The Under-utilization of Certification Trademarks by the Fashion Industry

A certification trademark is a trademark that is registered by a certification body. The certification body allows manufacturers to apply the certification trademark to their products, provided the manufacturers meet a set of standards laid down by the certification body. These standards might, for example, require that the manufacturers adhere to a particular method of farming, or that the products meet a minimum nutritional criteria.

When a certification trademark is applied to a product, a consumer can surmise that the product meets the standards of the certification body. In this way, a certification trademark acts to convey a great deal of information to the consumer via a simple visual cue.

Manufacturers in the food and beverage industry make good use of certification trademarks, including:

These certification trademarks give a consumer instant assurance that the food or beverage product is, for example: heart healthy, sourced via an ethical system of trade, or carbon neutral (i.e. all of the carbon emissions created during production of the product have been offset by the manufacturer).

With today's emphasis on consumer empowerment and conscious consumption, food and beverage manufacturers have realized that certification trademarks make for great marketing, as they quickly convey positive messages about the product. Consequently, it is not uncommon for a single food or beverage product to be labeled with several certification trademarks.

However, clothing and shoe manufacturers have not been as savvy. Certification trademarks are under-utilized by the fashion industry. This is a missed opportunity for clothing and shoe manufacturers to market their products to consumers based on ideologies, rather than just aesthetics.

It is not possible in this short blog to address all of the possible certification trademarks that could be used more effectively by the fashion industry. Thus, I will focus on two certification trademarks.

1) ANIMAL FREE CERTIFICATION TRADEMARKS

Approximately 1 million people in the United States currently adhere to a vegan diet. While many do so for the health benefits, there are also other reasons for adopting such a diet, including: animal cruelty and environmental sustainability. These other reasons apply equally as justification to shun the wearing of shoes that contain animal products, such as leather.

Approximately 2.3 million people in the United States are Hindu. In the Hindu religion, cows are sacred. Thus, many Hindus avoid eating beef. In some cases, they also avoid wearing shoes that contain cow hide.

Approximately 2.6 million people in the United States are Muslim. In the Islamic religion, pigs are not considered to be clean. Thus, many Muslims avoid eating pork. In some cases, they also avoid wearing suede shoes and other shoes that are lined with pig skin leather.

Even (unrealistically) assuming that the entire vegan population is either Hindu or Muslim, there are still at least 5 million people in the United States who are either Hindu or Muslim (or Hindu or Muslim and vegan) and who therefore have some incentive to avoid shoes that are leather or suede or contain cow hide or pig skin leather. The current United States population is roughly 313 million, so the persons concerned comprise 1.6% of the total United States shoe market. A 1.6% market share is certainly economically relevant. Thus, shoe manufacturers should take note.

It is currently extremely difficult for consumers to find shoes that do not contain leather or suede or cow hide or pig skin leather. Part of the difficulty is supply. There are very few stores, such as the New York botique Moo Shoes that only sell vegan shoes. Other stores such as Steve Madden sell both vegan and leather shoes. The difficulty in these stores is convenience. The consumer must search the shoe for a label (often on the inner lining) indicating whether the shoe is made from leather or synthetic materials. This is a repetitive and arduous process. Moreover, even if the label indicates that the shoe contains leather, it does not specify what type, or combination of types, of leather. This does not resolve the problem for Hindus or Muslims, who might not have a problem with all leather, just cow hide or pig skin leather. They still cannot tell whether the leather shoes contain the offending cow hide or pig skin leather or not.

By applying certification trademarks (such as a VEGAN trademark, COW FREE trademark or PIG FREE trademark) to the soles of shoes, manufacturers could convey a host of relevant information to potential buyers in a predictable and easy way. Consumers looking to avoid cow hide, pig skin, or all leather altogether, could easily pick up the shoe, look for the certification trademark predictably located on part of the sole where the ball of the foot rests, and immediately tell whether the shoe is compatible with their ideological and/or religious beliefs.

2) ENVIRONMENTAL CLOTHING MATERIALS CERTIFICATION TRADEMARKS

Animal sources of clothing materials include fur, leather, wool, and silk. The production of these materials, particularly fur, leather and wool, is damaging to the environment. To raise the animals that will be used for fur, leather and wool, and to treat the leather via tanning:

• Affects the earth's water supply through the use of vast amounts of water (for growing animal feed, hydrating the live animals, and operating the tanning facilities), and through the pollution of water systems (due to run off of waste produced by the live animals, and of chemicals used when growing animal feed, preventing disease amongst the live animals, and operating the tanning facilities);
• Contributes to greenhouse gasses, due to methane emissions by grazing animals;
• Results in waste, such as hair and flesh trimmings and chrome shavings (which are by products of chrome-tanning), that ends up in landfills; and
• Requires land clearing for pastures, which leads to soil salination, erosion, habitat destruction and decreased biodiversity.

Man-made sources of clothing materials (such as nylon and polyester) are not much better. In 2010, worldwide production of man-made fibres amounted to 53 million tonnes, accounting for 68% of fibres used worldwide. With this much material being produced every year, roughly the same must be discarded. Although great efforts are made to recycle discarded textile waste, still 5% of all landfill is textile waste. Of this textile waste, the man-made fibres are not biodegradable. Thus, the man-made fibres will still be around, polluting our planet, for centuries to come. Moreover, even before they are discarded, these man-made fibres cause damage. Just one garment manufactured from man-made fibres releases up to 1,900 microplastic particles per wash in the washing machine. When the washing machine cycle is finished, all the dirty water flows out into sewers before being treated and released out to sea. The microplastic particles are not filtered out by water treatment, so they make it out to sea.
 These microplastic particles are then swallowed by sea animals. It is not yet known what long term effects this may cause for the sea animals.

Sustainable and renewable fabrics such as hemp, cotton, bamboo and linen are now available. By applying an ENVIRONMENTAL CLOTHING MATERIALS certification trademark to clothing labels of garments made from these materials as opposed to animal or man-made materials, clothing manufacturers would arm the consumer with the knowledge required to make environmentally conscious choices. Over 70% of Americans claim to be an active participant in, or sympathetic to, the environmental movement. Thus, in using certification trademarks to promote the environmental consciousness of their goods, clothing manufacturers would be tapping into a considerable marketing advantage.

CONCLUSION

The food and beverage industry understands that consumers want to be able to make informed choices and has evolved accordingly. It is time for the fashion industry to catch up. Just as people don't make their food choices based on taste alone, discerning fashionistas don't want to make their clothing and shoe choices based on aesthetics alone. It is time for the fashion industry to start utilizing certification trademarks to convey ideological information to consumers. The associated marketing potential for clothing and shoe manufacturers is immense.

The Need for Regulations Regarding Nutritional Supplements with Epigenetic Effects

Epigenetics is the way in which proteins and RNA interact with DNA to affect the expression of the DNA. The proteins and RNA interact in such a way as to turn small lengths of DNA, called genes, either on or off. This process is called methylation. Via methylation, genes can be expressed more (meaning that the genes act as templates for the production of proteins) or the genes can cease being expressed at all (meaning that, even though genes for the coding of particular proteins exist, those genes will not be read and so the proteins will not be made). Thus, while a person might have a gene for a particular characteristic, that person will not necessarily exhibit that characteristic because the gene for that characteristic could have been turned off. This is how identical twins can appear so different despite the fact that they have identical DNA.

There are two crucial things to note about the science of epigenetics.

First, epigenetic changes are heritable. If a gene is turned off in the germ (egg or sperm) cells of a parent, the same gene will be turned off in the somatic (non reproductive) cells of the offspring (as well as the germ cells of the offspring). A prime example of this is what resulted from the prescription of the synthetic estrogen compound diethylstilbestrol (DES) to prevent miscarriages in pregnant women in the mid-20th century. Despite being lesser known than the horrific Thalidomide compound, DES was (in one way) worse. Specifically, it was not only associated with an increased risk for vaginal and breast cancers in daughters, but also an increased risk of ovarian cancer in maternal granddaughters. That is, it altered the epigenetics of the germ cells of the user and the altered epigenetics were then inherited by the offspring and the offspring's offspring, affecting generations to come.

Second, the nutrients we ingest, via the foods we eat, affect our epigenetics. One of the clearest examples of this is in the case of the honeybee. Honeybee colonies comprise of worker bees and queen bees. Worker bees live for approximately 20 days, and spend this time constructing honeycomb, feeding larvae, and foraging for nectar and pollen. They never produce offspring. In contrast, queen bees live for many years. They are fed and preened by worker bees, so that they are free to focus on their sole task: to lay up to 2,000 eggs a day. With such differences in lifespans and behavior patterns, it is surprising to discover that worker bees and queen bees are in fact genetically identical. The differences are solely a consequence of the queen bees being fed royal jelly, which methylates their DNA differently to the methylation of the DNA of worker bees. This in turn causes their DNA to be expressed differently than the DNA of the worker bees, resulting in lifespans and behaviors that are starkly different.

Before all the readers go out and buy royal jelly, it should be noted that it will not necessarily have such a profound effect on the methylation of human DNA. But there are some nutrients that will.

See the table below, for a list of some of the most important nutrients for humans from an epigenetic standpoint. Generally, in the right amounts, these nutrients have a positive effect by regulating gene expression in such a way as to protect against cancer and delay aging. However, in excess, these same nutrients can make too many epigenetic changes, thereby no longer helping but instead hindering the health of the individual. It is a classic case of “too much of a good thing”. In the right hand column, I have outlined some of the deleterious consequences resulting from the excess consumption of nutrients that have an epigenetic effect.

Nutrient	Food Origin	Epigenetic Role	Health Effect of Excess
Methionine	Sesame seeds, brazil nuts, fish, peppers, spinach	SAM-e synthesis (SAM-e then transfers a methyl group to the DNA, causing methylation)	One study has shown that excess methionine may exacerbate the symptoms of schizophrenia, as it leads to epigenetic changes that cause the dysfunction of GABAergic neurons.
Folic Acid	Leafy vegetables, sunflower seeds, baker's yeast, liver	Methionine synthesis (methionine is then converted into SAM-e, which transfers a methyl group to DNA, causing methylation)	Too much prenatal folic acid is associated with increased allergies and asthma in the offspring, likely due to epigenetic changes to the mother's oocyte (egg) cells.
Vitamin B12	Meat, liver, shellfish, milk (supplements are necessary for vegans)	Methionine synthesis (methionine is then converted into SAM-e, which transfers a methyl group to the DNA, causing methylation)	In one study, researchers found high vitamin B12 levels in patients suffering from prostate cancer, and their conclusion was that epigenetic changes caused by cobalamin (vitamin B12) stimulate prostate cancer development.
Vitamin B6	Meats, whole grain products, vegetables, nuts	Methionine synthesis (methionine is then converted into SAM-e, which transfers a methyl group to the DNA, causing methylation)	One child was born with pyridoxine (vitamin B6) dependency after the mother received large amounts of vitamin B6 during pregnancy, which altered the epigenetics of her oocyte cells. The child suffered from seizures and progressive mental retardation if not administered vitamin B6 daily.
SAM-e	Popular dietary supplement pill; unstable in food (produced in the body by metabolism of methionine)	Enzymes transfer methyl groups from SAM-e directly to the DNA	In mouse studies, excess SAM-e resulted in fatty livers, fibrosis and hepatocelular carcinomas. This is likely due to the epigenetic effect of SAM-e.
Choline	Egg yolks, liver, soy, cooked beef, chicken, veal and turkey (brocolli is a good source for vegans)	Methyl donor to SAM-e	Choline has been linked to down regulation of certain genes. These epigenetic changes have been associated with pre-eclampsia in pregnancy.
Betaine	Wheat, spinach, shellfish, and sugar beets	Breaks down the toxic byproducts of SAM-e synthesis	Excess betaine causes epigenetic changes that result in higher LDL (bad cholesterol) concentrations.
Resveratrol	Red wine	Removes acetyl groups from histones (condensing DNA structure and turning the genes “off” so proteins are not made)	Resveratrol causes epigenetic changes to many genes, causing blood thinning (which can be problematic for people already on blood thinners such as warfarin).
Genistein	Soy, soy products (it is also in coffee, for those who try to avoid soy)	Increased methylation of DNA via an unknown mechanism	As with DES (discussed above) and BPA's (in plastics) excess pre and post natal exposure to genistein is associated with epigenetic changes that result in weight gain in offspring.
Sulforaphane	Broccoli	Adds acetyl groups to histones, which turns “on” anti-cancer genes	Excess sulfurophane blocks a critical liver enzyme (possibly due to epigenetic changes) that functions as a bottleneck for breaking down common prescription drugs.
Butyrate	A compound produced in the intestine when dietary fiber is fermented	Adds acetyl groups to histones, which turns “on” 'protective' genes, increasing lifespan	Excessive butyrate may affect gene expression (i.e. cause epigenetic changes) so as to induce severe intestinal epithelial cell apoptosis and disrupt the intestinal barrier.
Diallyl sulphide (DADS)	Garlic	Adds acetyl groups to histones, which turns “on” anti-cancer genes	Excess DADS may affect gene expression (i.e. cause epigenetic changes) so as to trigger vomiting, irritate the oral mucosa, and cause severe burning sensations in the esophagus and stomach.

As stated above, when consumed in appropriate amounts, these nutrients create a state of “epigenetic health”, whereupon the right genes are expressed in the right amounts to achieve optimum health. However, as you will note from the right hand column, the same nutrients that cause positive epigenetic effects in natural doses, can cause deleterious epigenetic effects when consumed in excess amounts. The major determinant of whether an appropriate versus an excessive dosage is received is the means via which the nutrients are delivered. As is clear from the table, these nutrients are all either available from dietary sources or are created by the body. Generally, it is difficult to consume excess nutrients via dietary sources. However, it is common for people who believe their diet to be lacking, to take nutritional supplements. It is these nutritional supplements that lead to a risk of excess dosages and consequent deleterious epigenetic changes.

Thus, nutritional supplements should be treated with the respect they deserve, given the profound and long lasting consequences such supplements can have. However, currently, little respect is paid.

Nutritional supplements do not need to be approved by the FDA before they are released into the marketplace. Moreover, nutritional supplements are available for purchase from grocery stores, without prescription. And yet, nutritional supplements have intergenerational effects. Whereas, most allopathic drugs (i.e. those without epigenetic effects, which might, at most, affect the next generation if taken during pregnancy) must pass rigorous testing to receive FDA approval and are only available upon prescription.

Furthermore, when nutritional supplements are prescribed, they are generally prescribed by a naturopath. In New York State, naturopaths do not need to be registered. In contrast, allopathic doctors must be registered. And yet, the naturopaths are the ones responsible for prescribing nutritional supplements that have epigenetic effects. These affects will be inherited and therefore impact several generations of people. Thus, the consequences are far more severe and long lasting than for many allopathic drugs (aside from the emerging milliuea of epigenetic drugs) that are prescribed by allopathic doctors.

I propose the following solutions based on evaluation of foreign and domestic US laws:

1) REQUIRED FDA APPROVAL OF NUTRITIONAL SUPPLEMENTS WITH EPIGENETIC EFFECTS

The European Union's Food Supplements Directive of 2002 requires that nutritional supplements be demonstrated to be safe, both in dosages and in purity. In contrast, under the United States' Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers do not need to register their products with the FDA nor get FDA approval before producing or selling nutritional supplements. It is simply left up to the manufacturer to ensure that a nutrititional supplement is safe before it is marketed. The FDA can then take action against any unsafe nutritional supplement after it reaches the market. Clearly, at this point, it is too late. The DSHEA should be amended to require FDA approval of nutritional supplements with known epigenetic effects. In particular, this approval process should dictate that the dosages of the nutritional supplements accord closely with accepted RDI's (i.e. it should no longer be possible to purchase nutritional supplements with epigenetic effects with dosages of 3000 times the recommended daily intake).

2) REQUIREMENT FOR PRESCRIPTIONS FOR NUTRITIONAL SUPPLEMENTS WITH EPIGENETIC EFFECTS

SAM-e is a prescription only drug in Italy, Spain and Germany. These countries have recognized the profound and lasting effects that this supplement can have on epigenetics. The US should follow suit, making SAM-e available by prescription only, along with the other nutritional supplements that are known to impact epigenetics. Obviously, there is a risk associated with this approach as many people will be too lazy, time or cash poor, or doctor averse, to get a prescription. Thus, they will simply not access the supplements they need (and become deficient, which will cause a whole host of other epigenetic changes with deleterious effects). However, it is up to the US government to factor in this risk and draft the amendments in such a way as to minimize the risk. For example, perhaps in addition to doctors and naturopaths being granted the power to prescribe nutritional supplements, pharmacists might also be granted the power to prescribe. As these pharmacists are stationed at every Walgreens and Duane Reade, they are accessible to the public and pose a minimal psychological, time or financial barrier to people who wish to access the supplements they need.

3) REGISTRATION SYSTEM FOR NATUROPATHS

Currently, 16 States, the District of Columbia, and the United States territories of Puerto Rico and the US Virgin Islands have licensing laws for naturopaths. In these locations, naturopaths are required to graduate from an accredited four year naturopathy program and pass an extensive board examination in order to receive a license. New York State, and the remaining US States, should adopt similar requirements.

CONCLUSION

The lack of regulation of nutritional supplements and nutritional supplement prescribers, reflects a lack of understanding of the true power and consequences of nutritional supplementation. Nutritional supplements, particularly those with epigenetic effects, should be respected for what they really are and the impact that they can have, not just for the user, but for generations to come.

Until the government realizes the power and consequences of nutritional supplementation, and steps up to properly regulate the prescribers, implement prescription requirements, mandate warning labeling and require FDA approval of nutritional supplements, in order to protect consumers, it is up to us to protect ourselves. Before you buy the next nutritional supplement with 300% the RDI of folate for example, think twice about how that might affect you, and your children, and your children's children...

Loopholes in the US FTC Guidelines for Health Claim Labeling

The Australian and New Zealand bi-national government agency FSANZ* has finally taken the reigns from the Australian Food and Grocery Council and made a crucial amendment to the Food Standards Code. After 10 years of deliberations, on 18 January 2013, the new Standard 1.2.7 of the Australian New Zealand Food Standards Code became law. Amongst other things, this Standard dictates that eligibility criteria must be met for a food or beverage to qualify for the making of a health claim. That is, henceforth, for a company to make a health claim about a food or beverage, the food or beverage will have to meet a basic Nutrient Profile Score (NPS). This prevents a fast food company from fortifying its high saturated fat, high calorie french fries with vitamin D and labeling the french fries as being “good for healthy bones and teeth”. It might seem unnecessary, but food and beverage manufacturers are using these claims because the simple fact is that people are often either:

a) ignorant to the nutritional content of the foods and beverages they consume (because they are too busy or otherwise disinclined to read the nutritional panels), or

b) willing to overlook the negative health effects of the foods and beverages they consume if they are given cause for believing that there are positive health benefits that justify them in choosing to consume those foods and beverages.

In order for a health claim to be made, the NPS for foods (other than beverages, cheese, oil, margarine and butter) must be less than 4. The NPS is calculated by taking the baseline score (based on energy, saturated fatty acids, sugar and sodium content) and deducting points for fruit & vegetable, protein and fiber content.


A similar regimen exists in the United States. Part 101 of the US Federal Trade Commission Code of Federal Regulations states that “No expressed or implied health claim may be made …, unless: ....None of the disqualifying levels identified in paragraph (a)(4) of this section is exceeded in the food”. The disqualifying levels are the levels of total fat, saturated fat, cholesterol, or sodium in a food. These levels are 13.0 grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of sodium, per reference amount.


This leaves two major loopholes in the US FTC Federal Regulations, and it is my contention that the US FTC Federal Regulations are due for an overhaul in line with the amendments made to the Australia New Zealand Food Standards Code.


LOOPHOLE #1
As mentioned, the Australia New Zealand Food Standards Code evaluates a food or beverage based on a comprehensive formula that trades off the more negative characteristics of a food or beverage (the sodium content for example) with the positive characteristics of that food or beverage (its fiber content for example). In this way, the overall nutritional value of the food or beverage is assessed and considered when determining whether that food or beverage is eligible for a health claim. No one characteristic of the food or beverage is necessarily determinative.


In contrast, the US FTC Federal Regulations do not account for a combinatorial evaluation of a food or beverage. Each nutrient is considered in isolation. An excess of any one of total fat, saturated fat, cholesterol or sodium results in an automatic disqualification from that food or beverage being eligible for health claim labeling.


To give an example, the reference amount for nuts is 30 grams (that is, the amount of nuts a consumer is expected to consume in a normal serving size is 30 grams). A 30 gram serving of raw almonds comprises about 15 grams of fat. But the US FTC Federal Regulations state that the disqualifying level of fat is 13 grams. So, fat is a disqualifying nutrient for raw almonds, and it is not possible for US manufacturers to make health claims about raw almonds. This seems odd, since raw almonds are rich in vitamins, minerals, protein and anti-oxidants, and are recommended by the American Heart Association as a healthy snack. In contrast, a processed product of dubious health benefits, but which flies just under the radar in terms of fat, saturated fat, cholesterol and sodium composition, qualifies to be labeled with a health claim.


Anyone who has studied health and nutrition realizes that the various components of a food or beverage have a synergistic effect. It is unrealistic to consider any element of a food or beverage in isolation. The complex nature of nutrition should be reflected in the evaluation system laid out in the US FTC Federal Regulations. A more comprehensive formula, such as that outlined in the Australia New Zealand Food Standards Code, should be adopted by the US Federal Trade Commission.


LOOPHOLE #2
As mentioned, the Australia New Zealand Food Standards Code takes into account the sugar content of a food or beverage when evaluating the NPS of that food or beverage. The US FTC Federal Regulations do not. This allows sugary foods and beverages, such as candy and sodas, to escape the safeguards intended by the Federal Regulations. There is no automatic disqualification preventing health claim labelling on a food or beverage product that is basically pure sugar.


This has resulted in some major issues. For example, for years Vitamin Water has been portrayed as a healthy drink, with labeling such as “vitamins + water + all you need”, despite the fact that there are 33 grams of sugar in every bottle. The American Heart Association recommends that adult women intake only 20 grams of sugar per day. Thus, any health benefits of the vitamins in the Vitamin Water are more than offset by the deleterious effect of the excess sugar in the drink.


In January of this year, the Center for Science in the Public Interest (CSPI) filed a class action lawsuit against Vitamin Water claiming that it violates FDA policy by posing as a health drink. Coca-Cola, the owner of Vitamin Water, has countered with the argument that “no consumer could reasonably be misled into thinking Vitamin Water was a healthy beverage”. What will likely ensue will be a long battle as to whether the health claims are misleading or deceptive. It would be far simpler if the loophole was closed, and sugar was simply included in the US FTC Federal Regulations as one of the factors to be considered when determining whether a food or beverage product is eligible for health claim labeling.

CONCLUSION

The US Federal Trade Commission should seriously consider making these crucial amendments to the Federal Regulations. As the United States begins to place a premium on healthy eating in response to the growing obesity epidemic, food and beverages manufacturers are jumping at the opportunity to capitalize via marketing that speaks to the health benefits of a product. This will lead to consumer confusion and/or protracted litigation, unless the Federal Regulations provide clear and logical guidelines for which products are eligible for health claim labeling. The current guidelines do not suffice.

* Food Standards of Australia and New Zealand

The 3 Lines of Defense at the Disposal of Brand Name Biological Drug Companies

On Tuesday, the lead article on the front page of The New York Times was titled “Battle Over Generics of Biotech Drugs”. The word 'battle' is apt. There is a war at hand, and it is raging at both a Federal and State government level. Billions of dollars, and the United States deficit is at stake.

To understand this drug war, we first have to go back to basics...

Chemical drugs are made by the mixing of chemicals. This is a controlled process, making it simple for generic drug companies to create generics which are identical to the existing brand name chemical drugs. In contrast, biological drugs (generally proteins) are made by living cells that are kept alive in vats of nutrient medium. The cell line used and the composition of the nutrient medium might each affect the resultant biological drug. Thus, generally generic drug companies cannot create biological drugs which are identical to existing brand name biological drugs. The best the generic drug companies can do is create biosimilar drugs, namely biological drugs which comprise the same clinically active components as existing brand name biological drugs, but differ slightly in regards to one or more of the clinically inactive components.

Due to this difference in the clinically inactive components, biosimilar drugs have not been covered by the Hatch-Waxman Act legislation that allows generic drug companies to obtain expedited FDA approval of generic drugs. That is, generic drug companies have been required to independently establish the safety, purity, and potency of biosimilar drugs. The cost and time associated with this has been prohibitive. Consequently, even when the patents for lucrative biological drugs have expired, generic drug companies have not been able to get biosimilar drugs approved by the FDA. In this way, brand name drug companies have been enjoying a monopoly over the biological drugs market.This state of affairs is, however, about to change. In 2014, the Patient Protection and Affordable Care Act will come into place, providing a simplified pathway for generic drug companies to gain FDA approval of biosimilar drugs, in which the generic drug company may use the brand name drug company's data in order to forgo conducting its own clinical trials. This new pathway will make it feasible for generic drug companies to get FDA approval for biosimilars, and to compete against the brand name drug companies in the lucrative biological drugs market.

Not keen to lose any of their market share, and with the 2014 deadline looming, the brand name drug companies are mounting their defenses.

The brand name drug companies basically have three lines defense at their disposal, namely:

1) patent rights;

2) exclusivity rights; and

3) the right to prevent the substitution of biosimilars for brand name biological drugs.

PATENT RIGHTS

As the clinically active components of biosimilar drugs are identical, biosimilar drugs infringe valid biological drug patents. Thus, brand name drug companies in possession of valid biological drug patents can stop the manufacture and sale of biosimilar drugs for the life of the patent.

The life of a patent is normally 20 years. However, under the Hatch-Waxman Act, patents for biological drugs are eligible for an extension of time of up to 5 years, provided that the patent life does not extend beyond 14 years from the date of FDA approval of the biological drugs. The extension of time is meant to compensate for time lost due to clinical trials and regulatory review, which delay commercialization of the biological drugs. Thus, effectively, valid biological drug patents grant brand name drug companies a marketplace monopoly for at least 14 years.

However, this monopoly only acts as a defense where the biological drug patent is upheld. If the generic drug company can invalidate or circumvent the patent, it provides no protection at all. There is some cause for speculation that most existing biological drug patents may be vulnerable to invalidation. One of the requirements of a valid biological drug patent is that subsequent parties should be able to reliably reproduce the biological drug by following the information disclosed in the patent. However, most existing biological drug patents do not disclose specific details about the manufacturing process for the biological drug, such as the source of the cell line or the composition of the nutrient medium. This information is retained by the brand name drug company as a trade secret. Without providing access to this trade secret information, biological drug patents are not enabling and may be held to be invalid. If this is the case, the first line of defense is useless and brand name drug companies will be forced to turn to the second line of defense.

EXCLUSIVITY RIGHTS

Exclusivity rights prevent a generic drug company from applying for FDA approval to bring the biosimilar drug to the market for a set period of time after the brand name drug company receives FDA approval for the brand name biological drug. Without FDA approval, the generic drug company cannot release the biosimilar into the market, thereby giving the brand name drug company a market monopoly for the duration of the exclusivity period.

Exclusivity rights are intended to protect the brand name drug company in the event that the brand name drug patent is unexpectedly invalid, circumvented or challenged, or that the brand name drug is insufficiently novel and/or inventive to qualify for patent protection. In other words, it is a second line of defense, in case the first line of defense fails. If the patent rights are strong, exclusivity rights are somewhat superfluous. But, if the patent rights fail, exclusivity rights are crucial. These rights, which cannot be challenged, provide a solid back-up.

Because these rights are so powerful, they have become the subject of hot debate.

The 2010 Federal Health Care legislation proposed a 12 year period of market exclusivity for brand name biological drugs. This 12 year exclusivity period, coupled with the 2 years it generally takes for the FDA to grant approval once an application has been filed, gives an effective exclusivity period of 14 years, which is aligned with the effective monopoly period of a patented drug. That is, even if there is no valid patent, the second line of defense provides a virtually equivalent level of protection.

This length of market exclusivity grants brand name biological drugs 2 to 3 times the protection granted for brand name chemical drugs (which have long been granted market exclusivity for periods ranging from 3 to 7 years under the Hatch-Waxman Act). The question is then whether biological drugs should be granted a greater degree of protection than chemical drugs. The arguments in favor of a longer period of market exclusivity for biological drugs include that:

1) the cost of developing biological drugs is greater;

2) the time required to develop biological drugs is greater; and

3) biological drug patents are weaker (and thus more likely to be circumvented or held invalid, thus necessitating reliance on the second line of defense: market exclusivity).

Despite these arguments, the current deficit reduction plan proposes to reduce the market exclusivity period for biological drugs to 7 years (giving an effective exclusivity period of 9 years).

Because of the expense in creating a biosimilar drug, it is expected that these biosimilar drugs will only be about 10% to 20% cheaper than the actual brand name biological drug (whereas the generic versions of brand name chemical drugs are commonly 90% to 95% cheaper than the actual brand name chemical drug). Still, according to IMS Health, a market research firm, biological drugs accounted for $46 billion, or 16%, of total prescription drug sales in the United States last year. Thus, a 10% to 20% reduction in price equates to a significant cost saving to the Federal government, of between $1 and $10 billion a year. With these types of financial incentives on the table, exclusivity rights are a crumbling defense and may soon only provide brand name drug companies with an effective monopoly period of only about 9 years.

It has been estimated that it takes between 12 and 16 years for a brand name drug company to recoup the research and development expenses of bringing a biological drug to market. Thus, with the 9 year effective monopoly period falling short of the 12 to 16 year period required for recovery of their investments, brand name drug companies are turning to the third line of defense to bolster their position in the biological drug market.

SUBSTITUTION OF BIOSIMILARS FOR BRAND NAME BIOLOGICAL DRUGS

Substitution of generics for brand name chemical drugs is legal in all States and is common practice (substituted generics account for approximately 70% of all chemical drugs sold). This is through this substitution that generic drug companies achieve their market share. Doctors prescribe the brand name pharmaceutical drug, and the pharmacists automatically (or with permission) substitute for the cheaper generic drug.

The brand name drug companies are trying to pass legislation that would prevent a similar substitution of biosimilar drugs for brand name biological drugs. In that case, pharmacists would have to use the prescribed brand name biological drug despite the fact that there might be a cheaper biosimilar drug on the market. This would prevent the biosimilar drug from gaining any market share.

The brand name drug companies are pushing for this legislation on the grounds that biosimilar drugs are not identical, and so there is an element of uncertainty in terms of their effect. Hence, there is a need to protect patient safety. A patient who has been prescribed a clinically tested and approved biological drug, should not either knowingly or unknowingly then receive an alternative biosimilar drug that differs in a way that could result in it being less effective or even harmful . This is particularly true since biologically derived drugs have a much greater potential to illicit immune responses in patients.

Bills have been introduced in 8 States so far. The Virginia House of Delegates passed a bill last week by a 91 to 6 vote. Obama has a high approval rating in Virginia and yet the State has just passed a bill that effectively undermines the attempts that Obama is making to increase competition in the biological drug market (i.e. his attempts to reduce the market exclusivity period to 7 years). Thus, if even a State that supports Obama has passed such undermining legislation, maybe it is likely that other States, some of which may be less inclined to support Obama, would also pass such legislation. On the other hand, Virginia is typically a more conservative State, which would indicate that it might be more likely than most to adopt such legislation. Thus, other States might not necessarily follow suit. If that happens, and substitution of biosimilars is not prohibited, brand name drug companies won't even have a solid third line of defense on which to rely.

CONCLUSION

With both sides bringing their considerable resources into play, this is surely set to be a vicious battle.