The Phrase “Consist Of” Creates Strong Presumption That Anything Not Specified Is Excluded.
| March 3, 2017
Shire Development v. Watson Pharma
February 10, 2017
Before: Prost, Taranto and Hughes. Opinion by Hughes.
Summary
Shire sued Watson for infringing USP 6,773,720 by filing Abbreviated New Drug Application (ANDA) with the FDA seeking to market a generic version of Shire’s brand drug. The Patent claim recited “outer hydrophilic matrix consisting of . . . .” Watson’s ANDA product included a small amount of Mg stearate (which is lipophilic). The district court found infringement, but CAFC reversed and held that Watson’s ANDA Product does not satisfy claim 1(b), and remanded with instructions to enter judgment of non-infringement.
Shire社は、Watson社の新薬簡略承認申請(ANDA)が米国特許USP 6,773,720を侵害するとして提訴した。特許クレームは「外部親水性基質は、～なる群から選ばれた物質のみからなる(consisting of)」と限定していた。Watson社の申請新薬の外部親水性基質は、クレームにある群に含まれないステア燐酸Mg（しかも親油性）を少量含んでいた。CAFCは、Watson社の申請新薬を非侵害とした地裁判決を覆し、該新薬はクレーム1の限定(b)を満たさないとして、非侵害とした。
I. BACKGROUND
A. Patent Claims
The patent is directed to a controlled-release oral pharmaceutical composition of mesalamine used to treat inflammatory bowel diseases. The composition includes (a)the mesalamine active ingredient; (b) an inner, lipophilic matrix; (c) an outer, hydrophilic matrix; and (d) other optional excipients. In relevant part, claim 1 reads:
- Controlled-release oral pharmaceutical compositionscontaining as an active ingredient 5-amino-salicylic acid, comprising:
a) an inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, di- or triglycerids, waxes, ceramides, and cholesterol derivatives with melting points below 90° C., and wherein the active ingredient is dispersed both in said [sic] the lipophilic matrix and in the hydrophilic matrix;
b) an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and said outer hydrophilic matrix consists of compounds selected from the group consisting of polymers or copolymers of acrylic or methacrylic acid, alkylvinyl polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, dextrins, pectins, starches and derivatives, alginic acid, and natural or synthetic gums;
c) optionally other excipients . . . .
When the outer hydrophilic matrix interacts with a person’s digestive fluids, the matrix creates a swollen barrier to prevent aqueous solution from reaching the inner lipophilic matrix. This delay permits the product to proceed through the digestive system until the water breaks apart the outer matrix, releasing the lipophilic granules.
B. District Decision
The district court concluded that Watson’s ANDA Product satisfied the “inner lipophilic matrix” and “outer hydrophilic matrix” limitations and that Watson’s ANDA Product satisfied the Markush limitations because the excipients falling outside the Markush groups were “unrelated” to the invention since they did not drive the water-affinity property of their respective matrices. Watson appealed.
I. CAFC DECISION
CAFC noted that (a) and (b) in claim 1 use the phrase “consisting of,” to characterize the matrix, and “consisting of” to define the groups, which creates a very strong presumption that the claim element is closed and excludes any elements or ingredients not specified in the claim. CAFC also noted that overcoming this presumption requires “the specification and prosecution history” to “unmistakably manifest an alternative meaning,” such as when the patentee acts as its own lexicographer.
Although the presumption is very strong, there can be rare exception for “aspects unrelated to the invention.” Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331 (Fed Cir. 2004). In Norian, CAFC considered whether adding a spatula to a calcium phosphate chemical kit designed to repair teeth and bones took the accused product outside the scope of the asserted patent. The claim recited only aspects of the chemicals, and CAFC concluded that “infringement is not avoided by the presence of a spatula, for the spatula has no interaction with the chemicals, and is irrelevant to the invention.”
Here, Watson’s ANDA Product does not facially satisfy the claim 1(b) Markush limitation. The Product’s extragranular space (which correspond to the outer hydrophilic matrix) contained Mg stearate, an excipient not within the claim 1(b) Markush group within the extragranular space. Nonetheless, the district court found that Watson infringed because the component outside of the Markush group (i.e., the lipophilic Mg stearate in the hydrophilic outer matrix) is unrelated to the invention and falls within the exception (like spatula in Norian).
However, CAFC disagreed with the district court conclusion.
The district court concluded that the “Mg stearate in the extragranular space is overwhelmed by the hydrophilic properties of the sodium starch glycolate in the extragranular space” and credited expert testimony that the hydrophilic “sodium starch glycolate is more potent than the Mg stearate” when “outside” the granules.
The district court thereby found that the Mg stearate exerted lipophilic influence in the outer matrix, and that finding is well supported: Shire’s expert acknowledged that “the Mg stearate in the spaces between the granules is no less lipophilic than the Mg stearate in the granules,” and the court found that Mg stearate is so strongly lipophilic that it may “impart lipophilic characteristics to a composition even in low concentrations.”
CAFC noted that no one has suggested that Mg stearate is neither lipophilic nor hydrophilic when in the outer matrix, and CAFC concluded that, based on the district court’s findings, the Mg stearate retains its lipophilic character in the extragranular space, and that the Mg stearate structurally and functionally relates to the invention, and its presence in the outer matrix violates the “consisting of” requirement in claim 1(b).
Regarding Shire argument that the Mg stearate in Watson’s product—which Watson includes as a lubricant rather than for its lipophilic properties—is unrelated to the invention because it is not sufficiently lipophilic to render the outer matrix lipophilic. But CAFC ruled that Norian did not restrict “related” components to only those that advance or are intended to advance a Markush group’s allegedly inventive elements.
CAFC also distinguished “consisting of” from “consisting essentially of”, which does not exclude unspecified element unless it materially affect to the novel properties of the invention.
Thus, CAFC reversed the district court’s judgment and remanded for entry of judgment of non-infringement and other proceedings consistent with this opinion.
Takeaway
The phrase “consisting of” creates a very strong presumption that the claim element is closed and excludes any elements or ingredients not specified in the claim.
Even if an unspecified element is overwhelmed by the properties of the specified element, Norian exception is not applied as long as the unspecified element has some effect.
The phrase “consisting essentially of” is preferable to “consisting of”, but Examiners often reject to “consisting essentially of” and we have problem of support to effectively rebut the rejection.
How about the case where the unspecified element is detectable but too little to have recognizable effect?
Another Patent Invalidated by Inter Partes Review and BRI Standard
| February 27, 2017
MPHJ Technology Investments, LLC v. Ricoh Americas Corporation, XEROX Corporation, Lexmark International, Inc.
February 13, 2017.
Before Newman, Laurie and O’Malley. Opinion by Newman
Summary
This decision is another example of a patent being invalidated by prior art in an inter partes review based upon the broadest reasonable interpretation (BRI) standard. Interestingly, MPHJ had argued that a narrower interpretation should have been employed based upon the description in its provisional application. Although a provisional application can contribute to understanding the claims, the CAFC found that the non-provisional application had deleted the more limiting language which was in the provisional application. As such, the CAFC affirmed the PTAB’s claim construction, which resulted in affirmance of anticipation by the prior art.
When the acts of one are attributable to the other.
| February 16, 2017
Eli Lilly and Company, v. Teva Parenteral Medicines, Inc., APP Pharmaceuticals LLC., Pliva Hrvatska D.O.O., Teva Pharmaceuticals USA, Inc., Barr Laborites, Inc.
January 12, 2017
Before Prost, Newman and Dyk. Opinion by Prost.
Summary:
The case centered on Eli Lilly’s patent directed to methods of administering a chemotherapy drug after pretreatment with two common vitamins. The drug was marketed under the brand name ALIMTA®. The Defendants had submitted ANDAs seeking approval of a generic version of ALIMTA®. The CAFC upheld the district counts findings, in favor of Eli Lilly’s patent, in full. The issues addressed were induced infringement, and invalidity issues of indefiniteness, obviousness and obvious-type double patenting.
Details:
Eli Lilly is the owner of U.S. Patent No., 7,772,209 (patent ‘209), directed to methods of administering the chemotherapy drug “pemetrexed’ after pretreatment with two common vitamins (folic acid and vitamin B12). The purpose of the dual vitamin pretreatments is to reduce the toxicity of the pemetrexed to the patients. The drug was marketed under the brand name ALIMTA®.
The Defendants notified Eli Lilly that they had submitted ANDAs seeking approval of a generic version of ALIMTA®. After the ‘209 patent issued, Defendants sent Eli Lilly notices that they had filed Paragraph IV certifications under 21 U.S.C. §355(j)(2)(A)(vii)(IV), declaring that the patent was invalid, unenforceable or would not be infringed. Eli Lilly subsequently brought a consolidated action against the Defendants for infringement, alleging that the generic drug would be administered with folic acid and vitamin B12 pretreatments.
Eli Lilly asserted a number of claims at trial, all of which required patient pretreatment by ‘administering’ or ‘administration of’ folic acid, and a number of dependent claims which defined dosage restrictions.
The parties agreed for the purpose of appeal that no single actor performs all steps, rather they are divided between patient and physician. Specifically, physicians administered vitamin B12 and pemetrexed, while the patient folic acid.
Initially, in June 2013, Defendants conditionally conceded induced infringement under the then-current law set forth in Akamai II (Akamai II held that “induced infringement can be found even if there is no single party who would be liable for direct infringement”). At the time, Akamai was subject of a petition to the Supreme Court for a writ of certiorari. The parties’ stipulation included a provision reserving Defendants right to litigate infringement if the Supreme Court reversed or vacated Akamai II. While an appeal on invalidity was pending (district court had held the claims were not invalid), the Supreme Court reversed Akamai II, holding the liability for inducement cannot be found without direct infringement. In view of this, the parties in this case filed a joint motion to remand the matter to the district court for the limited propose of litigating infringement. CAFC granted the motion. The district court held a second bench trial and concluded that Defendants would induce infringement of the ‘209 patent. The court had applied the intervening Akamai V decision, which had broadened the circumstances in which others’ acts may be attributed to a single actor to support direct infringement liability.
Defendants timely appealed. The CAFC upheld the district courts findings, addressing each issue in turn.
(I) “Whoever actively induces infringement of a patent shall be liable as an infringer.” Importantly, liability for induced infringement “must be predicated on direct infringement.” (Akamai III). The patentee must also show that the alleged infringer “knew or should have known his actions would induce actual infringements.” A patentee seeking relief under §271(e)(2) bears the burden of prove.
The district court relied in part on the Defendants’ proposed product labeling as evidence of infringement. The labeling consisted of two documents: the Physician Prescribing Information and the Patient Information. Amongst other things, the information provides the following:
Instruct patients to initiate folic acid 400 [m]g to 1000 [m]g orally once daily beginning 7 days before the first dose of [pemetrexed]…
Instruct patients on the need for folic acid and vitamin B12 supplementation to reduce treatment-related hematologic and gastrointestinal toxicity…
To lower your chances of side effects of [pemetrexed], you must also take folic acid and vitamin B12 prior to and during your treatment with [pemetrexed].
It is very important to take folic acid and vitamin B12 during your treatment with [pemetrexed] to lower your chances of harmful side effects. You must start taking 400-1000 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of [pemetrexed].
The CAFC held that where, as here, no single actor performs all the steps of the method claim, direct infringement only occurs if “the acts of one are attributable to the other such that a single entity is responsible for the infringement.” Akamai V. In Akamai V, the CAFC held that directing or controlling other’s performance includes circumstances in which an actor (1) conditions participation in an activity or receipt of a benefit upon another’s performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance. The district court applied this two-point prong test to the subject case.
With respect to the first prong – the CAFC agreed with the district court’s findings. Specifically, the labeling information repeatedly instructs the patients to take folic acid and provides information about the dosage range and schedule. The labeling information explains that the folic acid is a “requirement for premedication” in order to “reduce the treatment-related hematologic and gastrointestinal toxicity” of pemetrexed. Eli Lilly’s expert testified that it is “the physician’s responsibility to initiate the supplementation of folic acid.” The patient information also informs patients that a physician may withhold pemetrexed treatment based on blood tests. Eli Lilly’s expert testified that a physician would withhold treatment if the patient had not taken their required dosage of folic acid to avoid toxicity.
The Defendants argued that the product labeling was mere guidance and insufficient to show conditioning. The Defendants also argued there is no evidence that physicians go further to “verify compliance” with their instructions. The CAFC replied that conditioning does not necessarily require double checking.
Next, the Defendants argued that an actor can only condition the performance of a step by imposing a legal obligation to do so. The CAFC rejected this argument, stating that infringement is not limited solely to contractual arrangements, and the like.
With respect to the second prong – the CAFC agreed with the district court’s findings. Specifically, the Physician Prescribing Information instructs physicians to tell patients to take folic acid at specific dosages and at a specific schedule. Moreover, the testimony of a Dr. Chabner was highlighted in part affirming that “it is the doctor” who “decided how much” the patient takes.
Defendants argued that patients are able to seek additional outside assistance regarding folic acid administration, but the CAFC held this was immaterial.
Thus, the two-point prong test of Akamai V was met. However, the mere existence of direct infringement by physicians is not sufficient to find liability for induced infringement. Eli Lilly carried this burden.
The district court held that the administration of folic acid before pemetrexed administration was ‘not merely a suggestion or recommendation, but a critical step,’ in light of the Defendants proposed labeling.
Defendants argued that Eli Lilly has not offered any evidence of what physicians do in general but only speculation about how they may act. They argued that physicians must go beyond labeling. The CAFC found this argument unavailing. For the purpose of inducement “it is irrelevant that some users may ignore the warnings in the proposed label,” if the label “encourage(s), recommend(s) or promote(s) infringement.” The product labeling included repeat instructions and warning regarding the importance of folic acid.
(II) Indefiniteness of “vitamin B12” – the Defendants argued in view of Nautilius that vitamin B12 is indefinite as the term is used in two different ways in the intrinsic record (vitamin B12 and Cyanocobalamin).
The district count accepted the testimony of Eli Lilly’s expert that one of ordinary skill in the art would understand in the context of the patent claims vitamin B12 to mean Cyanocobalamin. The CAFC saw no error in the districts court findings, holding that vitamin B12 has a plain meaning to one of skill in this particular art.
In addition, it was noted that claim 1 required administering a “methylmalonic acid lowering agent…” and claim 2 “vitamin B12.” Therefore, if vitamin B12 was to refer to a whole class of compounds it would be the same scope as claim 1. However, the doctrine of claim differentiation presumes that dependent claims are of narrower scope, and so reading the claims as to require ‘vitamin B12’ of claim 2 to be a specific compound within the scope of “methylmalonic acid lowering agent” avoids this problem.
The Defendants argued that if vitamin B12 means Cyanocobalamin, the given Markush group in claim 1 of the “methylmalonic acid lowering agent,” lists the same compound twice. The CAFC held that the mere fact that a compound may be embraced by more than one member of a Markush group recited in the claim does not necessarily render the scope unclear. The CAFC held the redundancy is support by the prosecution history (the Examiner had stated they were the same, in response the patentee removed Cyanocobalamin, but later put the term back into the claim).
(III) Obviousness – the CAFC agreed with the district counts finding that a skilled artisan would have concluded that vitamin B12 deficiency was not the problem in pemetrexed toxicity.
In brief, the Defendant had relied upon an Abstract published from an Eli Lilly scientist that showed homocysteine levels served as an indicator of either a folic acid or vitamin B12 deficiency and that such levels were elevated with increased pemetrexed toxicities. However, the levels of another marker methylmalonic acid (MMA), which more specifically is an indicator of just vitamin B12 deficiency, showed no correlation. The CAFC indicated this was sufficient for the claims not to be rendered obvious.
(V) Obviousness-type double patenting – the Defendants argued that the claims are not valid over an Eli Lilly’s earlier patent (US 5,271,974 – ‘974). The district court disagreed, and the CAFC upheld.
In brief, the ‘974 patent more broadly claimed a much greater amount of folic acid with an antifolate agent administrated to a mammal. The claims of the subject patent are much more specific with regards to the amount of folic acid and the administration of a specific antifolate agent to a patient. The CAFC held this was sufficient for the claims to be patentably distinct.
Comments:
Method claims drafted to encompass actions of a single entity are still preferable, in order to reduce burden of proving infringement. However, where no single entity performs all the steps, direct infringement can be found if the steps of the method claim are performed under the control or direction by a single entity.
Naturally, patent specification drafters should always endeavor to be careful in their use of claim terminology. Even so, where claim terms are have a specific meaning in their relevant arts, the courts tend to not apply those terms contrary to their common understanding, unless the applicant clearly intended to redefine the term.
Tags: ANDA > double patenting > Generics > indefiniteness > infringement > obviousness
Legislative History Does Not Replace Statute as Legal Standard in Determining Whether a Patent is Eligible For Covered Business Method (CBM) Review
| December 27, 2016
Unwired Planet, LLC v. Google
November 21, 2016
Before Reyna, Plager and Hughes. Opinion by Reyna.
Summary:
Google petitioned for CBM review of claims 25-29 of U.S. Patent No. 7,203,752 (the “’752 patent”) directed to a system and method for restricting access to a wireless device’s location information. The Patent Trial and Appeal Board (“the Board”) instituted review of all challenged claims, and, as a threshold matter, reviewed whether the ‘752 patent is a CBM patent, and therefore the subject of CBM review. The Board instituted the CBM review on several grounds, including lack of written description, obviousness, and the ground that claims 25-29 are not patent eligible under 35 U.S.C. §101. The Board upheld only the ground that the claims are not patent eligible under 35 U.S.C. §101.
Unwired Planet, LLC (“Unwired”) appealed the Board’s decision arguing, inter alia, that the Board erred in applying a standard that is broader than the AIA contemplates to determine whether the ’752 patent was a CBM patent. The CAFC reversed and remanded, holding that the Board relied on an incorrect definition of covered business method in evaluating the challenged patent.
A Patent Owner in an IPR is entitled to an opportunity to respond to asserted facts
| December 16, 2016
In Re: NuVasive, Inc.
November 9, 2016
Before Moore, Wallach and Taranto. Opinion by Taranto.
Summary:
Medtronic filed two petitions for inter partes review (IPR) against U.S. Patent 8,187,334 to a spinal fusion implant owned by NuVasive. The claims of the ‘334 patent recite two size requirements: that the length of the implant is greater than 40 mm and that the length to width ratio is 2.5. In both petitions, Medtronic cited the combination of two references for teaching the size limitations. In the patent owner responses, NuVasive addressed the combination of references as in Medtronic’s petition. However, in Medtronic’s reply, Medtronic changed its reliance to just one of the cited references for teaching both of the size limitations citing a different portion of the reference. The PTAB ultimately relied on Medtronic’s changed position in its final decision. In one IPR, the CAFC held that NuVasive had an opportunity to respond because Medtronic’s petition was at least minimally sufficient to provide notice. However, in the second IPR, NuVasive was not given proper notice to respond.
Evidence showing conversion of units to find anticipation
| December 9, 2016
REG Synthetic Fuels, LLC. v. Neste Oil Oyj
November 8, 2016
Before Prost, Taranto and Chen. Opinion by Chen.
Summary
REG Synthetic Fuels, LLC (REG) owns U.S. Patent No. 8,231,804 (’804 patent). Neste Oil Oyj (Neste) requested inter partes review against claims 1–5 and 8 of the ’804 patent, which were directed to a composition comprising paraffins (hydrocarbons) useful as heat-insulation material in a house. PTAB found that claim 1 was anticipated by cited references including Craig. CAFC affirmed. The key feature of claim 1 was the limitation: “comprising at least 75 wt% (weight percent) even-carbon-number paraffins.” Craig disclosed the production of hydrocarbon compositions and the hydrocarbon amounts therein defined by a different unit, “peak area percentages” measured by a mass spectral analysis. Neste relied upon their expert’s calculation using three different conversion factors to calculate corresponding wt.% from the peak area %. CAFC held that Neste’s expert’s calculation established by a preponderance of evidence that the claimed composition read on the prior art compositions.
Details
Claim 1 representative of the ’804 patent:
- A phase change material composition comprising at least 75 wt% even carbon number paraffins, wherein the paraffins are produced by hydrogenation/ hydrogenolysis of naturally occurring fatty acids and esters.
A key feature in claim 1 was the limitation with “at least 75 wt% even carbon number paraffins,” as CAFC agreed with the PTO’s interpretation that the preamble part (the phase change material) and the wherein-clause (the product-by-process limitation) are not limiting. The main issue in this appeal was whether Craig taught the limitation of “at least 75 wt% even carbon number paraffins.”
Craig disclosed hydrocarbon products obtained from naturally occurring feedstocks, and the results of quantitative analysis of the products. The critical disclosure was Table 9 (reproduced below in part). The table showed “peak area percentages” of each even-carbon-number paraffin such as C16, C18, or C20 in the hydrocarbon products. However, Craig did not disclose corresponding weight percentages. Nor did it disclose how to calculate weight percentages from weight percentages.
As evidence, Neste’s expert (Dr. Klein) submitted data showing conversion of peak area percentages to weight percentages. As shown in Table 2 (reproduced from the opinion), the peak area percentages of each hydrocarbon were calculated using three relative response factors, i.e., “Hsu,” “Gorocs,” and “Chaurasia.”
REG argued that the conversion of peak area percentages into weight percentages is “not straightforward” and Craig did “not provide enough information to accurately convert the GC-MS peak area percentages to weight percentages using relative response factors.” However, REG’s expert (Dr. Lamb) agreed that the peak area percentages could be converted to weight percentages by using relative response factors, and other references cited in Dr. Lamb’s opinion in fact disclosed two of the factors (Gorocs and Chaurasia).
REG’s arguments relied mostly upon the complex nature of the biological feedstocks and their own expert’s opinion that the resulting product is a very complex mixture which affects the phase change characteristic. REG argued that Craig disclosed a distillation process to separate the obtained mixture into fractions and such additional process would result in “structural and functional differences in the products.” However, REG did not submit any evidence or data showing the asserted differences. PTAB rejected the REG’s arguments because there was no credible evidence or disclosure in the specification supporting their arguments. Particularly, as noted by PTAB, claim 1 did not exclude distilled products.
Turning to the issue as to whether the peak area percentages disclosed in Craig read on the claimed weight percentages, CAFC noted, as PTAB held, that claim 1 was anticipated since “a person of ordinary skill in the art could readily convert the disclosed peak area percentages into their corresponding weight percentages, and the sum of the converted peak area percentages of Craig met the claim requirement that the overall weight percentage of even-carbon-number paraffins be at least 75 wt%.” It was specifically noted that each of the calculated weight percentages for “Canola Premium” met the claimed range and “82.31 wt%” was “more than 7% higher than” the claimed l limit, 75 wt%.
CAFC agreed with the PTAB’s view that “it unlikely that any correction required by the experimental conditions would result in a weight percentage of less than the 75 wt%” because Table 2 showed that the different weight percentages obtained by using the different relative response factors “were very small.”
CAFC added that “this is not an inherency issue, however, because the challenged limitation is not missing from Craig” as Neste’s expert “simply converted one unit of measurement (area percent) into another unit of measurement (weight percent) by using relative response factors from the prior art.”
Take Away
According to this decision, conversion of units or parameters one another is not an inherency issue, but all about evidence. This is one example showing that IPRs help the Patent Office find better interpretation of prior art, which may not easily be examined without expert’s opinions from each party. In addition, the preponderance of evidence standard is available to fill a gap between cited prior art and patented claims in IPRs. Good reasons to use IPRs.
Tags: anticipation > conversion of units or parameters > IPR > preponderance of evidence
Last month on §101: You Win Some (Amdocs), You Lose Some (FairWarning; Synopsys)
| November 21, 2016
Amdocs (Israel) Limited v. Openet Telecom, Inc.
November 1, 2016
Before Newman, Plager, and Reyna. Opinion by Plager. Dissenting opinion by Reyna.
Summary
A trio of Federal Circuit decisions on patent eligible subject matter in the past month offers additional guidance on how to survive scrutiny under 35 U.S.C. §101. The focus will be on Amdocs (Israel) Limited v. Openet Telecom, Inc., in which the Federal Circuit found eligibility, but for the sake of comparison, the Federal Circuit’s decisions in FairWarning IP, LLC v. Iatric Systems, Inc. and Synopsys, Inc. v. Mentor Graphics Corporation, in which the Federal Circuit reached the opposite conclusion, will be briefly summarized.
CAFC reiterates criteria for disavowal of broad claim scope based on patent’s disclosure and prosecution history.
| November 2, 2016
Poly-America, L.P. v. API Industries, Inc.
October 14, 2016
Before Prost, Reyna, and Hughes. Opinion by Reyna
Summary
Infringement of Poly-America’s patent hinged on construction of “short seal” in claim 10. Based on the specification and prosecution history, the district court adopted the accused infringer’s proposed construction, which incorporated structure described in the specification but not explicitly recited in the claim. The CAFC affirmed, finding clear and unequivocal statements in the specification and prosecution history “that the inventor intended to limit the claimed invention to a trash bag with ‘short seals’ at its upper corners that extend inwardly to narrow the bag’s upper opening,” and thus disavowed a broader interpretation.
Jury or Judge? CAFC struggles with the results of the Apple vs Samsung trial.
| October 28, 2016
Apple v. Samsung
Case Nos. 2015-1171, 2015-1195, 2015-1994
October 7, 2016
Before: En banc
Opinion for the court filed by Circuit Judge MOORE, in which NEWMAN, LOURIE, O’MALLEY, WALLACH, CHEN, and STOLL, Circuit Judges, join. Concurring in the result without opinion Circuit Judge HUGHES.
Dissenting Opinion filed by Chief Judge PROST.
Dissenting Opinion filed by Circuit Judge DYK.
Dissenting Opinion filed by Circuit Judge REYNA.
Summary
The Court sat en banc amid controversy for doing so without any additional briefing from the parties or amici curiae. The majority held that the previous CAFC three judge panel (“the panel”) had overstepped in reversing the District Court. Focusing on the substantial evidence standard of a JMOL (Judgment as a Matter of Law) needed to justify overruling the decision of a fact finder at the District Court level in the 9th Circuit, the majority overruled the prior panel and reinstated the District Court decision. The dissents opposed- warning that the majority’s ruling would be seen as precedent interfering in the Supreme Court established obviousness standards set down in the Graham and KSR decisions.
Priority document can inherently support subject matter first disclosed in later application
| October 27, 2016
Yeda Research and Development Co. Ltd. v. Abbott GmbH & Co. KG
September 20, 2016
Before Reyna, Wallach and Hughes. Opinion by Reyna
Summary:
In a case arising out of an interference, validity of the patent in question turned on the question of whether structural features of a protein, which were newly added in the U.S. application, were inherently supported by the priority document. Here, it was found that the priority document did inherently support the claimed protein, and any structural features thereof, even if it did not disclose the specific claimed structural features. This is because there was only one protein that could possibly be described by the priority document.
Details:
Abbott is the owner of U.S. Patent No. 5,344,915, which claims priority to German applications P39 15 072 and P29 22 089. The ‘915 patent discloses a protein called TBP-II, which neutralizes TNF-α, a key protein in immunological diseases. The key claim is as follows:
1. A purified and isolated TNFα-binding protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence
Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu
where Xaa is hydrogen, a phenylalanine residue (Phe) or the amino acid sequences Ala Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val Ala Phe.
Meanwhile, the German priority documents to which the ‘915 patent claims priority do not disclose the complete N-terminus sequence. These Germans priority documents disclosed a partial N-terminus sequence, as well as how the protein is obtained from its biological source, and several physical properties of the protein.
This case arises out of an interference between Abbott’s ‘915 patent and Yeda’s application in 1996. In 2000, the Board assigned Abbott the filing date of the ‘915 patent, not the date of the German priority applications. The Board concluded that the patent was invalidated by an intervening prior art reference (Engelmann). Engelmann disclosed the TBP-II protein and distinguished it from a similar protein, TBP-I. In 2008, Abbott appealed to district court, which indicated that one of the German priority document inherently discloses the TBP-II protein, and sufficiently supports the ‘915 patent. In 2010, the Board held that the other German priority document sufficiently discloses the TBP-II protein. Yeda then appealed to district court, which agreed with the Board, and then appealed to the CAFC.
Since Engelmann would be invalidating prior art, the question of validity of the ‘915 patent turns on whether the German priority documents provide written description support. Yeda first argued that the Board applied the wrong standard. Specifically, Yeda argued that for the priority document to support the ‘915 claims, the skilled artisan would have to understand that the partial sequence of the priority document includes the amino acids recited in the ‘915 claim. On the other hand, Abbott argued that the priority document only needs to sufficiently describe the TBP-II protein itself, and the partial sequence disclosure can be coupled with other characteristics.
The CAFC agreed with Abbott and held that the German priority document inherently supports the ‘915 claims. Citing to Kennecott v. Kyocera, 835 F.2d 1419 (Fed. Cir. 1987), the CAFC indicated that when a “specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as an adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.” It was not disputed that TBP-II is the only protein with the partial sequence and characteristics described in the priority document. The CAFC distinguished over two cases cited by Yeda (Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir. 1998) and In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)), indicating that unlike in those cases, here, it is undisputed that the invention of the earlier application is exactly the same as the invention of the later patent. Thus, the priority document sufficiently supports the claims reciting the full N-terminal sequence.
Yeda then argued that the prosecution history precludes reliance on inherent disclosure. Specifically, Yeda argued that in “the context of priority determinations, the allegedly inherent limitation cannot be material to the patentability of the invention,” relying on Hitzeman v. Rutter, 243 F.3d 1345 (Fed. Cir. 2011). Yeda argued that since Abbott relied on the amino acids in question to distinguish over Engelmann, they are material to patentability. In prosecution, the Examiner relied on cited art showing a protein with the same source, weight and function as that claimed. In response, Abbott pointed to Engelmann to show that TBP-I and TBP-II are different. Abbott also relied on Engelmann to show that TBP-II has five different amino acids than TBP-I, and that these were included in the claimed sequence. However, three out of the five TBP-II-unique amino acids disclosed in Engelmann were in fact also disclosed in the priority document. Thus, the sequence of the priority document alone was sufficient to distinguish over the art on its own. Therefore, Yeda’s argument fails.
Lastly, Yeda argued that the district court was incorrect in holding that the Board’s decision was supported by substantial evidence. However, the CAFC again reiterated that the priority document disclosed nine of the 15 amino acids of the claimed N-terminus sequence and various biological characteristics. Furthermore, it was undisputed that no other known protein besides TBP-II has this structure and characteristics. Thus, the CAFC concluded that the Board’s decision was supported by substantial evidence.
Take away
In many cases, adding a new disclosure to a US application, beyond what is disclosed in a priority application, can result in a breaking of the chain of priority. But here, because the priority document inherently disclosed the subject matter first disclosed in the US application—and only that subject matter—the claims had written description support as of the priority date. However, the outcome would have likely been different if the description of the protein in the priority document was later found to correspond multiple proteins, such as stereoisomers having different functions.
Abbott was saved by the fact that they disclosed not only the partial sequence of the protein, but also how it is obtained from its biological source, and several physical properties of the protein. Thus, in emerging technologies, it is best to try to claim the subject matter as completely as possible to insulate the applicant from written description problems in the future, and to provide the flexibility to claim the subject matter in terms newly added in a later application.
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