Management Forum Blog

Despite ongoing efforts to develop new technology solutions, legislative actions, or enforcement strategies to combat counterfeit drugs, it seems no one has yet found the weapon to finally bring down the $800 billion (and growing) counterfeit drugs industry. But pharmaceutical manufacturers, take note. The US Food & Drug Administration (FDA) recently released a document – “Guidance for Industry Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-counterfeiting” – that states that incorporating physical chemical identifiers (PCIDs) into drug formulations could be a cost-effective way of differentiating the genuine from the counterfeit.

According to an article on the subject by Gareth Macdonald for in-pharmatechnologist.com, ideal PCID candidates are pharmacologically inactive and would be “food additives, colorants, or excipients with established safety profiles”. Macdonald said that just like other anti-fake labeling methods, PCIDs can easily be detected in the laboratory. But what’s different – and better – about them is that they can also be easily identified by patients, medical practitioners and pharmacies. The draft guidance also emphasized that the PCIDs should be tested for potential toxicity, and for any interaction they may have with the drug’s release technology.

A security printing and imaging blogger has some worries, though. According to a post by Steven Simske for communities.hp.com, the FDA advice:

Goes against a trend to include less, rather than more, exogenous chemicals — dyes, expedients, etc. — in food and drugs

Does not clarify if the list of PCIDs to add is public knowledge (“with established safety profiles”) – and therefore easier for the would-be counterfeiter to obtain – or that PCIDs used should only be sold by authorized suppliers to authorized buyers to prevent insidious insiders who order PCIDs and sell them for profit to counterfeiters

Does not consider that incorporating PCIDs may complicate the authentication process –requiring the deployment of specialized analysis equipment and personnel – while track and trace and authentication through the appropriate combination of security printing may be easier, and more cost-effective, scalable, and effective

Meanwhile, should pharmaceutical manufacturers heed FDA’s advice, Colorcon is ready to offer exclusive tablet identification and authentication systems. A world leader in film coatings, modified release technologies, functional excipients, and tablet branding services, Colorcon provides a complete line of customized film coating and ink formulations that can be used to give a unique appearance to solid oral dosage forms (SODFs) — making it easier for a patient or pharmacists to identify the product at a glance. According to the company, these excipients offer established safety profiles, do not interact with core components, and have no potential effect on the quality, performance, and stability of the SODF — all of the important pharmacological and toxicological considerations covered in the FDA guidance document.

Incorporating PCIDs into pharmaceuticals may have its pros and cons – but with the FDA behind it, it’s surely an idea worth examining. As recently appointed FDA commissioner Margaret Hamburg said, “Drug counterfeiting is a serious public health concern,” and the agency is committed to ensuring that fake products are stamped out.

The human gene patentability controversy is back. ACLU’s lawsuit against Myriad Genetics, charging that the latter’s patents on the BRCA genes are unconstitutional and invalid, has brought out various legal, medical, and ethical implications. Will the litigation’s outcome finally settle the issue?

* The implications of Myriad’s exclusive right to the BRCA1 and BRCA2 genes
* Arguments for patenting human genes
* Is the price of innovation well worth its benefits to mankind?

The American Civil Liberties Union, together with the Benjamin N. Cardozo School of Law-affiliated Public Patent Foundation (PUBPAT), recently filed a lawsuit against the US Patent and Trademark Office (USPTO), Myriad Genetics, and the University of Utah Research Foundation. The latter two hold the patents on the BRCA genes, the mutations (BRCA 1 and BRCA2) of which are responsible for most cases of hereditary breast and ovarian cancers.

According to an ACLU press statement, the patents give Myriad the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes (at a cost of $3000) and to prevent any researcher from even looking at the genes without Myriad’s permission. ACLU officials stated that this would hamper clinical diagnosis; discourage research on possible future mutations of the BRCA2 genes; and have negative consequences on women who need medical screening but can’t afford Myriad’s test, want a second opinion on test results, or seek other options for inconclusive results.

The lawsuit – filed on behalf of breast cancer and women’s health groups, scientific researchers’ associations, pathologists and laboratory professionals – charges that granting the patent to Myriad is illegal because genes are “products of nature” and unconstitutional because limiting the free flow of information violates the First Amendment.

But other experts disagree. An article by Rosalie Westlenskow for The New York Times quoted genome science and ethics expert Robert Cook-Deegan, who said that the granting of patents for human genes encourage invention by rewarding researchers, leads to investments in businesses that own patents, and prevents “free riders” who pay nothing to sell a product that cost the original developers millions. “The system of innovation will not work…if, as soon as you put something on the market, someone else can make your product and they don’t have to pay you anything,” he added.

To those who would argue that gene patents negatively impact research, other evidence contradicts it. Westlenskow’s article also quoted Scott Kieff, law professor and research fellow at Stanford University, who said that other  countries that have stricter rules about gene patents have not seen as much innovation as the United States, where an increase in new drugs and devices in the market was seen after 1980, correlating with the increase in gene patents.

To those who would say that this case can be won based on Section 101 of the Patent Law (that defines patentable subject matter), other experts contend that while a naturally occurring biomolecule is not patent-eligible by itself, one that is isolated and purified with sufficient human intervention that it acquires “markedly different characteristics” from their naturally occurring counterparts is patent-eligible – an interpretation, says law professor and blogger Chris Holman says has not been challenged for 25 years..

What about moral and ethical implications? Genes are the basic unit of heredity and, with modern technology, researchers have been able to isolate specific genes that carry an associated risk of illness. According to an article on the lawsuit by Elizabeth Landau for cnn.com, some experts say that while a moral argument could be made that human genetic material belongs to all or that human genome is sacred, what can be said, states molecular biology professor Lee Silver, when one considers that about 25 percent of human genes are shared by chimpanzees.
Indeed, the patent law says nothing about ethics. And of course, companies should not use patents to profit unreasonable and exploit people at risk. On the other hand, patents do serve these very same people. Silver said that the patentability of such tests (such as Myriad’s diagnostic test) is what gives companies the incentive to create them in the first place. In the same article, M. Sara Rosenthal, a bioethics expert, cited another example of a good use of a gene patent -. the insulin gene, which eventually led to essential treatments for diabetes.

Obviously, gene patenting is not a question of absolutely right or absolutely wrong. Remember, too, that such patents expire 20 years after application. The bottom line though is, with all the pros and cons, does the potential harm to patients outweigh (or not) the benefit to mankind that comes from encouraging innovation?

The outcome of ACLU vs. Myriad may provide the answer.

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