Adalimumab - USA

Decision on IPR:

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	Status
IPR2016-00408 & IPR2016-00409	12/29/2015	07/07/2016	Boehringer Ingelheim GmbH	8,889,135	AbbVie Biotechnology Ltd.	Final Written Decision - Jul 6, 2017 (Claims 1-5 are unpatentable)

The ’135 patent, titled “Methods of Administering Anti-TNFα Antibodies,” issued on November 18, 2014. The ’135 patent discloses methods of treating rheumatoid arthritis (“RA”) with a human anti-tumor necrosis factor α (“TNFα”) antibody.

Esomeprazole – Canada

On Jun 30, 2017 in a unanimous decision, the Supreme Court held that the promise doctrine is not the correct approach to determine whether a patent has sufficient utility. As a result, the lower court decisions finding the patent CA 2,139,653 at issue directed to optically pure salts of esomeprazole invalid for want of utility, were set aside [AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 (on appeal from 2014 FC 638 and 2015 FCA 158)].

Apotex sought to sell a generic version of NEXIUM, applying for a Notice of Compliance to the federal Minister of Health to enable it to do so. AstraZeneca then applied to the Minister of Health to stop the issuance of a Notice of Compliance to Apotex. This application was dismissed by Justice Hughes in 2010, allowing Apotex to launch. AstraZeneca brought an action for patent infringement against Apotex. Apotex counterclaimed for invalidity.

At first instance, Justice Rennie found that the '653 was novel and inventive, but lacked utility.  Although the patent proved to be useful for some purposes, it was invalid because "it promised more than it could provide".  Thus, falling foul of the Promise Doctrine.  The Federal Court of Appeal dismissed AstraZeneca's appeal.  AstraZeneca appealed to the Supreme Court arguing that the Promise Doctrine was unsound. The Supreme Court agreed.

The ruling spells an end to the so-called “Promise Doctrine”. This allowed a patent on a drug to be ruled invalid if a court decided the medication had not lived up to all the promises that a firm had made to be granted the patent in the first place. The Court found that the Doctrine is excessively onerous in two ways: (1) it determines the standard of utility that is required of the patent by reference to the promises expressed in the patent; and (2) where there are multiple expressed promises of utility, it requires that all be fulfilled for a patent to be valid.

The Court stated that utility requires the subject matter of an invention to be useful.  This means that the invention must be capable of an actual use relevant to the subject matter and not devoid of utility.  The Court stated: "A single use related to the nature of the subject-matter is sufficient and utility must be established by either demonstration or sound prediction as of the filing date."

To determine whether a patent discloses an invention with sufficient utility, the courts should adopt a two-stage test:

1      1. Courts must identify the subject-matter of the invention as claimed in the patent

2  2. Courts must ask whether that subject-matter is useful - is it capable of a practical purpose (ie. actual result)

In the case at issue the subject of the patent that must be useful for the purposes of section 2 is the "optically pure salts of the enantiomer of omeprazole". It was accepted at first instance that at the filing date the optically pure salts of the enantiomer of omeprazole would be useful as a proton pump inhibitor to reduce the production of gastric acid.  Use as a proton pump inhibitor is related to the subject matter of the patent, thereby making it useful within the meaning of section 2.  This is sufficient utility to satisfy the requirements of section 2.

The doctrine, which came into force in 2005, has already been used to invalidate almost 30 medical patents.

Asenapine – USA

On Jun 30, 2017 a Delaware court issued opinion in SAPHRIS® (Asenapine) case & upheld validity and partly an infringement of U.S. Patent No. 5,763,476.

This consolidated case arises out of the filing of Abbreviated New Drug Applications ("ANDAs") by defendants Sigmapharm Laboratories, LLC ("Sigmapharm"); Breckenridge Pharmaceutical, Inc. ("Breckenridge"); Hikma Pharmaceuticals, LLC, Hikma Pharmaceuticals, PLC, and West-Ward Pharmaceutical Corporation (collectively, "Hikma"); Alembic Pharmaceuticals Ltd., Alembic Global Holding S.A., and Alembic Pharmaceuticals, Inc. (collectively, "Alembic"); and Amneal Pharmaceuticals, LLC, Amneal Pharmaceuticals of New York, LLC, and Amneal Pharmaceuticals Co. India PVT.LTD (collectively, "Amneal"). All defendants may be collectively referred to as "defendants." Each of the defendants has submitted an ANDA in an attempt to market generic versions of asenapine before the expiration of U.S. Patent No. 5,763,476 ("the '476 patent"), which claims sublingual or buccal compositions of asenapine and methods of using such compositions to treat mental disorders, including schizophrenia. Plaintiffs Forest Laboratories, LLC and Forest Laboratories Holdings, Ltd. (collectively, "Forest" or "plaintiffs") brought patent infringement suits against each of the defendants, which suits were consolidated into the above captioned suit.

In the case tried before the court, each of the defendants conceded infringement of claim 1 of the '476 patent and two of the four defendants (Amneal and Hikma) conceded infringement of claim 4. Therefore, the focus of the trial (conducted in the fall of 2016) was infringement of claim 4 and the validity of the '476 patent. Based on the invention as disclosed in the specification, asserted claim 4 recites:

"A method for treating tension, excitation, anxiety, and psychotic and schizophrenic disorders, comprising administering sublingually or buccally an effective amount of a pharmaceutical composition comprising trans-5-chloro-2-methyl-2,3,3a, 12b-tetrahydro- 1Hdibenz[2,3:6,7]oxepino[4,5-c]pyrrole [asenapine] or a pharmaceutically acceptable salt thereof."

Infringement:

As noted, all defendants have conceded infringement of claim 1, as well as dependent claims 2, 5, and 6 of the '476 patent. Only defendants Alembic and Breckenridge challenge infringement of claim 4. Consistent with the parties' dispute, claim 4 contains essentially three relevant limitations: "A method for treating ... [1] excitation ... disorders, comprising [2] administering sublingually or buccally an [3] effective amount of a pharmaceutical composition [asenapine] or a pharmaceutically acceptable salt thereof." Defendants Alembic's and Breckenridge's proposed labels provide literal instructions to carry out elements [2] and [3] of the claim i.e., [2] sublingually administering [3] an effective amount of asenapine maleate to treat the indicated disorder, that is, manic episodes associated with bipolar I disorder. The only issue for the court to decide concerns limitation [1] in the claim, that is, whether defendants infringe claim 4 even though their generic asenapine products are indicated only for the treatment of "manic episodes" associated with bipolar I disorder & not for excitation.

1. Direct infringement under the doctrine of equivalents

The court construed the phrase "tension, excitation, anxiety, and psychotic and schizophrenic disorders" as not literally including the treatment of bipolar disorder, including manic or mixed episodes associated with bipolar I disorder. The court explained that the word "bipolar" was not used or described in the specification and, indeed, the use of asenapine to treat bipolar disorder was claimed in a later patent application. Forest argued that the term "excitation" in the claim includes within its literal scope "mania" and, therefore, the claim covers the treatment of the manic component of bipolar disease. To put the point differently, Forest argues that, to the extent there are any differences between the treatment of manic episodes associated with bipolar I disorder with asenapine and the treatment of excitation with asenapine recited in claim 4, such differences are insubstantial; i.e., the two treatments are equivalent.

Despite Dr. Mcintyre's efforts to convince the court that those of skill in the art in 1994, as a general proposition, equated the term "excitation" with "mania," the court remains unconvinced. In the first instance, there is no reference of record that literally describes "excitation" as the defining feature of mania. Instead, the references refer to "excitement" (and the words Dr. Mcintyre equates with excitement) as one of several criteria that must be present to properly diagnose a manic episode of bipolar I disorder. In sum, there is no dispute that "excitation" is not itself a disorder. There is also no dispute that "excitation" can be symptomatic of many disorders. The court, however, finds no persuasive objective evidence that those of skill in the art in 1994 considered "excitation" the sine qua non of "mania" such that the two terms would be equated for purposes of treating a patient with asenapine.

2. Indirect infringement

In the absence of direct infringement, there can be no liability for indirect infringement. Nevertheless, the court will address Forest's evidence relating to inducement for completeness. Alembic's and Breckenridge's original ANDA submissions (like the other defendants at bar) contained proposed labels that included all of the Saphris approved indications - schizophrenia and manic and mixed episodes associated with bipolar I disorder. Subsequent to the court's claim construction order, Alembic and Breckenridge submitted new labels to the FDA that proposed removing schizophrenia as an indication. According to Forest, the proposed labels also provide sufficient instructions for doctors and patients to administer the generic asenapine products sublingually, and to use an "effective amount" of asenapine to treat schizophrenia, as required by claim 4. More specifically, defendants' proposed labels include a section titled "Dosage Forms and Strengths," which indicates that their asenapine sublingual tablets are available in 5 mg and 10 mg doses. The recommended dosing for schizophrenia and bipolar mania are similar. The Saphris label indicates that the starting dose for schizophrenia is 5 mg sublingually twice daily, with a recommended dose of 5 to 10 mg sublingually twice daily and a maximum dose of 10 mg sublingually twice daily.

Despite these essentially undisputed facts, the Federal Circuit has held that even the "knowledge of off-label infringing uses" will not establish inducement. The facts at bar are unusual, 17 but not more compelling than the facts reviewed by the Federal Circuit in Takeda. The court concludes that the evidence proferred by Forest in this regard is insufficient to establish a specific intent on the part of Alembic or on the part of Breckenridge to induce infringement of claim 4 of the '476 patent.

Invalidity due to Obviousness

Defendants rely on the teachings of three different prior art combinations to demonstrate that the subject matter of claim 1 of the '476 patent is obvious: (1) Sitsen (PTX 37) 19 in view of the '516 patent (PTX 28); (2) Van der Berg '434 patent (PTX 133) in view of the '516 patent; or (3) Van der Berg '434 patent in view of the '423 application (PTX 30), each combined with the knowledge of the ordinarily skilled artisan. Defendants argue that the prior art identified above would have motivated persons of skill in the art to formulate asenapine ("a new and promising antipsychotic in 1994," D.I 288 at 26) as a rapidly disintegrating composition (consistent with the improved composition platforms disclosed in the '516 patent and '423 application) with a reasonable expectation of success.

The court discerns no motivation from the record evidence to use a sublingual formulation-a formulation that had never before been used for an antipsychotic drug. Courts have recognized that solving an unrecognized problem in the art can itself be an nonobvious patentable invention, even where the solution is obvious once the problem is known. Eibel Process Co. v. Minn. & Ontario Paper Co., 261 U.S. 45, 68 (1923). The record at bar demonstrates that it was unknown in the art that oral or IV administration of asenapine could cause severe cardiotoxic side effects. There were numerous other formulations that could have been experimented with to try to solve the problem, but no reasonable expectation that any of them would have. Accordingly, the use of a sublingual formulation was not obvious.

Invalidity due to Lack of Written Description

Defendants allege that the claims of the '476 patent lack adequate written description because the specification does not adequately describe asenapine free base. The evidence adduced at trial demonstrates that a skilled artisan would understand that the inventors of the '476 patent were in possession of compositions comprising asenapine free base and methods of using these compositions to treat the claimed conditions. Not only does the '476 patent explicitly describe asenapine in its free base form, it indicates that "[t]he invention therefore relates to a sublingual or buccal pharmaceutical composition comprising [asenapine free base. The fact that there is no explicit example of a sublingual or buccal composition containing asenapine free base or use of such a composition is not dispositive. Under controlling precedent, explicit examples are not needed to provide adequate written description support. Ariad, 598 F .3d at 1352; Fa/ko-Gunter, 448 F .3d at 1366.

Invalidity due to Lack of Enablement

Defendants' non-enablement contention rests on the allegation that a single embodiment (a composition comprising asenapine free base) out of many is not enabled. This argument is legally insufficient. See In re Angstadt, 537 F.2d 498, 502- 503 (C.C.P.A. 1976) (holding that patent applicants are not required to enable every species encompassed by their claims). Defendants have failed to establish, by clear and convincing evidence, that the asserted claims are not enabled.

Objective indicia

The record at bar demonstrates that it continues to be a surprising and unexpected result of the claimed invention that the sublingual route of administration successfully resolved the serious cardiotoxic event reported in the '476 patent. Based on the IV study, even the inventors of the '476 patent believed that sublingual administration would also result in a negative outcome. (D.I. 311 at 269:24-270:18) And there is nothing in the prior art suggesting that sublingual administration could be used to resolve this type of side effect.

Given the problems with typical antipsychotics and the two atypical antipsychotics available as of 1994, skilled artisans recognized the need for additional antipsychotic drugs that had minimal EPS symptoms as well as a favorable weight gain, metabolic, and prolactin profile. Asenapine met the criteria for Long-felt need.

CONCLUSION: For the reasons stated, Forest has not carried its burden to prove, by a preponderance of the evidence, that defendants Alembic and Breckenridge infringe claim 4 of the '476 patent. Defendants have failed to carry their burden to prove, by clear and convincing evidence, that claims 1 and 4 of the '476 patent are invalid by reason of obviousness, lack of written description, or lack of enablement.

Naproxen & Esomeprazole – USA

On  June 27, 2017 a  United States District Court for the District of New Jersey upheld the validity of two patents owned by a subsidiary of Aralez and licensed to Horizon Pharma plc covering VIMOVO® (naproxen/esomeprazole magnesium), and that Dr. Reddy's Laboratories Inc. and Dr. Reddy's Laboratories Ltd. ("Dr. Reddy's"), Mylan Pharmaceuticals Inc., Mylan Laboratories Ltd., and Mylan Inc. ("Mylan"), and Lupin Ltd. and Lupin Pharmaceuticals Inc. ("Lupin") would infringe at least one of the two patents with their proposed generic naproxen/esomeprazole magnesium products.

On April 21, 2011, July 25, 2011, and June 28, 2013, an Aralez subsidiary filed patent infringement lawsuits in District Court against Dr. Reddy's, Lupin, and Mylan, respectively, related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market generic versions of VIMOVO.  The lawsuits claim infringement of U.S. Patent Nos. 8,557,285 ('285 patent) and 6,926,907 ('907 patent) titled "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs," which cover VIMOVO.  The District Court's decision was made based on the validity of the '285 and '907 patents for VIMOVO and the Court's judgment will prevent Dr. Reddy's, Mylan, and Lupin from launching generic versions of VIMOVO in the United States until at least the expiration of the relevant patent.

VIMOVO has 14 Orange Book listed patents with terms that extend to 2031. Other ANDA filers include Anchen pharma & Watson. Coalition for Affordable Drugs filed 4 different Inter Partes Reviews (IPR) on US 6,926,907; US 8,858,996; US 8,852,636 & US 8,945,621 patents. PTAB denied institution of all IPRS except one which is related to US’621. In final decision w.r.t US’621 patent, Board upheld the claims as patentable. No appeal was taken.   

        

Sofosbuvir - USA

On Jun 21, 2017 a Federal Circuit panel affirmed a Patent Trial and Appeal Board (PTAB) ruling in Interference proceedings that Gilead Pharmasset LLC invented a hepatitis C treatment before Idenix Pharmaceuticals LLC and will be granted a patent.

The patent interference contest involved methods of treating hepatitis C by administering compounds having a specific chemical and stereochemical structure. The interference was declared between an issued patent (US 7,608,600, Storer; assigned to Idenix Pharmaceuticals) and a pending application (US11/854,218, Clark; assigned to Gilead), both of which were filed before the effective date of the America Invents Act. PTAB held that Storer’s provisional application was not enabling for the count of the interference, and on that ground the PTAB entered judgment granting priority to Clark. Storer appeals that judgment.

The only question focuses on whether the Storer’s provisional application together with the prior art enabled compounds having a 2´F(down) substituent. “When a party to an interference seeks the benefit of an earlier-filed United States patent application, the earlier application must meet the requirements of 35 U.S.C. § 120 and 35 U.S.C. § 112 ¶ 1 for the subject matter of the count.” Hyatt v. Boone, 146 F.3d 1348, 1352 (Fed. Cir. 1998). To establish enablement of a claim whereby new chemical compounds are provided for use to treat disease, the application must enable production or synthesis of the new compounds. In re Brebner, 455 F.2d 1402, 1404 (C.C.P.A. 1972).

The Board determined that the claimed compounds having a 2´F(down) substituent were not enabled in Storer’s S1 provisional application, in that undue experimentation would be required to produce this structure. The Board analyzed the disclosure in terms of the evidentiary factors set forth in Wands & concluded that:

(1) synthesis of a 2ˊ-fluoro-2ˊ-methyl nucleoside with the fluoro moiety in the “down” position required at least two years of a high-priority experimentation by persons skilled in the art, including multiple consultations with experts at the top of their fields and additional formal training;

(2) the S1 application provides little in the way of direction or guidance as to how to synthesize such a compound;

(3) the S1 application provides no explicit example of a 2ˊ-fluoro-2ˊ-methyl nucleoside, nor was an example provided by the relevant art as of the S1 application’s filing date;

(4) the invention is characterized as the administration of a genus of nucleosides used in the treatment of viruses, particularly those of the family Flaviviridae (which includes HBV and HCV) and an embodiment of the count requires a 2ˊ-fluoro(“down”) 2ˊ-methyl nucleoside;

(5) although organic fluoridation techniques were well-known in the art at the time the S1 application was filed, fluoridation of tertiary alcohols to produce a 2ˊ “down” tertiary fluorine was not taught or suggested by the prior art;

(6) the level of skill in the art was highly sophisticated: a person possessing the ordinary level of skill in this art, as of the time of invention, would hold a doctoral degree in the field of organic, synthetic, or medicinal chemistry with at least a year’s experience in the field of nucleoside synthesis or relevant drug discovery; and

(7) the art, at least with respect to fluoridation of tertiary alcohols to produce a tertiary fluorine in the 2ˊ “down” position, was highly unpredictable.

We therefore find that Wands factors 1, 2, 3, 5, and 7 strongly indicate that a person skilled in the art would not arrive at the claimed invention without undue experimentation.

On appeal Storer argues that the Matsuda reference, together with the information in the S1 provisional, enable synthesis of 2´F(down) compounds. On review, Federal circuit concluded that substantial evidence supports the Board’s findings that the synthetic schemes in Storer’s provisional application do not teach or suggest conversion of any precursor into the 2´F(down) structure, and that the Matsuda synthesis of a corresponding 2´- methyl (down), 2´-hydroxyl (up) structure does not enable a person of ordinary skill to produce the target compounds without undue experimentation.

The first Wands factor is concerned with “undue” experimentation, and recognizes that what is “undue” of itself depends on the subject matter and skill. The Board discussed the amount of experimentation needed to produce the claimed compounds, and correctly found that: a high amount of experimentation is necessary to synthesize a 2´-fluoro-2´-methyl nucleoside with the fluoro moiety in the “down” position, requiring at least two years of a high priority experimentation by persons skilled in the art, including multiple consultations with experts at the top of the fields and additional formal training.

Federal circuit finally concluded that substantial evidence supports the Board’s finding & we affirm the PTAB decision.

Carvedilol - USA

On Jun 20, 2017 a Delaware federal jury ordered Teva Pharmaceuticals USA Inc. to pay GlaxoSmithKline LLC more than $235 million for willfully infringing a patent tied to the hypertension drug Coreg (Carvedilol). The jury found that GlaxoSmithKline lost $234.11 million in profits and deserved an additional $1.4 million in royalties.

The U.S. Food and Drug Administration approved Teva's generic version of Coreg, or carvedilol, in 2007. GSK said that while Teva's FDA application had a carve-out to address its use for treating chronic heart failure, which GSK said remained under patent, the generic drugmaker changed its label in 2011 to add that use. GSK said that as a result, Teva induced healthcare providers to infringe its patent by selling a generic version of the drug and marketing it as a substitute for Coreg.

GSK alleges that Defendants induce infringement of United States Patent No. RE40,000 by making, offering to sell, selling, importing, and otherwise promoting and distributing generic carvedilol tablets in the period between January 2008 and May 2011.

GSK in a statement said that it was pleased with the trial's outcome. Teva said it was disappointed. "We still intend to present our equitable defenses to the court at a separate hearing which could eliminate the liability determination or significantly reduce the assessed damages," Teva said in a statement. "We are also considering an appeal."

Paroxetine - USA

On June 09, 2017 a New Jersey federal judge delivered a victory to ANDA filers accused of infringing patents related to Sebela International Ltd.’s nonhormonal drug Brisdelle® (Paroxetine) for menopausal hot flashes, finding that they did not infringe one patent and invalidating the other two.

Prinston & Actavis were seeking to market a generic version of Brisdelle®, a non-hormonal (i.e., non-estrogen based) treatment for hot flashes associated with menopause. Plaintiff Sebela International Limited filed a Hatch-Waxman suit against both drug companies, alleging they had infringed patents related to Brisdelle®.

The U.S. District Court for the District of New Jersey held a five-day bench trial in Dec. 2016 and allowed additional days of closing arguments in Feb and Mar. 2017, after post-trial briefing was concluded.

The court issued a ruling concluding that one patent (US 7,598,271) claiming a particular solid form of the active ingredient was not infringed and that two other patents (US 8,658,663 & US 8,946,251) were invalid because their claims would have been obvious over what was previously known in the field.  Additionally, the court determined that had it not found the latter two patents obvious, it would have invalidated them on two other, independent grounds.

Mesalamine - USA

On Jun 15, 2017 a Florida federal judge vacated her earlier decision on reconsideration and found that Mylan’s proposed generic version of Shire’s gastrointestinal drug Lialda does not infringe U.S. Patent Number 6,773,720 (expiring in Jun 2020).

U.S. Judge Charlene Edwards Honeywell of the Middle District of Florida made the ruling after the U.S. Court of Appeals for the Federal Circuit unanimously reversed a patent infringement decision in favor of Shire against Watson Pharmaceuticals Inc., finding that Watson’s generic version of the same drug did not infringe the ‘720 patent.

“Having considered the motions, having heard argument from counsel, and otherwise being fully advised in the premises, [the Court] will grant the Motion for Reconsideration Pursuant to Rules 59(e) and 60(b) … [b]ecause Mylan has demonstrated that there has been an intervening change in controlling law,” Judge Honeywell wrote in her Order, adding that in light of this change, “The Court has reconsidered its Opinion and Order and will vacate its Opinion and Order and Final Judgment and Permanent Injunction.”

Zydus & Watson have already received favorable opinion form CAFC on non-infringement in May 2017 & Feb 2017 respectively. Zydus has recently got final approval from USFDA & was the first ANDA applicant for Mesalamine Delayed-Release Tablets USP, 1.2 g, to submit a substantially complete ANDA with a paragraph IV certification.

Fingolimod - USA

On Jun 13, 2017 a Virginia federal judge handed Alembic Pharmaceuticals Ltd. a win saying the Indian pharmaceutical company’s generic alternative to Novartis AG and Mitsubishi Tanabe Pharma Corp.'s multiple sclerosis drug Gilenya does not infringe their patent.

Alembic pharma filed complaint for Declaratory Judgment on Mar 13, 2017 seeking a declaration that Alembic has not infringed, does not infringe, and will not infringe any valid claim of U.S. Patent No. 8,324,283 (“the ’283 patent”). Alembic sought a declaratory judgment of non-infringement and/or invalidity of the ’283 patent that would free the FDA to approve Alembic’s generic drug application at the earliest possible date, thereby allowing Alembic to market its low-cost, generic fingolimod drug product.

On Apr 12, 2017, the Federal Circuit affirmed the Patent Trial and Appeal Board's decision invalidating a US’283 patent (expiring on Mar 29, 2026) in a win for generics makers Apotex, Mylan and Torrent pharma. The ‘283 patent covers a solid combination of a sphingosine-1 phosphate (S1P) receptor agonist (fingolimod) and a sugar alcohol (mannitol). 

Hydrocodone - USA

On Jun 13, 2017 CAFC affirmed the decision of PTAB in Interference proceedings & refused Purdue pharma’s patent applications for lack  written description support under 35 U.S.C. § 112.

Purdue Pharma L.P. (“Purdue”), the senior party in an interference proceeding, appeals from a judgment of the Patent Trial and Appeal Board (“Board”) refusing claims in Purdue’s Applications 13/833,263 (“’263 Application) and 14/094,968 (’968 Application) (collectively, the “Applications”). The Board granted junior party Recro Technology, LLC’s (“Recro”) motion for judgment that Purdue’s claims lack written description, concluding that claims 1, 6, 9, 10, 12–15, 23–26, 32, 39, 41–46, and 53–55 of the ’968 Application and claims 63–67 and 70–71 of the ’263 Application (collectively, the “involved claims”) are unpatentable for lack of written description support under 35 U.S.C. § 112. The Board found that the specifications do not describe “separate particles of inert beads coated with the each different formulation together in one dosage form.”

Purdue’s Applications are directed to controlled-release oral formulations of hydrocodone, a drug used to treat pain. Importantly for purposes of this appeal, each of the claimed dosage forms (capsules, for example) includes two types of multiparticulates: controlled release (“CR”) multiparticulates and immediate release (“IR”) multiparticulates. The CR and IR multiparticulates are each comprised of inert beads coated with hydrocodone. The claims also recite various in vitro dissolution rates and in vivo pharmacokinetic properties of the claimed dosage forms. The issue here is whether the specifications adequately disclose the claimed separate populations of IR and CR multiparticulates, which each comprise inert beads coated with hydrocodone, combined in a single dosage form.

The Board found that the claimed formulation is not disclosed. CAFC concluded that substantial evidence supports the Board’s finding. Although the written description generally discloses that a single dosage form may include both IR and CR hydrocodone components, it does not disclose a formulation wherein the IR and CR components exist as separate multiparticulates each containing an inert bead core. The specifications explain, “[i]n certain embodiments of the present invention, an effective amount of opioid in immediate release form is included in the formulation.” The specifications provide several possible formulations combining CR and IR components. The disclosed embodiments include inert beads that are first coated with a CR layer and then additionally coated with an IR layer. The embodiments do not include inert beads coated directly with an IR layer. Purdue finally urges that the claimed formulations are supported by U.S. Patent No. 5,472,712, (“the ’712 Patent”), which was incorporated by reference into the Purdue applications. The Board was “not persuaded that the ’712 patent sufficiently describes the specific dosage forms Purdue claims. The descriptions do not recite the actual elements of Purdue’s claims, most notably inert beads coated with hydrocodone. Instead, the examples of . . . [the] ’712 patent describe formulations of [a] different drug[]: . . . hydromorphone . . . .”

Court said that we have considered Purdue’s remaining arguments and conclude that they are without merit. We affirm the Board’s determination that claims 1, 6, 9, 10, 12–15, 23–26, 32, 39, 41–46, and 53–55 of the ’968 Application and claims 63–67 and 70–71 of the ’263 Application are unpatentable for lack of written description support under 35 U.S.C. § 112.