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Intellectual Property Rights - News Letter                                       Issue No:2020--082

April 2020 Issue

1. Kaken Pharmaceutical Co. v. Iancu (Fed. Cir. 2020)

Ever since the Supreme Court's decision in Dickinson v. Zurko, patent applicants (and with the advent of inter partes review proceedings before the Patent Trial and Appeal Board, patentees) have found it difficult to overcome Patent Office determinations of obviousness, due to the deference to factual issues the Zurko case imposed on the Federal Circuit in reviewing PTO de- cisions. But one Achilles' heel to these difficulties arises over how the PTO construes claims, which remains subject to de novo review (because all the evidence before the Patent Office is inherently intrinsic evidence). And when the Office (through the PTAB) makes an error in con- struing a claim, the Federal Circuit remains ready to pounce, which was the basis for the Court overturning the PTAB's invalidation on obviousness grounds of Kaken Pharmaceutical's claims in the recent Kaken Pharmaceutical Co. v. Iancu decision. More

2. Impact of COVID-19 Pandemic on Patent Offices and Federal Courts

On March 11, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear." At the time of the announcement, the WHO noted that there were 118,000 cases reported globally. In the fifteen days since the COVID-19 outbreak was de- clared a pandemic, the number of global cases has almost quadrupled, with the WHO reporting in its latest situation report that as of March 26 there have been 462,684 cases. The Director- General also stated that "[t]his is not just a public health crisis, it is a crisis that will touch eve- ry sector – so every sector and every individual must be involved in the fight." The WHO's March 11 declaration -- and global developments since then -- raise the question of how the pandemic is affecting the patent community. More

3. Thryv, Inc. v. Click-to-Call Technologies, LP (2020)

Thryv, Inc. v. Click-to-Call Technologies, LP, the Supreme Court ruled that the provisions of 35 U.S.C. § 315(b), which preclude a petitioner from filing an inter partes review petition more than one year after being served with a complaint alleging infringement, are barred from judicial review under 35 U.S.C. § 314(d). The Court's decision reversed an en banc Federal Circuit opinion that the time bar was reviewable, Wi-Fi One, LLC v. Broadcom Corp., as well as the panel decision in the case at issue below. More

4. Cardionet, LLC v. Infobionic, Inc. (Fed. Cir. 2020)

There are (at least) two ways of looking at the course of the Federal Circuit's evolving interpre- tation of the Supreme Court's subject matter eligibility jurisprudence under Mayo Collaborative Services v. Prometheus Labs., Inc. and Alice Corp. v. CLS Bank Int'l. One way is to consider the Court to be adrift, unable to come to a consensus on how the law should be interpreted and thus calling into question the wisdom of Congress's decision to establish a court with purported- ly specialized expertise in patent law (see, e.g., "In Defense of the Federal Circuit"). Alterna- tively, the exercise can be analogized to sausage-making (more usually an analogy used for how legislation is crafted), in recognition that the Supreme Court's Mayo/Alice jurisprudence, while enunciated as a two-part test has been, in the practice, much less straightforward in application. The understanding and interpretation of either analysis is influenced anew with every Federal Circuit decision, and the Court's recent decision in Cardionet, LLC v. Infobionic, Inc. il- lustrates anew the internal divisions, where one judge (Judge Dyk) agreed with the outcome but felt compelled to write in partial dissent on one aspect of the majority's reasoning. More

5. USPTO Extends Trademark And Patent Deadlines Due to Coronavirus Pan- demic

The Coronavirus Aid, Relief, and Economic Security (CARES) Act signed into law on March 27, 2020, which provides relief to individuals and businesses affected by the COVID-19 crisis, also of- fers relief to intellectual property owners facing challenges meeting filing and response deadlines due to the unprecedented health crisis.Section 12004 of the CARES Act gives additional authority to the Director of the United States Patent and Trademark Office to “toll, waive, adjust, or modify any timing deadline” established by law in order to help bring relief to trademark and patent own- ers currently facing business uncertainties due to the pandemic.On Tuesday, the USPTO an- nounced that various trademark filing and Trademark Trial and Appeal Board deadlines originally due between March 27, 2020 and April 30, 2020 will be extended 30 days from the initial due date for those affected by the crisis. More

6. Roche patents on Herceptin falter at Fed Circuit

A federal appeals court on Thursday upheld the invalidation of two patents on Herceptin, the blockbuster breast cancer drug sold by Roche Holding AG subsidiary Genentech Inc now facing biosimilar competition.The U.S. Court of Appeals for the Federal Circuit affirmed an administrative court’s determination that the two patents, which expired, were invalid on obviousness grounds. More

7.Broad Reply No. 4 to CVC's Opposition No. 4 to Broad's Motion No. 4 for Priority to U.S. Provisional Application No. 61/736,527

On March 23rd Senior Party The Broad Institute, Harvard University, and the Massachusetts Insti- tute of Technology (collectively, "Broad") filed its Reply to Junior Party the University of Califor- nia/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") Motion No. 4 in Opposition to Broad's Substantive Motion No. 4 for priority to U.S. Provisional Application No. 61/736,527.Broad in its substantive Motion No. 4 argued that it had satisfied the standard for priority to USSN 61/736,527 to Zhang (termed "Zhang B1" in the motion). The following diagram, showing the interrelatedness of the various Broad patents and applications in the interference, il- lustrates this: More

8. CVC Files Reply to Broad Opposition to CVC's Motion to Exclude Broad Ev- idence

On April 17th, CVC filed its Reply to Broad's Opposition (filed on April 9th) to CVC's Miscellane- ous Motion No. 2 to Exclude Evidence filed (on April 2nd), in Interference No 106,155 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technol- ogy (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC"). More

9. Broad Reply No. 3 to CVC's Opposition No. 3 to Broad's Motion No. 3 to De- designate Claims as Not Corresponding to Count No. 1

On March 23rd, Senior Party The Broad Institute, Harvard University, and the Massachusetts In- stitute of Technology (collectively, "Broad") filed its Reply to Junior Party the University of Califor- nia/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") Motion No. 3 in Opposition to Broad's Substantive Motion No. 3 to de-designate claims as not corre- sponding to Count 1. More

10. Broad Reply No. 2 to CVC's Opposition No. 2 to Broad's Motion No 2 to Substitute the Count

On March 23rd Senior Party The Broad Institute, Harvard University, and the Massachusetts In- stitute of Technology (collectively, "Broad") filed its Reply to Junior Party the University of Cal- ifornia/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") Motion No. 2 in Opposition to Broad's Substantive Motion No. 2 to Substitute the Count. More

11. Supreme Court Bars Appeal of PTAB Time-Bar Decisions

On Monday, April 20th, the Supreme Court ruled in Thryv, Inc. v. Click-To-Call Techs., LP, No. 18-916, 590 U.S.           (2020), that decisions by the Patent Trial and Appeal Board finding that peti- tions for inter partes review are timely filed can no longer be appealed. The Court’s decision re- stricts the arguments patent owners can make and reverses the Federal Circuit’s prior ruling on the issue. More

12. Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.

Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Dela- ware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative mo- tion for new trial, in Amgen Inc. v. Hospira, Inc., Nos. 2019-1067, 2019-1102. The ruling maintained the jury’s verdict that: (1) Hospira infringed one of Amgen Inc.’s two asserted patents, (2) fourteen batches of drug substance for Hospira’s biosimilar was not covered by the Safe Harbor provision of 35 U.S.C. § 271(e)(10), and (3) Amgen was entitled to $70 million in damages. More

13. Akebia, Fibrogen and Astellas battle over anaemia drugs

A two-week trial involving patents for an anaemia drug has just concluded at the UK High Court. Although GSK settled its strand of the complex case beforehand, the remaining three parties con- tinue to debate questions of infringement and equivalence. The drugs at the centre of the pro- ceedings are both commercially and scientifically significant. More

14.  Fed. Circ. Wipes Out $110M Ericsson Patent Win Under Alice

On April 14, 2020, the U.S. Court of Appeals for the Federal Circuit overturned a $110 million judg ment in favor of Finnegan client TCL Communication. The court ruled that Ericsson’s computer se- curity patent is invalid under Section 101, as the patent covers an abstract idea and abstract ideas cannot be patented.The case began in 2015, when Ericsson sued TCL in the Eastern District of Texas, accusing TCL of infringing five patents (four of the patents were eventually dropped from the case). The district court ruled that TCL willfully infringed Ericsson’s patent and the jury awarded Ericsson $110 million. On appeal, the Federal Circuit sided with TCL, ruling that the technical aspects of the patent do not make it patentable, thus vacating the $110 million judgment.

15.    US Update: Double Patenting

The law of obviousness-type double patenting continues to evolve in the United States. In early 2017, we discussed how the Federal Circuit’s Gilead decision expanded the scope of obviousness- type double patenting (ODP)1. In a split decision, the court held that the ODP analysis must focus on the expiration dates of the patents, not the issue dates, which were previously used2. By focus- ing on the expiration dates, the court in Gilead found that a later-issued but earlier-expiring patent could be applied as an invalidating ODP reference against an earlier issued but later-expiring pa- tent3. Thus, as the facts in Gilead showed, a first patent with a term completely subsumed within the term of a patently indistinct second patent could shorten the term of exclusivity otherwise avail- able to that second patent regardless of the issue dates of those patents. More

16.  Bozeman Financial LLC v. Federal Reserve Bank (Fed. Cir. 2020)

Less than two years ago, in Return Mail, Inc. v. U.S. Postal Service, 139 S. Ct. 1853 (2018), the Supreme Court held that a government entity -- in that case, the U.S. Postal Service -- is not a "per- son" under the America Invents Act, and therefore unable to avail itself of the AIA's post-issuance review proceedings. But the Court did not resolve whether quasi-governmental entities would be barred from post-issuance proceedings as well. Here, the twelve regional Federal Reserve Banks brought covered business method (CBM) review proceedings seeking to invalidate two Bozeman Financial patents. And the Federal Circuit found, contrary to the Supreme Court, that they are "per- sons," entitled to do so under the AIA. More

17. Federal Circuit Affirms Inequitable Conduct Holding Against GS CleanTech

In 2000, David Cantrell founded Vortex Dehydration Technology (VDT) for selling products and methods of processing factory waste. The Inventors of the patents-in-suit began developing an oil recovery process product for animal waste products. Shortly thereafter, Cantrell shifted his focus to the creation of an ethanol recovery system. In June 2003, Cantrell sent an email to Argi-Energy employees explaining how the oil recovery system for animal waste products may be useful for eth- anol recovery. He included an image of an oil recovery system and an operational cost spread- sheet. Cantrell later indicated to Greg Barlage, a market unit manager at Alfa Laval AB, that Argi- Energy would send Barlage a sample of its “thin stillage and syrup” for oil recovery. More

18. IP Team Wins Patent Invalidity Claim before the Patent Trial and Appeal Board

Representing the client, South Korea biopharma company Genome & Company, Nelson Mullins has successfully invalidated University of Chicago’s U.S. Patent No. 9,855,302, which has claims cover- ing a method of treating cancer by co-administering an immune checkpoint inhibitor and probiotic Bifidobacterium. The Patent Trial and Appeal Board (PTAB) issued a decisive 57-page decision, finding all of the claims invalid on multiple grounds, including being rendered obvious by the cited prior art and/or not being enabled due to the patent specification’s insufficient disclosure. (Case No. PGR2019-00002, April 14, 2020 Final Written ) More

19.   Nike, Inc. v. Adidas AG (Fed. Cir. 2020)

The procedural niceties of the U.S. Patent and Trademark Office's implementation of the post-grant re- view features of the Leahy-Smith America Invents Act continue to be explicated in the Federal Circuit (and of course, the Supreme Court). Most recently, the question before the Federal Circuit in Nike, Inc. Adidas AG was whether the Patent Trial and Appeal Board (PTAB) complied with the due process provisions of the Administrative Procedures Act, finding that it did not, and remanding for further pro- ceedings that did so comply. More

20. ION, WesternGeco Settle Decade-Long Seismic Tech Dispute

Marine seismic data company ION Geophysical has said it has settled a decade-long patent liti- gation with WesternGeco. The litigation was related to ION's use of WesternGeco's patented technology used for lateral streamer positioning. The companies signed an agreement where WesternGeco will permanently dismiss the pending lawsuit, grant ION a license to the patents and lift the injunction preventing ION from manufacturing DigiFIN tech, based on WesternGeco patent, in the United States, ION Geo said. More

21. Gilead Rips Merck's New Bid To Restore $2.5B Patent Verdict

Gilead Sciences Inc. urged the Federal Circuit on Thursday to nix a Merck & Co. subsidiary's bid for the full court to review a panel decision that wiped out a $2.5 billion verdict in a patent dispute, calling the Merck unit’s "attacks" on the panel's ruling "an exercise in selective omis- sion."

22.  British American Tobacco Sues Altria and Philip Morris over IQOS

British American Tobacco (NYSE:BTI) is about two years behind Philip Morris International (NYSE:PM) in getting government approval for its heat-not-burn glo brand of electronic cigarette. But BAT may be able to play catch-up since it sued its rival earlier this month for patent infringe- ment. The tobacco giant says Philip Morris' IQOS holder (which includes a rechargeable and reus- able power unit, a disposable tobacco stick, and a charger) violates its patents. Because British American has sued Philip Morris through the International Trade Commission (ITC) as well as in federal court, it may be able to block Philip Morris from importing the IQOS device into the U.S. More

23. Valeant Pharmaceuticals Int'l v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

Summary judgment, while clearly advantageous, requires that there be no disputed question of material fact and that the moving party is entitled to judgment as a matter of law. When a district court grants judgment improvidently, by misapplying the law, judgment can be reversed and the matter returned to the court for proceedings under the correct application of the More

24. Juno Awarded Over $1.1B In Final Judgment For IP Case

A California federal judge on Wednesday entered final judgment awarding Juno Therapeutics and Sloan Kettering enhanced damages of over $389 million while boosting the total award to over $1.1 billion after a jury found that Kite Pharma willfully infringed a patent for a cancer immuno- therapy.

25. Claimed Process Not Anticipated by Third-Party’s Prior Secret Use

Declining to extend the public-use bar to third-party commercial uses of secret processes, the US Court of Appeals for the Federal Circuit reversed a summary judgment ruling that found a patent invalid under the “known or used by others,” “on-sale” and “public-use” bars of 35 S.C.

  • 102. BASF Corp. v. SNF Holding Co. et al., Case No. 19-1243 (Fed. Cir. Apr. 8, 2020) (Lour- ie, J.). BASF owns a patent on a process for preparing certain polymers. The claimed polymeri- zation process allows easy removal of “sticky” polymers from walls of the tubular reaction ves- sel by including a conical taper with specific dimensions at the bottom of the vessel. BASF filed a patent infringement suit against SNF, who in turn alleged that the prior art “Sanwet” process invalidated the patent. More

26. Celgene v. Sun Pharma Global: Satisfying Subject Matter Jurisdiction Un- der § 271(e)(2)

On April 6, 2020, the U.S. District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, No. 19-cv-10099, denied Sun’s motion to dismiss Celgene’s claims that Sun’s generic Revlimid® (lenalidomide) Abbreviated New Drug Application (ANDA) product infringes three patents not listed in the Orange Book for Revlimid® and for which Sun did not make any Paragraph IV certifications. Sun alleged that under those facts, Celgene’s claims lacked subject matter jurisdiction under the Hatch-Waxman Act. The court held that neither the lack of Paragraph IV certification nor the asserted patents’ absence from the branded drug’s Orange Book entry deprived the court of subject matter jurisdiction under 35 U.S.C. § 271(e)(2).  More

27. US patent board upholds Teva patents on migraine drug in challenge by Eli Lilly

The validity of Teva Pharmaceutical Industries Ltd.'s migraine drug patents was upheld by the appeal board of the U.S. Patent and Trademark Office, rejecting a challenge by Eli Lilly and Co.The Patent Trial and Appeal Board's decision covers three patents related to Teva's migraine drug Ajovy.The dispute be- tween the companies arose when Petah Tikva, Israel-based Teva sued Eli Lilly in 2018, alleging the In- dianapolis-based drugmaker's Emgality infringed on the three patents. Lilly responded by seeking an in- ter partes review of Teva's patents, arguing that they were unpatentable from the start.The board ruled that Eli Lilly failed to prove its claims that the three patents were unpatentable.Ajovy belongs to a group of medicines known as calcitonin gene-related peptide, or CGRP, inhibitors. Other CGRP inhibitors in- clude Lilly's Emgality and Novartis AG's Aimovig.In March, the U.K.'s National Institute for Health and Care Excellence recommended Ajovy as a cost-effective therapy for treating chronic migraine. The therapy is also approved in the U.S. and Europe.