Torrey Pines Law Group's diagnostics patent attorneys and patent agents have decades of experience with protecting and enforcing intellectual property rights related to in vitro diagnostics, clinical diagnostics, companion diagnostics, genetic testing, next-generation sequencing, precision medicine, diagnostic imaging, and bioinformatics innovations. In addition, our attorneys and regulatory advisors have had hands-on experience with actually bringing in vitro diagnostics (IVD) innovations to market through the FDA regulatory process and related hurdles including clinical trials, investment funding, mergers, acquisitions, international supply and distribution, packaging, labeling, and licensing, among many other hurdles.
Our clients ask us to protect and enforce intellectual property rights related to some of the world's most challenging technical areas, and the field of in vitro diagnostics is very often the most challenging from a legal perspective.
Patent laws in the United States related to in vitro diagnostics (IVD) are, unfortunately, uncertain. Fortunately, however, the law is more certain in Europe and other jurisdictions. The uncertainty is derived from an unusual trifecta of Supreme Court opinions from 2012 to 2014 that have altered previously settled law: (e.g., Mayo 1, Myriad 2, and Alice 3). The US Supreme Court has had the opportunity to clarify its opinions but has refused to hear more than ten appeals since issuing those opinions.
As a result, patent practitioners can only glean from more recent appellate court opinions and other federal court decisions as to the most durable approaches to draft, prosecute, and enforce in vitro diagnostics patents. Our firm has substantial experience with obtaining and enforcing diagnostics patents worldwide, but our clients are always prepared for strategic adjustments.
Technologies that "fit" within the definition of an in vitro diagnostic innovation are continuously evolving. The US Food & Drug Administration defines an in vitro diagnostic as “those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.” See 21 CFR § 809.3. One can imagine that this definition now captures precision medicine, next-generation sequencing, medical imaging, artificial intelligence, companion diagnostics, bioinformatics, and so on.
Our IVD clients regularly ask us to assist them with:
Most medical treatments are designed for the "average patient" as a one-size-fits-all-approach, which may be successful for some patients but not for others. Precision medicine, sometimes known as "personalized medicine" is an innovative approach to tailoring disease prevention and treatment that takes into account differences in people's genes, environments, and lifestyles. The goal of precision medicine is to target the right treatments to the right patients at the right time.
We have assisted our clients with protecting and enforcing precision medicine intellectual property rights throughout the world. We have also helped them with identifying and successfully commercializing both FDA regulated and non-FDA regulated (direct to consumer, or DTC) pathways to market.
Precision medicine is only as good as the tests that guide diagnosis and treatment. Next Generation Sequencing (NGS) tests are capable of rapidly identifying large sections of a person's genome or cancerous tumor. Patients, physicians and researchers can use these tests to find genetic variants that help them diagnose, treat, and understand more about human disease.
Our firm has significant experience with protecting those technologies worldwide, and with identifying both FDA regulated and non-FDA regulated pathways to market.
Diagnostic imaging describes the use of various medical imaging techniques for viewing inside the human body to help determine the cause of an illness or injury and confirm a diagnosis. Doctors also use this technique to see how well a patient’s body responds to treatment.
Our attorneys and advisors have years of expereince with protecting and commercializing medical imaging technologies. We have experience with worldwide patent portfolio development for diagnostic imaging technologies using a variety of different modalities: X-Ray, MRI, 3D tomography, ultrasound, CT scan, and so on. We have hands-on experience with obtaining FDA regulatory clearances and reimbursement for companies developing these technologies.
A companion diagnostic is a medical device which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks. We are often asked to help our clients protect related intellectual property when considering our clients' Risk Evaluation and Mitigation Strategies (REMS) related to a particular drug or biological product. In addition, we have significant expereince with protecting IP and developing FDA regulatory strategies with using certain medical imaging and artificial intelligence systems as a companion diagnostic.
The IP attorneys, patent lawyers, engineers, scientists, and patent agents at Torrey Pines Law Group have also worked in a variety of medical device industries and have assisted with commercializing, researching, and developing technologies including:
We welcome the opportunity to provide you more detailed information about our firm and see how we can work together. Please contact us to schedule a free initial consultation, and follow us on Facebook, Twitter, and LinkedIn.
1 Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
2 Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
3 Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014).
Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.
We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.