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Exploring the Latest in Intellectual Property Law
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Exploring the Latest in Intellectual Property Law
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Only Human: Broadest Reasonable Interpretation Standard Applies to Intentionally Expired Patent

by | Oct 22, 2020 | ,

Affirming an invalidity finding by the Patent and Trial Appeal Board (PTAB), the US Court of Appeals for the Federal Circuit found that the claims of the now-expired patent should be construed under the broadest reasonable interpretation (BRI) standard, and not under the Phillips standard, because the patent owner intentionally gave up the remainder of the patent term only after the appeal was fully briefed. Immunex Corp. v. Sanofi-Aventis U.S. LLC, Case Nos. 19-1749, -1777 (Fed. Cir. Oct. 13, 2020) (Prost, C.J.).

Immunex owns a patent directed to human antibodies that inhabit certain receptors to treat inflammatory diseases such as arthritis. After being sued for infringement, Sanofi and Regeneron (collectively, Sanofi) requested inter partes review (IPR) of the patent, which the PTAB instituted. Based on the IPR filing date and because the patent was unexpired during the pendency of the IPR proceeding, the PTAB used the BRI standard to construe various claim terms. Had the patent been expired, the PTAB would have used the more stringent Phillips standard to construe the claims. Ultimately, the PTAB found all of the challenged claims unpatentable. Immunex appealed.

After appellate briefing was complete, Immunex filed a terminal disclaimer of its patent. The US Patent and Trademark Office accepted the terminal disclaimer, and as a result the patent term expired approximately two months before oral argument. Immunex then filed a citation of supplemental authority informing the Federal Circuit of the terminal disclaimer and asking the Court to change the applicable claim construction standard from BRI to Phillips.

The Federal Circuit found that the application of the BRI standard to Immunex’s patent was appropriate. Although the PTAB currently applies the Phillips claim construction standard in all newly filed IPRs, at the time that Sanofi filed its IPRs, the PTAB applied the Phillips standard only to expired patents. For unexpired patents, it applied the BRI standard. The Court noted that the use of the Phillips standard in cases where the patent expired during the appellate process should not be an absolute, particularly when the patent term expired at an unexpected early date, such as through the filing of a terminal disclaimer.

The Federal Circuit further affirmed the PTAB’s claim construction under the BRI standard and the invalidity finding predicated on that claim construction. The issue on appeal was whether a “human antibody” must be entirely human (as asserted by Immunex) or whether it may also be “partially human,” including “humanized” (as asserted by Sanofi and construed by the PTAB). The Court agreed with the PTAB and found that the patent’s specification supported the conclusion that the BRI of “human antibody” “includes both fully human and partially human antibodies.” The Court also found that “human antibodies” in the context of the patent-in-suit is a broad category that encompasses both partially and completely human antibodies. The Court therefore affirmed the PTAB’s finding.

The Federal Circuit also commented on the PTAB’s departure from an earlier claim construction ruling by a district court in which “human” was construed to mean “fully [...]

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Inventor Uses Abstention to Avoid Getting “Screwed”

by | Oct 22, 2020 |

The US Court of Appeals for the Federal Circuit affirmed the dismissal of a declaratory judgment complaint related to patent validity under the federal abstention doctrine because the issue had been decided in state court. Warsaw Orthopedic, Medtronic Inc., et al. v. Rick C. Sasso, M.D., Case No. 19-1583 (Fed. Cir. Oct. 14, 2020) (Newman, J.).

Warsaw Orthopedic and Medtronic (collectively, Medtronic) filed a declaratory judgment complaint against Sasso, a surgeon and inventor. The district court dismissed the complaint, without prejudice, under the doctrine of federal court “abstention” because of a concurrent lawsuit in state court between the same parties and concerning the same dispute. As described by the respective plaintiffs, the state court case is “a contract case for payment of patent rights,” and the federal case is “a patent case in which payment requires valid patents.”

In 1999, Medtronic and Sasso entered into an agreement that provided for quarterly royalty payments based on Medtronic’s sales of medical devices using Sasso’s inventions related to screw delivery systems and methods. The agreement does not terminate until “the last to expire of the patents included in Intellectual Property Rights, or if no patent application(s) issue into a patent having valid claim coverage of the Medical Device, then seven (7) years from the Date of First Sale of the Medical Device.” Two patents issued for the invention at issue, and Medtronic made royalty payments from 2002 to 2018.

In 2014, Sasso filed a lawsuit in Indiana state court for breach of contract and damages because Medtronic was not paying royalties on all relevant devices. Medtronic argued that Sasso was seeking royalties for products not covered by a valid patent claim. The district court granted Sasso’s motion for summary judgment on the term of the agreement and on patent validity as a defense to payment, stating that the monies to be paid under the agreement depend on the issuance of the patents and their expiration—not their validity. At trial, the jury found that Medtronic had breached the agreement and awarded damages. Medtronic filed an appeal to the Indiana Court of Appeals.

Medtronic also filed a declaratory judgment action in Indiana district court. Medtronic alleged that no valid claim of the patents covered the Medtronic products for which Sasso sought royalties. The district court dismissed the action without prejudice, stating that the state court had already entered judgment in favor of Sasso and no order from the district court could undo that judgment—only the Indiana Court of Appeals and the Indiana Supreme Court have authority to review that judgment.

Medtronic appealed to the Federal Circuit, asserting that the district court’s “abstention” was an abuse of discretion. Medtronic argued that because the agreement required valid claim coverage, and patent validity is within exclusive federal jurisdiction, the district court had an obligation to receive and resolve the dispute.

The Federal Circuit found that the district court had reasonably relied on the Supreme Court’s Wilton/Brillhart abstention doctrine (1995), which provides support for district courts to dismiss or [...]

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Define Frustration: Appealing from Decision in Suit Against Co-Owner’s Wholly Owned Subsidiary with Major Issues Still Undecided

by | Oct 22, 2020 |

The US Court of Appeals for the Federal Circuit vacated a grant of summary judgment of non-infringement and remanded for resolution of numerous factual issues in a case addressing “extremely frustrating” issues involving the litigant’s failure to differentiate statutory prerequisites for bringing suit under 35 USC §262 and Article III standing, waiver of a co-owner’s right to refuse to join a patent enforcement action, and the existence of an express or implied license. AntennaSys, Inc. v. AQYR Techs., Inc., Case No. 19-2244 (Fed. Cir. Oct. 7, 2020) (O’Malley, J.).

AntennaSys and Windmill International are co-owners of the patent in suit. AntennaSys and Windmill entered into a license agreement pursuant to which Windmill acquired an exclusive license to AntennaSys’s one-half interest in the patent in two separate markets. In exchange, AntennaSys was entitled to a royalty of 3% of gross sales. Windmill was also required to create a wholly owned LLC, GBS Positioner, which would own both the license interest and Windmill’s ownership interest in the patent. In the event that Windmill failed to meet the minimum sales targets, the exclusive license became non-exclusive and either party was granted the right to commence a lawsuit against “third party” infringers.

Windmill did not meet its sales targets. AntennaSys subsequently brought suit against AQYR Technologies, a wholly owned subsidiary of Windmill, for patent infringement and several state-law claims. The suit named Windmill as a co-defendant. Following claim construction, AntennaSys conceded that it could not prevail on its patent infringement claim under the court’s construction of one of the claim terms. In an apparent attempt to moot the affirmative defenses of invalidity and unenforceability, AntennaSys sought summary judgment of non-infringement, which the district court granted. Additionally, after a hearing where AntennaSys admitted that its state law claims were dependent on the success of its patent infringement claim, the court entered judgment in favor of defendants on the state law claims. AntennaSys appealed.

AntennaSys challenged the district court’s claim construction. Windmill and AQYR countered that the Federal Circuit need not reach the merits because AntennaSys “lacks standing” to bring an infringement action in federal court absent joining co-owner Windmill as a co-plaintiff.

The Federal Circuit agreed that the need to join Windmill as a co-plaintiff was a threshold question, but stressed that the issue did not affect AntennaSys’s Article III standing. Instead the issue stemmed from AntennaSys’s ability to satisfy the statutory prerequisites for bringing an infringement action. Under 35 USC § 262, each joint owner of a patent may make, use, offer to sell, or sell the patented invention without the consent of, and without accounting to, the other owners. Furthermore, in order to bring an action for infringement, all co-owners must be joined as plaintiffs. The Court acknowledged two exceptions to this rule: (1) when any patent owner has granted an exclusive license, and (2) when a co-owner waives its right to refuse to join an infringement action.

As the license in this case had morphed into non-exclusive status, the question became whether [...]

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Significant Third-Party Discovery Too Complex for ITC Early Disposition Program

by and | Oct 22, 2020 | ,

The US International Trade Commission (ITC) denied a proposed respondent’s request to use the early disposition program to determine whether a complainant met the domestic industry requirement in a Section 337 investigation. The ITC concluded that the issues proposed for resolution were too complex to be decided within 100 days of institution because significant third-party discovery was likely necessary. Certain Video Processing Devices, Components Thereof, and Digital Smart Televisions Containing Same, Comm’n Order, USITC Inv. No. 337-TA-1222 (Oct. 14, 2020).

The early disposition program aims to limit unnecessary litigation and save time and resources for litigants and the ITC by resolving obvious and fatal deficiencies in a complainant’s case before the parties embark on a full Section 337 investigation. The program provides for an initial determination by the presiding administrative law judge within 100 days of institution on potentially dispositive issues. The administrative law judge may hold expedited hearings and stay discovery of any other issues during the pendency of the 100-day proceeding. The ITC has indicated that appropriate issues for resolution include domestic industry, importation, standing and patent subject matter eligibility.

Complainant DivX, LLC, a video software technology company, relied on its licensee’s assembly of smart TVs in the United States to satisfy the domestic industry requirement. Proposed respondent Realtek Semiconductor Corporation, a chipmaker for consumer electronics, argued that DivX would be unlikely to meet the domestic industry requirement because DivX’s licensee stopped identifying several of its products as “Assembled in the USA” to avoid deceiving consumers in connection with a petition filed before the Federal Trade Commission. Realtek also argued that DivX could not identify smart TVs as the domestic industry product for purposes of the economic prong and a different video processor product for purposes of the technical prong. Realtek sought to resolve these issues through the early disposition program, and DivX opposed. Although neither party raised the issue of third-party discovery, the ITC denied Realtek’s request because such discovery was likely necessary, making adjudication within 100 days impracticable.

Practice Note: The ITC places great emphasis on the expeditious adjudication of Section 337 investigations because of the ITC’s statutory mandate to complete them at the earliest practicable time. The early disposition program builds on that mandate and can provide an even speedier timeframe by streamlining and resolving dispositive issues within 100 days of institution. A proposed respondent should consider requesting early disposition for clear weaknesses in a complainant’s case where the issue to be decided is not complex and does not require significant discovery. While the ITC does not grant use of the early disposition program often, where it has done so, several cases have ended with withdrawal of the complaint or termination before a hearing.



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Supreme Court to Consider Whether PTAB Judges Are Unconstitutionally Appointed

by | Oct 22, 2020 |

The Supreme Court of the United States agreed to consider whether Patent Trial and Appeal Board (PTAB) judges are unconstitutionally appointed. The United States of America v. Arthrex, Inc., Case Nos. 19-1452, -1458, -1459 (Supr. Ct. October 13, 2020) (certiorari granted).

In what quickly turned into a controversial decision, the US Court of Appeals for the Federal Circuit held the appointment of administrative patent judges at the PTAB unconstitutional. Arthrex, Inc. v. Smith & Nephew, Inc.  The Federal Circuit found that PTAB judges were appointed as if they were “inferior officers” but vested by the PTAB with authority that is reserved for Senate-confirmed “principal officers.” Smith & Nephew, Arthrex and the United States of America petitioned the Supreme Court for review of the decision.

The questions presented are:

  1. Whether, for purposes of the Appointments Clause, US Const. Art. II, § 2, Cl. 2, administrative patent judges of the US Patent and Trademark Office are principal officers who must be appointed by the president with the Senate’s advice and consent, or “inferior officers” whose appointment Congress has permissibly vested in a department head.
  2. If administrative patent judges are principal officers, whether the court of appeals properly cured any Appointments Clause defect in the current statutory scheme prospectively by severing the application of 5 USC 7513(a) to those judges.


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Eye Don’t: No Counterfeiting Without Likelihood of Confusion

by | Oct 15, 2020 |

Referring to the act of counterfeiting as “hard core” or “first degree” trademark infringement, the US Court of Appeals for the Ninth Circuit for the first time confirmed that the Lanham Act requires a likelihood of confusion in order for the trademark holder to prevail on a counterfeiting claim. Arcona, Inc. v. Farmacy Beauty, LLC, et al., Case No. 19-55586 (9th Cir. Oct. 1, 2020) (Lee, J.) In doing so, the Court affirmed a grant of summary judgment in favor of defendant Farmacy Beauty in a counterfeiting action brought by skin care brand Arcona.

Arcona’s counterfeiting claims (which remained in the district court action after Arcona requested dismissal of its trademark infringement and unfair competition claims) stemmed from Farmacy Beauty’s use of the term EYE DEW on its skincare products, which Arcona asserted to be counterfeit versions of its eye cream sold in the United States under the registered EYE DEW trademark. The district court, however, found that dissimilar packaging and branding made it “implausible” that consumers would be tricked into believing that Farmacy’s EYE DEW product was actually one of Arcona’s skin care products, and granted partial summary judgment for Farmacy on the counterfeiting claim. Arcona appealed.

Arcona argued that it was not required to show a likelihood of consumer confusion with respect to the parties’ EYE DEW eye creams in order to pursue its trademark counterfeiting claim. The Ninth Circuit starkly disagreed, finding that the plain language of the Lanham Act, 15 USC § 1114, expressly states that likelihood of confusion is a requirement for a counterfeiting claim.

The Ninth Circuit also rejected Arcona’s alternative argument, that there should be a presumption of likelihood of confusion based on the parties’ use of the identical mark EYE DEW. The Court explained that in a claim of counterfeiting—even with identical trademarks—there is no presumption of consumer confusion if the products themselves are not identical. Here, evidence demonstrated that the parties sold their respective EYE DEW products in very different packages, with Arcona’s eye cream being in a “tall, cylindrical, silver bottle encased in a slim, cardboard outer box,” and Farmacy’s eye cream sold in a “short, wide, white jar, along with a squarish outer box.” In reviewing the parties’ respective products as a whole, including prominent displays of the respective house marks FARMACY and ARCONA, as well as differences in packaging, size, color, shape and “all other attributes,” the Court determined that the parties’ products were not identical and that there was no presumption of consumer confusion.

The Ninth Circuit concluded that summary judgment of no counterfeiting was proper because there was no genuine dispute of material fact about the likelihood of consumer confusion factor. The Court acknowledged that the parties’ eye cream products do compete in the same space and in the same geographic markets, but explained that a claim of counterfeiting nevertheless requires that the parties’ marks be “considered in their entirety and as they appear in the marketplace.” Noting that the available evidence demonstrated significant differences between [...]

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Federal Circuit Restores Induced Infringement Verdict Against Teva

by | Oct 15, 2020 |

Addressing the issue of whether a generic pharmaceutical company can be found to induce infringement even when all patented uses have been “carved out” of the label (resulting in a so-called “skinny label”), the US Court of Appeals for the Federal Circuit held that circumstantial evidence of inducement was sufficient. The Court relied on evidence that defendant stated its drug was a “complete replacement” for plaintiff’s drug covered by the asserted patent. GlaxoSmithKline LLC et al. v. Teva Pharmaceuticals USA Inc., Case Nos. 18-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Newman, J.) (Prost, C.J., dissenting). The Court reinstated a jury verdict against Teva Pharmaceuticals, ordering it to pay GlaxoSmithKline (GSK) $235 million.

GSK brought suit against Teva in 2014 in response to Teva’s attempt to market a generic form of carvedilol, developed and marketed by GSK under the brand name Coreg®. Coreg® was US Food and Drug Administration (FDA) approved for three separate indications: hypertension, congestive heart failure (CHF), and left ventricular dysfunction following a myocardial infarction (post-MI LVD). After March 2007, however, no GSK Orange-Book-listed patent covered the hypertension or post-MI LVD indications. A reissue patent that issued in January 2008 remained in force for CHF.

In 2002, Teva filed an abbreviated new drug application (ANDA) with the FDA. Before Teva’s carvedilol product was finally approved in September 2007, Teva amended its ANDA and proposed label to “carve out” the CHF indication according to 21 USC § 355(j)(2)(A)(viii)—often referred to as a “section viii carve-out.” Thus, Teva’s carvedilol “skinny label” was only indicated for hypertension and post-MI LVD, neither of which was, at that time, covered by any GSK patent.

After a trial, the jury found that Teva had willfully induced infringement of GSK’s patent and awarded GSK $235 million in damages. The district court then granted Teva’s motion for judgment as a matter of law, concluding that the inducement verdict was not supported by substantial evidence. GSK, the district court reasoned, had failed to prove by a preponderance of the evidence that Teva’s alleged inducement (as opposed to other factors) had actually caused even at least one physician to prescribe generic carvedilol for CHF. GSK appealed.

On appeal, the Federal Circuit overturned the grant of judgment as a matter of law, reasoning that the “intent element” of inducement may be proven through circumstantial evidence. The Court noted that the jury had received evidence of, e.g., “Teva’s promotional materials [referring] to Teva’s carvedilol tablets as AB rated equivalents of the Coreg® tablets,” press releases identifying Teva’s product as “Generic Coreg® Tablets,” Teva’s Monthly Prescribing References, and testimony from GSK’s cardiologist witness that physicians are “completely reliant” on information provided by the generic companies. The majority concluded that this was “ample record evidence . . . to support the jury verdict of inducement.”

Chief Circuit Judge Prost authored a lengthy dissent warning of the broad implications of the majority’s ruling, including contravening the congressional design and intent of the generic approval system, and potentially stifling innovation by giving rise to [...]

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Non-Respondent’s Product Cannot Be Adjudicated for Infringement in Context of General Exclusion Order

by and | Oct 15, 2020 |

The US International Trade Commission issued a general exclusion order (GEO) excluding from entry into the United States products infringing patents directed to luxury vinyl tile, but vacated findings in the Initial Determination (ID) adjudicating infringement for products belonging to entities not named as respondents in the investigation. The Commission explained that a finding should not be made as to whether a non-respondent’s product infringes a patent in the context of a GEO, but instead the analysis should be limited to whether the “alleged” infringement supports a finding that there is a pattern of violation of Section 337. Certain Luxury Vinyl Tile and Components Thereof, USITC Inv. No. 337-TA-1155, Comm’n Op. (Oct. 5, 2020).

The ITC instituted an investigation against multiple respondents. The administrative law judge granted summary determination of violation by certain defaulting respondents and recommended a GEO. Unlike limited exclusion orders (LEO), which only prohibit infringing goods imported by a named respondent in an investigation, GEOs prohibit entry of the infringing products regardless of the source. GEOs are issued when necessary to prevent circumvention of an LEO or when there is a pattern of violation and it is difficult to identify the source of infringing products. In connection with the request for a GEO in this investigation, the complainants accused two additional products from non-respondents of infringement. In the ID, the administrative law judge analyzed the two products and determined that they infringed the asserted patents.

The Commission determined to review the ID in part. On review, the Commission determined that a GEO was appropriate, but vacated the findings of the ID that adjudicated infringement of the asserted patents by the two products belonging to the non-respondents. The Commission explained that in considering a GEO, a finding should not be made as to whether a non-respondent’s product infringes a patent and instead the analysis should be limited to whether there is a pattern of violation of Section 337. The Commission therefore vacated the infringement findings to avoid confusion and possible prejudice to the non-respondents in future proceedings.

Practice Note: A GEO is an attractive remedy for companies confronted by widespread infringement by imported products originating from sources that are difficult to identify or companies that dissolve and re-emerge as new entities and can therefore circumvent an LEO. The Commission has now made it easier to obtain a GEO because “alleged” infringement by products from a non-respondent can be used to show a pattern of violation warranting a GEO without a full adjudication of infringement for those products.



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By the Book: Unauthorized Material Doesn’t Forfeit Training Guide’s Copyright Protection

by | Oct 8, 2020 |

The US Court of Appeals for the Sixth Circuit affirmed a jury verdict in favor of a copyright owner in a lawsuit alleging infringement of the copyright in a home-services training manual, finding that the jury was correctly instructed that a work’s incorporation of some copyrighted content does not invalidate the copyright in the work’s original parts. Hiller LLC v. Success Grp. Int’l Learning Alliance LLC, Case No. 19-6115 (6th Cir. Sept. 23, 2020) (Suhrheinrich, J.).

Hiller is a home-services company providing HVAC services. Hiller was a paying member of Success Group International, which offered customer service training to home services companies. Success Group conducted training courses using manuals copyrighted by its owner, Clockwork Home Services. Hiller sent its employees to Success Group’s courses and had access to the manuals. Clockwork later sold Success Group to another company, but retained ownership of the copyrights in the manuals and granted a perpetual license for use of the manuals in Success Group’s training business.

Hiller later hired a contractor to create a more interactive training guide for its technicians as a replacement for the manuals. To create the guide, the contractor conducted a two-day workshop with Hiller employees and representatives from Success Group. The workshop included a series of interactive brainstorming sessions. One of the manuals was referred to during the workshop. Ultimately the new guide incorporated some content generated at the design workshop. Other “gap-filling” content was taken directly from the manuals. The contractor also added other original content. The contractor assigned its copyright in the guide to Hiller.

The Success Group subsequently conducted a training class using a workbook that closely resembled the guide. Hiller ended its Success Group membership and sued Success Group for copyright infringement for its use of the workbook. Clockwork intervened, alleging that it owned the guide and seeking declaratory relief invalidating Hiller’s copyright in the guide. Following a seven-day trial, a jury concluded that Hiller had a valid copyright in the guide and that the Success Group workbook copied protected elements of the guide. Clockwork moved for a judgment notwithstanding the verdict, which the district court denied. Success Group ultimately settled with Hiller. Clockwork appealed.

The Sixth Circuit affirmed. First, the Court found that sufficient evidence supported the jury’s verdict that Hiller owned a copyright in the guide. The Court rejected Clockwork’s two-pronged argument that the guide lacked independently created material (required to meet the Copyright Act’s originality requirement) and that Hiller should lose its copyright because the guide contained content taken from the manuals. Based on its selection and organization, the guide contained enough originality created independently by or on behalf of Hiller (through Hiller’s contractor) to meet the originality threshold for copyright protection. The original material included information and graphical depictions selected and organized at the design workshop. The Court also rejected Clockwork’s argument that Hiller should lose copyright protection because the guide was based on Clockwork’s “copyrighted system.” Copyright protection does not preclude others from copying or using the underlying ideas contained [...]

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Product-by-Process Analysis Applies to Method of Treatment Claims

by | Oct 8, 2020 |

In a case relating to use of recombinant human interferon-β (IFN-β) proteins for the treatment of viral diseases, the US Court of Appeals for the Federal Circuit ruled that a “product-by-process” analysis applies even when the product-by-process limitation is nested within a method of treatment claim. Biogen MA Inc. v. EMD Serono, Inc., et al., Case No. 19-1133 (Fed. Cir. Sept. 28, 2020) (Linn, J.).

The claims at issue relate to a method of treating a viral condition, a viral disease, cancers or tumors by administration of a pharmaceutically effective amount of recombinant IFN-β. The claims contained a product-by-process limitation that partially defined the recombinant IFN-β in terms of the method or process by which it is made:

a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of . . .

It was undisputed that native IFN-β proteins comprise sequences identical to those recited in the claims at issue, and that native IFN-β had been used in the prior art to treat viral conditions. At issue was whether the use of native IFN-β to treat viral conditions anticipated the use of recombinantly produced IFN-β for the claimed treatment.

When considering product-by-process claims, the Federal Circuit has long held that “an old product is not patentable even if it is made by a new process.” See, e.g., Amgen v. Hoffmann-La Roche (Fed. Cir. 2009). The district court granted Biogen’s judgment as a matter of law (JMOL) motion and reversed the jury verdict on anticipation, reasoning that the Amgen analysis did not apply here because the claims were directed to a method of treatment and not a product. Further, the “source limitations” (i.e., the limitations requiring that the IFN-β be produced using recombinant methods) overcame the shortcoming of the prior art. Namely, the unavailability of native IFN-β in sufficient quantity to facilitate practical treatment “lies at the heart of the benefit of this invention” and should be given “force and effect in the anticipation analysis.” Serono appealed.

The Federal Circuit reversed, explaining that the nesting of the product-by-process limitation within a method of treatment claim does not change the proper construction of the product-by-process limitation itself. The Federal Circuit reasoned that “an old method of administration of an old product made by a new process is not novel and cannot be patented.” Further, the Court found that the district court erred in considering the advantages of the recombinant process—the new capability of manufacturing sufficient quantities of IFN-β through recombinant technology—as a reason not to apply the product-by-process analysis. The proper anticipation analysis does not turn on the source of the claimed polypeptide, but on a comparison of the claimed recombinant polypeptide and the prior art native polypeptide.

In granting JMOL, the district court alternatively reasoned that under a product-by-process analysis, the native IFN-β could not anticipate recombinant IFN-β, because the prior art did not disclose that the native and recombinant IFN-β shared an identical three-dimensional structure or that [...]

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