Neridronic acid - USA

PGR decision: Jul. 28, 2020

AIA Review #	Filing Date	Institution Date	Petitioner	Patent	Respondent	Final Written Decision
PGR2019-00026	03/01/2019	07/30/2019	Grunenthal GmbH	9,931,352	Antecip Bioventures	All Claims Unpatentable
PGR2019-00027	03/01/2019	07/30/2019	Grunenthal GmbH	10,039,774	Antecip Bioventures	All Claims Unpatentable
PGR2019-00028	01/03/2019	08/20/2019	Grunenthal GmbH	10,052,338	Antecip Bioventures	All Claims Unpatentable

US  9,931,352 (ANTECIP BIOVENTURES II LLC): Non-OB

1. A method of treating hyperalgesia associated with complex regional pain syndrome, comprising parenterally administering neridronic acid in a salt form or an acid form to a human being suffering from hyperalgesia associated with complex regional pain syndrome.

17. A method of treating edema associated with complex regional pain syndrome, comprising parenterally administering neridronic acid in a salt form or an acid form to a human being suffering from edema associated with complex regional pain syndrome.

US  10,039,774 (ANTECIP BIOVENTURES II LLC): Non-OB

1. A method of treating changes in skin blood flow associated with complex regional pain syndrome, comprising parenterally administering neridronic acid in a salt or an acid form to a human being suffering from changes in skin blood flow associated with complex regional pain syndrome, wherein the human being has a pain intensity of at least 7 cm on the 10 cm visual analogue scale (VAS) or at least 7 on the 0-10 numerical rating scale (NRS).

16. A method of treating abnormal sudomotor activity associated with complex regional pain syndrome, comprising parenterally administering neridronic acid in a salt or an acid form to a human being suffering from abnormal sudomotor activity associated with complex regional pain syndrome, wherein the human being has a pain intensity of at least 7 cm on the 10 cm visual analogue scale (VAS) or at least 7 on the 0-10 numerical rating scale (NRS).

US  10,052,338 (ANTECIP BIOVENTURES II LLC): Non-OB

1. A method of treating allodynia associated with complex regional pain syndrome, comprising parenterally administering neridronic acid in a salt form or an acid form to a human being suffering from allodynia associated with complex regional pain syndrome.

17. A method of treating autonomic motor change associated with complex regional pain syndrome (CRPS), comprising administering neridronic acid in a salt form or an acid form to a human being suffering from autonomic motor change associated with CRPS.

Weekly Patent Litigation Round-Up

Federal Circuit: Amended Claims in IPR Should be Subject to Full Examination (Including 101)

A divided Federal Circuit has authorized the PTAB to consider patent-eligibility challenges during inter partes review (IPR) proceedings in the context of a patentee’s motion to amend the claims.   Uniloc had moved to amend with substitute claims and Hulu opposed. The PTAB then denied the motion to amend — concluding that the proposed claims were not subject matter eligible under Section 101.  The PTAB’s subsequent rehearing denial was designated as precedential — holding that any ground of unpatentability can be considered in the context of a motion to amend..

https://patentlyo.com/patent/2020/07/federal-examination-including.html

Moderna loses challenge over vaccine tech patent to Arbutus, may have to share in royalties

Shares of Moderna Inc fell nearly 10% after it lost a bid to invalidate a U.S. patent owned by Arbutus Biopharma that poses a potential obstacle to Moderna’s efforts to develop next-generation vaccines, including a coronavirus vaccine. An administrative court run by the U.S. Patent and Trademark Office rejected arguments by Moderna that an Arbutus patent known as the ‘069 patent should be revoked because it described obvious concepts. The ‘069 patent relates to lipid nanoparticle (LNP) technology that allows the human body to make its own therapeutic proteins..

https://www.firstpost.com/business/moderna-loses-challenge-over-vaccine-tech-patent-to-arbutus-may-have-to-share-in-royalties-8637301.html

Cipla, Amgen reach settlement on pending litigation involving cinacalcet HCl tablets

Cipla Ltd announced that its wholly owned step-down subsidiary Cipla USA Inc, and Amgen Inc reach a settlement on pending litigation in the US District Court for the District of Delaware in January 2019 involving generic cinacalcet hydrochloride tablets. A formal stipulation of dismissal has been filed with the Court and is awaiting signature by the presiding Judge. The resolution entitles Cipla and its affiliates to continue importing, marketing, and selling its generic cinacalcet hydrochloride tablets 30mg, 60mg and 90mg in the United States...

http://pharmabiz.com/NewsDetails.aspx?aid=129740&sid=2

The UK Supreme Court on pemetrexed: judicial colonialism or a step towards harmonization?

On 9 June 2020 Barcelona Commercial Court no. 4 issued a decision rejecting the opposition filed by a company (the “Defendant”) against a decision of 2 September 2019 from the same Court that had ordered an “ex parte” preliminary injunction preventing the Defendant from marketing pemetrexed diarginine in Spain. The background of the case can be summarized as follows: In 2016 the Defendant obtained a marketing authorization (“MA”) to commercialize pemetrexed disodium generics in Spain. The patent owner (Eli Lilly & Company) sent a warning letter to the Defendant, and the latter undertook not to launch the product for which it had just obtained an MA without giving the patentee 30 days’ prior notice…

http://patentblog.kluweriplaw.com/2020/07/20/the-uk-supreme-court-on-pemetrexed-judicial-colonialism-or-a-step-towards-harmonization/?doing_wp_cron=1595743610.3852109909057617187500

Time for the third round

Truvada® (Gilead) is an anti-HIV drug comprised of the combination of tenofovir disoproxyl fumarate (TDF) and emtricitabine (FTC) approved for Pre-exposure Prophylaxy (PreP) of HIV infection, since it has been shown to allow for a reduction of 86% of the risk of being infected by HIV. Truvada® was covered until 25 July 2017 by European patent EP 0915894. The effects of the patent have been extended by supplementary protection certificates (SPCs) expiring between 21 and 24 February 2020 depending on the countries. The SPCs are based on European Union marketing authorization EU/1/04/305/001…

http://patentmyfrench.com/time-for-the-third-round/

Asenapine - USA

On Jul. 21, 2020, Delaware Court on remand found Asenapine sublingual composition patent not obvious.

Forest Laboratories / Allergan (Plaintiffs) owns NDA for Saphris® (Asenapine maleate) sublingual tablet. Plaintiffs sued five generic manufacturers, Sigmapharm, Hikma, Breckenridge, Alembic and Amneal (Defendants) for infringement of U.S. Patent No. 5,763,476. US’476 patent claims sublingual and buccal compositions of asenapine and their methods of use. At trial, Defendants argued, amongst other things, that the ’476 patent was invalid for obviousness because there was a motivation to develop sublingual and buccal forms of asenapine based on compliance concerns with the orally administered forms in schizophrenic patients. After trial in 2016, District Court held that the ’476 patent was not invalid for obviousness. Defendants appealed. During appeal, Federal Circuit remanded case back to District Court because summarizing testimony regarding motivation to combine prior arts based on compliance issue was not a clear finding. Federal Circuit observed that  review would be aided by an express finding regarding whether compliance concerns regarding patients with swallowing difficulties would provide a motivation to combine.

Back to district court, there were 2 issues: (1) “the limited question of whether compliance concerns with patients who have trouble swallowing would provide a motivation to combine”; and (2) “its impact on the obviousness analysis.”

District court with respect to first issue said that there was no motivation to combine the prior art references. Because none of these references discuss schizophrenic or bipolar patients experiencing compliance problems or difficulty swallowing. Instead, one of the references discusses geriatric and pediatric patients “in particular” as the type of patients that raises compliance concerns. In addition, none of the references identify asenapine in particular or antipsychotics in general as suitable for a sublingual or buccal route of administration.  In addition, a general understanding that a certain dosage form may improve patient compliance is not enough, by itself, to show that a POSA would have been motivated to develop a specific drug or a drug for a specific illness using that dosage form.

With respect to reasonable expectation of success, court said that even if a skilled artisan was motivated to solve compliance problems for schizophrenic or bipolar patients using orally administered tablets, there was no reasonable expectation that sublingual and buccal routes of administration would lead to success. The testimony in the record from clinical experts establishes that sublingual and buccal dosage forms are more difficult to use for patients with schizophrenia and bipolar disorders. Plaintiff’s clinical expert, Dr. McIntryre, testified that sublingual formulations require an atypical set of instructions that must be carefully followed, including refraining from food and water for a certain period of time and holding the dosage form in the mouth under the tongue for a period of time. In addition, Defendants’ own prior art references do not provide a reasonable expectation of success. Instead, some references cast doubt on using sublingual dosage form. Court thus held that there was neither a motivation based on compliance concerns to combine the drug compound asenapine with sublingual and buccal dosage forms nor a reasonable expectation of success.

With respect to second issue, court said that there is no impact of findings on compliance concerns to the overall obviousness analysis. Court found several factors weighed in favor of nonobviousness such as  solution to the unrecognized problem of cardiotoxicity & long-felt need. Thus, court held that Defendants have not established by clear and convincing evidence that the ’476 patent was obvious.

Ciclosporin - EU

On Jul. 09, 2020, The Court of Justice of the European Union (CJEU) issued its decision on interpretation of Article 3(d) of SPC regulation & held that SPC cannot be granted for new indication.

Background:

Santen holds European patent (FR) No 057959306, which relates to an ophthalmic emulsion containing ciclosporin. Santen obtained a marketing authorisation (MA) on 19 March 2015 by the European Medicines Agency (EMA) for a medicinal product marketed under the name ‘Ikervis’ (ciclosporin). This product is used to treat severe keratitis in adult patients with dry eye disease. On 3 June 2015 Santen filed an application for an SPC for a product called ‘Ciclosporin for use in the treatment of keratitis’. By decision of 6 October 2017, the Director-General of the INPI rejected the application for an SPC, taking the view that the MA at issue was not the first MA, for the purpose of Article 3(d) of Regulation No 469/2009. Because there was another product (Sandimmun) which also contains ciclosporin, approved on 23 December 1983. Santen then brought an action against the decision of the Director-General of the INPI before the referring court, the Cour d’appel de Paris (Court of Appeal, Paris, France). Before that court, Santen sought, as its primary claim, the annulment of that decision and, in the alternative, to refer a question to the Court of Justice for a preliminary ruling concerning the interpretation of Article 3 of SPC regulation.

Article 3 of SPC regulation reads:

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive;

(c) the product has not already been the subject of [an SPC];

(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.’

CJEU analysis:

In the present case, the questions referred for a preliminary ruling concern the interpretation of Article 3(d) of SPC Regulation and, more specifically, the interpretation of the concept of ‘first [MA for the product] as a medicinal product’ read in the light of the judgment in Neurim. In Neurim it was held that the mere existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different therapeutic application of the same product for which an MA has been granted in human. CJEU said that for this issue it is necessary to examine whether Article 3(d) of Regulation must be interpreted as meaning that an MA may be considered to be the first MA, where it covers a new therapeutic application of an active ingredient and that active ingredient has already been the subject of an MA for a different therapeutic application. In this respect, the MA to which Article 3(d) of Regulation refers must be granted for a specified “product”, as defined in Article 1(b) of that regulation. Under that provision, ‘product’ means the “active ingredient” which have, at least, a therapeutic effect of their own. In conclusion, the term ‘product’ is understood to mean an active ingredient in the strict sense and that minor changes to the medicinal product such as a new dose, the use of a different salt or ester or even of a different pharmaceutical form will not lead to the issue of a new SPC. Therefore, the fact that an active ingredient is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product. Moreover, this new MA granted for new indication is not the first MA to place the product on the market.

Therefore, the answer to the questions referred is that Article 3(d) of Regulation No 469/2009 must be interpreted as meaning that an MA cannot be considered to be the first MA, where it covers a new therapeutic application of an active ingredient, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application.

On those grounds, the Court (Grand Chamber) hereby rules:

Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.

Bendamustine - USA

Memorandum (District of Delaware): Jul. 06, 2020

Civil Action No.: 17-1154

Plaintiffs: Cephalon, Inc. et al.

Defendants: Slayback Pharma Limited et al.

On Apr. 27, 2020 court issued an opinion in a Hatch-Waxman litigation & found asserted patents not invalid & infringed by ANDA filers. The decision summary can be "read here" on this blog. The issue here is related to dispute regarding proposed order of final judgment. The parties were unable to agree on a proposed final judgment order because they dispute which claims should be included in the judgment. Defendants argued that the judgment should be limited to the 11 claims asserted at trial. Plaintiffs proposed a judgment that covers those 11 claims plus 86 claims they had asserted earlier in the litigation.

Court said that the resolution depends on the meaning of two paragraphs in two stipulated orders which reads:

"The parties stipulate that a determination as to non-infringement and/or invalidity of the asserted claims at trial will result in a final judgment as to each Defendant of all patents that have been asserted by Plaintiffs in this case as to each such Defendant, respectively, with the exception of U.S. Patent No. 8,791,270, which has been resolved by the granting of covenants not to sue and/or consent judgments."

Paragraph 4 of the second Stipulation and Order reads:

"Plaintiffs and Slay back stipulate that a determination as to invalidity of the asserted claim at trial will result in a final judgment as to Slay back of all claims of the patent that has been asserted by Slayback in this case, with the exception of U.S. Patent No. 8,791,270, which has been resolved by the granting of a consent judgment."

Defendants argued that the stipulations apply "only to a situation in which Defendants won"-i.e., a situation in which the court found that the asserted claims were invalid and/or not infringed-because the stipulations apply only to a "determination as to non-infringement and/or invalidity." Plaintiffs countered that "Defendants misread the stipulations to apply only to determinations of non-infringement or invalidity-not as they actually provide, to determinations "as to non-infringement and/or invalidity." Court said that the phrase (as to) is typically used as "a passable shorthand form of regarding, with regard to, or on the question of, and it "is also (minimally) defensible when used for about." It is equally clear that the stipulations do not apply only to "a situation in which Defendants won." Court’s determination that Plaintiffs had established that the Defendants' proposed products infringe the asserted claims necessarily entailed a determination that Defendants had failed to prevail on their claim that the proposed products were noninfringing. Defendants' contention that a "determination as to non-infringement" differs from a "determination as to infringement" makes no sense in a case like this one where Plaintiffs seek a declaratory judgment of infringement and Defendants seek a declaratory judgment of noninfringement. The accused products in such a case either infringe the asserted patents or don't infringe the asserted patents.

In the same vein, "invalid" and "not invalid" are inseparable concepts in a patent case. Court’s determination that the asserted claims were not invalid constitutes a determination on the question of invalidity. Defendants argued that the stipulated orders apply only to findings of "invalidity" as opposed to findings of"validity." Court said that but it is not the role of the court (or jury) to declare a patent valid. Because under 35 U.S.C. § 282, "[a] patent shall be presumed valid." When a patent's validity is challenged, the court ( or jury) is tasked with deciding if the challenger has proven that the patent is invalid. The "determination" to be made in such cases is whether the patent is invalid or not invalid.

Because the stipulated orders apply to determinations that the asserted claims are infringed and not invalid, the judgment in this case should extend to all the claims of all the patents that were asserted in the case by Plaintiffs except for U.S. Patent No. 8,791,270. The phrase "all patents/claims that have been asserted by Plaintiffs in this case" is unambiguous. It clearly covers every claim of every patent asserted by Plaintiffs at any time in the case before the date of the Stipulation and Order. Therefore, the stipulation covers all claims of the asserted patents & not only the 11 claims which were asserted at trial.

Bevacizumab – USA

On Jul. 06, 2020, Federal Circuit dismissed Genentech’s emergency motion and a motion for a temporary restraining order & held that Amgen is not required to provide again notice of commercial marketing for its supplements.

Amgen filed a aBLA with USFDA pursuant to market a biosimilar version of Avastin—Mvasi. USFDA approved Mvasi on Sept. 14, 2017. On Oct. 6, 2017, Amgen sent a letter pursuant to 42 U.S.C. § 262(l)(8)(A) notifying Genentech of its intent to commercially market Mvasi starting no earlier than 180 days from the date of the letter. But after that Amgen filed supplements to its Mvasi application to add a manufacturing facility & to update drug label. By July 8, 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately. Genentech then filed motions in the District of Delaware seeking to preclude Amgen from commercially marketing Mvasi “until such time as Amgen . . . provides notice of commercially marketing”. The district court denied motions, reasoning that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied Section 262(l)(8)(A)’s notice requirements. Genentech appealed.

Section 262(l)(8)(A) recites:

The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under sub-section (k).

Federal Circuit said that the statute under Section 262(l)(8)(A) makes clear that the biosimilar applicant must provide notice to the reference product sponsor prior to commercially marketing “the biological product”. The definition of biological product provided under Section 262 does not include supplements. Genentech argued that the phrase “licensed under sub-section (k)” is defined “by particular manufacturing facilities and labeling”. Federal Circuit disagreed & said that Section 262(k), not Section 262(l)(8)(A), details the contents and requirements for biosimilar licensure, including manufacturing and labeling. And this interpretation is consistent with the Supreme Court’s decision in Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017) (Sandoz II). In Sandoz II, the Supreme Court explained that the term “licensed” in Section 262(l)(8)(A) simply means that the product must be licensed on the date of the first commercial marketing, not that each supplemental application results in a new license requiring the biosimilar applicant provide further notice. Thus, Genentech’s interpretation, which would impose several timing requirements where each supplement necessarily triggers another notice requirement, is inconsistent with the statute and with Sandoz II. A biosimilar applicant that has already provided Section 262(l)(8)(A) notice regarding its biological product need not provide another notice for each supplemental application concerning the same biological product.

Etanercept – USA

On Jul. 01, 2020, Federal Circuit affirmed district court’s decision which found Enbrel® patents valid in a challenge by Sandoz.

Background:

Hoffmann-La Roche Inc. (“Roche”), its exclusive licensee Immunex Corp., and exclusive sublicensee Amgen Manufacturing, Ltd., initiated patent infringement suit pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”) act against Sandoz which filed Biologics License Application (“aBLA”) to market Erelzi®, a biosimilar version of Immunex’s biologic drug, Enbrel®. Enbrel® is covered by the patents-in-suit: U.S. Patent Nos. 8,063,182 and 8,163,522. The patents-in-suit are directed to the fusion protein etanercept and methods of making the same. Etanercept is made by combining a portion of a 75 kilodalton (“kDa”) human tumor necrosis factor (hTNF) receptor protein with a portion of immunoglobulin G1 (“IgG1”). During district court proceeding Sandoz stipulated to infringement but asserted that patents-in-suit are invalid. After a two-week bench trial, New Jersey court entered final judgment for Immunex and Roche, holding that Sandoz failed to prove that the asserted claims of the patents-in-suit were invalid. Sandoz appealed.

Court’s analysis:

On appeal, Sandoz argued that the patents-in-suit are invalid for (1) obviousness-type double patenting; (2) failure to meet the written description requirement; and (3) obviousness.

(1) obviousness-type double patenting (OTDP):

Sandoz asserted that the patents-in-suit are invalid for OTDP over several patents filed by Immunex Corporation. Specifically, Sandoz argued that patents-in-suits are owned by Roche but these patents were assigned to Immunex and thus there is common-owenership which is required for OTDP. Thus all substantial rights in the patents-in-suit transferred to Immunex pursuant to the “2004 Accord & Satisfaction agreement”. Borrowing from 35 U.S.C. § 281 case law, Sandoz argued that an agreement that conveys “all substantial rights” in a patent is tantamount to an assignment of ownership. In Sandoz’s view, this “all substantial rights” test—to date used only to determine who may sue for infringement as a “patentee” pursuant to 35 U.S.C. § 281—should apply in the OTDP context as well. Federal Circuit agreed with Sandoz that the “all substantial rights” test can be informative in determining common ownership in the OTDP context, but it concluded that the agreement at issue here did not transfer all substantial rights from the assignee, Roche, to the exclusive licensee, Immunex.

Court said that the main issue here is whether an assignment transferred all substantial rights in the patents-in-suit to Immunex. For this court must ascertain the intention of the parties to the license agreement and the substance of what was granted by examining the ‘totality’ of the agreement. Review of the Accord & Satisfaction agreement reveals the following: Section 3.5 of the agreement gives Immunex the first right to rectify any suspected infringement, at Immunex’s sole expense and under its sole control, by instituting suit or by sublicensing the patents. Roche is required to cooperate in any Immunex-initiated infringement suit, including by participating as a party only to the extent required by the court in order to bring suit. But, under Section 3.6, Roche retains the secondary right to sue if Immunex fails to rectify any infringement within 180 days after written request by Roche. After this 180-day notice period, Roche may, at its sole expense and under its sole control and direction, initiate suit. Immunex further has a duty to cooperate in such a Roche-initiated suit. Notably, “the right to rectify infringement under . . . Section 3.6 is solely with” Roche. As to alienation rights, under Section 11.4, neither party may assign its rights to third parties without the written consent of the other.

Sandoz argued that these provisions, taken together, effectuated a transfer of all substantial rights from Roche to Immunex. Sandoz points to Immunex’s “paid-up, irrevocable, exclusive license” and “first right to rectify any alleged infringement” on the one hand, and Roche’s loss of control over licensing and litigation activities on the other, to argue that Roche was “stripped of any of the traditional attributes of ownership.” Sandoz also contended that Immunex’s ability to drive the prosecution of the patents is another indication that Roche transferred all substantial rights. Immunex responded that Roche is still the effective patentee because it retained several key rights under the Accord & Satisfaction. Immunex points to: (1) Roche’s secondary right to sue; (2) Roche’s right to practice the patents for internal, non-clinical research; (3) Immunex’s option to convert the license into an assignment by paying an additional consideration of $50,000; and (4) Roche’s right to veto the assignment of Immunex’s interest under the agreement to any unrelated party. Federal Circuit agreed with Immunex and held that based on the totality of the Accord & Satisfaction, Roche did not transfer all substantial rights in the patents-in-suit to Immunex. As such, the Immunex Patents and the patents-in-suit are not “commonly owned,” and obviousness-type double patenting does not apply.

(2) Written Description:

On appeal, Sandoz argued that the district court erred in concluding that the priority application for the patents-in-suit disclosed possession of the claimed invention. Specifically, Sandoz argued that the priority application did not include written description support for (1) the full-length p75 DNA sequence; and (2) the claimed p75-IgG1 fusion protein.

According to Sandoz, the ’013 Application described a fusion protein based on the truncated/mutated p75 DNA sequence disclosed in Figure 4 of the patent, not the full-length p75 sequence used in etanercept. Sandoz contended that the fact that the full-length p75 sequence was known in the prior art is of no moment because the real issue is exactly which p75 sequence Roche had in its possession as of the time of the filing of the priority application. In Sandoz’s view, the district court’s finding of adequate written description impermissibly rests on information outside the patent. Federal Circuit disagreed with Sandoz & said that it is well-established that a patent specification need not re-describe known prior art concepts. District court properly concluded that the inventors possessed the full-length p75 DNA sequence. The specification identifies both p55 and p75 TNFRs. According to the district court, the Smith 1990 article, referenced in the priority application, shows that a POSA would have known the entire p75 sequence at the time of the invention. The Smith 1990 article guided a POSA that the “entire nucleotide sequence is available upon request and has been deposited with GenBank, accession number M32315.” The court also credited the testimony of Immunex’s expert, who opined that a POSA would have been encouraged from the disclosure in the priority application to look to Smith, and therefore, the full-length p75 protein. As to Sandoz’s arguments that later amendments show that the Roche inventors did not have possession of the full p75 sequence at the time of invention, the district court correctly noted that actual reduction to practice is not required to show possession.

With respect to p75-IgG1 protein, Sandoz argued that the priority application did not adequately demonstrate possession of the claimed p75-IgG1 fusion protein. Sandoz repeated its arguments that the Figure 4 truncated sequence was “preferred,” and points out that to arrive at the claimed invention, a POSA would have had to select the “never-referenced” full Smith sequence. Sandoz also argued that the specification disclosed a range of immunoglobulin classes, and even if the IgG1 and exon-encoded hinge were described as possible options, the priority application provided no “blaze marks” that would have led a POSA to their selection. Federal Circuit again disagreed with Sandoz & said that the specification identified four preferred fusion proteins, including the claimed p75-IgG1 fusion protein, and that Example 11 provided the steps required to make these fusion proteins. Citing expert testimony, the court concluded that Example 11 discloses this concept with p55, and a POSA would have followed that example to create etanercept based on the claims and specification. The district court’s findings are supported by the as-filed specification and are not based on the language of the issued claims. Therefore, district court’s written description analysis is not clearly erroneous.

(3) Obviousness:

Sandoz appealed the district court’s obviousness analysis, arguing that (1) the district court’s motivation to combine analysis erroneously focused on the inventors’ subjective motivation rather than the claims’ objective reach with respect to treatment part; and (2) the district court’s analysis regarding objective indicia of non-obviousness was legally erroneous. Federal Circuit said that although Sandoz criticizes the district court’s focus on the therapeutic anti-inflammatory effect of TNFR binding proteins, that focus was a result of the arguments and evidence presented at trial and in the parties’ post-trial submissions. Therefore, district court’s analysis regarding motivation to combine was not legally erroneous because the treatment of illnesses that involve TNF is a stated objective of the claimed invention; the arguments at trial were focused on therapeutic effects of the claimed invention (and not on their benefits as diagnostic and research tools); and at least two of the asserted claims are directed to pharmaceutical compositions. Next, Sandoz argued that the district court incorrectly analyzed the required nexus between the claims and the objective indicia of non-obviousness, such as clinical success, long-felt need, and failure of others. Federal Circuit said that district court correctly found that there was a sufficient nexus between the claimed invention and the various objective indicia of non-obviousness. Nexus is appropriately presumed in this case where the court concluded that the claims are directed to the active ingredient in Enbrel® and its method of manufacture. Thus, Federal Circuit did not see clear error in the district court’s findings regarding the objective indicia of non-obviousness.

REYNA, Circuit Judge, dissent:

“…The majority determines that obviousness-type double-patenting does not apply here because appellee Immunex is not a common owner of the patents-in-suit. The majority’s common ownership determination hinges on its interpretation of the 2004 Accord & Satisfaction between Roche, the licensor of the patents-in-suit, and Immunex, the exclusive licensee. Because I interpret the 2004 Accord & Satisfaction as an effective assignment of the patents-in-suit to Immunex, I would hold that Immunex is a common owner for obviousness-type double patenting purposes. I would also hold that Immunex’s patents-in-suit are invalid for obviousness-type double patenting in view of Immunex’s previously issued U.S. Patent No. 7,915,225 (“the ’225 patent”) under the one-way test…”