Friday, January 23, 2009

Inside Life Sciences & Medical Frontiers

Patent strategies for personalized medicine

Recent advances in our understanding of the impact of genomic factors on disease have led to patient-specific diagnostic and therapeutic alternatives. Established links between specific genomic alterations and the etiology of diseases, such as cancer, have made it possible to differentially diagnose and treat patients in a manner that optimizes clinical outcome.

As a result, patients increasingly are receiving prognoses and treatments that are informed by, and tailored to, the “genomic elements” of their disease. More broadly, a new clinical paradigm has emerged that takes into account a combination of genomic and phenotypic information in assessing a course of treatment and prognosis. Thus, medicine truly is becoming personalized.

Patent strategies for companies involved in personalized medicine must take into account these new developments in order to participate at all levels of the value chain. Effective strategies will provide key barriers to entry in areas of critical commercial importance.

New models
To take advantage of the opportunities that personalized medicine presents, companies have to move away from traditional models of patenting. For example, the pharmaceutical industry has used a “one patent for one drug” approach designed to block generic competition under the Hatch-Waxman framework. The result has been a small number of composition-of-matter patents protecting a handful of blockbuster drugs and promising candidates. While those types of patents will continue to have value, companies must broaden their perspective to meet the challenge of personalized medicine.

The basis for any effective patent strategy is the recognition that patenting should be driven by prospective business opportunities that arise from developments in technology. It is necessary to determine the intersection of technology developments and business opportunity in order to identify areas in which patents are likely to have the greatest impact. However, it is not enough simply to identify the ideal intersection between business and technology.

Once the areas of potential commercial impact are identified, it is then necessary to draft patent claims that create commercially relevant barriers to entry.

In the personalized medicine space, there are myriad opportunities. Therapeutic compounds, including derivatives, pro-drugs, conjugates, metabolites and the like remain the first order of protection. However, compounds alone will not be sufficient to protect, and therefore to monetize, personalized medicine. Patent strategies should also contemplate genomic assays that underlie the ability to tailor treatment options for optimal clinical outcome. For example, in cancer, the association between specific mutations and the efficacy of standard chemotherapeutic regimens has been characterized. As a result, therapeutic selection, as well as reimbursement, increasingly is being guided by genomic analysis in order to match treatment with a patient’s genomic signature.

In addition, diagnostic biomarkers and biomarker assays are being used to drive differential diagnosis and therapeutic selection. Life sciences companies at all levels are taking an increasing role in these important adjuncts to therapy. Moreover, drug development companies may be best positioned to correlate genomic and biomarker standards to therapeutic efficacy. Developments in these areas can enhance the value of the overall drug portfolio and provide key barriers for competitors.

Recent court decisions have made it more challenging to patent assays for diagnostics or therapeutic selection. Those decisions may affect the patentability of clinical algorithms and assays. As a result, companies wanting to extract additional value from their patents must be even more aware of potential commercial barriers and ways to implement them. A key consideration in that regard is to view patents as business documents having more to do with incremental commercial advances than incremental advances in technology.

Focusing on commercial advantages created by developments in technology will drive the patent process toward a successful outcome. Patent claims must do more than meet the statutory requirements and reflect an advance in technology. Rather, they must create barriers that will prevent competition along the commercial value chain. Companies that focus their patent strategy on creating commercial barriers will, as a by-product, achieve a patent portfolio that is more likely to meet current statutory and judicial requirements. More importantly, they will recognize value on many levels in the developing area of personalized medicine.

Thomas Meyers is a partner and Philip Zhang is special counsel in the intellectual property group in the Boston office of law firm Cooley Godward Kronish LLP.