MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government regulates value-based care, to shifts in the marketplace for medtech mergers and acquisitions (M&A), 2020 will prove to be another year of evolution.

Based on recent trends and developments, Akin Gump has prepared this client alert to provide the medtech industry with a landscape overview of the following issues in the year ahead: FDA regulatory developments; federal health care programs; international trade; transactions; intellectual property (IP) litigation; False Claims Act enforcement and health information and privacy and data protection.

Expect Possible Changes to Section 101 Challenges on “Patentable Subject Matter.

Potential changes to 35 U.S.C. § 101 would affect at least two areas of medical technology—diagnostic tests and computer-associated devices.

• Diagnostic Tests. Courts have routinely struck down claims that link genetic or biomarker information to specific human conditions as unpatentable laws of nature. For example, a court invalidated claims to a new maternal blood test that allowed detection of fetal abnormalities in a pregnant mother. Another court invalidated claims to a method of detecting an autoimmune disease in a group of individuals for whom other tests failed. Some industry stakeholders are concerned that such decisions lead to uncertainty in patent rights and a decrease in investment into new technologies. The proposed reforms would eliminate the “law of nature” exception. If enacted, claims to useful, new and nonobvious diagnostic tests would be more likely to withstand a Section 101 challenge.

Source: https://www.jdsupra.com/legalnews/medtech-update-2020-legal-and-80791/