the case from yesterday is here. In addition, here is a link to the Complaint, with Exhibits A, B, and C.

As is typical when the manufacturer of a national brand wants to stop what it perceives as unfair retail store brand competition, Schering-Plough brought suit not against either of its retail customers Kroger or CVS — despite both being mentioned in the complaint — instead, it sued Perrigo the private label manufacturer who provided the competitive products bearing those retailers’ well-known, if not famous store brand names.

Perrigo says it is "the world’s largest manufacturer of OTC pharmaceutical products for the store brand market." Here is how Perrigo describes its business model:

The Perrigo Company manufactures products that compare to national brand products such as Tylenol®, Advil® or ONE-A-DAY®. For example, Tylenol® has acetaminophen as an active ingredient and is available in a store’s analgesic (pain relief) section. Store brand acetaminophen is located right next to the national brand acetaminophen, offering the same active ingredient (acetaminophen) and the same relief.

Store brands and national brand products are both manufactured to meet or exceed quality standards set by the Food and Drug Administration (FDA). Store brand products are sold by retail stores under their own labels and compete with nationally advertised brands. All Perrigo products meet or exceed quality standards set by the Food and Drug Administration (FDA). Store brand OTC and nutritional products have saved consumers many millions of dollars in health-care costs over the past six years.

Although the national brand owner’s strategy of not suing its retail customer directly may be attractive from a business relations perspective, unless the case is promptly resolved on an amicable basis, it will be hard to avoid having representatives of Kroger, CVS, and other retail customers of Schering-Plough, put on the "hot seat" in discovery depositions to determine who created, controlled, and/or approved the "look and feel" of the store brand packaging. It remains to be seen how this strategy will play out here for Schering-Plough.


Continue Reading MiraLAX Won’t “Loosen Up” Against OTC Store Brand Competition

It’s the last quarter of the year, and if you haven’t done your planning for 2010, I’ve got two things to say to you: 1) you’re late (you undoubtedly know that), and 2) you’re not alone.

But whether you’re in the middle of developing your 2010 plans, directing planning input from multiple sources, or reviewing plans for clarity and consistency, this blog’s for you.

Working with many different clients over the years, I have worked with many who have been given responsibility for planning who are not themselves trained strategic planners. This means that many of them have a limited understanding of the basics of strategic planning. Oh, they know their stuff and are often brilliant marketers, but some come from the technical side, some come from sales, some from communications – you get the picture. I will see the words “Objective”, “Goal”, “Strategy”, and “Tactic” used interchangeably. A stated “Mission” will have the hallmarks of “Vision”; a “Threat” is labeled a “Weakness”, etc. This makes me crazy, as these are all very different things, and they have very different meanings and functions.

In response I have prepared a primer of sorts that covers the basics of strategic planning terms and explanations for the many who are not trained strategic planners. I share its essence here, knowing that some of you will find this a tad didactic and below your level of operation. I would suggest that you can view this as a refresher. Overall I have the belief and fervent hope that others will certainly benefit from it.


Continue Reading Getting Familiar With the Basics: A Planning Primer

Tommy The Who.jpg

Tommy has a lot to offer in advancing the recognition of certain kinds of non-traditional trademarks, especially touch marks. Yes, The Who’s tune from the Tommy Soundtrack “See Me, Feel Me / Listening to You” repeats these lyrics over and over: “See me, feel me, touch me, heal me.”


Continue Reading Non-Traditional Trademarks Revisited: Feel Me, Touch Me

In April the FDA sent formal letters to a number of pharma companies warning them of their misleading paid search ads in Google. Essentially the FDA wants pharma brands to put their full name of their product and associated risks in the ad. The problem as stated by pharma companies is that these paid search ads in search engines are only 95 characters in length and there isn’t enough space to include the name and the risks, not to mention the benefits.

If you’ve been following the subsequent online discussion about these FDA letters, you’ll see that much of the debate is centered around the idea that the FDA suggestions may be making things more confusing for the consumer rather than helping them. Although there is the potential for the FDA to drive some unintended, consequences, it seems to me that there is some common sense interpretations of the FDA suggestions that are the right thing to do for all parties.

The unintended consequence most mentioned, is that forcing further requirements on pharma companies has reduced participation from them and thus opened the door for Canadian online pharmacies and natural supplements. If you do a drug search today, you’ll see this is already happening. (Side note: Google has a fairly responsive protocol for a brand to file trademark paperwork to stop other brands from using their trademark.)


Continue Reading Misleading Pharma Ads on Search Engines (Google)