Source: https://www.schwabe.com/newsroom-publications-14074
Timestamp: 2019-04-23 10:21:25+00:00

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Spectrum – Sandoz submitted an ANDA for single use 175-mg and 250-mg bottles of its cancer drug to be sold under the Fusilev mark. Spectrum sued for infringement, but the district court granted summary judgment of non-infringement and in a bench trial found the other claims to be invalid as being obvious. The Circuit affirms the summary judgment of non-infringement based on there being no literal infringement, and prosecution history estoppel precluding use of the doctrine of equivalents. Specifically, the district court found and the Circuit affirms that Sandoz's ANDA product, in vials of 175 mg or 250 mg of levoleucovorin, would not meet the limitation of at least two doses of 2000 mg each. Spectrum was precluded from using the doctrine of equivalents because, when submitting an amendment with the application claims that eventually issued as claims 5-9, the applicants asserted that the newly added claims "include specific limitations as to quantities of materials," and distinguished the prior art by pointing to the "quantities of these specific mixtures specified in the claims."
As to invalidity, the panel rejects Spectrum's argument that the district court used hindsight, and that the prior art did not disclose a motivation to produce the claimed substantially pure compound. The panel rules that there will always be a motivation to try to obtain the purest compound possible, so that motivation does not need to be taught in the cited prior art. The panel also agrees with the district court that there was no long-felt but unmet need since numerous other research groups had responded to the motivation to obtain a pure isomer and were pursuing purified leucovorin prior to the priority date. "In short time, many succeeded."
Shukh – Dr.Shukh, an expert in semiconductor physics, appeals from the grant of summary judgment on his claim for correction of inventorship as to several Seagate patents pursuant to 35 U.S.C. § 256. Dr. Shukh alleged three distinct interests in the patents: an ownership interest, a financial interest, and a reputational interest, but the district court granted summary judgment, determining that he assigned his inventions pursuant to an employment agreement signed at the initiation of employment, and ruling that there were no issues of fact as to Dr. Shukh's reputational harm caused by his omission from the disputed patents.
The panel affirms dismissal of Dr. Shukh's claim that the assignment provision of the employment agreement was unenforceable. The panel then reviewed the evidence of Dr. Shukh's inability to obtain subsequent employment, including his being challenged in subsequent job applications as to his ability to get along with co-workers, and determined that there were issues of fact as to the reputational harm at not being named a co-inventor. However, the significant ruling from the case is the panel's reversal of its past refusal to decide whether reputational injury, standing alone, may satisfy the constitutional standing requirements for a § 256 claim. "Today, we hold that concrete and particularized reputational injury can give rise to Article III standing." Therefore, the district court's grant of summary judgment as to correction of inventorship under § 256 is vacated and remanded.
1. A pharmaceutical composition for therapeutic use which consists essentially of a therapeutically effective amount sufficient for the treatment of human beings for methotrexate rescue or folate deficiency, of a pharmaceutically acceptable compound which is a (6S) diastereoisomer selected from the group consisting of (6S) leucovorin (5- formy1-(6S)-tetrahydrofolic acid) and pharmaceutically acceptable salts and esters of (6S) leucovorin; wherein the compound consists of a mixture of (6S) and (6R) diastereoisomers and consists of at least 92% by weight of the (6S) diastereoisomer, the balance of said compound consisting of the (6R) diastereoisomer; in combination with a pharmaceutically acceptable carrier.
Sandoz submitted an ANDA in October 2011, seeking approval from the FDA for a drug product that will be imported in the form of single-use vials with 175 mg or 250 mg of levoleucovorin, indicated for methotrexate rescue at doses of 7.5-75 mg per dose ("the ANDA product"). Spectrum filed a timely patent infringement suit in January 2012, alleging that Sandoz's ANDA submission infringed the '829 patent.
After construing the claims, the district court granted Sandoz's motion for summary judgment of noninfringement of claims 5-9. Sandoz stipulated to infringement of claims 1 and 2, and the district court subsequently conducted a bench trial as to the validity of those claims, finding both to have been obvious.
We first address Spectrum's argument that the district court erred in holding claims 1 and 2 of the '829 patent invalid as obvious. Spectrum asserts that the district court improperly used hindsight to provide a reason or motivation to modify the prior art pure (6S) isomer compound to obtain a slightly impure compound. Even though one of skill in the art admittedly could have added some (6R) isomer to contaminate the 100% pure (6S) isomer disclosed by Rees to produce the claimed substantially pure compound, Spectrum argues that none of the record evidence supplied a logical motivation to do so.
Most issues relating to purified diastereoisomers or enantiomers involve the question whether a pure, resolved compound would have been obvious over the corresponding mixture. This case is unusual in involving a slightly different question, namely, whether a substantially pure compound would have been obvious when both the 50/50 mixture and the pure compound were known in the art. We agree with the district court that the claimed substantially pure compound would have been obvious over both the 50/50 mixture and the pure (6S) isomer compound in the prior art.
First, the district court did not clearly err in finding that one of skill would have been motivated to modify the prior art 50/50 mixture to make the claimed mixture. If it is known that the desired activity all lies in one isomer, surely, it is better, and there is generally motivation, to try to obtain the purest compound possible. Conversely, if the pure material is known, no reason has been shown why one would want to have an impure material. As the district court correctly decided, because the desirable properties of the prior art 50/50 mixture are attributable to only one component, and the slightly impure mixture – one that contains the substantially pure (6S) isomer in an amount of at least 92-95%—has not been shown to possess unexpected advantages over the prior art pure material, the less-than-pure material, and any others of similar concentration, cannot be found to have been nonobvious.
We also agree with the district court that, given the 50/50 mixture, there would have been a motivation to pursue the goal of obtaining either pure or the clinically interchangeable substantially pure (6S) isomer. A person of skill knew that the desired activity of leucovorin came from the (6S) isomer, which therefore provided a motivation to purify the (6S) isomer, even without an explicit teaching. Although the claimed compounds are not 100% pure, they are described as "substantially pure" and as not patentably different from pure material.
The evidence showed that "numerous other research groups had responded to the motivation to obtain a pure isomer and were pursuing purified (6S) leucovorin prior to the priority date for the '829 patent," and, as the district court noted, "[i]n short time, many succeeded." As in Aventis, here there was no need to find an express teaching to prove sufficient motivation to modify the prior art to arrive at the claimed invention, where various techniques to purify the isomers were reported in the art and, importantly, it was known that the (6S) isomer alone provided the therapeutic effect.
Finally, we agree that the district court did not clearly err in finding that there was no long-felt but unmet need. Moreover, even if there were a long-felt need, the court found that a purified (6S) isomer compound would not have satisfied that need because it was shown to be clinically interchangeable with the 50/50 mixture. The court also credited expert testimony that the claimed substantially pure (6S) isomer compound "offers no meaningful difference" from the pure (6S) isomer compound.
We owe the district court's factual findings considerable deference on appeal, and we see no clear error based on the record before us. Based on those findings, we affirm the court's conclusion that Sandoz proved by clear and convincing evidence that claims 1 and 2 of the '829 patent are invalid as obvious.
We also address the district court's finding that claims 5-9 of the '829 patent would not be infringed by Sandoz's ANDA product. The key language at issue in claim 5 is "said composition being of a quantity at least sufficient to provide multiple doses of said mixture of (6S) and (6R) diastereoisomers in an amount of 2000 mg per dose." Based on its claim construction, the district court found that Sandoz's ANDA product, in vials of 175 mg or 250 mg of levoleucovorin, would not meet the limitation of at least two doses of 2000 mg each. The court also found that the patent applicant had explicitly disclaimed smaller dosage amounts during prosecution. The district court therefore decided that no genuine issue of material fact on the infringement question had been raised, finding that Spectrum had not shown literal infringement and was estopped from applying the doctrine of equivalents.
Viewing the record in the light most favorable to Spectrum, we do not find the evidence in the record sufficient to prove infringement. The product that is likely to be sold following FDA approval is what Sandoz's ANDA describes: single-use vials with 175 mg or 250 mg of substantially pure levoleucovorin, indicated only for methotrexate rescue at doses between 7.5 mg and 75 mg per dose, which would be far less than at least two doses of 2000 mg each. We discern no clear error in the finding that Sandoz's product would not meet the dosage claim limitation, and thus would not literally infringe claims 5-9.
Moreover, by claim amendments and distinguishing statements during prosecution, Spectrum is estopped from invoking the doctrine of equivalents. When submitting an amendment with the application claims that eventually issued as claims 5-9, the applicants asserted that the newly added claims "include specific limitations as to quantities of materials," and distinguished the prior art by pointing to the "quantities of these specific mixtures specified in the claims." Those claims were also added following a rejection of the claims as obvious in view of Rees. Applicants again explicitly highlighted the significance of the dosage limitation during its Board appeal. Those statements are clear and unmistakable expressions of the intent to surrender coverage of quantities of the compound in lower doses.
Alexander Shukh appeals from the dismissal of some of his claims for failure to state a claim and the grant of summary judgment on his remaining claims in favor of the defendant Seagate. Of particular interest is the district court's grant of summary judgment as to Dr. Shukh's claim for correction of inventorship under 35 U.S.C. § 256.
Dr. Shukh, a native of Belarus, is a leading scientist in the field of semiconductor physics, with a Ph.D. in Condensed Matter Physics and a B.S. and an M.S. in Electronics and Electronic Engineering. Dr. Shukh was employed at Seagate from September 1997 until his termination in early 2009. At Seagate, Dr. Shukh was named as an inventor on 17 patents. He received numerous awards for his achievement and innovation generally and on specific products, and was named to the Seagate Technology Inventor's Hall of Fame. The district court found that Dr. Shukh had a reputation as "an extremely successful innovator in the hard disk drives engineering community."
When he was hired, Dr. Shukh executed Seagate's standard At-Will Employment Agreement, in which he agreed to assign to Seagate his interest in any inventions made while at Seagate. Dr. Shukh's time at Seagate was undisputedly tumultuous. He did not work well with others due to his confrontational style and his conduct interfered with his productivity. For example, Dr. Shukh applied a "three strikes" rule to interactions with his coworkers, under which he would stop communicating with coworkers who had engaged three times in behavior he considered dishonest. Dr. Shukh also frequently accused others of stealing his work, and his managers criticized him for his insistence on receiving credit for his work. To avoid accusations of plagiarism, some Seagate employees refused to attend presentations by Dr. Shukh.
In 2009, Seagate terminated Dr. Shukh and 178 other employees. Although he has submitted many job applications to other potential employers, Dr. Shukh has not yet secured employment. He claims that the hiring manager of Hitachi, a company to which he applied, contacted a Seagate employee to discuss rumors the Hitachi manager had heard about Dr. Shukh. Moreover, a Hitachi engineer told Dr. Shukh during his interview that he would never find employment at Hitachi with his reputation.
Dr. Shukh alleges that during his tenure at Seagate, Seagate wrongfully omitted him as an inventor from six patents and four pending patent applications. In his complaint, Dr. Shukh asserted many claims, the most pertinent of which was his claim for correction of inventorship pursuant to 35 U.S.C. § 256. He also sought a declaratory judgment that certain provisions of his Employment Agreement were unenforceable.
Seagate moved to dismiss Dr. Shukh's § 256 claim for lack of standing. Dr. Shukh alleged three distinct interests in the patents: an ownership interest, a financial interest, and a reputational interest. At the motion to dismiss stage, the district court held that Dr. Shukh had no ownership or financial interest in the patents because he automatically assigned all of his inventions to Seagate pursuant to his Employment Agreement. The court initially left open the possibility that Dr. Shukh had standing to sue based on reputational harm caused by his omission from the disputed patents, but later granted Seagate's motion for summary judgment on the § 256 claim, holding that there was no genuine dispute of material fact as to whether he suffered reputational harm from not being named an inventor on the patents.
Does Dr. Shukh have Standing Based on Reputational Harm?
To establish standing, a plaintiff must demonstrate that he suffered an injury-in-fact, that the injury is traceable to the conduct complained of, and that the injury is redressable by a favorable decision. The alleged harm must be concrete and particularized. Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992).
Dr. Shukh challenges the district court's decision that he lacked standing to pursue his § 256 claim on two grounds. First, he argues that we should overrule our holding in Filmtec Corp. v. Allied-Signal, Inc., 939 F.2d 1568 (Fed. Cir. 1991). Under Filmtec, Dr. Shukh's assignment in the Employment Agreement of his ownership interest in his inventions conveyed legal title in those inventions to Seagate. Because of this conveyance, the court found that Dr. Shukh has no ownership interest or financial interest in the patents that would give him standing to pursue his § 256 claim. As a panel, we are bound by Filmtec; we cannot overrule that holding without en banc action.
Reputational Injury Has an Economic Component Sufficient to Demonstrate Article III Standing.
Dr. Shukh also argues that the district court erred in granting summary judgment to Seagate on his § 256 claim for lack of standing. He argues that a trier of fact could conclude that his reputation was damaged because he was not recognized as the inventor of the patents. In the past, we have declined to decide whether reputational injury, standing alone, may satisfy the constitutional standing requirements for a § 256 claim. Today, we hold that concrete and particularized reputational injury can give rise to Article III standing. Being considered an inventor of important subject matter is a mark of success in one's field, comparable to being an author of an important scientific paper. Pecuniary consequences may well flow from being designated as an inventor. This is particularly true when the claimed inventor is employed or seeks to be employed in the field of his or her claimed invention. For example, if the claimed inventor can show that being named as an inventor on a patent would affect his employment, the alleged reputational injury likely has an economic component sufficient to demonstrate Article III standing.
Dr. Shukh presented evidence such that a trier of fact could conclude that this omission injured his reputation in at least two ways: first, it harmed his reputation as an inventor in the field of semiconductor physics, and second, it contributed to his reputation for poor teamwork due in part to his accusations that others were stealing his work. Moreover, Dr. Shukh presented evidence from which a trier of fact could conclude that these reputational harms had economic consequences—namely, that Dr. Shukh was unable to find employment after he was terminated from Seagate. We find that there is a question of material fact as to whether Dr. Shukh's omission as a named inventor on the disputed patents caused him reputational injury. Therefore, the grant of summary judgment as to that claim is vacated and remanded.

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