Pemetrexed – USA

On Dec. 30, 2019, Southern District of Indiana court granted Lilly’s Motion for Summary Judgment of infringement & found Apotex’s product infringing under DOE as prosecution history estoppel did not apply.

Lilly owns U.S. Patent No. 7,772,209, titled “Antifolate Combination Therapies.” The ‘209 patent concerns a method of administering pemetrexed disodium along with folic acid and vitamin B12, a methylmalonic acid lowering agent, in order to reduce the toxicities associated with the administration of pemetrexed disodium. The US’209 patent covers Lilly’s ALIMTA® product which was approved by USFDA on Feb 4, 2004 in 500mg vial as lyophilized powder for intravenous administration. Apotex filed New Drug Application with USFDA & later Lilly sued Apotex. Both parties filed Cross-Motions for Summary Judgment regarding Lilly’s claim of infringement of the ‘209 patent. As an initial matter, the Court noted that Lilly argued in its opening brief that “Apotex’s only defense to infringement under the doctrine of equivalents is prosecution history estoppel. If the Court determines that Lilly is not barred from pursuing the doctrine of equivalents, Apotex has conceded that its product will infringe.”

Apotex argued that prosecution history estoppel bars Lilly from asserting infringement under the doctrine of equivalents. Apotex asserted that, beginning with Lilly’s January 2005 amendment, the claim term “ALIMTA” was amended to be “pemetrexed disodium,” and that amendment was a narrowing amendment. Specifically, Apotex contended the claims and the specification do not define the term “ALIMTA,” and the term would have been understood to mean “pemetrexed,” not “pemetrexed disodium.” Thus, when Lilly amended the claims from “ALIMTA”—meaning “pemetrexed”—to “pemetrexed disodium,” Lilly narrowed its claims from “pemetrexed” to “pemetrexed disodium.” Therefore, because the amendment of the claims from “ALIMTA” to “pemetrexed disodium” was a narrowing amendment, prosecution history estoppel applies.

Court said that it has carefully reviewed the evidence submitted by the parties, reviewed the patent claims, specification, and prosecution history record, and concludes that Lilly’s amendment from “ALIMTA” to “pemetrexed disodium” was not a narrowing of Lilly’s claims. Court further said that while the term “ALIMTA” was used throughout the patent applications to refer to an “antifolate,” the patent applications did not use “ALIMTA” to refer to “pemetrexed” in isolation. And the ‘209 patent claims and specification do not use the term “pemetrexed” without combining it with “disodium.” The June 2000 patent application referred to “pemetrexed disodium (Alimta®, Eli Lilly and Company, Indianapolis, IN).” Then in September 2004, the patent examiner rejected the “ALIMTA” claims because using the trademark or trade name was improper and rendered the claims indefinite. The patent examiner understood “ALIMTA” to mean “pemetrexed disodium.” Directly responding to the September 2004 rejections, Lilly canceled the “ALIMTA” claims to moot the rejections concerning the use of the trademark or trade name. The language in the specification and the prosecution history record indicate that “ALIMTA” means “pemetrexed disodium,” and when Lilly amended its claims, it was not narrowing its claims from “pemetrexed” to “pemetrexed disodium.” Therefore, prosecution history estoppel does not apply & Apotex has conceded the merits of doctrine-of-equivalents infringement.

Thus, Court granted Lilly’s Motion for Summary Judgment of infringement.

Hydrocodone bitartrate - USA

On Dec 27, 2019, Federal Circuit affirmed Delaware court’s decision & found Zohydro® ER patents patents invalid under obviousness.

Persion Pharmaceuticals LLC owns U.S. Patent Nos. 9,265,760 and 9,339,499, both entitled “Treating Pain in Patients with Hepatic Impairment.” The relevant claims of the ’760 and ’499 patents can generally be grouped into two sets: the “non-adjustment” claims and the “pharmacokinetic” claims.

Independent claim 1 of the ’760 patent is representative of the non-adjustment claims, and recites:
1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising: administering to the patient having mild or moderate hepatic impairment a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, and wherein the starting dose is not adjusted relative to a patient without hepatic impairment.

Independent claim 12 of the ’760 patent is representative of the pharmacokinetic claims, and recites:
12. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising: administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, wherein the dosage unit provides a release profile of hydrocodone that: 
(1) does not increase average hydrocodone AUC0–inf in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%; 
(2) does not increase average hydrocodone AUC0–inf in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 30%; 
(3) does not increase average hydrocodone Cmax in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 9%; and 
(4) does not increase average hydrocodone Cmax in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%.

On March 4, 2016, Persion sued Alvogen for infringement of claims 1–4, 11– 12, 17, and 19 of the ’760 patent. After the ’499 patent issued, Persion filed an amended complaint additionally asserting infringement of claim 1 of that patent. Persion alleged that Alvogen infringed these claims by filing an ANDA seeking to market a generic version of Zohydro ER. After a bench trial, The district court determined that the asserted claims are invalid as obvious over Devane in view of Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels. In addition, the district court determined that the asserted claims of the ’760 and ’499 patents are invalid under 35 U.S.C. § 112(a) for lack of adequate written description support. Please see the previous post “here” for more details.

During appeal, Persion raised four primary challenges to the district court’s obviousness conclusion. First, Persion contends that the district court improperly relied on inherency to conclude that Devane discloses the pharmacokinetic limitations of the asserted claims. Second, Persion argues that the district court improperly relied on pharmacokinetic profiles from drugs other than extended-release single-active-ingredient hydrocodone formulations and from patients other than those with hepatic impairment in reaching its obviousness conclusion. Third, Persion contends that the district court erred by finding the asserted claims obvious before considering the objective indicia factors. Fourth, Persion argues that the district court’s factual findings concerning obviousness are inconsistent with its findings concerning the lack of written description support.

Federal Circuit finally found no error in districts court’s analysis & affirmed its decision while rejecting Persions arguments.

With respect to first point, Federal Circuit said that the district court correclty found that Devane, together with Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels, taught the combination of elements that inherently result in the claimed pharmacokinetic parameters. The district court found that a person of ordinary skill in the art would have been motivated, with reasonable expectation of success, to administer an unadjusted dose of the Devane formulation to hepatically impaired patients. There was also no dispute that the Devane formulation, which was identical to the Zohydro ER formulation described in the patents in suit, necessarily exhibited the claimed parameters under these conditions.

With respect to second point, Federal Circuit said that district court provided several reasons for its conclusion that a person of ordinary skill in the art would have considered other types of drug products in developing a hydrocodone-only extended-release formulation. In particular, the district court found that in light of acetaminophen’s hepatotoxicity, a person of skill in the art would have expected that an acetaminophen-free hydrocodone formulation, such as the one disclosed in Devane, would have been even safer for patients with hepatic impairment than the combination formulations disclosed in Jain and other references.

With respect to third point, Federal Circuit said that while the district court’s discussion of objective indicia follows its discussion of the asserted prior art, the substance of the court’s analysis makes clear that it properly considered the totality of the obviousness evidence in reaching its conclusion and did not treat the objective indicia as a mere “afterthought” relegated to “rebut[ting]” a prima facie case.

With respect to fourth point, Federal Circuit said that Persion’s entire argument with respect to this issue is based on incomplete quotations from the district court’s opinion. The district court stated that “there was nothing in the state of the art as of July 2012 that would have provided guidance as to which of the broadly claimed formulations would work and which would not, with the exception of the single embodiment described in Example 8.” The embodiment described in Example 8 of the common written description of the ’760 and ’499 patents is the Devane formulation, which formed the basis for the district court’s obviousness findings. In contrast to the “essentially limitless number of formulation species” covered by the claims of the ’760 and ’499 patents, the district court found that the prior art provided adequate guidance with respect to the sole formulation described in Example 8: the Devane formulation. Thus, there is no inconsistency between the statement Persion quotes and the district court’s conclusion that a person of ordinary skill in the art would have been motivated to combine Devane with Jain and the Vicodin and Lortab labels to arrive at the claimed invention.

Tenofovir disoproxil & Emtricitabine - UK

On Dec 19, 2019, Court of Appeal dismissed Gilead's appeal & found SPC protecting combination HIV anti-retroviral drugs, Truvada®, invalid.

Gilead’s SPC (SPC/GB05/041) describes a product containing two ingredients, tenofovir disoproxil fumarate and emtricitabine which covers product marketed by Gilead under the trade name, Truvada. In lower court, Justice Arnold handed down decision on 18 September 2018, & held that the SPC was invalid, in the light of the ruling of the Grand Chamber of the CJEU.

Gilead appealed & issue upon appeal is related to criteria for deciding whether the 'product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation. Gilead contends that the product described in the SPC is protected by European Patent (UK) No 0 915 894, because it has a claim (claim 27) to TD "and optionally other therapeutic ingredients". Emtricitabine, says Gilead, is another therapeutic ingredient. The claimants contend that claim 27 does not protect the combination in the manner required by the SPC Regulation.

Court of Appeal said that the question is whether the combination of the active ingredients TD and emtricitabine must ‘necessarily’, in the light of the description and drawings of that patent, fall under the invention covered by the patent. Court further said that the addition of "other therapeutic ingredients" to TD in claim 27 is expressly made optional. That is no different in principle to a claim which "comprises" TD, which we know is not good enough to protect a combination. As to the wording of the claim, it is not possible to understand claim 27 as requiring the presence of another therapeutic ingredient when it expressly states that it is optional. It is clear that claim drafting is of importance in this area, as cases such as C-577/13 Actavis (cited above) make clear. Finally, it is by a focus on the claims and the description that the skilled person (albeit with the benefit of his common general knowledge) decides what the claims necessarily relate to. Although the patent contains lengthy, standard form, material as to how the compounds of the invention can be formulated, there is nothing to suggest to the skilled person that claim 27 requires the presence of another ingredient. Everything points the other way. The skilled person might well know from the common general knowledge that other anti-viral agents would be useful in practice in the treatment of HIV, but he would not therefore assume that the presence of emtricitabine was required by the claim.

Thus, court dismissed the appeal.

Bendamustine – USA

On Dec. 16, 2019, Delaware court granted-in-part & denied-in-part Hospira’s motion to dismiss infringement of Cephalon’s composition patent covering Bendeka®.

Plaintiffs Eagle Pharmaceuticals, Inc., Teva Pharmaceuticals International GMBH, and Cephalon, Inc. have sued Defendant Hospira, Inc., alleging infringement of nine OB patents. These patents cover liquid formulations of the cancer drug Bendeka®(bendamustine). Plaintiffs alleged that Hospira' s submission of NDA to the FDA constituted an artificial act of infringement of the these patents. Hospira' s filed motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6).

The claims of eight of the asserted patents require some combination of two solvents in the claimed liquid bendamustine formulation: propylene glycol and polyethylene glycol (PG patents). Plaintiffs allege that Hospira's NDA product, which contains polyethylene glycol but uses ethanol instead of propylene glycol as its second solvent, infringes the PG patents under the doctrine of equivalents. The ninth asserted patent, U.S. Patent No. 9,572,887 requires a "non-aqueous" bendamustine formulation. Plaintiffs allege that Hospira's NDA product, which contains 2%-4% water, infringes the claims of the ‘887 patent both literally and under the doctrine of equivalents.

Infringement of US’887 patent:

Hospira contends that its NDA product does not literally infringe the ‘887 patent because it contains some amount of water. It similarly contends that claim vitiation bars application of the doctrine of equivalents to its NDA product because "the term 'non-aqueous' presents a black-or-white proposition: either a composition is non-aqueous [i.e. completely lacking in water] or, if it is not, it is the complete opposite (i.e., aqueous)." And, finally, Hospira contends that prosecution history estoppel applies because the patentee amended the claims to specify that the claimed formulations are "non-aqueous" in order to overcome prior art that referenced "aqueous" solutions. Plaintiffs, however, argue that "non-aqueous" to a person of ordinary skill in the art (POSITA) does not require the complete absence of water, and they point to the fact that Hospira represented to the FDA that its NDA product is "predominantly a non-aqueous formulation." Court said that, Hospira's arguments boil down to a claim construction dispute that is not suitable for resolution in the context of a motion to dismiss. Thus court denied Hospira' s motion to dismiss Plaintiffs' claim of infringement of the ‘887 patent.

Infringement of PG patent:

Hospira argues that Plaintiffs' claims of equivalence infringement of the PG patents fail as a matter of law because they are barred by the disclosure-dedication rule and prosecution history estoppel. Court agreed with Hospira & said that a corollary to the principle that only the claims define the scope of a patented invention is the disclosure-dedication rule. That rule precludes a finding of infringement that is based on subject matter disclosed in the written description but not claimed. For the disclosure-dedication rule to apply, "[t]he disclosure must be of such specificity that one of ordinary skill in the art could identify the subject matter that had been disclosed and not claimed ["PSC Comput. Prods. v. Foxconn Int'!, Inc., 355 F.3d 1353, 1360 (Fed. Cir. 2004)], and the "unclaimed subject matter must have been identified by the patentee as an alternative to a claim limitation,["Pfizer, Inc. v. Teva Pharm. USA, Inc., 429 F.3d 1364, 1379 (Fed. Cir. 2005)].

Court further said that the written description of the ‘533 patent explicitly and repeatedly identifies Hospira' s second solvent, ethanol, as an alternative to propylene glycol in embodiments of the patented invention. In light of the clear and unambiguous disclosure of ethanol as a substitute for propylene glycol in the ‘533 patent's written description and the fact that the PG patents do not claim ethanol as the second solvent in the claimed liquid bendamustine formulation, the disclosure-dedication rule bars Plaintiffs from alleging that Hospira's NDA product infringes the PG patents under the doctrine of equivalents.

Erythropoietin – USA

On Dec 16, 2019, Federal Circuit affirmed district court’s decision which awarded $70 million to Amgen as certain batches of Hospira’s biosimilar found to infringe method of preparation claim.

The patents-in-suit are US 5,856,298 and US 5,756,349. The claims of the ’298 patent claim related to methods of producing EPO isoforms having a specific number of sialic acids per molecule, and methods for obtaining EPO compositions having a predetermined in vivo specific activity. The ’349 patent is directed to recombinant cells that are capable of producing EPO at certain rates when grown in culture.

In 2014, Hospira submitted BLA to the FDA, seeking approval for a biosimilar to Amgen’s Epogen product. Amgen sued Hospira for infringement of the ’298 patent under 35 U.S.C. §§ 271(a) and 271(e)(2)(C), and for infringement of the ’349 patent under 35 U.S.C. § 271(a). Amgen asserted that Hospira’s manufacture of twenty-one batches of drug sub-stance for its EPO biosimilar drug product infringes claims 24 and 27 of the ’298 patent and claims 1–7 of the ’349 patent. A jury trial was held in September 2017. The jury found the asserted claims of the ’298 patent not invalid and infringed, and the asserted claims of the ’349 patent not invalid and not infringed. Of the twenty-one accused drug substance batches, the jury found seven batches entitled to the Safe Harbor defense. The jury awarded Amgen $70 million in damages. The district court then denied Hospira’s post-trial Rule 50(b) Motion for Judgment as a Matter of Law on issues of non-infringement and invalidity of the ’298 patent, Safe Harbor, and damages, or in the alternative, for remittitur or a new trial.

Hospira appealed on various issues.

With respect to infringement of claim 27, Hospira contended that it is entitled to a judgment of noninfringement.

Claim 27 of US’298 recites:

A method for obtaining an erythropoietin composition having a predetermined in vivo specific activity comprising preparing a mixture of two or more erythropoietin isoforms of claim 1.

Claim 1 recites:

An isolated biologically active erythropoi-etin isoform having a single isoelectric point and having a specific number of sialic acids per molecule, said number selected from the group consisting of 1-14, and said isoform being the product of the expression of an exogenous DNA sequence in a non-human eucaryotic host cell.

During appeal Hospira argued that, Amgen’s evidence is insufficient to establish that Hospira’s EPO has a “predetermined in vivo specific activity,” as required by claim 27. Amgen contended that Hospira’s statements in its BLA show that its EPO falls within a specified range of in vivo specific activity, a range that was, in Amgen’s view, “predetermined based on the reference product”. Court said that substantial evidence supports the jury’s infringement verdict. As to whether Hospira’s process results in EPO that has a predetermined in vivo specific activity, Hospira’s BLA states that 100% of its EPO batches have a specified range of in vivo activity, i.e., 93–147 U/μg. Amgen’s expert, Dr. Cummings, testified that all of Hos-pira’s EPO batches have an in vivo specific activity within a specified range, a range predetermined based on Epogen, the reference product.

With respect to safe harbor provision, Hospira contended that no reasonable jury could have found that some, but not all, of Hospira’s drug substance batches were protected by the Safe Harbor defense. Hospira argued that all twenty-one batches were used for the development and submission of information included in the original BLA filing or in a subsequent filing necessitated by a Complete Response Letter (CRL) from the FDA. In Hospira’s view, “the jury instructions and verdict form improperly focused the jury on the reasons why each batch of EPO was manufactured, not how each batch was used or whether that use was reasonably related to the development and submission of in-formation to support Hospira’s BLA.” According to Amgen, the jury instructions “properly focused the jury on Hospira’s use of the patented invention, that is, the manufacture of [Hospira’s EPO] drug substance, and then asked whether each act of manufacture was for uses reasonably related to seeking FDA approval.”

Court said that here, the patented inventions are Amgen’s claimed methods of manufacture. The accused activity is Hospira’s use of Amgen’s claimed methods of manufacture. The relevant inquiry, therefore, is not how Hospira used each batch it manufactured, but whether each act of manufacture was for uses reasonably related to submitting information to the FDA as required by safe harbor. At issue are twenty-one batches of EPO Hospira manufactured in 2013, 2014, and 2015. The jury found seven batches were protected under the Safe Harbor, whereas fourteen were not. The protected batches include two batches used for qualifying Hospira’s process to make the drug and for qualifying alternate equipment (manufactured in 2013) and five batches used for a mandatory pre-approval inspection by the FDA (manufactured in 2015). For all other batches, the jury found no Safe Harbor protection.

Hospira used the EPO batches at issue for various types of testing, including biosimilarity, revisions to re-lease specifications, stability testing, and continued process verification (CPV). According to Hospira, each type of testing was conducted as part of its BLA submission or its response to the FDA’s CRL.

Court further said that substantial evidence supports the jury’s finding that the batches at issue were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA. For example, Amgen’s expert, Dr. Martin-Moe, testified that Hospira was not required to manufacture additional batches after it made its 2012 batches. She also explained that stability testing of Hospira’s 2013 batches was not required but would be part of a “continuing program for stability that is a post-approval commitment.” She further explained that CPV is an ongoing process that applies to batches made for commercial use. Hospira’s regulatory witness, Ms. Dianis, admitted that CPV is not required before FDA approval. Further, Hospira’s Senior Director of Analytical R&D, Dr. Srebalus-Barnes, admitted that Hospira did not manufacture any drug substance batches in response to the FDA’s CRL and the CRL did not require manufacture of additional batches. Accordingly, the jury reasonably found that certain batches at issue were not protected under the Safe Harbor.

Weekly Patent Litigation Round-Up

Jury orders Gilead's Kite Pharma to pay $752M for CAR-T patent infringement

In a high-stakes patent lawsuit between CAR-T companies Bristol-Myers Squibb and Gilead Sciences, BMS has come up with a victory. After a two-week trial, jurors in California ordered Gilead’s Kite Pharma to pay $752 million to BMS’ Juno Therapeutics and its partners, which sued in 2017 for patent infringement. A BMS spokesperson said the company is "pleased" with the decision, while a Gilead representative said the company is "steadfast in our opinion" that the patent isn't infringed and is invalid. Gilead said it'll address its concerns in post-trial motions and through a potential appeal. In its lawsuit, Juno alleged Kite scientific collaborators copied research by scientists at Sloan Kettering to advance Kite’s CAR-T work and eventually win approval for Yescarta. In 2013, Juno exclusively licensed a patent from Sloan Kettering and the Memorial Sloan Kettering Cancer Center covering the technology. .

https://www.fiercepharma.com/pharma/juno-lawsuit-jury-orders-gilead-s-kite-pharma-to-pay-752m-for-car-t-patent-infringement

Judge Connolly Denies Orexo’s Motion for a New Trial in Hatch-Waxman Patent Action

By Memorandum Opinion entered by The Honorable Colm F. Connolly in Orexo AB et al. v. Actavis Elizabeth LLC et al., Civil Action No. 17-205-CFC (D.Del. December 11, 2019), the Court denied Plaintiffs’ Orexo AB and Orexo US, Inc. (collectively, “Orexo”) motion for a new trial, pursuant to Federal Rule of Civil Procedure 59(a), on the issues of infringement, willfulness and damages. Orexo had alleged that Defendants generic versions of the anti-opioid addiction drugs Suboxone® and Subutex® directly and indirectly infringe claim 2 of U.S. Patent No. 8,454,996 (“the ‘996 patent”). Following a five-day trial, the joint verdict form did not ask the jury whether Orexo had proven direct infringement and the jury found that Defendants did not induce or contribute to infringement. Accordingly, the Court entered judgment for Defendants…

https://delawareintellectualproperty.foxrothschild.com/2019/12/articles/anda/judge-connolly-denies-orexos-motion-for-a-new-trial-in-hatch-waxman-patent-action/

HIV Prevention Group Files Petition with U.S. Patents Office Alleging Gilead Delayed Improved HIV Drug Development to Gain Profits from Older Medicines

Gilead delayed safer HIV drug to extend monopoly profits, advocates allege

“…An HIV-prevention group called PrEP4All Collaboration filed a petition Wednesday with the U.S. Patent and Trademark Office contending Gilead knew its new, improved drug — approved in 2015 and now part of Gilead’s combination therapies Genvoya and Descovy — was safer. But it alleged Gilead postponed development so it could continue to gain monopoly profits from its older combination HIV drugs, including Viread and Truvada, for a longer period, before those drugs went off patent and faced generic competition. Gilead used the delaying tactic even though the older drugs posed more risks to bone and kidney health, PrEP4All alleged…”

https://www.kff.org/news-summary/hiv-prevention-group-files-petition-with-u-s-patents-office-alleging-gilead-delayed-improved-hiv-drug-development-to-gain-profits-from-older-medicines/

Supreme Court: PTO Cannot Recoup its Attorney Fees in Defending §145 Civil Actions

In a short, unanimous decision, the Supreme Court has upheld the “American Rule” of fee shifting — holding that the “all expenses of the proceedings” provision of § 145 does not authorize reimbursement of PTO attorney/paralegal costs associated with working on the case. The question presented in this case is whether such “expenses” include the salaries of attorney and paralegal employees of the United States Patent and Trademark Office (PTO). We hold that they do not.

The court’s interpretation of “all the expenses of the proceedings” is as follows:

The complete phrase “expenses of the proceeding” is similar to the Latin expensæ litis, or “expenses of the litigation.” This term has long referred to a class of expenses commonly recovered in litigation to which attorney’s fees did not traditionally belong. See Black’s Law Dictionary 461 (1891) (defining “expensæ litis” to mean “generally allowed” costs) … These definitions suggest that the use of “expenses” in §145 would not have been commonly understood to include attorney’s fees at its enactment. .

https://patentlyo.com/patent/2019/12/attorney-defending-%C2%A7145.html

Guidelines published for filing a PPH request

Guidelines for filing PPH (Patent Prosecution Highway) request under the PPH pilot program between IPO (Indian Patent Office) and JPO (Japan Patent Office) have been published. Union Cabinet chaired by the Prime Minister Shri Narendra Modi had approved in Novemebr 2019 the proposal for adoption of Patent Prosecution Highway (PPH) programme by the Indian Patent Office (IPO) with patent offices of various other interest countries or regions. The PPH programme would initially commence between Japan Patent Office (JPO) and Indian Patent Office (IPO) for a period of three years and the guidelines fo filing a PPH rquest under this programme have now been published.

https://patentsrewind.wordpress.com/2019/12/11/guidelines-published-for-filing-a-pph-request/

TAG supports opposition of Sanofi TB drug patents in India

Treatment Action Group (TAG), a US-based organisation focused on research of diseases such as HIV/AIDS and tuberculosis (TB), has applauded an opposition that aims to block Sanofi from patenting a new TB drug in India. On December 5, TAG issued a statement of support for a TB survivor, Ganesh Acharya and Delhi Network of Positive People (DNPP), saying that the drugs being claimed by Sanofi are “public goods”. The oppositions, submitted on November 5 at the Indian Patent Office in Kolkata, are against two patents applied-for by Sanofi. The first patent, titled “Anti-tuberculosis stable pharmaceutical composition in the form of a coated tablet comprising of granules of isoniazid and granules of rifapentine and its process of preparation” covers a new TB treatment. The second patent covers a water-dispersible formulation for young children…

https://www.lifesciencesipreview.com/news/tag-supports-opposition-of-sanofi-tb-drug-patents-in-india-3825

Solicitor General Recommends against Cert in Vanda, Perhaps Bolstering Athena’s Bid for Review

The United States Office of the Solicitor General (SG) has filed its brief in response to the Supreme Court’s March request for views in Hikma Pharmaceuticals v. Vanda Pharmaceuticals. The December 6 brief says that the Federal Circuit correctly held the relevant claims of Vanda’s patent-in-suit eligible, and that the case is therefore “not an optimal vehicle for bringing greater clarity” on the topic of Section 101 law. Instead, said the SG, the High Court should grant certiorari in a case like Athena Diagnostics v. Mayo Collaborative Services, in which the order denying en banc rehearing “was accompanied by multiple separate opinions articulating different understandings of Mayo and seeking clarification from this Court.”…

https://www.ipwatchdog.com/2019/12/09/solicitor-general-recommends-cert-vanda-perhaps-bolstering-athenas-bid-review/id=116870/

Abraxis Bioscience dismisses patent infringement complaint filed against SPARC

Sun Pharma Advanced Research Company announced that Abraxis Bioscience LLC. has dismissed the patent infringement complaint filed against SPARC regarding SPARC's New Drug Application for PICS (Paclitaxel Injection Concentrate for Suspension). SPARC will also inform the USFDA of the dismissal of the complaint to vacate the 30-month stay…

https://www.business-standard.com/article/news-cm/abraxis-bioscience-dismisses-patent-infringement-complaint-filed-against-sparc-119120900383_1.html

Full Fed. Circ. Won't Review Celgene's Retroactive IPRs

The full Federal Circuit said Monday it won't review whether the government violated the Fifth Amendment by invalidating in inter partes review two Celgene Corp. cancer drug patents that were issued a decade before the American Invents Act passed, creating the IPR procedure...

https://www.law360.com/articles/1226540/full-fed-circ-won-t-review-celgene-s-retroactive-iprs

Fed. Circ. Affirms Actavis Infringed Anti-Nausea Drug Patent

The Federal Circuit on Wednesday upheld a Texas federal judge's decision that Actavis' proposed generic version of Sancuso, a drug administered through a skin patch used to prevent nausea and vomiting after chemotherapy, infringes a ProStrakan Inc. patent..

https://www.law360.com/articles/1227446/fed-circ-affirms-actavis-infringed-anti-nausea-drug-patent

New USMCA agreement scraps ten-year marketing exclusivity provision

The US, Canada and Mexico have signed a new, finalised trade agreement to replace the old North American Free Trade Agreement. In a press conference on Tuesday, December 10, Nancy Pelosi, the speaker of the US House of Representatives, said the agreement will not include an earlier proposition which would have given pharmaceutical companies ten-years of market exclusivity for biologics in both Canada and Mexico. Pelosi said the new agreement is “infinitely better than what was initially proposed by the Trump administration”. Also speaking at the conference, congresswoman Jan Schakowsky, who serves on the US-Mexico-Canada (USMCA) Working Group, described the administration’s initial proposal as “deeply flawed” …

https://www.lifesciencesipreview.com/news/new-usmca-agreement-scraps-ten-year-marketing-exclusivity-provision-3830

AAI Defends California’s Pay-for-Delay Legislation in Federal Court (AAM v. Becerra)

AAI has submitted an amicus brief in the Eastern District of California opposing a motion by a generic pharmaceutical association seeking to thwart pro-consumer pay-for-delay legislation. California Assembly Bill 824 (AB 824), signed into law by Governor Gavin Newsom in October 2019 and scheduled to take effect in January 2020, creates a framework for California courts to treat pay-for-delay agreements as presumptively unlawful under the Cartwright Act.  AAI has long advocated for a similar approach under both state and federal law in numerous amicus filings in courts throughout the United States. In November, the Association for Accessible Medicines (AAM), a trade association that represents the interests of generic pharmaceutical manufacturers, filed a motion for a preliminary injunction against California Attorney General Xavier Becerra, seeking to bar the state from implementing or enforcing AB 824.  Among other things, AAM argues that AB 824 will prevent procompetitive patent litigation settlements, leading to fewer generic challenges to branded pharmaceuticals, higher drug prices, and diminished public health..

https://www.antitrustinstitute.org/work-product/aai-defends-californias-pay-for-delay-legislation-in-federal-court-aam-v-becerra/

Granisetron - USA

On Dec. 11, 2019, Federal Circuit (Rule 36 judgment) upheld a Texas court’s decision that Actavis' proposed generic version of Sancuso® infringes the transdermal composition patent.

The sole patent at issue, US 7,608,282 covered the transdermal patch which enabled the administration of granisetron through an acrylic adhesive of certain specifications.

Claim 1 reads:

1. An adhesive patch suitable for the transdermal administration of granisetron to a subject in need thereof, said patch comprising: an acrylic adhesive consisting essentially of: 50 to 98% w/w of a primary acrylate monomer wherein said primary acrylate monomer is either 2-ethylhexyl acrylate or butyl acrylate, and 0.5 to 20% w/w of a monomer containing non-acidic hydroxyl moieties, and a physiologically effective amount of granisetron loaded in the acrylic adhesive, wherein the granisetron content of said patch remains substantially unchanged when stored at 25⁰C for six weeks.

District court decision summary:

Plaintiffs ProStrakan, Inc. and Strakan International (“ProStrakan”) filed suit against Defendant  Actavis  Laboratories  UT,  Inc. (“Actavis”) for infringement of  US ‘282 patent as Actavis sought approval of its ANDA. Actavis used Duro-Tak® 387 2287 acrylic adhesive in its patch. Duro-tak is a random    copolymer    of    2-ethylhexyl    acrylate    (68.2%),    vinyl    acetate    (26.5%),    2-hydroxyethylacrylate (5.2% ) and glycidyl methacrylate (0.15%). The 2-ethylhexyl acrylate (68.2%) present in the Duro-Tak® 387-2287 of Actavis’s Accused Product satisfies the feature of claim 1 that requires “50 to 98% w/w of a primary acrylate monomer wherein said primary acrylate monomer is either 2-ethylhexyl acrylate or butyl acrylate.” The  2-hydroxyethyl  acrylate  (5.2%)  present  in  Duro-Tak®  387-2287  that  is used to prepare Actavis’s Accused Product satisfies the feature of claim 1 that requires “0.5 to 20% w/w of a monomer containing non -acidic hydroxyl moieties.”

Actavis  argued  that  its  Accused  Product  does  not  infringe  claim  1  of  the ’282 Patent because Actavis’s Accused Product: (1) administers granisetron at a greater or lesser  rate than disclosed in the ’282 Patent; (2) has a greater or lesser granisetron stability than that disclosed in the ’282 Patent; and/or (3) provides less than the complete release of granisetron. However, Court said that Actavis’s Accused Product does not  show  a  substantial  difference  in  any  of  the  rate  of  transdermal  delivery  of  granisetron,  the stability of granisetron, and/or the complete release of granisetron as compared to either the data set forth in the ’282 Patent and/or Sancuso®. Court also said that there is no evidence to support Actavis’s argument that its Accused Product does not infringe claim 1 of the ’282 Patent because the acrylic adhesive used in its Accused Product  includes additional unclaimed monomers (or other materials) that  materially  affect  the  basic  and  novel  properties of  its  patch  Accused  Product. As  construed  by  the  Court,  the  term  “consisting  essentially  of”  merely requires that no additional materials present in the acrylic adhesive have a material effect on the basic and novel properties of the claimed invention. Last, there is neither evidence to support a finding, nor did Actavis assert, that any additional unlisted ingredients such as ethanol, ethyl acetate, the release liner, or backing layer used in Actavis’s Accused Product materially affect the basic and novel properties of the claimed patch, as construed by the Court. Thus, Actavis product infringes the asserted claims.

The Court with respect to Invalidation concluded that the prior art neither anticipated certain claims of the patent nor rendered them obvious.

Filgrastim & Pegfilgrastim - USA

IPR/PGR decision: Dec 06, 2019

AIA Review #	Filing Date	Institution Date	Petitioner	Patent	Respondent	Status
IPR2019-00791	03/07/2019	09/11/2019	Kashiv BioSciences, LLC	8,940,878	Amgen Inc.	Terminated-Settled
IPR2019-00797	03/07/2019	09/11/2019	Kashiv BioSciences, LLC	9,643,997	Amgen Inc.	Terminated-Settled
PGR2019-00001	10/01/2018	04/19/2019	Adello Biologics, LLC	9,856,287	Amgen Inc.	Terminated-Settled

On US’997, Fresenius filed IPR (IPR2019-01183) on 06/08/2019 which is pending.

US 8,940,878 (Amgen Inc.)

1. A method of purifying a protein expressed in a non-native soluble form in a non-mammalian expression system comprising: (a) lysing a non-mammalian cell in which the protein is expressed in a non-native soluble form to generate a cell lysate; (b) contacting the cell lysate with a separation matrix under conditions suitable for the protein to associate with the separation matrix; (c) washing the separation matrix; and (d) eluting the protein from the separation matrix, wherein the separation matrix is an affinity resin selected from the group consisting of Protein A, Protein G and a synthetic mimetic affinity resin.

7. A method of purifying a protein expressed in a non-native limited solubility form in a non-mammalian expression system comprising: (a) expressing a protein in a non-native limited solubility form in a non-mammalian cell; (b) lysing a non-mammalian cell; (c) solubilizing the expressed protein in a solubilization solution comprising one or more of the following: (i) a denaturant; (ii) a reductant; and (iii) a surfactant; (d) forming a refold solution comprising the solubilization solution and a refold buffer, the refold buffer comprising one or more of the following: (i) a denaturant; (ii) an aggregation suppressor; (iii) a protein stabilizer; and (iv) a redox component; (e) directly applying the refold solution to a separation matrix under conditions suitable for the protein to associate with the matrix; (f) washing the separation matrix; and (g) eluting the protein from the separation matrix, wherein the separation matrix is a non-affinity resin selected from the group consisting of ion exchange, mixed mode, and a hydrophobic interaction resin.

US 9,643,997 (Amgen Inc.)

1. A method of purifying a protein expressed in a non-native soluble form in a non-mammalian expression system comprising: (a) lysing a non-mammalian cell in which the protein is expressed in a nonnative soluble form to generate a cell lysate; (b) contacting the cell lysate with a separation matrix under conditions suitable for the protein to associate with the separation matrix; (c) washing the separation matrix; and (d) eluting the protein from the separation matrix.

9. A method of purifying a protein expressed in a non-native limited solubility form in a non-mammalian expression system comprising: (a) solubilizing the expressed protein in a solubilization solution comprising one or more of the following: (i) a denaturant; (ii) a reductant; and (iii) a surfactant; (b) forming a refold solution comprising the solubilization solution and a refold buffer, the refold buffer comprising one or more of the following: (i) a denaturant; (ii) an aggregation suppressor; (iii) a protein stabilizer; and (iv) a redox component; (c) applying the refold solution to a separation matrix under conditions suitable for the protein to associate with the matrix; (d) washing the separation matrix; and (e) eluting the protein from the separation matrix.

US 9,856,287 (Amgen Inc.)

1. A method of refolding proteins expressed in a non-mammalian expression system, the method comprising: contacting the proteins with a preparation that supports the renaturation of at least one of the proteins to a biologically active form, to form a refold mixture, the preparation comprising: at least one ingredient selected from the group consisting of a denaturant, an aggregation suppressor and a protein stabilizer; an amount of oxidant; and an amount of reductant, wherein the amounts of the oxidant and the reductant are related through a thiol-pair ratio and a thiol-pair buffer strength, wherein the thiol-pair ratio is in the range of 0.001-100; and wherein the thiol-pair buffer strength maintains the solubility of the preparation; and incubating the refold mixture so that at least about 25% of the proteins are properly refolded.

10. A method of refolding proteins expressed in a non-mammalian expression system, the method comprising: contacting the proteins with a preparation that supports the renaturation of at least one of the proteins to a biologically active form, to form a refold mixture, the preparation comprising: at least one ingredient selected from the group consisting of a denaturant, an aggregation suppressor and a protein stabilizer; an amount of oxidant; and an amount of reductant, wherein the amounts of the oxidant and the reductant are related through a thiol-pair ratio and a thiol-pair buffer strength, wherein the thiol-pair ratio is in the range of 0.001-100; and wherein the thiol-pair buffer strength maintains the solubility of the preparation; and incubating the refold mixture so that about 30-80% of the proteins are properly refolded.

16. A method of refolding proteins expressed in a non-mammalian expression system, the method comprising: preparing a solution comprising: the proteins; at least one ingredient selected from the group consisting of a denaturant, an aggregation suppressor and a protein stabilizer; an amount of oxidant; and an amount of reductant, wherein the amounts of the oxidant and the reductant are related through a thiol-pair ratio and a thiol-pair buffer strength, wherein the thiol-pair ratio is in the range of 0.001-100, and wherein the thiol-pair buffer strength maintains the solubility of the solution; and incubating the solution so that at least about 25% of the proteins are properly refolded.

26. A method of refolding proteins expressed in a non-mammalian expression system, the method comprising: preparing a solution comprising: the proteins; at least one ingredient selected from the group consisting of a denaturant, an aggregation suppressor and a protein stabilizer; an amount of oxidant; and an amount of reductant, wherein the amounts of the oxidant and the reductant are related through a thiol-pair ratio and a thiol-pair buffer strength, wherein the thiol-pair ratio is in the range of 0.001-100, and wherein the thiol-pair buffer strength maintains the solubility of the solution; and incubating the solution so that about 30-80% of the proteins are properly refolded.

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Insulin Glargine - USA

On Nov. 19, 2019, Federal Circuit affirmed PTAB’s decision & found formulation patents covering insulin glargine (Lantus®) invalid under obviousness.

Sanofi-Aventis Deutschland GMBH’s owns U.S. Patent Nos. 7,476,652 and 7,713,930, which describe and claim certain formulations of a particular kind of insulin ie —insulin glargine. Mylan filed IPR petitions & board finally concluded that the subject matter of the claims is unpatentable for obviousness. Sanofi appealed.

Claim 7 of the ’652 patent is illustrative for present action:

 7. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin, at least one chemical entity chosen from polysorbate and poloxamers; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

Sanofi first commercially sold glargine in the U.S. in May 2001 (before priority), under the trade name Lantus®, whose product label identifies, among other things, a pH of 4. Some patients soon began reporting problems with turbidity in the vials, i.e., before injection. Sanofi determined that the turbidity was caused by undesirable “non-native” aggregation of the glargine protein while still in solution. Sanofi then resolved the vial-turbidity problem by adding a nonionic surfactant to the glargine formulation to prevent non-native aggregation.

During appeal Sanofi challenged the Board’s finding based on (1) KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), required the Board to find that the prior art disclosed an aggregation problem for glargine specifically (not just insulins in general); (2) the Board improperly relied on each patent’s own (shared) specification in finding a motivation to combine; and (3) substantial evidence does not support the Board’s finding because key evidence cited by the Board concerned insulins in general rather than glargine specifically.

With respect to first point, Sanofi argued that the Board was required, under KSR, to find in the prior art a recognition of an aggregation problem for glargine specifically, not just for insulins generally. But Federal Circuit said that in KSR, the Supreme Court criticized a rigid approach to determining obviousness based on the disclosures of individual prior-art references, with little recourse to the knowledge, creativity, and common sense that an ordinarily skilled artisan would have brought to bear when considering combinations or modifications. Nothing in KSR demands the kind of prior-art identifications of a problem at the level of specificity that Sanofi urges. The Board thus properly examined the evidence in this particular case to determine whether a relevant artisan would have recognized an insulin aggregation problem in the prior art and expected glargine to share that problem.

With respect to second point, Federal Circuit also rejected Sanofi’s contention that the Board committed legal error when it cited the shared patent specification, specifically background section. Sanofi challenged the Board’s reliance on this material as legally improper, invoking court’s longstanding recognition that a tribunal should not “look to knowledge taught by the inventor . . . and then use that knowledge against its teacher.” But Federal Circuit said that the Board did not violate that principle, because it did not use the specification for its teachings about the inventor’s discovery. Rather, it used the specification for its teachings about prior-art knowledge, and that use of a specification is not just common, given patent drafters’ standard practice of reciting prior art in setting out the background of the invention, but permissible. Moreover, the Board used the cited material not as the sole support for any finding but in conjunction with support from other sources. The Board found evidence of insulin aggregation on hydrophobic surfaces and at air/water interfaces in a handful of other prior-art references.

With respect to third point, Federal Circuit said that the Board’s findings with respect to the motivation to combine are detailed and well supported. The Board correctly found that insulins “had a known tendency to aggregate in the presence of hydrophobic surfaces” and at air-water interfaces and that a relevant artisan would have expected glargine to behave similarly to other insulins when in contact with hydrophobic surfaces and at air-water interfaces. The Board also found that nonionic surfactants, including the claimed ones, were well known and had been used successfully to stabilize insulin formulations, and so would have been looked to by a relevant artisan concerned about aggregation in glargine. Sanofi argued that the prior art discloses aggregation only in insulin pumps, but the Board disagreed, finding instead that “it is the air-water interfaces and interactions with hydrophobic surfaces that promote insulin aggregation, and not the type of device used to deliver the insulin formulation.”  Prior art & expert testimony supports the Board’s determination. The evidence also supports the Board’s finding that the prior art taught use of nonionic surfactants like those claimed in the present patents to address the aggregation problem.

Sanofi also challenged the Board’s finding that a relevant artisan would have had a reasonable expectation of success in adding the claimed surfactants to the existing glargine preparation in the way claimed in the patents at issue here. Sanofi specifically argued that, although surfactants were known to stabilize insulins generally, a relevant artisan would not have expected the same result for glargine specifically because its mechanism of action depends on some favorable native aggregation. Federal Circuit said that nonionic surfactants—were shown in the prior art to have been successfully used to prevent aggregation of various types of insulins and other peptides. Moreover, presence of phenols in a glargine formulation would not have dissuaded a relevant artisan from expecting success in using nonionic surfactants. Therefore, Board’s finding is supported by substantial evidence. Finally, Federal Circuit also rejected Sanofi challenge with respect to commercial success.

Federal Ciruit thus affirmed the Board’s decisions that all claims of the ’652 and ’930 patents are unpatentable for obviousness.

Weekly Patent Litigation Round-up

Federal Circuit Won't Restore Merck's $2.5 Billion Patent Win Over Gilead

The Federal Circuit Court of Appeals has decided not to restore Merck’s historic $2.5 billion patent win over Gilead in a hepatitis C drug dispute. Merck and its subsidiary Idenix Pharmaceuticals sued Gilead in 2013 alleging that its hepatitis C treatments Sovaldi and Harvoni infringed on a patent Idenix had for treating hepatitis C. The case went to trial in December 2016 and a jury ruled in Merck’s favor, awarding the drugmaker $2.5 billion — the largest patent award ever. A federal judge threw out the verdict in 2018 finding that the patent was invalid. The Federal Circuit Court of Appeals has upheld the judge’s ruling, agreeing that the patent was invalid for “lack of written description” of how the invention worked…

https://www.fdanews.com/articles/193412-federal-circuit-wont-restore-mercks-25-billion-patent-win-over-gilead

6 things readers should know about Liconsa v. Boehringer Ingelheim

Our friends from the EPLAW Patent Blog recently published an interesting blog commenting on the judgment of 29 March 2019 from the Court of Appeal of Barcelona (Section 15) where, among other aspects, the requirements for requesting the limitation of a European patent before the Spanish Patents and Trademarks Office (“SPTO”) were discussed. As explained in such blog, the Court came to the conclusion that the limited patent published by the SPTO was not enforceable because the judicial authorization foreseen in article 105.4 of the new Patents Act had not been obtained. For the readers’ benefit, it will be helpful to remember that, according to that article 105 “4. If judicial proceedings on the validity of the patent are pending and without prejudice to the provisions of article 120, the request for limitation, addressed to the Spanish Patent and Trademark Office, must be authorized by the Judge or Court that handles the proceedings….

http://patentblog.kluweriplaw.com/2019/11/12/6-things-readers-should-know-about-liconsa-v-boehringer-ingelheim/

Gilead vs. Dutch Patent Office (tenofovir / emtricitabine), District Court of The Hague 30 October 2019

The plaintiff in this matter, Gilead Sciences Inc. (“Gilead”), markets a medicinal product under the name Truvada. As many European patent practitioners will know, this product consists of a combination of the active ingredients tenofovir dispoproxil and emtricitabine. According to its SmPC, Truvada is used in combination with other antiretroviral drugs for the treatment of HIV. Gilead was the patentee of the – meanwhile expired – patent EP 0 915 894 B1 titled ‘Nucleotide Analogs’ (“EP 894”). The compound mentioned in claim 25 of this patent concerns tenofovir disoproxil. Gilead has applied for a supplementary protection certificate (“SPC”) for this medicinal product on the basis of the SPC Regulation with the Dutch Patent Office. Gilead based its SPC application on the basic patent EP 894..

http://eplaw.org/nl-gilead-vs-dutch-patent-office-spc-tenofovir-emtricitabine/

Roche's Chugai claims Alexion co-opted its patented tech in building Ultomiris

Alexion has a lot riding on the launch for Ultomiris, its long-acting follow-up to Soliris. But Roche's Chugai says the new med is built on its own patented drug-delivery technology—and it's suing to stop the new launch in its tracks. Chugai filed a lawsuit in Delaware federal court alleging Alexion deliberately infringed its patent on the technology that cuts Ultomiris' typical dosing to once every eight weeks from Soliris' biweekly schedule. Both drugs are C5 inhibitors designed to treat certain rare diseases. Chugai developed and patented technology that “extends the half-life of an antibody in blood plasma, thereby improving the duration of time in which the antibody binds and neutralizes target antigens," the lawsuit states…

https://www.fiercepharma.com/pharma/roche-s-chugai-says-alexion-s-long-acting-ultomiris-infringes-one-its-patents

Nuvo Pharmaceuticals™ Announces United States District Court Denies Dr. Reddy's Laboratories Motion for Summary Judgment of Nuvo's '996 and '920 VIMOVO Patents

MISSISSAUGA, ON, Nov. 11, 2019 /CNW/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI; OTCQX:NRIFF), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, today announced that the United States District Court for the District of New Jersey has denied a motion for summary judgment filed by Dr. Reddy's Laboratories Inc. (DRL).  As a result, the patent infringement litigation against DRL, involving Nuvo Pharmaceuticals (Ireland) DAC's (Nuvo Ireland) U.S. Patent Nos. 8,858,996 and 9,161,920 (the '996 and '920 patents), will continue. The parties have mutually agreed on a pre-trial litigation schedule with the court through to April 2021.  The term of the '996 and '920 patents extends to May 31, 2022.…

https://www.prnewswire.com/news-releases/nuvo-pharmaceuticals-announces-united-states-district-court-denies-dr-reddys-laboratories-motion-for-summary-judgment-of-nuvos-996-and-920-vimovo-patents-300955249.html

Allergan Agrees to Pay $750M to Settle Alzheimer’s Drug Lawsuit

Allergan will pay $750 million to settle lawsuits related to their Namenda Alzheimer’s drug. The settlement will resolve a class-action lawsuit alleging that the Ireland-based company attempted to prevent or delay the entry of generic competitors. The lawsuit came after the New York attorney general won a settlement that made similar claims. The trial was slated to begin at the end of October. The lawsuit claimed that in 2014, Allergan tried to prevent access to lower-cost generics of its Namenda product by requiring patients to switch to a longer-acting and more expensive version of the drug: Namenda XR. The practice is known as “product hopping” or “hard switch.”…

https://www.legalscoops.com/allergan-agrees-to-pay-750m-to-settle-alzheimers-drug-lawsuit/

Terlipressin - USA

IPR decision: Nov. 13, 2019

AIA Review #	Filing Date	Institution Date	Petitioner	Patent	Respondent	FINAL WRITTEN DECISION
IPR2018-00974	04/27/2018	11/14/2018	Mallinckrodt	9,655,945	BioVie, Inc.	All Challenged Claims Unpatentable

US 9,655,945 (Biovie Inc.; Exp: Jun 30, 2036) – Non-OB

1. A method for treating a patient diagnosed with ascites due to liver cirrhosis, the method comprising administering terlipressin or salt thereof as a continuous infusion dose of about 1.0 mg to about 12.0 mg per day to the patient for about one day to about 12 months.

7. A method for reducing the accumulation of ascitic fluid in the abdominal cavity in an ambulatory ascites patient, the method comprising administering to the patient terlipressin or salt thereof as a continuous infusion dose of about 1.0 mg to about 12.0 mg per day for about one day to about twelve months with an ambulatory infusion pump.