Saturday, December 14, 2019

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. .



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…



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…”



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. .



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.



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…



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.”…



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…



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...



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..



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” …



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..


Thursday, December 12, 2019

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.

Friday, December 6, 2019

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.

Thursday, November 28, 2019

Job Update

Function: IPR-API

Company: Enaltec labs

Location: Ambernath, Mumbai

Experience: 4-9 years

Qualification: M. Pharmacy / Msc (Chemistry)

Contact info: Namita Raul
E mail: namita.raul@enaltecpharmaresearch.com


If you know or have any vacancy in your IP department then you can contact me at: 
mahen_gunjal@yahoo.co.in 
WhatsApp: +91-7774007489

Wednesday, November 20, 2019

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.

Sunday, November 17, 2019

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…


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….


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..


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…


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.…


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/

Thursday, November 14, 2019

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.

Friday, November 1, 2019

Sofosbuvir - USA

On Oct 30, 2019, Federal Circuit affirmed Delaware Court's decision which found Idenix’s patent invalid for lack of enablement and additionally CAFC also found that said patent is invalid for lack of written description requirements.

Previously plaintiffs, Idenix Pharmaceuticals LLC and Universita Degli Studi di Cagliari (together, "Idenix") sued Defendant Gilead Sciences, Inc. ("Gilead"). Prior to trial, Gilead stipulated that, under the Court's claim construction, its accused products, Harvoni and Sovaldi, infringe the asserted claims of ldenix's patent, U.S. Patent No. 7,608,597 ("'597 patent"). After a two week-trial in December 2016, a jury found that Gilead failed to prove that the asserted claims are invalid and awarded Idenix $2.54 billion in damages. Gilead then requested judgment as a matter of law ("JMOL"). In its JMOL motion, Gilead argued that Idenix's asserted patent claims are invalid for failure to meet 35 U.S.C. § 112's written description and enablement requirements. District court granted motion with respect to lack of enablement & found patent invalid. However, court denied motion with respect to written description. Please see the previous blog "reported here".

During appeal, Federal Circuit affirmed district court regarding lack of enablement. Specifically, court held that patent fails to disclose "2-methyl up & 2-fluro down" position on nucleoside as claimed. Therefore, claimed method of treatment using generic formula encompasses thousands of compounds & POSA would not be able to come up with specific compound without undue experimentations. Court considered "Wands factor" and held that it favours lack of enablement.

With respect to written description, Federal Circuit reversed district court which denied the motion. Federal Circuit said that the question is whether the inventor had possession of "2-methyl up" along with "2-fluro down" nucleoside compounds having antiviral activity as per entire scope of claim. Idenix argued that generic compounds can be satisfied by representative number of species in the specification. But court said that there should be blaze marks instead of pointers in the specification in order to satisfy written description requirement. Here, specification fails to provide blaze marks for "2-methyl up" compounds which are used to treat HCV. Specification does not identify which compounds are useful in treating HCV and which are not. Moreover, the absence of "2-fluoro down" is indeed conspicuous. Examples disclose this "2-fluoro" group at "up" position and not at "down" position. Idenix argued that though fluorine is not directly mentioned at "down" position but POSA would have find it obvious to include it there in view of the other halogens. But Federal Circuit said that a description that merely renders the invention obvious does not satisfy the written description requirement.

Thus, the patent is invalid for lack of enablement as well as for lack of written description requirement.

Wednesday, October 23, 2019

Ivermectin - USA


Claim Construction (District of Delaware): Oct 22, 2019

Presently before the Court is the issue of claim construction of a term in U.S. Patent No. 10,206,939 ("the '939 patent"). The patent relates to methods and compositions for topical treatment of rosacea with ivermectin. The parties dispute a term recited in claims 8, 9, 20, 21, and 22 of the '939 patent.


CONSTRUCTION OF DISPUTED TERMS:

1. "wherein the subject has no adverse reaction, [wherein/and] the adverse reaction is skin burning sensation or skin irritation"

a. Plaintiffs' proposed construction: "wherein the treatment results in a low incidence of skin burning sensation or skin irritation"

b. Defendant 's proposed construction: "wherein the pharmaceutical composition is well tolerated with a low incidence of skin burning sensation or skin irritation"

c. Court 's construction: "wherein the treatment results in a low incidence of skin burning sensation or skin irritation"





Saturday, October 12, 2019

Diclofenac - USA


On Oct 10, 2019, Federal Circuit affirmed district court’s decision which prohibited Actavis from marketing generic version of PENNSAID 2% till Oct 2027.

Horizon is the assignee of U.S. Patent Nos. 8,217,078; 9,132,110; 8,618,164; 8,546,450 (method of use patents); and US 9,168,304; 9,168,305; 9,101,591; 8,563,613; 9,220,784; 8,871,809; 8,252,838; 9,066,913 (formulation patents). These patents are listed in orange book for PEENSAID 2% (diclofenac topical solution). It is used for trating knee pain. Actavis sought to market a generic version of PENNSAID 2% and filed ANDA.Horizon then sued Actavis in New Jersey court.

Claim 10 of the ’450 patent is illustrative of the asserted claims of the method-of-use patents:

10. A method for applying topical agents to a knee of a patient with pain, said method comprising: applying a first medication consisting of a topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation comprises a therapeutically effective amount of a diclofenac salt and 40–50% w/w dimethyl sulfoxide; waiting for the treated area to dry; subsequently applying a sunscreen, or an insect repellant to said treated area after said treated area is dry, wherein said step of applying a first medication does not enhance the systemic absorption of the subsequently applied sunscreen, or insect repellant; and wherein said subsequent application occurs during a course of treatment of said patient with said topical diclofenac preparation.

Claim 49 of the ’838 patent is illustrative of the asserted claims of the formulation patents:

49. A topical formulation consisting essentially of: 1–2% w/w diclofenac sodium; 40–50% w/w DMSO; 23–29% w/w ethanol; 10–12% w/w propylene glycol; hydroxypropyl cellulose; and water to make 100% w/w, wherein the topical formulation has a viscosity of 500–5000 centipoise.

New Jersey court in its deciosn found certain terms indefinite, noninfingement with respect to ANDA label & finally nonobviouness of particular claim. Horizon appealed and Actavis cross-appealed the district court’s final judgment.

I Claim construction:

During claim construction, the district court found that the term “the topical formulation produces less than 0.1% “impurity A” after 6 months at 25°C and 60% humidity” was indefinite the identity of “impurity A” is unknowable to a person of ordinary skill in the art (“POSITA”). Second, the district court found that the term “the formulation “degrades” by less than 1% over 6 months” was indefinite because neither the claims nor the specification disclose the means to evaluate degradation. Third, the district court found that the term “consisting essentially of” was indefinite.

Upon appeal, Federal Circuit with respect to term “impurity A” agreed with district coiurt & said that POSITA would not know, with reasonable certainty, the identity of the substance as claimed. The term “impurity A” only appears in claim 4 and Example 6 of the ’913 patent. Court daid that Horizon does not cite to any part of the specification, the claims, or the prosecution history that defines or directly connects “impurity A” to USP Compound A which Horizon attemped to connect. Because the specification omits the details of the HPLC experiment—such as the column, the mobile phase, and the flow rate—a POSITA faced with this specification would not reasonably presume that Example 6 was undertaken using a pharmacopoeia chromatographic system. This outcome undermines Horizon’s reliance on the pharmacopoeias to extrapolate meaning into “impurity A.”

With respect to “degrades” term, federal circuit said that district court’s finding that the claims reciting the “degrades” term are indefinite follows from the indefiniteness determination about “impurity A.” Since “impurity A” is indefinite, it logically follows that another term, such as the “degrades” term, which relies on “impurity A” for its construction, must also be indefinite.

With respect to “Consisting Essentially Of” term, federal circuit said that district court properly considered this term in accordance with legal meaning: “consisting of only the specified materials and those that do not materially affect the basic and novel properties of the claimed invention.” Parties’ dispute focuses on the basic and novel properties of the formulation patents. Court said that the specification of the formulation patents identified five basic and novel properties: (1) better drying time; (2) higher viscosity; (3) increased transdermal flux; (4) greater pharmacokinetic absorption; and (5) favorable stability.

Horizon argues that the Nautilus definiteness standard focuses on the claims and therefore does not apply to the basic and novel properties of the invention. Court further said that Supreme court’s Nautilus definiteness standard applies to the basic and novel properties of an invention. Because by using the phrase “consisting essentially of” in the claims, the inventor in this case incorporated into the scope of the claims an evaluation of the basic and novel properties. Having determined that the basic and novel properties of an invention are part of the scope of the claims in this case, it follows that those basic and novel properties, “when read in light of the specification and the prosecution history, must provide objective boundaries for those of skill in the art.” Now with respect to drying time, court found that the two different methods for evaluating “better drying time” do not provide consistent results at consistent times. Court also found persuasive the testimony of Actavis’s expert that a POSITA would not know under what standard to evaluate the drying rate. Therefore, court concluded that the phrase “consisting essentially of” was indefinite based on its finding that the basic and novel property of “better drying time” was indefinite on this record.

II. Summary Judgment of non-infringement:

On January 27, 2017, after the district court reaffirmed its claim constructions and related indefiniteness determinations, Actavis filed a motion for summary judgment of noninfringement. Actavis argued that there was no dispute that Actavis did not directly infringe the patents-atissue, and that, while Horizon premised its allegations of induced infringement upon the labeling of Actavis’s ANDA product.

Court said that Actavis’s ANDA product, diclofenac sodium topical solution 2%, is a generic version of Horizon’s PENNSAID®2%. Both products are directed to the treatment of osteoarthritis pain on the knees.

Main disputed part of the label was following warning portion which states:

“Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution”.

Court evaluated Actavis’s label vis-à-vis the claims of the method-of-use patents and noted that the dispute between the parties centered around the warning in Actavis’s label to wait until the treated area is dry before covering it or applying another substance.  Although Horizon recognizes that not every user will need to apply sunscreen, insect repellant, or another topical medication, it contends that, when such need arises, Actavis’s instruction will lead to an infringing use.  Actavis argues that its proposed label does not induce infringement because, unlike the method-of-use patents, its label does not promote the application of a second topical agent after application of the diclofenac sodium gel. Actavis maintains that its label never affirmatively instructs the patient to apply anything after the diclofenac sodium gel; the label merely permits applying a second topical agent after the patient waits for the diclofenac sodium to dry. Its label, therefore, does not contain any instruction that induces infringement.

Court said that the patented method here requires three distinct steps. The user must: (1) apply the inventive formulation, (2) wait for the area to dry, and (3) apply sunscreen, insect repellant, or a second topical medication. The instructions in Actavis’s label, however, only require the first step of this method, nothing else. The warning, then, operates in an “if/then” manner: if the user wants to cover the treated area with clothing or apply another substance over it, then the patient should wait until the area is dry. This does not encourage infringement, particularly where the label does not require subsequent application of sunscreen, insect repellant, or a second medication. Court thus held that “Actavis’s proposed label does [no] more than simply permit, rather than require or direct, the post-product application of sunscreen, insect repellant, or a second topical medication.”  The fact that Actavis’s label does not require subsequent application of other products reflects that the product has “substantial noninfringing uses, [and] intent to induce infringement cannot be inferred even [if Actavis] has actual knowledge that some users of its product may be infringing the patent.”

III. Trial on obviousness:

The district court’s Markman and summary-judgment orders disposed of most of the asserted claims of the patents-at-issue. At trial, only one claim remained—claim 12 of the ’913 patent. Actavis maintained that claim 12 of the ’913 patent was invalid as obvious. Actavis stipulated that if the claim was found not invalid at trial, its ANDA product would infringe the claim. On May 12, 2017, the district court found that Actavis had not shown, by clear and convincing evidence, that claim 12 of the ’913 patent is invalid for obviousness.

During appeal, Actavis argued that the district court erred by requiring that the prior art predict the exact formulation of the asserted claim. For obviousness arguments Actavis relied on previous formulation i.e. PENNSAID 1.5% which differes qualitatively with respect to HPC & quantitatively  with respect to certain excipients when compared to PENNSAID 2%. Federal Circuit sided with district court which credited Horizon’s expert’s (Dr. Bunge’s) testimony that the inventive formulation was complex and that a POSITA would be challenged to predict relative ratios in order to achieve the desired goal of PENNSAID® 2%. Court also found that the combination of changes to the PENNSAID® 1.5% formulation were not obvious optimizations of result-effective “variables that would produce a predictable result, particularly as to the formulation’s absorption, thickness, and drying time.” Court also found that the variables involved in this case, including the components of the inventive formulation, interact in an unpredictable or unexpected way, such that the results emanating into PENNSAID® 2% were not obvious. Court found that nothing in the prior art allowed a POSITA to find “the schematic or roadmap to a diclofenac gel effective at two doses a day compared to prior art’s four doses a day.” Court thus held that claim 12 of the ’913 patent was nonobvious.