About Deerfield

Launched in 1994, Deerfield Management Company is an investment firm dedicated to advancing healthcare through information, investment, and philanthropy—all toward the end goal of cures for disease, improved quality of life, and reduced cost of care.

Read More

Supporting companies across the healthcare ecosystem with flexible funding models…

Read More

Delivering market research to the Deerfield team, its portfolio companies and other partners.

Read More ---

A New York City-based not-for-profit devoted to advancing innovative health care initiatives.

Read More
Portfolio Companies

Deerfield generally maintains a combined portfolio of more than 150 private and public investments across the life science, medical device, diagnostic, digital health and health service industries at all stages of evolution from start-up to mature company.

Read More View Portfolio Companies
Research Collaborations

Deerfield partners with leading academic research centers, providing critical funding and expertise to further sustain and accelerate the commercialization of discoveries toward meaningful societal impact by advancing cures for disease.

Read More View Research Collaborations
Strategic Partners

As a strategic partner, Deerfield offers capital, scientific expertise, business operating support, and unique access to innovation.

Read More
Deerfield Foundation

The Deerfield Foundation is a New York City-based not-for-profit organization whose mission is to improve health, accelerate innovation and promote human equity.

Read More Meet the Foundation Team
Cure Campus

Cure is a 12-story innovations campus in New York City that intends to bring together innovators from academia, government, industry, and the not-for-profit sectors to advance human health and accelerate the fight against disease.

Read More Join the Cure Email List
Cure Programming

Cure has a series of expert lectures intended to advance thought in healthcare, management, innovation, policy, and other relevant subjects. This fosters growth and education for those at Cure and its guests.

Events at the Cure

Do Prior Secret Sales Invalidate Patents?

The quid pro quo of the U.S. patent law is that the inventor is awarded commercial exclusivity for a limited period of time in exchange for public disclosure.  However, once knowledge enters the public domain it cannot be recalled; thus public disclosure before a certain date (called “critical date”) precludes subsequent attempts to obtain patent protection.  If it is discovered that a sale or an offer for sale of a product covered by a later filed patent occurred prior to the critical date for the filing of the patent, the patent is invalidated.  This is because a commercial sale made prior to the critical date is viewed as an unfair extension of the period of exclusivity granted by the patent.  An issue arises when a sale or an offer of sale is first made privately followed by a later patent filing.  In the pharmaceutical industry, such sales are sometimes made between a small business innovator and its contract supply manufacturers or research organizations because the small business lacks the necessary resources to manufacture the product and conduct clinical trials by themselves.  These sales often precede patent filing because in the early stages of development, companies often don’t realize the commercial value of what they have.  The law was aimed at large companies that have an internalized supply chain, but disadvantages small companies that rely on external suppliers to help conduct their research and development.

Historically, the courts have interpreted the patent statute in a way that even secret sales disqualified subsequently filed patents.  The America Invents Act (AIA) that applies to patents filed on or after March 16, 2013 may have changed this law.  Under the current widespread interpretation of the AIA law, only public sales will render later-filed patents unenforceable.  However, there is still a lot of uncertainty in that interpretation, but a pair of cases that are now percolating through the courts should provide much needed clarity to the pharmaceutical industry.

October 12, 2016, Merck asked the Supreme Court to review the decision of the Court of Appeal for the Federal Circuit that even a secret offer of sale invalidates later filed patents.  Merck & Cie, et al. v. Watson Laboratories, Inc., No. 16-493. (Sup. Ct.).  In this case, Merck and Weider Nutrition negotiated sale terms for 2 kg of a drug for evaluation purposes.  The relevant patent was filed before the AIA law kicked in. The Federal Circuit applied “traditional contract law” and found that “[Merck’s] detailed fax — providing essential price, delivery, and payment terms — contained all the required elements to qualify as a commercial offer for sale” that invalidated Merck’s later filed patent.  On January 9th, 2017 the Supreme Court declined to review this case. 

Another interpretation of the “on sale bar” is the issue in Helsinn Healthcare SA et al. v. Teva Pharmaceuticals USA Inc. et al., which was decided in the U.S. District Court for the District of New Jersey in 2016.  In this case, the judge held that Helsinn’s licensing and supply agreement did not qualify as a patent-invalidating sale. “The new requirement that the on-sale bar apply to public sales comports with the plain language meaning of the amended section, the USPTO’s interpretation of the amendment, the AIA Committee Report, and Congress’ overarching goal to modernize and streamline the U.S. patent system.”  “The post-AIA on-sale bar inquiry . . . requires that the sale make the claimed invention available to the public . . .”  In this case, the patent was filed after the AIA took effect.  Teva is currently appealing the decision to the Court of Appeal for the Federal Circuit.  The decision is expected to eventually be appealed to the Supreme Court.

The ability to use outside contract manufacturing and research organizations without losing patent exclusivity is critical to small pharmaceutical and biotechnology companies.  There is hope in the pharmaceutical and biotech patent communities that “on sale bar” will not apply to secret sales that occurred after the AIA.  The uncertainty remains, and the investment community has to  pay close attention to the contract dates in relation to patent filing dates when evaluating potential investments.  The upcoming Helsinn case should some provide much-needed clarity.