Gene Patenting and Biological Methods in the Personalized Medicine Space

Richard S. Meyer contributed to this post.

Personalized medicine, including the application of genomic and molecular data to better target the delivery of health care and determine a person’s predisposition to a particular disease or condition, continues to expand and become the clinical standard of care for many medical conditions or diseases.  For the past several years, players in the personalized medicine space have seen the federal courts and the legislature debate the extent to which patent protection is available under U.S. law when it comes to biological molecules and methods of assessing biological molecules (e.g., diagnostic testing).

Recently, the debate has heated as a line of lawsuits have made their way through the legal system with sights set on the Supreme Court.  While the technology at issue in these cases is diverse, the questions before the courts always come back to where to draw the line between patent-eligible subject matter (an invention) and patent-ineligible subject matter (an abstract idea, scientific principle or natural phenomenon).  By excluding this type of subject matter from patent eligibility, naturally occurring phenomenon, scientific principles, and laws of nature remain available to all innovators and researchers.

These cases have drawn attention and input not only from biotechnology and diagnostics companies and industry organizations, but also from public interest, policy, legal, and medical organizations.  In particular, the Myriad case[i], focuses on the patent eligibility of isolated genetic sequences associated with breast cancer and diagnostic methods based on detecting those sequences.  How this case is decided will be partly guided by the Supreme Court’s decision in the Prometheus case[ii], for which oral arguments before the Supreme Court were held on December 7, 2011.  In the Prometheus case, the parties are arguing over the patent eligibility of biological methods involving measuring drug breakdown products (metabolites) after administering a drug to a patient to assist in determining appropriate drug dosage.

The courts have been presented with a number of policy arguments on the ramifications of either having or eliminating patent protection for these technologies.  Perhaps the largest policy debate focuses on whether the market exclusivity provided by patents on genetic sequences or diagnostic methods foster commercialization and thus availability of personalized medicine.  Supporters of patent protection for gene patents and diagnostic testing say that this protection enables better patient care by facilitating investment in and commercialization of diagnostic testing and dissemination of data to broaden medical understanding, which in turn leads to new research endeavors and the development of new technologies, and improves long-term public health.  Opponents argue that patent protection for these technologies impair patient health by limiting dissemination of medical knowledge and use thereof, limiting access to diagnostic testing by raising testing costs, and prevents access to second opinion testing to confirm diagnosis.

While important, these policy arguments may be outside the scope of the courts’ patent eligibility analysis of genetic sequences, diagnostic testing, and other biological methods under U.S. patent laws.  The recently implemented patent reform law (America Invents Act)[iii] made no changes to the patent eligibility standards, but did commission the US. Patent & Trademark Office to study access to second opinion testing for genetic testing, indicating that Congress feels further inquiry is needed before legislative action.

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[i]  Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, No. 10-1406 (Fed. Cir. July 29, 2011).

[ii]  Mayo Collaborative Services v. Prometheus Laboratories, Inc., 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, 79 U.S.L.W. 3554 (U.S. June 20, 2011)(No. 10–1150).

[iii]Leahy-SmithAmerica Invents Act, Pub. L. No. 112-29, 125 Stat. 284, 325 (2011) (to be codified at 35 U.S.C. § 257)(enacted Sept. 16, 2011).

Adriana Jenkins and the Case for Personalized Medicine

Adriana Jenkins passed away on February 9, 2011 after battling breast cancer. Known for her tenacious advocacy on behalf of targeted therapies, Kelly Lindenboom, honored her passionate work within the personalized medicine community at the Boston Reception hosted by the Personalized Medicine Coalition on November 8, 2011.

Adriana Jenkins had an intoxicating personality and lived every day to the fullest — until, earlier this year, when she died from a rare form of breast cancer at age 41. Adriana was in the prime of her life — she had a thriving career in biotech public relations, was an incredible artist and had an extensive network of friends, that to Adriana, were her family. I’m part of her family.

At age 32, Adriana was engaged to be married, getting ready to start a new job with an up-and-coming biotechnology company and excited for what was to be the best time of her life. And then came the phone call from her doctor that changed everything. With a diagnosis of stage 3B inflammatory breast cancer — a rare, aggressive form of the disease — she had limited options to consider.

With less than a 50 percent chance of survival beyond five years, Adriana was desperate to explore any and all options that might give her better odds. Unlike the majority of people who are diagnosed with cancer every year, Adriana possessed a unique and intimate understanding of the pharmaceutical industry and was able to be her own best advocate after her diagnosis. When a colleague suggested she look into an investigational therapy — Herceptin — being tested locally at the Dana Farber Cancer Institute (DFCI) in Boston, she jumped at the chance. And as it turned out, she was a perfect fit for the trial and was enrolled in the study.

While the clinical trial was not always easy, Adriana responded wonderfully to the Herceptin, which was eventually approved by the Food and Drug Administration and is used today to treat many women with the same type of genetic marker, HER2, that was present in Adriana’s cancer.

Because of her success with Herceptin, one of the first so-called personalized medicines to be approved for use, Adriana was able to beat the odds. Really beat the odds. She credited personalized medicine treatment for giving her the nearly 10 years she was told she wouldn’t have. And she was thankful for every day that she had.

Unfortunately, despite encouraging results, personalized medicine is still a rarity in most cancer treatments. In her article “A Dying Wish,” published in Forbes magazine, written shortly before her death, Adriana made an eloquent appeal for the broad adoption of personalized medicines for cancer and other diseases based on her own incredible, nearly decade-long fight with breast cancer. In the article, she posed a question related to personalized medicine:

How do we convince drugmakers to focus their shrinking R&D budgets on this area of scientific discovery?

And then offered this potential challenge to our nation’s pharmaceutical companies and lawmakers:

“One idea is to create an incentive for drugmakers comparable to that in the Orphan Drug Act. Passed in 1983, it encourages companies to develop drugs for diseases that have a small market (fewer than 200,000 patients in the U.S.). Under the law, companies that develop such a drug may sell it without competition for seven years, in addition to often receiving quicker “fast track” regulatory review… A comparable law could push drugmakers to develop PM drugs for cancer and other deadly ailments.”

At the end of the article she offered this plea:

I urge patients, physicians and insurers to create a similar group to support the commercialization of personalized cancer drugs.

After her diagnosis with cancer, Adriana had the word “hope” tattooed onto the inside of her wrist as a constant reminder to herself for how she wanted to embrace life.

In the years that followed her remission, Adriana remained a strong advocate for the potential of personalized medicine, putting her public relations know-how to work by partnering with Herceptin’s developers to share her experience with the media and bring awareness to other women receiving a new cancer diagnosis.

The week that Adriana passed away, her article about the power and potential of personalized medicine was published in Forbes. And today, her friends are supporting her vision — keeping her “hope” alive — through the Adriana Jenkins Foundation for Personalized Medicine and a fundraising team with Stand Up To Cancer. Formed in Adriana’s name, the goal of the group is to raise awareness and be a proponent for development of personalized medicines, like the one that gave Adriana the nearly 10 years she never expected she would have.

Cancer is an extraordinarily complicated problem, and will only be solved through new approaches and ideas. Personalized medicine is one of them.

– These remarks were first made by Ms. Lindenboom at the Personalized Medicine Coalition Boston Reception on November 8, 2011. They were also posted on HuffingtonPost.com.