Safe Harbor (35 U.S.C. 271(e)(1)) and Medical Devices

Attorney: Richard D. Kelly
October 13, 2020

In two decisions this year district courts have addressed the “safe harbor” provision of 35 U.S.C. § 271(e)(1) in motions to dismiss a patent infringement count. The first involved the display of artificial heart valves by Meril Life Sciences Pvt. Ltd. (Meril) at the 2019 Transcatheter Cardiovascular Therapeutics Conference (“TCT Conference”) in San Francisco, California. Edwards Life Sciences Corporation (Edwards) asserted that the display infringed its 5 patents on the displayed valves under §§ 271(a) and (g) by importing the valves made using its patented process. Meril defended by asserting that such display was protected by the safe harbor provision. The facts were not favorable. First, Meril did not have a marketing application pending with the FDA. While a pending application is unnecessary there must be evidence that the acts were calculated to lead to the possible submission of such evidence. See Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).    Alternatively, the activity was at least in part to attract clinical investigators for FDA trails. See Telectronics Pacing Systems, Inc. v. Ventritex, Inc., 982 F.2d 1520, 1523 (Fed. Cir. 1992). There was no evidence that defendants  recruited or could have recruited investigators for studies that could be submitted to the FDA. Edwards asserted that Meril’s sole objective was to promote sales in Europe. Thus, Teletronics was deemed irrelevant.<... Read more

A Diagnostic Patent Is Found Patent Eligible At the Federal Circuit

Attorney: Richard D. Kelly
August 4, 2020

In March the Federal Circuit reversed a lower court decision finding Illumina’s patents (U.S.Ps. 9,580,751 and 9,738,931) for diagnosing Down’s Syndrome to be patent ineligible, 952 F.3d 1367 (Fed. Cir. 2020). On August 3, the Federal Circuit denied a petition for rehearing and rehearing enbanc but did issue a new decision adding the term “human-engineered” in several portions of the opinion discussing the separation of fetal DNA from maternal DNA which the inventors had discovered were of different sizes, fetal cell DNA is shorter than the maternal DNA. The inventors recognized that the DNA to be analyzed for genetic aberrations was that of the fetus. The problem was to isolate the small amount of fetal DNA from the maternal DNA so the fetal DNA could be analyzed for genetic aberrations. Prior to the invention there was no known way to distinguish and separate maternal DNA from the tiny fraction of fetal DNA present. The inventors found that by selectively removing DNA having more than 500 or 300 base pairs they could produce a sample where the fetal DNA content in the sample would be enriched and analyzed. The following claim is exemplary:<... Read more

Can One Have Too Many Patents?

Attorney: Richard D. Kelly
July 7, 2020

As is common with a blockbuster drug, AbbVie's Humira faced an antitrust challenge from third-party payers. The third-party payers filed an antitrust action claiming AbbVie's patent strategy stifled competition by forcing prospective competitors to settle on terms allowing Humira to enjoy a monopoly long after patent protection should have ended. The complaint alleges that AbbVie cornered the market for Humira and its biosimilars by obtaining a thicket of patents which allowed it to gain the market power it needed to prevent competitors from entering the U.S. market (violation of Sherman Act section 2). It used this market power to enter into settlement agreements with potential competitors to keep their products out of the U.S. market in return for early launch dates in Europe, also an important market which they termed a pay-for delay and market division (violation of Sherman Act section 1). Judge Shah, of the Northern District of Illinois, dismissed the complaint without prejudice on June 8, 2020. The opinion begins with a discussion of three reasons Humira might hold its commanding position foreshadowing his decision. First, the more than one hundred Humira-related patents made it difficult if not impossible to seek a non-infringing competing product.... Read more

FDA Seeking Comments on Orange Book Patent Listing

Attorney: Richard D. Kelly
June 29, 2020

The FDA has published a public notice requesting comments on the submission and listing of patent information. See the notice here. The information requested could lead to the implementation of changes having a significant impact on pharma, including combination products in the future, especially on combination products.<... Read more

MCRO's Pyrrhic Victory

Attorney: Richard D. Kelly
May 21, 2020

On May 20 the Federal Circuit for the second time found McRO’s patent for automatically generating animations to be patentable, this time reversing the district court’s finding of invalidity for lack of enablement. In its previous decision, McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016) (McRO I), the Federal Circuit reversed the district court’s holding that the claims were directed to a judicial exception, an abstract idea. In McRo I the Court had reversed based on its determination that the claims were to a genus limited to rules with certain common characteristics, a genus. Id. at 1313. In particular, the “rules are limiting in that they define morph weight sets as a function of the timing of phoneme sub-sequences.” Id. <... Read more

USPTO Decides an "Inventor" as a "Natural Person"

Attorney: Richard D. Kelly
April 28, 2020

The USPTO has published an apparently January 2020 Commissioner Decision effectively precluding the filing of patent applications where the invention was made solely by artificial Intelligence (AI). This decision has implications in the pharmaceutical industry where the use of AI to identify new compounds or uses for old compounds is utilizing AI. It also provides some guidance as to how the problem may be avoided.<... Read more

Listing the Medical Device Part of a Combination Product in the Orange Book May Trigger Antitrust Liability

Attorney: Richard D. Kelly
March 30, 2020

A patent listing in the Orange Book provides the innovator drug company with a potent tool for excluding generic competitors who wish an ANDA application or 505(b)(2) drug approval applications relying upon the innovator's efficacy and safety data. If a patent is listed in the Orange Book the generic applicant must provide notice to the NDA holder and the patentee (if different) of the application's filing. The patentee then has 45 days to initiate litigation which would cause a 30-month stay of the FDA approval of the generic drug. Normally patents to a drug's packaging are not listable in the Orange Book, however, an exception exists for packaging which also functions as the drug's applicator. Sanofi took advantage of this provision to list U.S.P. 8,556,864 (‘864 patent) which was directed to the drive mechanism used in its injector pen for its Lantus® insulin product. The product plus injector was sold as Lantus Solostar®.... Read more

Pharma Claiming Practice Under Fire

Attorney: Richard D. Kelly
February 28, 2020

The Federal Circuit has launched an assault on common claiming techniques in pharma and chemical patents. In October 2019 the Federal Circuit issued two opinions, the first was HZNP Medicines[1] involving the limitation “consisting essentially of” and the second, Idenix[2], striking at Markush Groups. This post concerns the HZNP decision. On February 25 the Federal Circuit denied HZNP’s request for a rehearing and rehearing en banc. According the Drug Patent Watch reported there were 244 drug patents using the language “consisting essentially of,” a number which seems low based on my experience.<... Read more

Solicitor General on Patent Eligibility

Attorney: Richard D. Kelly
December 16, 2019

The Solicitor General (SG) was invited by the Supreme Court to provide comments on the certiorari petitions filed by Berkheimer and Hikma to review the Federal Circuit's 101 decisions adverse to them. The two briefs have numerous similarities including identifying the Court's decision in Bilski[1]as starting the patent eligibility confusion by not grounding its decision on interpreting the meaning of the 35 U..S.C. 101 terms "process, machine, manufacture, [and] composition of matter." The SG asserts that in Bilski the Court did not ground its decision on the stature terms but instead found three exceptions to be not required by the statutory text: laws of nature, physical phenomenon, and abstract ideas. While these concepts are found earlier Supreme Court decisions, Bilski represented the first time they were used independent of the statutory language or constitutional concept of the "useful arts." The SG then described Mayo[2] as continuing the Court's Bilski practice of not tying patent eligibility to any of the statutory or Constitutional language. Alice[3] characterized the Mayo decisional approach as a two step process.... Read more

Some Natural Phenomena are Better than Others: How which Natural Phenomenon a Claim is Directed to Influences Alice Step 2

Attorney: Richard D. Kelly
October 16, 2019

In patents for diagnostic methods, which natural phenomena the patent is directed to may be just as important as whether it is directed to a natural phenomenon at all. A January 2019 decision of the Patent Trial and Appeal Board (PTAB) suggests that which natural phenomena a court determines the patent claim is directed to under Alice step one could have significant implications for Alice step 2. The Board’s decision in Ex parte Lee stands in contrast to the Federal Circuit’s decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. And comparing the two side-by-side reveals that patent applicants have an incentive to not only argue whether their patent is directed to a natural phenomenon, but also to which natural phenomena it is directed.

Ex Parte Lee
 concerned an appeal from the Examiner’s determination that the diagnostic claims were patent ineligible. Claim 1 of the application was representative and describes:<... Read more