Author: George W. Johnston

Proposed “Safeguarding American Innovation Act” Would Target Foreign Influence in Research

A bipartisan group of U.S. Senators is sponsoring proposed legislation to stop China and other countries from allegedly stealing federally funded research and using the information to damage U.S. economic and national security. The bill was introduced on June 18, 2020 and is entitled the “Safeguarding American Innovation Act.” The proposed legislation was drafted and co-sponsored by Senator Rob Portman (R-OH) and Senator Tom Camper (D-DE). It is currently supported by eight Republican Senators and five Democratic Senators.  There is no counter legislation pending in the House of Representatives. According to Senator Portman, “We cannot continue to allow our global competitors to steal taxpayer-funded research and innovation in order to benefit their military and economy.”  The legislation contains several key provisions of interest to U.S. Research Institutes and Organizations regarding: Disclosing Foreign Funding and Relationships: Key purposes of the legislation are to disclose foreign sources of support to academic institutions and to provide information about foreign relationships when applying for federal research grants. The proposed legislation not only provides a fine for not reporting foreign sources of funding, but for the first time, it also criminalizes not reporting the relationships when applying for federal research money grants.  The criminal penalty proposed in the legislation consists of a term of up to five years. Expanding Funding...

USPTO Takes Measures to Help Small Businesses Patent and License COVID-19 Inventions

On May 8, 2020, the United States Patent and Trademark Office (USPTO) announced a new COVID-19 Prioritized Examination Pilot Program. Under this Pilot Program, the USPTO will grant qualified requests for prioritized examination of COVID-19-related patent applications without requiring payment of fees associated with other prioritized examination programs. Why is the COVID-19 Prioritized Examination Pilot Program important? This Pilot Program is the latest measure by the USPTO to spur innovation related to fighting the coronavirus. “Independent inventors and small businesses are often the difference makers when it comes to cutting-edge innovation and the growth of our economy,” said USPTO Director Andrei Iancu. “They are also in most need of assistance as we fight this pandemic.” Iancu continued, “Accelerating examination of COVID-19-related patent applications, without additional fees, will permit such innovators to bring important and possibly life-saving treatments to market more quickly.” Who may participate in the Pilot Program? Applicants of COVID-19-related patent filings who qualify for either small entity (37 C.F.R. §1.27) or micro entity status (37 C.F.R. §1.29) may participate. When can I apply? On May 14, 2020, the USPTO started accepting requests for prioritized examination under the COVID-19 Prioritized Examination Pilot Program. How long will the Pilot Program continue? The program will continue until the USPTO has accepted a total of 500 requests....

Organizations Commit to Share Their Intellectual Property to Support the Fight Against the Coronavirus

The Open COVID Pledge calls on organizations around the world to make their patents and copyrights freely available to combat the coronavirus. The Pledge was developed by the Open COVID Coalition (“Coalition”), an international group of scientists and lawyers, seeking to accelerate the rapid development and deployment of diagnostics, therapeutics, medical equipment, and software solutions to this urgent public health crisis. Many major technology companies and academic organizations have “signed onto” the Pledge. The Pledge, however, does not appear to be as popular with biopharmaceutical companies. Am I eligible? How do I make the Pledge? Anyone who holds intellectual property rights is eligible by either issuing a public statement making the Pledge or issuing a press release and notifying the Coalition. What IP is covered? Pledging parties may share any of their intellectual property rights, including patents and copyrights relating to the coronavirus pandemic. The Pledge does not cover trademarks or trade secrets. How do I implement the Pledge? The Coalition has published three standard licenses. A pledging party may adopt one of these standard licenses, adopt its own compatible license, or adopt an alternative license. What are some of the key terms of the standard licenses? Grant: Simply stated, the standard licenses grant a non-exclusive, royalty-free, worldwide license to use and commercialize the intellectual...

Federal Circuit Considering En Banc Rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc.

The United States Court of Appeals for the Federal Circuit is deciding whether to reconsider en banc its panel decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. Numerous amici have lined up in support of rehearing. At stake is what room recent U.S. Supreme Court jurisprudence leaves for obtaining patent claims involving diagnostic innovations that use established processes.

USPTO Proposes a Pilot Program to Allow a Single APJ to Institute an Inter Partes Review

The United States Patent and Trademark Office (“USPTO”) has published a request for comments in the Federal Register for a proposed pilot program which would allow for a single Administrative Patent Judge (APJ) to determine whether to institute an inter partes review (IPR), with two additional APJs being assigned to the IPR if a trial were instituted.

Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity

In Mylan Pharm., Inc. v. FDA, generic drug manufacturer Mylan Pharmaceuticals, Inc. (“Mylan”) challenged an FDA letter decision describing the agency’s treatment of original and reissue patents as “a single bundle of patent rights” when determining eligibility for 180-day exclusivity under the Hatch Waxman Act (pre-MMA). The United States District Court for the Northern District of West Virginia deferred to the FDA’s interpretation of the statute under step 2 of Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc..

It Ain’t that Obvious to Try

In Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms Inc., the Federal Circuit followed previous precedent in holding that the combination of compounds is not “obvious to try” if unexpected properties are supported by evidence. The patent-at-issue was directed to an antihypertension drug, Tarka®, which is the combination of an angiotension-converting enzyme inhibitor (such as trandolapril or quinapril, both double-ring compounds) and a calcium channel blocker. The jury found that the patent had not been proven invalid and defendant, on appeal, argued that “if a combination of classes of components is already known, all selections within such classes are obvious to try . . . .” The Federal Circuit found that there was substantial evidence supporting the jury’s verdict that obviousness had not been proved by clear and convincing evidence because of the unpredicted “longer-lasting effectiveness” achieved with the drug.

Potential For Harm: Indemnity Agreements and Willfulness Determinations

Patent indemnification agreements, common in asset purchases, mergers and acquisitions, manufacturing, and patent licensing agreements, reduce the possibility of liability should a third party later assert its patent against the asset purchaser or licensee. However, entering into such agreements to mitigate risk can actually increase exposure. During the damages stage of patent infringement lawsuits plaintiffs often seek, with varying success, to bring in evidence of the existence of a defendant’s indemnification agreement to show that defendant knew of the patent and committed willful infringement. Thus, the very vehicle used to shift the risk of monetary liability can sometimes itself be used as a mechanism to enhance damage awards.

Big Pharma Mutating from Small Molecules into Biotech Drugs

According to the Tufts Center for the Study of Drug Development, the pharmaceutical industry, particularly Big Pharma, has decidedly changed course, shifting its R&D focus away from small molecule drugs towards biotech products. Such biotech products are muscling out small molecules’ prior domination of the top 10 drug product sales. For example, in 2012, biotech products accounted for 71% of the revenues generated by the world’s top selling biopharmaceutical products. This remarkable growth mirrors the successful evolution of biotech research over the last three decades. Drilling down further, the Tufts Report notes that monoclonal antibody (mAb) biotech products saw the largest increase in growth over the last decade and now account for almost 60% of the biotech products being clinically developed by the largest pharmaceutical companies.