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Clients seeking advice in establishing and maintaining patent portfolios worldwide in all areas of biotechnology and pharmaceuticals can benefit from the education and experience of Lynn L. Janulis, Ph.D. Her advanced graduate and post-doctoral scientific training in molecular and developmental biology, reproductive endocrinology and cancer, along with her legal experience, allow her to counsel clients in strategic management of their scientific intellectual property. She assists clients in obtaining worldwide patent rights with her experience in patent prosecution, opinions, due diligence analyses, and interference proceedings. Read full bio here.

Neptune Generics v. Eli Lilly & Company, Case No. 2018-1257, 2018-1258 (Fed. Cir. April, 2019), concerns an Eli Lilly & Co. patent protecting method of administering folic acid and a methylmalonic acid (MMA) lowering agent, e.g., vitamin B12. Specifically, the method concerns the administration of these products before administering pemetrexed disodium, an anti-folate chemotherapeutic, to reduce toxic effects of the anti-folate.
Continue Reading Section 101 Challenges are Out of Bounds in IPR Appeals

Incorporation by reference is not sufficient to satisfy specific reference to each prior-filed patent application to be entitled to an earlier priority date (Droplets, Inc. v. E*Trade Bank (887 F.3d 1309 (2018)). This appeal to the Federal Circuit stems from a dispute between Droplets, Inc. and E*TRADE Bank, over a patent (U.S. Patent No. 8,402,115 (“the ’115 Patent”)) owned by Droplets. At issue is the effective filing date of Droplets’ ‘115 patent.
Continue Reading Have You Included Specific Reference to Every Document in Your Priority Claim?

The Federal Circuit recently affirmed the PTAB’s decision that tribal immunity cannot be asserted in an IPR (Saint Regis Mohawk Tribe v. Mylan Pharma Inc., Case No. 2018-1638 (Fed. Cir. July 20, 2018). On appeal, Allergan, Inc. (“Allergan”) argued that the Board improperly denied its motion to withdraw from IPR proceedings, and the Saint Regis Mohawk Tribe (“the Tribe”) argued that the Board improperly denied its motion to terminate the IPR based on sovereign immunity. See Mylan Pharma Inc. v. Saint Regis Mohawk Tribe, Case IPR2016-01127, Paper 130 (February 23, 2018) (discussed here).
Continue Reading Federal Circuit Affirms Tribal Sovereign Immunity Does Not Apply to IPR

In late March, the Federal Circuit issued an order staying the PTAB proceedings concerning numerous related IPRs of patents issued to Allergan, Inc. (“Allergan”), but assigned to the Saint Regis Mohawk Tribe (“the Tribe”). These IPRs were headed toward a final hearing on the merits previously scheduled for April 3rd. In those IPRs, the PTAB denied the Tribe’s motions to terminate the proceedings based upon the Tribe’s sovereign immunity. Mylan Pharma Inc. v. Saint Regis Mohawk Tribe, Case IPR2016-01127, Paper 130 (February 23, 2018). This post explains the PTAB’s decision that the court will now review on appeal.
Continue Reading Tribal Sovereign Immunity Alone Cannot Protect Patents from IPR

Serial IPR petitions directed to previously-challenged patents account for many of the petitions filed with the PTAB; however, 35 U.S.C. § 325(d) provides the Board with discretion to reject petitions where the same, or substantially the same, prior art or arguments have already been presented to the USPTO.  The Board recently designated as precedential part of its decision in General Plastic Industrial Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357, Paper 19 (6 September 2017), addressing factors to be considered in determining whether to institute review for a serial, or “follow-on” petition.  Petitioner General Plastic filed a first set of petitions seeking IPR of U.S. Patent No. 9,046,820 B1 (“the ’820 patent”) and U.S. Patent No. 8,909,094 B2 (“the ’094 patent”).  Institution of a trial was denied for each petition based upon the merits.
Continue Reading Precedential and Informative Board Decision on Serial IPR Petitions

If a Petitioner does not timely file the required petition fee, an IPR will not be instituted. In Cultec, Inc. v. Stormtech LLC  [Case No. IPR2017-00526, Paper 14 (July 17, 2017)], consistent with earlier decisions, the Board denied institution of an IPR because the Petitioner, Cultec, Inc., did not pay the required filing fee until the day after filing its petition, which was one day after the statutory filing deadline under 35 U.S.C. § 315(b).
Continue Reading Late Payment of Petition Fee Thwarts IPR

When a patent is co-owned by a state university and another party, an IPR may proceed against the remaining party even after the state university co-owner has been determined to have sovereign immunity from the proceeding.  Reactive Surfaces Ltd., LLP v. Toyota Motor Corp., [Case No. IPR2017-00572, Paper 32 (July 13, 2017)]. This recent decision was the first to address a situation where a university owned a patent jointly with a company.  This decision follows two earlier cases, Covidien v. University of Florida , discussed here, and NeoChord, Inc. v. University of Maryland, Baltimore, [Case No. IPR2016-00208, Paper 28 (PTAB, May 23, 2017)], where the Board determined that sovereign immunity under the Eleventh Amendment as an “arm of the state” prevents an IPR from being instituted regarding patents owned by state universities.
Continue Reading IPR Challenge May Proceed Even in the Absence of Some Patent Owners

In a recent final written decision (Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs VIII, LLC, IPR2015-01835, Paper No. 56 (PTAB Mar. 6, 2017)), the Board determined that the Coalition for Affordable Drugs (“Petitioner”) failed to demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 (“the ’135 patent) were obvious. The claims recite methods of treating a subject suffering from a disorder associated with hyperlipidemia and/or hypercholesterolemia. Petitioner asserted these claims were obvious because the alleged prior art taught applying step-wise escalating doses of a microsomal triglyceride transfer protein (MTP) inhibitor to treat hyperlipidemia and hypercholesterolemia. As in cases we have previously discussed here and here, the Petitioner failed to satisfy its burden of proof because it did not show that the alleged prior art qualified as a “printed publication.”
Continue Reading Presentation Not Qualified as a Printed Publication Because Audience Lacked Expertise

Petitioners are finding themselves caught in a Catch-22.  The PTAB declares claims too indefinite under Section 112 to construe, but then declines to address the patentabilty of the claims.  Section 112 deficiencies are not grounds to challenge a patent in an IPR, but the PTAB has authority to find such deficiencies.

Recently, the PTAB decided that only some claims of Immersion Corporation’s U.S. Patent No. 8,659,571 were challengeable by Apple Inc. in an IPR because the ‘571 patent failed to disclose sufficient structure corresponding to the “drive module limitation” recited in claim 12 to determine the scope and meaning of claim 12.  Apple Inc., v. Immersion Corporation, IPR2016-01372, Paper 7 (January 11, 2017).
Continue Reading PTAB Declines to Institute IPR on Immersion’s Indefinite Means Plus Function Claims

In Apple, Inc. v. Ameranth, Inc. (Fed. Cir. 2016), the Federal Circuit reviewed the final written decisions in CBM reviews of three related patents owned by Ameranth, Inc., directed to computerized systems for generating and displaying menus for use in the restaurant industry.  The court determined that the PTAB properly construed all disputed claim terms, determined that the patents are CBM patents, and determined that most challenged claims were unpatentable under § 101, but that the PTAB erred in concluding that some dependent claims were not unpatentable under § 101.

More specifically, the claims in the disputed Ameranth patents are directed to a “first menu that has categories and items, and software that can generate a second menu from the first menu by allowing categories and items to be selected.” 
Continue Reading PTAB Should Have Canceled All Challenged Claims in CBM Reviews