Header graphic for print

“Earth and Table”—Lane Powell's food, beverage, and hospitality law reporter

Your Pacific Northwest Law Firm™

Strawberry Patent Rights, Forever

Posted in Patents and Food Technology

Ripe strawberries define lusciousness.  Fragile, with fleeting taste, these heart-shaped berries inspired Shakespeare’s pen: “The strawberry grows underneath the nettle; and wholesome berries thrive and ripen best; neighbour’d by fruit of baser quality.”[1]  Regarded as an aphrodisiac in provincial France, newlyweds were served strawberry soup.

Bringing the perfect strawberry to market is the driving force behind an entire industry of growers and distributors.  Consumer surveys show that “sweetness” and “complex flavor” are the favorable attributes of an “ideal” strawberry experience.[2]  In the words of research scientists, “a ripe strawberry is metabolically poised to elicit the greatest sensory and hedonic responses from consumers.”[3]

With a product so flavorful and evocative, it is small wonder that strawberries continue to be an active source of patentable innovations.  This article examines some recent U.S. patents issued for strawberry varieties and their cultivation methods.

The Columbian Exchange

Strawberries originated in the Americas.  Native Americans crushed strawberries into cornmeal and created a precursor to strawberry shortcakes.  Through the Columbian Exchange, strawberries arrived on European shores.  They soon became an emblematic feature of the aristocratic dining table.  Jean de Quintinye, a gardener for Louis XIV, developed the first named variety of a musk strawberry known as the Capron in 1672.  That strawberry variety is still available today.

New Strawberry Variety Plant Patents

One of the leading owners of U.S. strawberry variety plant patents is Driscoll Strawberry Associates, Inc., located in Watsonville, California.  Indeed, Driscoll’s founders patented the “Sweet Briar” strawberry—later known as the “Banner” strawberry—in the early 20th century.  Driscoll’s continues to patent new and distinct varieties of strawberries.  USPTO records show that the company has patented at least 86 different varieties of strawberry plants over time. The company’s website states that it studies “thousands of potential varieties” and that it takes 5-7 years to develop each new patented variety.

The most recent Driscoll’s strawberry plant patent issued on December 17, 2013, for a “Strawberry Plant Named ‘DrisStrawThirty’” (U.S. Plant Patent No. 24,096).  This new strawberry variety was discovered in Avitorejo, Spain in February 2007 and underwent testing for five years.  It is distinguishable from other strawberry varieties due to its high yield, dark red fruit color and large fruit with medium sweetness.

A second strawberry plant patent application filed by Driscoll’s on the same day as the ’096 patent did not fare as well.  The USPTO rejected the company’s patent application for a “Strawberry Plant Named ‘DrisStrawTwentyNine” because its specification presented “less than a full, clear, and complete botanical description of the plant and the characteristics which define same per se and which distinguish the plant from related known cultivars and antecedents.”  This strawberry plant had also been discovered in February 2007 in Avitorejo, Spain.  Perhaps because of the USPTO’s issuance of the “DrisStrawThirty” patent, the company abandoned the companion strawberry patent application for “DrisStrawTwentyNine.”

Closer to home, the Washington State University Research Foundation obtained a patent for a “Strawberry Plant Named Puget Crimson” (U.S. Plant Patent No. 22,781) in June 2012.  This strawberry is the result of a hand pollinated cross between “Schwartze” and “Valley Red” strawberry varieties.  The Puget Crimson “is distinguished by fruit that is large, firm and easily capped, with excellent flavor.”  The fruit ripens in late June.

Interestingly enough, a group of Seattle chefs taste-tested the strawberry varieties being developed by the Washington State University Research Foundation.  The one that came out on top—the Puget Crimson—was then known only as “No. 2833.”  Be sure to sample the Puget Crimson strawberry when it appears in your local grocery store or farmers’ market this summer![4]

Strawberry Plasticulture

While strawberries are visually and aromatically enticing, the strawberry fields on which they are grown are not.  As one author put it, strawberries “begin and end in plastic.”[5]  Commercial production of strawberries involves heavy use of plastic film mulches and drip irrigation/fertilization systems. This commercial production method is known in the industry as strawberry plasticulture.

Strawberries are also notoriously hard to harvest.  To migrant workers, they are known as la fruta del diablo, “the fruit of the devil.”  “Picking strawberries is some of the lowest paid, most difficult, and therefore least desirable farm work in California.”[6]  To the extent processing advancements can reduce the backbreaking toil of harvesting strawberries, patents are a natural means to protect such grower innovations.

Thus, the difficulties experienced in growing and harvesting strawberries can and do provide a fervent ground for patenting activities.  A recent example related to strawberry plasticulture is a “Process for Enhancing Plant Growth,” U.S. Patent No. 8,505,237, issued on August 13, 2013.  The ’237 patented invention involves incorporating one or more yellow pigments or dyes into plastic mulch film or greenhouse coverings so that specific ratios of light are transmitted, emitted or reflected.  Research underlying this invention shows that plants “see” colors very differently than humans do.  Spectral modifications of light can profoundly impact plant growth.  This patent is part of a large wave of patents directed to plasticulture technology.  See, e.g., “Stabilized Polyolefins Having Increased Agrochemical and UV Resistance and Methods of Use” (patent application published on October 10, 2013).

No End to Potential Strawberry Patents

Through cross-breeding of strawberry varieties and in light of heavy commercial reliance on plasticulture systems and methods for strawberry cultivation, the possibilities for strawberry-related patenting activities appear to be endless.  Truly, strawberry patents, forever.[7]


[1] William ShakespeareHenry V (c. 1599), Act I, scene 1, line 60.

[2] M. Schwieteman, et al., “Strawberry Flavor: Diverse Chemical Compositions, a Seasonal Influence, and Effects on Sensory Perception,” PLoS ONE 9(2): e88446.  DOI: 10.1371/journal.pone.0088446 (published February 11, 2014).

[5] E. Schlosser, “In the Strawberry Fields,” from the Atlantic Monthly online (accessed on 3/4/14).  The article focuses on the hardships encountered by migrant workers harvesting strawberries in California.

[6] Id.

[7] Most readers will immediately recognize the weak pun related to the famous Beatles psychedelic pop/rock song, “Strawberry Fields Forever.”  The Beatles’ song hit the airwaves in February 1967 as a double A-side single with “Penny Lane.”  “Strawberry Fields” refers to the name of a Salvation Army children’s home near John Lennon’s boyhood home in Liverpool, England.  John’s mother forbade him from playing with his friends in the wooded lot behind the Salvation Army’s children’s home.  They would play there anyway.  Lennon would tell his mum that they couldn’t hang you for being there, hence, there was “nothing to get hung about.”  See http://en.wikipedia.org/wiki/Strawberry_Fields_Forever.

 

 

Will the Recent Scientific Attack on Vitamin Use Spawn a New Wave of False Advertising Litigation?

Posted in False Advertising, FDA Regulation, Food Adulteration, Food Labeling

For centuries, we’ve ingested magic elixirs in pill and syrupy forms to cure whatever ails us and to ward off future illness.  Hard scientific evidence of efficacy may have been lacking for these nostrums, but lingering doubts fell sway to the testimonial charms and hard-sell tactics of proverbial snake oil salesmen.  Once operating door-to-door, these smiley faces are nowadays more likely to be wearing white lab coats in glossy advertorials. [1]

“Enough is Enough”

A recent headline-generating editorial in the Annals of Internal Medicine calls into doubt the health value of taking daily multivitamins and mineral supplements—the sacred cow of the over-the-counter pharmaceutical world; the pablum we mindlessly swallow believing it’s good for us.  

The Annals editorial authors proclaim: “Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements.”[2]  Their survey of study results concluded with this emphatic statement:

[W]e believe the case is closed—supplementing the diet of well-nourished adults with (most) mineral and vitamin supplements has no clear benefit and might even be harmful.  These vitamins should not be used for chronic disease prevention.  Enough is enough.

Even worse, it turns out that consuming some vitamins or minerals in supplement form may be downright harmful.  The editorial further states that “[i]n conclusion, β-carotene, vitamin E, and possibly high doses of vitamin A supplements are harmful.  Other antioxidants, folic acid and B vitamins and multivitamins and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases.”[3]

Food vs. Dietary Supplements vs. Food Additives vs. Drugs

Dietary supplements occupy a curious nether world of regulation in the continuum that distinguishes “food”[4] on the one hand, and “food additives” and “drugs” on the other.  When marketers ascribe curative “healing” powers to food and dietary supplements—i.e., statutorily defined as vitamins, minerals, herbs or other botanical substances, amino acids or combinations or concentrates of these forgoing substances—an unsubstantiated choice of words regarding curative health benefits can instantly transform a food or dietary supplement into a “drug” under the Food, Drug and Cosmetic Act of 1938, as amended.[5]

The term “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” per 21 U.S.C. § 321(g)(1)(B).  A “drug” generally must undergo expensive randomized, double-blind testing to demonstrate efficacy before the drug can be sold to the public.[6]  A “food additive”—i.e., a substance which is expected to become a component of food or otherwise affect the characteristic of foods—can only be introduced into the market if the substance is generally recognized as safe by qualified scientific experts or has been commonly ingested in the food chain since prior to 1958.  Dietary supplements are specifically excluded from the definition of a “food additive.”[7]  Thus, dietary supplements do not have to undergo such pre-market testing before being ingested by the public.

The False Advertising Implications of the Annals Editorial

For vitamin and mineral supplement manufacturers, the Annals of Internal Medicine editorial throws down a gauntlet for false advertising litigation purposes.  Pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA) [8], and its predecessor, the Nutrition Labeling and Education Act of 1990 (NLEA), a purveyor of a dietary supplement can claim “preventative” health benefits associated with its ingestion, such as describing (a) the role of the dietary supplement in addressing a nutritional deficiency, (b) how it affects the structure or function of our human anatomy, or (c) how it impacts our general well-being.  See 21 U.S.C § 343(r)(6).

Under the DSHEA, the FDA “may not establish maximum limits on the potency of any synthetic or natural vitamin or mineral within a food” and “may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the [FDA] determines is nutritionally rational or useful . . . .”  21 U.S.C.  §§ 350(a)(1)(A) and (a)(1)(B).

Whither the Scientific Substantiation
for Dietary Supplement Health Claims?

Whenever manufacturers or distributors tout “preventative” health claim benefits for ingesting a dietary supplement, they must have scientific substantiation that the claim is truthful and not misleading.  While the DSHEA does not define what constitutes proper or sufficient substantiation for dietary supplement health claims, the FDA and FTC generally require “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that [have] been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”[9]

By way of example, even a casual review of Internet advertisements for beta-carotene shows that dietary supplement manufacturer health claims appear to be out of sync with an emerging scientific consensus that ingesting too much beta-carotene can be detrimental to your health and well-being.  For example, a website page for beta-carotene dietary supplements states that:

Beta-Carotene is a carotenoid that readily converts to vitamin A in your body when needed.**

Beta-Carotene supports eye health.**

Beta-Carotene supports antioxidant health and immune health by helping to fight free radicals.**

Beta Carotene is essential for healthy skin and hair.**

Unlike Beta-Carotene, fewer than 10% of other carotenoids convert into vitamin A.

This advertisement includes a disclaimer (marked by the double asterisks) that “These statements have not been evaluated by the Food and Drug Administration.  These products are not intended to diagnose, treat, cure or prevent any disease.” [10]

The beta-carotene advertisement does not include any disclaimer or qualification that would notify the consumer regarding the potential negative health implications of ingesting beta-carotene as a dietary supplement.  It implies that taking beta-carotene only brings health benefits as a universal good.  However, the scientific consensus regarding beta-carotene is best summarized as follows:

“There are many authorities – including the American Heart Association, the American Cancer Society, the World Cancer Research Institute in association with the American Institute for Cancer Research, and the World Health Organization’s International Agency for Research on Cancer – that recommend getting beta-carotene and other antioxidants from food instead of supplements, at least until research finds out whether supplements offer the same benefits.  Eating 5 servings of fruits and vegetables daily provides 6-8 mg of beta-carotene.”[11]

Because the scientific consensus undermines the asserted benefits of ingesting beta-carotene and other vitamins or minerals in supplement form, purveyors of dietary supplements may well soon find themselves named as defendants in false advertising claims brought by the FTC or by crafty class action plaintiffs.  False or misleading statements about dietary supplements can give rise to non-preempted, private rights of action under state unfair competition and deceptive trade practice laws.[12]

An analogous type of FDA-based false advertising claim is discussed in the Federal Circuit Court of Appeals decision in Allergan, Inc., et al. v. Athena Cosmetics, Inc., et al.  (decided on December 30, 2013).  Athena sells a “RevitaLash” line of products that contains a prostaglandin derivative as its active ingredient.  However, no new drug application had been submitted for this line of products.  The active ingredient in this product amounts to a “new drug” subject to FDA pre-market approval.  Athena violated FDA requirements by marketing and selling its “RevitaLash” line of products before undergoing that clearance/approval process.  Because California incorporates FDA laws into its Health Code, Athena’s FDA violation gave rise to a non-preempted, private right of action under California’s unfair competition laws.  Athena’s liability was so clear cut that it was liable for false advertising as a matter of law.

It is important to take the Annals editorial with a grain of salt.  Its broadside against taking multivitamins itself deserves further qualification.  As Darya Rose—a self-described neuroscience PhDork and food and health writer—aptly observes in her excellent food blog, Summer Tomato, “I think they overstate the case against a basic multivitamin.  I can think of dozens of potential benefits they did not test for (e.g. immunity, fatigue, etc.), and very few of us can eat a perfectly balanced diet every single day.  I continue to recommend a food-based multivitamin . . . that does not contain megadoses of any single nutrient.”[13]

Conclusion

As some early DSHEA commentators foretold, distinguishing dietary supplement health claims “from ‘drug claims,’ which allege to diagnose, cure, mitigate or prevent a disease and thereby render the product a drug (and not a dietary supplement) poses one of the most difficult challenges for marketers of dietary supplements . . . .”[14]

With scientific substantiation eroding with respect to the supposed efficacy of ingesting certain vitamins and minerals, dietary supplement marketers are skating on very thin legal ice if they continue to advertise and promote the health benefits of taking certain vitamin and mineral supplements without including prominent disclaimers or qualifications regarding potential negative health implications.  Since the U.S. dietary supplement industry reached $28 billion in sales in 2010, this industry could serve as a deep pocket for funding the attorneys’ fees recoverable by pre

 


[1] The advertisement for “Mrs. Winslow’s Soothing Syrup” that appears at the beginning of this article on Lane Powell’s Earth and Table website is one of the most popular advertisements of the 19th and early 20th centuries.  These ads claimed that the syrup had “magical effects and medical virtues” and that Mrs. Winslow was an experienced nurse.  The syrup contained one grain of morphine per fluid ounce, and also sodium carbonate, spirits foeniculi, and aqua ammonia.  Kids who did not overdose on it often became addicted to morphine.  It was banned for sale in the U.S. in 1906.  See “Patent Medicines & Miracle Cures” (September 2011) available online at http://www.nycbar.org/library/featured-exhibitions/patent-medicines-and-miracle-cures.

[2] An article about this editorial can be found at http://disinfo.com/2013/12/enough-enough-stop-wasting-money-vitamin-mineral-supplements/.  The editorial article itself may be purchased from the website, http://annals.org.

[3] “Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements,” 159 Annals of Internal Medicine No. 12, pp. 850-51 (December 17, 2013).

[4] “Food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.  21 U.S.C. § 321(f).

[5] The complete definition of a “dietary supplement” is very detailed and set forth in 21 U.S.C. § 321(ff).

[6] Randomized, double-blind testing means that neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment.  Such testing seeks to prevent experimenter bias and placebo effects from subtly influencing experimental test results.

[7] See 21 U.S.C. § 321(s)(6).

[8] Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. §§ 321, et. seq.).

[9] See “Guidance for Industry Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug and Cosmetic Act,” available online at http://tinyurl.com/lvmse2u

[12] A previous Earth and Table blog posts discusses the interplay between FDA regulations and California false advertising laws in more detail.  See P. Swanson, “Fruit Juice Misbranding Claims Lose Their Lanham Act Bite,” posted on June 11, 2012, http://www.earthandtablelawreporter.com/2012/06/11/the-ninth-circuit-takes-a-lanham-act-bite-out-of-fruit-juice-misbranding-lawsuits/#more-153.

[14] R. Pinco and T. Halpern, “Guidelines for the Promotion of Dietary Supplements: Examining Government Regulation Five Years After the Enactment of the Dietary Supplement Health and Education Act of 1994,” 54 Food and Drug Law Journal 567, 577 (1999).

Will the Recent Scientific Attack on Vitamin Use Spawn a New Wave of False Advertising Litigation?

Posted in False Advertising, FDA Regulation, Food Adulteration, Food Labeling

For centuries, we’ve ingested magic elixirs in pill and syrupy forms to cure whatever ails us and to ward off future illness.  Hard scientific evidence of efficacy may have been lacking for these nostrums, but lingering doubts fell sway to the testimonial charms and hard-sell tactics of proverbial snake oil salesmen.  Once operating door-to-door, these smiley faces are nowadays more likely to be wearing white lab coats in glossy advertorials. [1]

“Enough is Enough”

A recent headline-generating editorial in the Annals of Internal Medicine calls into doubt the health value of taking daily multivitamins and mineral supplements—the sacred cow of the over-the-counter pharmaceutical world; the pablum we mindlessly swallow believing it’s good for us.   The Annals editorial authors proclaim: “Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements.”[2]  Their survey of study results concluded with this emphatic statement:

[W]e believe the case is closed—supplementing the diet of well-nourished adults with (most) mineral and vitamin supplements has no clear benefit and might even be harmful.  These vitamins should not be used for chronic disease prevention.  Enough is enough.

Even worse, it turns out that consuming some vitamins or minerals in supplement form may be downright harmful.  The editorial further states that “[i]n conclusion, β-carotene, vitamin E, and possibly high doses of vitamin A supplements are harmful.  Other antioxidants, folic acid and B vitamins and multivitamins and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases.”[3]

Food vs. Dietary Supplements vs. Food Additives vs. Drugs

Dietary supplements occupy a curious nether world of regulation in the continuum that distinguishes “food”[4] on the one hand, and “food additives” and “drugs” on the other.  When marketers ascribe curative “healing” powers to food and dietary supplements—i.e., statutorily defined as vitamins, minerals, herbs or other botanical substances, amino acids or combinations or concentrates of these forgoing substances—an unsubstantiated choice of words regarding curative health benefits can instantly transform a food or dietary supplement into a “drug” under the Food, Drug and Cosmetic Act of 1938, as amended.[5]

The term “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” per 21 U.S.C. § 321(g)(1)(B).  A “drug” generally must undergo expensive randomized, double-blind testing to demonstrate efficacy before the drug can be sold to the public.[6]  A “food additive”—i.e., a substance which is expected to become a component of food or otherwise affect the characteristic of foods—can only be introduced into the market if the substance is generally recognized as safe by qualified scientific experts or has been commonly ingested in the food chain since prior to 1958.  Dietary supplements are specifically excluded from the definition of a “food additive.”[7]  Thus, dietary supplements do not have to undergo such pre-market testing before being ingested by the public.

The False Advertising Implications of the Annals Editorial

For vitamin and mineral supplement manufacturers, the Annals of Internal Medicine editorial throws down a gauntlet for false advertising litigation purposes.  Pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA) [8], and its predecessor, the Nutrition Labeling and Education Act of 1990 (NLEA), a purveyor of a dietary supplement can claim “preventative” health benefits associated with its ingestion, such as describing (a) the role of the dietary supplement in addressing a nutritional deficiency, (b) how it affects the structure or function of our human anatomy, or (c) how it impacts our general well-being.  See 21 U.S.C § 343(r)(6).

Under the DSHEA, the FDA “may not establish maximum limits on the potency of any synthetic or natural vitamin or mineral within a food” and “may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the [FDA] determines is nutritionally rational or useful . . . .”  21 U.S.C.  §§ 350(a)(1)(A) and (a)(1)(B).

Whither the Scientific Substantiation
for Dietary Supplement Health Claims?
 

Whenever manufacturers or distributors tout “preventative” health claim benefits for ingesting a dietary supplement, they must have scientific substantiation that the claim is truthful and not misleading.  While the DSHEA does not define what constitutes proper or sufficient substantiation for dietary supplement health claims, the FDA and FTC generally require “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that [have] been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”[9]

By way of example, even a casual review of Internet advertisements for beta-carotene shows that dietary supplement manufacturer health claims appear to be out of sync with an emerging scientific consensus that ingesting too much beta-carotene can be detrimental to your health and well-being.  For example, a website page for beta-carotene dietary supplements states that:

Beta-Carotene is a carotenoid that readily converts to vitamin A in your body when needed.**

Beta-Carotene supports eye health.**

Beta-Carotene supports antioxidant health and immune health by helping to fight free radicals.**

Beta Carotene is essential for healthy skin and hair.**

Unlike Beta-Carotene, fewer than 10% of other carotenoids convert into vitamin A.

This advertisement includes a disclaimer (marked by the double asterisks) that “These statements have not been evaluated by the Food and Drug Administration.  These products are not intended to diagnose, treat, cure or prevent any disease.” [10]

The beta-carotene advertisement does not include any disclaimer or qualification that would notify the consumer regarding the potential negative health implications of ingesting beta-carotene as a dietary supplement.  It implies that taking beta-carotene only brings health benefits as a universal good.  However, the scientific consensus regarding beta-carotene is best summarized as follows:

There are many authorities – including the American Heart Association, the American Cancer Society, the World Cancer Research Institute in association with the American Institute for Cancer Research, and the World Health Organization’s International Agency for Research on Cancer – that recommend getting beta-carotene and other antioxidants from food instead of supplements, at least until research finds out whether supplements offer the same benefits.  Eating 5 servings of fruits and vegetables daily provides 6-8 mg of beta-carotene.[11]

Because the scientific consensus undermines the asserted benefits of ingesting beta-carotene and other vitamins or minerals in supplement form, purveyors of dietary supplements may well soon find themselves named as defendants in false advertising claims brought by the FTC or by crafty class action plaintiffs.  False or misleading statements about dietary supplements can give rise to non-preempted, private rights of action under state law unfair competition and deceptive trade practice laws.[12]

An analogous type of FDA-based false advertising claim is discussed in the Federal Circuit Court of Appeals decision in Allergan, Inc. v. Athena Cosmetics, Inc. (decided on December 30, 2013).  Athena sells a “RevitaLash” line of products that contains a prostaglandin derivative as its active ingredient.  However, no new drug application had been submitted for this line of products.  The active ingredient in this product amounts to a “new drug” subject to FDA pre-market approval.  Athena violated FDA requirements by marketing and selling its “RevitaLash” line of products before undergoing that clearance/approval process.  Because California incorporates FDA laws into its Health Code, Athena’s FDA violation gave rise to a non-preempted, private right of action under California’s unfair competition laws.  Athena’s liability was so clear cut that it was liable for false advertising as a matter of law.

It is important to take the Annals editorial with a grain of salt.  Its broadside against taking multivitamins itself deserves further qualification.  As Darya Rose—a self-described neuroscience PhDork and food and health writer—aptly observes in her excellent food blog, Summer Tomato, “I think they overstate the case against a basic multivitamin.  I can think of dozens of potential benefits they did not test for (e.g. immunity, fatigue, etc.), and very few of us can eat a perfectly balanced diet every single day.  I continue to recommend a food-based multivitamin . . . that does not contain megadoses of any single nutrient.”[13]

Conclusion

As some early DSHEA commentators foretold, distinguishing dietary supplement health claims “from ‘drug claims,’ which allege to diagnose, cure, mitigate or prevent a disease and thereby render the product a drug (and not a dietary supplement) poses one of the most difficult challenges for marketers of dietary supplements . . . .”[14]

With scientific substantiation eroding with respect to the supposed efficacy of ingesting certain vitamins and minerals, dietary supplement marketers are skating on very thin legal ice if they continue to advertise and promote the health benefits of taking certain vitamin and mineral supplements without including prominent disclaimers or qualifications regarding potential negative health implications.  Since the U.S. dietary supplement industry reached $28 billion in sales in 2010, this industry could serve as a deep pocket for funding the attorneys’ fees recoverable by prevailing parties in false advertising cases.

 


[1] The advertisement for “Mrs. Winslow’s Soothing Syrup” that appears at the beginning of this article on Lane Powell’s Earth and Table website is one of the most popular advertisements of the 19th and early 20th centuries.  These ads claimed that the syrup had “magical effects and medical virtues” and that Mrs. Winslow was an experienced nurse.  The syrup contained one grain of morphine per fluid ounce, and also sodium carbonate, spirits foeniculi, and aqua ammonia.  Kids who did not overdose on it often became addicted to morphine.  It was banned for sale in the U.S. in 1906.  See “Patent Medicines & Miracle Cures” (September 2011) available online at http://www.nycbar.org/library/featured-exhibitions/patent-medicines-and-miracle-cures.
[2] An article about this editorial can be found at http://disinfo.com/2013/12/enough-enough-stop-wasting-money-vitamin-mineral-supplements/.  The editorial article itself may be purchased from the website, http://annals.org.
[3] “Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements,” 159 Annals of Internal Medicine No. 12, pp. 850-51 (December 17, 2013).
[4] “Food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.  21 U.S.C. § 321(f).
[5] The complete definition of a “dietary supplement” is very detailed and set forth in 21 U.S.C. § 321(ff).
[6] Randomized, double-blind testing means that neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment.  Such testing seeks to prevent experimenter bias and placebo effects from subtly influencing experimental test results.
[7] See 21 U.S.C. § 321(s)(6).
[8] Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. §§ 321, et. seq.).
[9] See “Guidance for Industry Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug and Cosmetic Act,” available online at http://tinyurl.com/lvmse2u.
[12] A previous Earth and Table blog posts discusses the interplay between FDA regulations and California false advertising laws in more detail.  See P. Swanson, “
Fruit Juice Misbranding Claims Lose Their Lanham Act Bite,” posted on June 11, 2012,
[14] R. Pinco and T. Halpern, “Guidelines for the Promotion of Dietary Supplements: Examining Government Regulation Five Years After the Enactment of the Dietary Supplement Health and Education Act of 1994,” 54 Food and Drug Law Journal 567, 577 (1999).

“Faux” Foods and False Advertising Claims: A New Recipe for Whipping Up Lawsuits

Posted in False Advertising, Food Labeling

With an era of 3D printable food dawning,[1] the Star Trek “food replicator” is beginning to look more like modern reality instead of the stuff of science fiction.  Every day and in every way, food scientists and flavor technologists are figuring out ways to deconstruct and reassemble our favorite dishes out of whole cloth.

This is not a new trend.  The desire to mimic basic foodstuffs began in earnest in the 19th century.  French scientists invented margarine as a cheap substitute for butter to better feed Napoleon’s standing armies.  Soon after margarine’s introduction into the U.S. consumer marketplace, palming it off as butter became rampant.[2]

The increasing ability to manufacture and promote “faux” foods that compare or contrast in some manner to their natural counterparts spawns a host of intriguing and perplexing legal issues.  This article focuses on just one of those issues: a “faux” food producer’s “standing” to pursue a Lanham Act false advertising claim against a producer of comparable “real” food.

Faux Gras v. Foie Gras

A case pending in California federal court offers a stunning example of what happens when a “fake” food producer targets a real food counterpart by simply adopting a similarly sounding name (or playful variant thereof) and selling a food intended to mimic or substitute for that of its would-be competitor.  Voilà, the ersatz food producer instantly manufactures standing sufficient to satisfy the “competitor” requirement of a Lanham Act false advertising claim pursuant to 15 U.S.C. § 1125(a)(1)(B).

The case is Regal Vegan v. HVFG (d/b/a Hudson Valley Foie Gras, Case No. 3:12-cv-05809 (N.D. Cal.)  Plaintiff Regal Vegan sells “Faux Gras,” a “toasted walnut lentil pâté.”  The defendant Hudson Valley produces and sells both fresh foie gras (duck liver) and a foie gras mousse (a pâté form).  Regal Vegan claims that Hudson Valley falsely advertises its foie gras as “the humane choice” for such products.  Regal Vegan asserts that foie gras production involves force-feeding of ducks to enlarge their livers—and that this “gavage” technique cannot possibly be labeled or categorized as humane under any circumstances.  Hudson Valley’s website notes that its ducks used for foie gras production are “Cage Free.”

Foie gras is considered a delicacy, especially in French culture.  The “gavage” fattening technique of waterfowl can itself be traced back to ancient Egyptian culture.[3]  Hudson Valley’s foie gras products are depicted on its website as follows:[4] Continue Reading

Why Does Food Mislabeling Outrage Consumers?

Posted in FDA Regulation, Food Adulteration, Food Labeling, Food Safety Modernization Act

Co-Authored by June K. Campbell and Paul D. Swanson

“There’s a Chinese restaurant on every block, and if you think mouths won’t water when you come strolling by, then you don’t know squat about Oriental cuisine.  They prize the taste of dog, friend.  The chefs round up strays and slaughter them in the alley right behind the kitchen—ten, twenty, thirty dogs a week.  They might pass them off as ducks and pigs on the menu, but the in-crowd knows what’s what, the gourmets aren’t fooled for a second.” — Willy G. Christmas talking to Mr. Bones, his dog, from the novel Timbuktu, by Paul Auster

Europe is abuzz with the horsemeat scandal.  After the Food Safety Authority of Ireland first discovered that a range of frozen beef products contained a large percentage of horse DNA, the story struck a viral nerve and spread like wildfire.

For consumers at the convoluted end of frozen food supply chains, the idea that you have been eating “Bessie” the horse probably comes as an emotional shock to the system.  It is yet another nagging reminder of how distant we are from our original sources of food and how easy it is to be fooled by food appearances and masked tastes.[1]

For the companies whose grocery store or packaged food brands are entangled in the horsemeat scandal, the damage to reputational interests can be profound.  Affected companies took public relations repair action first and terminated supply chain contracts in a peremptory fashion.  IKEA stopped serving its famous Swedish meatballs.  Burger King changed to a different supplier of burgers.  Tesco, a major European supermarket chain, dropped a major vendor after discovering its frozen spaghetti bolognese contained over 60% horsemeat. Continue Reading

Antitrust Monopolization Considerations in Licensing Cutting-Edge Food Technology Patents

Posted in Antitrust Issues, Patent Litigation, Patents and Food Technology

The term pioneer patent [1] is often misapplied with hyperbole and exaggeration.  When it comes to the shrimp peeling machine invented by Fernand and James Lapeyre, however, that blockbuster label is spot-on. [2]  Their automated way of processing shrimp rocked the seafood processing industry in the 1950s by driving manual labor costs virtually out of existence.  In today’s vernacular, it was a real game-changer.

Patents (and intellectual property rights in general) do not necessarily confer natural monopoly rights as economists would understand the concept.  This is because excluding “others from using a particular name, word, image, product or process does not imply any substantial market power when substitutes are plentiful.” [3] When a groundbreaking patent is issued, however, the governmental grant can take on monopolistic tendencies—paradoxically even if unused and seemingly unexploited.

A monopoly is commonly defined as the “exclusive control by one group of the means of producing or selling a commodity or service.”[4]  A pioneer patent—and even more importantly nowadays, a conglomeration of related patents owned by a single entity—can sometimes create new product and service markets and legal barriers to entry capable of commanding what economists call “monopoly rents.”  As rational actors, it is also an economics truism that “monopolists invariably act like monopolists” as they strive to maximize profits.

Even though the United States Patent and Trademark Office is empowered to issue broad exclusionary rights to worthy inventors, another broad federal statute—the Sherman Act—exists to prevent abuses to the competitive process.  Section Two of the Sherman Act provides that every “person who shall monopolize, or attempt to monopolize, or combine or conspire with any other person or persons, to monopolize any part of the trade or commerce among the several States, or with foreign nations, shall be deemed guilty of a felony ….”  15 U.S.C. § 2.  The right to exclude others from co-opting inventions (in the absence of a license from the patent owner) is accurately described as a “time-limited government” conveyance of “potential monopoly power, which can be put to ‘good’ or ‘bad’ uses from a societal standpoint.”[5]

Where is the line drawn between lawfully exploiting patent rights and running afoul of antitrust law prohibitions regarding monopolization?  The answer is murky and perhaps unsatisfying to those seeking bright line licensing and competition rules.  The boundary line often only becomes clear in retrospect.  The demarcation between a patent owner lawfully exploiting exclusionary rights vs. an illegal monopolist abusing those same rights is highly fact-dependent.

The Lapeyre family’s very creative leasing scheme for its patented shrimp peeling machines offers a vital case in point.  With the invention of a single processing machine, the company irrevocably altered the cost dynamics of an entire shrimp processing industry.  Licensing disputes—collectively known as the “shrimp peeler” cases[6]—arose soon after the commercialization of the Lapeyre’s invention and were finally resolved in the mid-1960s.  These case holdings help demonstrate how the Lapeyre’s crossed the line between “good” and “bad” exercises of a patent’s potential market power.

The shrimp peeler cases predate wholesale policy changes in antitrust analysis that emerged out of the “Chicago School” of economic theory—especially the demand for the more rigorous determinations of market power championed by Judge Richard Posner.  However, despite paradigmatic changes in antitrust jurisprudence, the outcome of the shrimp peeler cases would likely be no different today.  Continue Reading

So, Are Organic Foods Really Safer and Healthier For Us After All?

Posted in Food Labeling

Some of America’s best organic and sustainable food research is being conducted by the faculty, students and staff of Washington State University’s Center for Sustaining Agriculture and Natural Resources.

As Washington’s original and largest land grant university, WSU is fulfilling its mission and mandate “to teach such branches of learning as are related to agriculture . . . .”  7 U.S.C. § 304.

A clear case in point is Professor Charles Benbrook’s detailed analysis and critique of a recent Stanford study of organic versus conventional food consumption.  The Stanford study—entitled Are Organic Foods Safer and Healthier Than Conventional Alternatives? A Systematic Review[1]appeared in a September 2012 issue of the Annals of Internal Medicine and immediately spawned eye-catching headlines in major newspapers, such as the New York Times, proclaiming that Stanford Scientists Cast Doubt on Advantages of Organic Meat and Produce.[2]  

The Stanford study came to two major conclusions: Continue Reading

“Hey Barkeep, Pour Me A Pint of…”: Trademark Tips for Microbreweries

Posted in Food Labeling, Trademark Litigation

Nancy Pham is a Lane Powell 2012 summer associate and is currently attending her second year of law school at the University of Washington Law School.  She may be contacted at npham17@gmail.com.

For microbrewers, taste and memorable names mean everything.  Loyal customers often ask for specific brews and word-of-mouth advertising is indispensable, since microbrews are often purchased in local restaurants and bars.  

Like many small businesses though, protecting your microbrewery brand and trademarks often raises a basic financial issue: Is it worth it?  This brief article explores some cost-effective ways to build your own beer brand identity, while also guarding against the possibility that you may be infringing upon the already established trademark rights of others.  

The “Knockout” Search

So, before you begin taking that home brewing hobby to the next level and coming up with the perfect name for your craft beer and perhaps your own brewpub, you should take advantage of some readily available resources to make sure that someone else has not already beat you to the punch.   

What you’re undertaking is called a “knockout” search in trademark circles.  Your goal is to find a brand name that is not confusingly similar to other products already on the market for beers or other products that may be related to alcohol or beer consumption.  The goal of trademark laws is to prevent confusion among consumers as to the source or origin of products or services.

While it may seem tempting to be playful and incorporate someone else’s famous trademarks[1] on your microbrew label, you should avoid that form of potential instant name recognition.  Famous marks are protected from having their commercial impression diluted by even unrelated goods or services.   

Likewise, the owners of famous marks can prevent “tarnishment” of their marks by use on products they deem to be unsavory—alcohol being a common such product.  Owners of famous marks often have the financial means and incentives to pursue even small-time poachers of their brands. 

In the age of robust Internet search engine capabilities, the good news is that a simple knockout search only requires an investment of your time. 

First, visit the United States Patent and Trademark Office website.  Running a free Trademark Electronic Search System (TESS) search will come up with all federally registered trademarks (with a margin of error based on search terms or how marks may have been categorized in that database).  

Second, a similar search should be conducted for state-registered trademarks.  Each state varies and while there are currently no TESS-equivalent knock-out searches available[2] in Washington or Alaska, Oregon does have its own trademark search.  This is another reason why a thorough Internet search is valuable, since it is more difficult to research state-registered trademarks.  

Third, because trademark rights under common law accrue automatically when they are being used in commerce, a search on the Google, Bing, or other search engines may also provide useful information about business websites and social media pages that are using trademarks that may be protectable, even though they are not registered in state or federal trademark databases.   

You’ve Explored the World Wide Web.  Now What?  

There are several scenarios that can happen after a knockout search is performed:  Continue Reading

The Growing Allure of Plant Patenting for Brand Differentiation

Posted in Patent Litigation, Patents and Food Technology, Trademark Litigation

Plant patents occupy a seldom studied corner of potential patent protection.  But plant patenting is taking on new importance as growers and producers of fruits and vegetables—once branded only as commodities—take advantage of the premium price points more specific patent and trademark rights can yield.  Commodities appeal to the undifferentiated masses; but marketing targeted to individual taste preferences is now the order of the day.

What are Plant Patents?

Established through the Plant Patent Act of 1930 (the PPA), this intellectual property right is granted to any person who “invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings . . . .”  35 U.S.C. § 161.[1]

The Act’s legislative history describes this provision in layperson terms: “[T]he bill provides that any person who invents or discovers a new and distinct variety of plant shall be given by patent an exclusive right to propagate that plant by asexual reproduction; that is by grafting, budding, cuttings, layering, division, and the like, but not by seeds.”

The PPA does not provide patent protection for varieties of plants found growing in an uncultivated or wild state.  So, sorry to all you plant foragers!  Tuber propagated plants (e.g., potatoes) are also excluded from plant patent protection.

Before the PPA was enacted in 1930, patent laws seemed to favor industrialists over farmers.  This rankled the most famous American plant breeder of the time, Luther Burbank.  He bemoaned the fact that:

I have been for years in correspondence with leading breeders, nurserymen, and Federal officials and I despair of anything being done at present to secure to the plant breeder any adequate returns for his enormous outlays of energy and money.  A man can patent a mousetrap or copyright a nasty song, but if he gives to the world a new fruit that will add millions to the value of earth’s annual harvests, he will be fortunate if he is rewarded by so much as having his name connected with the result.[2]

In the 21st century, the goals of the PPA may be coming closer to fulfilling Luther Burbank’s plant breeder aspirations.  Take cherries, for example, which are now coming into season in droves.  While Bing cherries—Royal Annes in an earlier era of canned cherries—still dominate the U.S. market for fresh cherries, it is becoming more highly differentiated with new market entries.[3]  Aficionados can distinguish among and may prefer a Rainer, a Chelan, a Lapin or a Summit cherry, instead of that good ol’ Bing cherry. Continue Reading

Patenting Enhanced Taste and Food Processing: Some Engaging Current Developments

Posted in Patent Litigation, Patents and Food Technology

Patenting food processing and flavor-enhancing techniques is a cutting-edge legal endeavor.  This article reviews some fascinating new developments in food processing technology and patent litigation.

Today’s patent law market basket is filled with two patentable innovations: an edible biofilm to address and prevent the problem of cherry cracking; and an acoustic sound technique designed to enhance the taste of food.  On the patent litigation front, a sizable plaintiff’s jury verdict in roiling litigation over patented egg pasteurization techniques shows that infringing food processing patents can lead to expensive life lessons.

“SureSeal” Biofilm and Harvesting the Perfect Cherry

Pacific Northwest rains are both a boon and a curse for cherry growers.  Rain-induced cherry cracking is a perennial problem.  Most growth in cherries occurs in the final few weeks before their harvesting.  That is when cherry cracking susceptibility develops.[1]  Nearly ripe cherries absorb moister faster than their skins can expand.  If the cherries split, a year’s crop may be ruined in one fell swoop.

Manual efforts to prevent cherry splitting can lead to tragic results.  After a recent brief, but heavy rainfall, a helicopter pilot and his passenger were fanning moisture off a cherry tree orchard near Wenatchee, Washington.[2]  The helicopter’s main rotor clipped a power line.  The helicopter crashed into the orchard.  The passenger died, and the pilot suffered severe injuries.

Oregon State University scientists are trying to solve this vexing cherry cracking problem.  They developed SureSeal, a hydrophobic, elastic biofilm that consists of a copolymer of stearic acid, cellulose and calcium.  It significantly reduced cherry cracking in field tests.  The United States Patent and Trademark Office (USPTO) recently published the inventors’ patent application directed to this SureSeal innovation.  It is entitled  “Flexible Films and Methods of Making and Using Flexible Films.”

Continue Reading