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Heather R. Kissling

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Heather R. Kissling draws from over fifteen years of experience securing biotechnology patents to develop worldwide filing and prosecution strategies that further her clients’ business objectives. She actively collaborates with bench scientists, business development personnel, and in-house counsel to maximize protection of biotechnology innovations in a broad range of technologies. Her background in interference and opposition proceedings also benefits clients seeking advice with respect to competitor patent positions and third party challenges in the patent office. Read full bio here.

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Recently updated statistics from the USPTO provide little comfort for patent owners seeking to amend claims during an IPR proceeding.  The Motion to Amend Study, Installment 5 through FY2018, updated March 2019, reports that patent owners have filed a motion to amend in 326 of the 3,599 completed trials (9%) and in 90 of the 670 pending trials (13%).  Of the 326 motions filed in completed trials, the Board decided a motion to amend requesting to substitute claims in 205 trials (63%), and of those decided motions, Board granted or granted-in-part a motion to amend in only 21 of the 205 trials (10%).
Continue Reading USPTO to Patent Owners – Don’t Forget About Reexams and Reissues

Inter partes review not only provides a faster and cheaper way to challenge patent validity, but also expands the Patent Office’s ability to develop law on esoteric issues relating to prior art. The Federal Circuit’s decision Nobel Biocare Services AG v. Instradent USA, Inc. is another in a line of cases arising out of IPR proceedings dealing with the availability of conference and trade show materials as prior art. See, for example, PTABWatch posts here and here. Interestingly, the court affirmed the PTAB’s decision finding certain claims of the challenged patent anticipated by a trade show publication, whereas the court came to the opposite conclusion in a related ITC appeal based on the same publication.
Continue Reading Trade Show Publication Dooms Patent in IPR Appeal Despite Contrary Decision in ITC Appeal

The Patent Trial and Appeal Board has received 37 petitions for post grant review of patents issuing from examination conducted by the Patent Office’s Group Art Unit 1600. The Board has issued four final written decisions thus far.  We discussed the first final written decision here, where all claims were upheld in the face of a challenge based on obviousness grounds only.  Three of the four final written decisions issued so far on biotech/pharma subject matter dealt only with art-based challenges.  Grünenthal GmbH v. Antecip Bioventures II LLC, Case PGR2017-00008 (June 22, 2018) marks the first PGR final written decision addressing written description of a patent arising from Art Unit 1600; all claims were held to be unpatentable under Section 112.
Continue Reading PTAB Issues First Biotech/Pharma PGR Final Written Decision Based On Written Description Challenge

A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018). The PTAB determined that the Petitioners failed to establish that the challenged claims of the patent were obvious over prior art, in part, because of the Petitioners’ failure to establish the prior art status of the product label for RITUXIN®, which contains rituximab.
Continue Reading Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication”

March 13, 2018, marked the fifth anniversary of the transition from the previous “first to invent” system to the AIA’s “first to file” regime.  The PTAB seemingly marked the occasion by instituting the first ever derivation proceeding one week later in Anderson Corporation v. GED Integrated Solutions, Inc., Case DER2017-00007, Paper 32 (March 21, 2018).

The concept of “derivation” was not created by the AIA.  Pre-AIA 35 U.S.C. § 102(f) dictated that a person shall not be entitled to a patent if he did not himself invent the claimed subject matter. 
Continue Reading First Derivation Proceeding Instituted by PTAB

PTABWatch Takeaway: Sovereign immunity is not available to dismiss an IPR challenge where the Patent Owner has filed an infringement action against the Petitioner. Ericsson v. Regents of the University of Minnesota, IPR2017-01186, -01197, -01200, -01213, -01214, and -01219 (Dec. 19, 2017).

The Eleventh Amendment was rarely mentioned in the same breath as patent law until last year, which began with the Board’s decision in Covidien LP v. University of Florida Research Foundation Inc., IPR2016-01274, -01275, -01276 (Jan. 25, 2017), discussed here. In Covidien, the Board dismissed petitions for IPR challenging the claims of a patent owned by the University of Florida Research Foundation, determining that the university is an arm of the state and entitled to invoke sovereign immunity to bar IPR institution. Sovereign immunity does not shield against any and all challenges, however. In Reactive Surfaces Ltd., LLP v. Toyota Motor Corp., Case No. IPR2017-00572 (July 13, 2017), discussed here, the Board acknowledged that sovereign immunity may be asserted by a state university in an IPR, but held that an IPR may continue against a non-sovereign co-owner of the challenged patent.
Continue Reading PTAB Defines Further Limitation to Sovereign Immunity Defense

The Federal Circuit’s decision in Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) attracted much attention for applying the theory of divided infringement in the context of pharmaceutical therapeutic regimen claims.  Before the Federal Circuit decision, a scrum of petitioners successfully petitioned for IPR of the Lilly patent, alleging that the claims were obvious in view of a combination of references that included prior art considered by the court in the litigation. Our previous post highlighted the potential for inconsistent results that AIA trials may present relative to district court actions concerning the same patent. 
Continue Reading Eli Lilly’s Pemetrexed Therapy Claims Survive Challenge At PTAB

Recent Federal Circuit decisions reversing or remanding PTAB holdings of obviousness have faulted the Board for failing to clearly articulate its reasoning.  See our previous posts here and here.  In In re Stepan Co., No. 2016-1811 (Fed. Cir. Aug. 25, 2017), a split CAFC panel vacated a PTAB ex parte appeal decision affirming an obviousness rejection based on “routine optimization” for failing to explain why one of ordinary skill would arrive at the claimed subject matter.
Continue Reading Assertion of “Routine Optimization” Without Additional Reasoning Insufficient to Support Obviousness Conclusion

The PTAB recently canceled the University of Pennsylvania’s U.S. Patent No. 7,625,558, a potentially fatal blow to the University’s suit against Eli Lilly and Company alleging its cancer therapeutic Erbitux® (centuximab) infringes the patent.  Eli Lilly and Co. v. Trustees of the Univ. of Penn., Case IPR2016-00458 (July 13, 2017). The PTAB’s decision resolved testimony from the parties’ competing expert witnesses in favor of the Petitioner (Eli Lilly and Company), thus highlighting how the PTAB’s scientific acumen can be leveraged to effectively short-circuit an otherwise expensive and time-consuming lawsuit.
Continue Reading Eli Lilly Successfully Challenges U Penn Erbitux® Claims at PTAB, Derailing Infringement Suit

Illustration and Painting

Third parties seeking to challenge pre-AIA patents in the USPTO often choose between IPR and ex parte reexamination.  In some cases, petitioners pursue both proceedings, sequentially or in parallel, taking advantage of different timelines to completion, different standards for institution, and using insights gained in one proceeding in the other.  The PTAB recently exercised its discretion to terminate three reexaminations filed against patents also challenged by IPR in Ariosa Diagnostics, Inc. v. Illumina, Inc., IPR2014-01093, Paper 81 (May 24, 2016).  In the pending appeal, the stage is set for the Federal Circuit to consider the extent of the PTAB’s discretion in terminating post-grant proceedings in these circumstances.  Case Nos. 2016-2388, 2017-1020 (Fed. Cir.).
Continue Reading PTAB Exercised Discretion to Terminate Ex Parte Reexaminations in Ariosa v. Illumina; CAFC to Review

Resources & Info

Arthrex and the Supreme Court Resource Center

In United States v. Arthrex, Inc., the Supreme Court has heard whether 125+ PTAB decisions rendered through October 2019 must be remanded for new decisions. Read about how that issue developed through our post.

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Our Team

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.