Earlier today the United States Court of Appeals for the Federal Circuit ruled that Dolly the cloned sheep, and any other genetic clones, are patent ineligible in the United States because the “claimed clones are exact genetic copies of patent ineligible subject matter.” The case decided was In re Roslin Institute(Fed. Cir. May 8, 2014).
The Roslin Institute of Edinburgh, Scotland (Roslin) is the assignee of U.S. Patent Application No. 09/225,233 (the ’233 application) and had appealed from a final decision of the Patent Trial and Appeal Board, which held that all of Roslin’s pending claims were unpatentable subject matter under 35 U.S.C. § 101. The Board also rejected Roslin’s claims as anticipated and obvious under 35 U.S.C. §§ 102 and 103. Having determined that genetic clones are not patent eligible the Federal Circuit, in a decision by Judge Dyk who was joined by Judges Moore and Wallach, did not reach the 102 or 103 issues, instead simply affirming the Board’s rejection of the claims under § 101.
To tell the story involved in this case we must travel back to July 5, 1996, when Keith Henry Stockman Campbell and Ian Wilmut successfully produced the first ever cloned mammal from an adult somatic cell: Dolly the Sheep. The cloning method Campbell and Wilmut used to create Dolly was a significant scientific breakthrough. Campbell and Wilmut obtained U.S. Patent No. 7,514,258 (the ’258 patent) on the somatic method of cloning mammals, which was been assigned to Roslin. The ’258 patent was not at issue in this case.
There’s an old expression that Murphy (of Murphy’s Law fame) “was an optimist.” That expression certainly applies to the recent Federal Circuit panel decision in Novartis AG v. Lee, as well as the companion decision in Exelixis, Inc. v. Lee on the meaning of the Patent Term Adjustment (PTA) Statute (35 U.S.C. § 154(b)), and particularly what’s called the “B period” portion (i.e., 35 U.S.C. § 154(b)(1)(B)) of PTA. In Novartis, this Federal Circuit panel (opinion by Judge Taranto, joined by Judges Newman and Dyk) ruled that the second exclusion from PTA in the “B period” portion (i.e., 35 U.S.C. § 154(b)(1)(B)(ii)) excludes from PTA any time consumed by a Request for Continued Examination (RCE), even if that RCE is filed more than 3 years after the “actual filing date” of the patent application. Not only is this ruling a questionable interpretation of 35 U.S.C. § 154(b)(1)(B)(ii) for reasons I’ll discuss below, but it creates an unfortunate, and surely unintended impact on RCEs specifically, as well as continuation practice generally. And the more I dig into the PTA statute, the more problematical this ruling in Novartis becomes.
Novartis also addresses another thorny issue of when a patent applicant dissatisfied with the PTA determination by the USPTO may timely challenge such a determination (i.e., 35 U.S.C. § 154(b)(4)(A) (and which also went against the patentee, Novartis), but I’m going to focus solely on the B period exclusion issue. I’m also going to provide here a summary of the PTA statute as it relates to these 3 periods used for determining the cumulative PTA that the patent applicant gets. See the 2012 Eastern District of Virginia’s decision in Exelixis, Inc. v. Kappos which was vacated by the Federal Circuit’s companion decision to Novartis, and provides a nice, concise explanation of how these 3 periods work for determining the cumulative PTA owed the patent applicant.
The en banc Federal Circuit on September 13, 2013, heard oral argument on whether to overrule its en banc decision in Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998), and hold that claim construction can involve issues of fact reviewable for clear error, and that it is not entirely an issue of law subject only to de novo review. Lighting Ballast Control LLC v. Universal Lighting Technologies, Inc., Fed. Cir., No. 2012-1014, 3/15/2013.
Lighting Ballast Control LLC (LBC) owns a patent (5,436,529) on control and protection circuits for electronic lighting ballasts commonly used in fluorescent lighting. The patent includes the term “voltage source means” in the following context: “voltage source means providing a constant or variable magnitude DC voltage between the DC input terminals.” LBC sued Universal Lighting Technologies, Inc. (ULT).
District Court Decision
On appeal is the district court decision that a person of ordinary skill in the art would understand the claim term “voltage source means” to correspond to a rectifier or other voltage supply device. It thus rejected ULT’s argument that the term invokes Section 112 ¶6 and that the claim is invalid for indefiniteness for lack of specific structure in the specification. A Federal Circuit panel reversed in a nonprecedential decision, concluding from a de novo review that “voltage source means” does invoke Section 112 ¶6 and that the claim is invalid for indefiniteness. That panel decision was vacated when the appellate court decided to consider the claim construction issue en banc.
In what can only fairly be characterized as utterly ridiculous, 5 of the 10 judges on the Federal Circuit to hear CLS Bank v. Alice Corporationen banc would find that claims that satisfy the machine-or-transformation test are not patentable. While I think it is inappropriate to find the systems claims patent ineligible that isn’t what makes the decision utterly ridiculous. The decision is an embarrassment because 5 other judges would have found the systems claims patent eligible. Thus, we have an even split of opinion at the Federal Circuit.
The Federal Circuit decision in CLS Bank v. Alice Corp. is now being horribly mischaracterized in the media, which will now only further complicate the matter in the court of public opinion. This decision offers no precedent whatsoever regarding systems claims because it was a tie. Alice Corporation loses the systems claims not because that is the law of the land announced by the Federal Circuit, but rather because a single district court judge determined that the systems claims were patent ineligible. Had that same district court judge found the systems claims patent eligible then Alice would have prevailed.
In other words, the Federal Circuit is essentially abdicating its authority relative to whether systems claims are patentable to the district courts and presumably also to the Patent Trial and Appeals Board at the United States Patent and Trademark Office. Whatever the district court or PTAB does is just fine. Well, not quite.
In USPTO v. Bilski, U.S. Supreme Court confronted us with a “fuzzy” composite of opinions about the standard for patent-eligibility under 35 U.S.C. § 101. See Through the Fuzzy Bilski Looking Glass: The Meaning of Patent-Eligible under 35 U.S.C. § 101 where I noted five key “takeaways” from those composite opinions, including what to make of Justice Scalia joining the Opinion of the Court except for Part II B-2 and C-2. The Federal Circuit is also not immune from composite opinions that make you scratch your head as to what the final ruling is. See Ariad Pharmaceuticals, Inc. v. Eli Lilly & Company where an en banc ruling by the Federal Circuit on whether there is a separate “written description” requirement under 35 U.S.C. § 112, first paragraph, spawned (in addition to the Opinion of the Court), four additional concurring and dissenting-in-part opinions. In affirming the judgment of the district court “by an equally divided court,” the recently issued Marine Polymer Technologies, Inc. v. Hemcon, Inc. case requires yet some more figuring about another “muddled” Federal Circuit en banc decision.
The “muddle” that became the en banc decision in Marine Polymer revolved around two primary questions: (1) the meaning of the claim term “biocompatible”; and (2) when does “intervening rights” apply to reexamined claims? See CAFC: Intervening Rights for Claims Unamended During Reexam* where I discussed both of these questions in the Federal Circuit panel decision in Marine Polymer. In the en banc decision, and by a 5 “yea” to 5 “nay” vote (with Judges Moore and O’Malley not taking part), the Federal Circuit deadlocked over the district court’s interpretation of “biocompatible” to mean “low variability, high purity, and no detectable biological reactivity as determined by biological reactivity as determined by biocompatibility tests.” In jurisprudential parlance, such a “tie vote” means the district court interpretation prevails by default.
On September 26, 2011, the a three-judge-panel of the United States Court of Appeals for the Federal Circuit issued a ruling in Marine Polymer Technologies, Inc. v. HemCon, Inc., which found intervening rights due to certain patent claims due to the fact that Marine Polymer made arguments about claim language during reexamination, but without actually amending the claims. See Marine Polymer vacated opinion. On January 20, 2012, the full Federal Circuit decided to hear this case en banc and ordered that the original panel decision be vacated and the appeal reinstated. No additional briefing by the parties was requested, but on January 26, 2012, the Federal Circuit issued an Order allowing amicus briefs to be filed on or before February 10, 2012. On February 10, 2012 the Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America filed a joint Amici Curiae Brief supporting the appellee and seeking affirmance of the district court decision.
Before getting into the arguments made by the Bio/Pharma brief, let’s go over the now vacated original panel decision to set the table.
CAFC Rules “Intervening Rights” May Be Based on Arguments Even Though Claims Unamended During Reexamination.
I like writing about esoteric patent law topics and the question of “intervening rights” in reexaminations/reissues is one of the more esoteric. See my 1998 JPTOS article entitledIntervening Rights: A Potential Hidden Trap for Reexamined Patent. The case of Marine Polymer Technologies, Inc. v. HemCon, Inc. is one of those rare instances in this esoteric area of patent law where the Federal Circuit announced a new “wrinkle” on when “intervening rights” apply in reexamination. Unfortunately, the rule announced by the majority in Marine Polymer Technologies (“intervening rights” apply to unamended claims based on statements made during reexamination) is squarely in conflict with the express language of 35 U.S.C. § 307(b), as Judge Lourie’s dissent vigorously (and more importantly, correctly) points out.
In CyberSource Corporations v. Retail Decisions, Inc., Judge Dyk (joined by Judges Bryson and Prost) ruled that a method and system for detecting credit card fraud in Internet transactions was patent-ineligible under 35 U.S.C. §101. But in Ultramercial, LLC v. Hulu, LLC, Chief Judge Rader (joined by Judges Lourie and O’Malley) just ruled that a claimed method for monetizing and distributing copyrighted products over the Internet was patent-eligible. In fact, our good Chief Judge has “thrown down the gauntlet” at his Federal Circuit colleagues by stating “breadth and lack of specificity does not render the claimed subject matter impermissibly abstract.” Wow! That “judicial donnybrook” I mentioned in my recent article on the remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC (see CAFC on Patent-Eligibility: A Firestorm of Opinions in Classen ) on what the standard is (or should be) for patent-eligibility under 35 U.S.C. §101 has now broken out.
In Ultramercial, the patentee (Ultramercial) asserted that U.S. Pat. No. 7,346,545 (the ‘545 patent) was infringed by Hulu, LLC (“Hulu”), YouTube, LLC (“YouTube”), and WildTangent, Inc. (“WildTangent”). The ‘545 patent,relates to a method for distributing copyrighted products (e.g., songs, movies, books, etc.) over the Internet for free in exchange for viewing an advertisement with the advertiser paying for the copyrighted content. What is interesting in this case is that Claim 1 of the ‘545 patent that is allegedly infringed by Hulu, YouTube, and WildTangent recites a method having not one, not two, but eleven total steps. (Side note: One might wonder how anyone can infringe an eleven step method.) WildTangent’s motion to dismiss for failure to state a claim was granted by the district court based on the claimed method being patent-ineligible under 35 U.S.C. § 101. (Hulu and YouTube were dismissed from the case apparently for other reasons.)
Back in the “good ol’ days,” the Supreme Court rarely granted review of a Federal Circuit case involving patent law doctrines. One such “rare” instance where the Supreme Court did review (and partially affirmed and partially overturned the Federal Circuit) was the 2002 case of Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. involving when the doctrine of prosecution history estoppel barred an assertion of patent infringement based on the doctrine of equivalents when there was any amendment that narrowed the patent claim at issue.” See When Patent Doctrines Collide: Supreme Court Rules Claim Amendments Do Not Necessarily Preclude Assertion of Infringing Equivalents.
Like the most recent run of decisions overturning Federal Circuit patent jurisprudence, the Supreme Court found, in Festo, that the Federal Circuit’s rule that, whenever prosecution history estoppel applied, there would be no range of equivalents for the amended element, was too “inflexible” for the High Court’s taste.
After the Federal Circuit ruled in Ariad Pharmaceuticals v. Eli Lilly there is a separate and distinct “written description” requirement in the first paragraph of 35 U.S.C. § 112, some may have thought that all might be quiet on the “written description” front. But the recent case of Crown Packaging Technology, Inc. v. Ball Metal Beverage Container Corp., suggests that all may no longer be quiet on that front. In fact, I’ll express the “heretical” view that the Federal Circuit missed the real “written description” issue in this case, namely what is (or should be) the impact of the “characterised in that” (or as we Americans would phrase it “characterized in that”) language used in the common patent specification of the two patents involved in this case.