Patent Docs

Biotech/Pharma Docket

    By Suresh Pillai --

Infosint Seeks Increased Damages Award in Citalopram Suit

Following a decision by the U.S. District Court for the Southern District of New York in October finding Forest Laboratories and Lundbeck A/S liable for infringement of Infosint's patent covering the antidepressant citalopram, Infosint has now returned to the District Court seeking an increase in its damages award.  In particular, Infosint seeks additional damages and interest totaling $43 million.  At the close of trial, Infosint was awarded $15 million as a reasonable royalty (see "Biotech/Pharma Docket," October 21, 2009).

In April 2006, Infosint filed suit against Lundbeck and Forest Labs, accusing them of infringing U.S. Patent No. 6,458,973.  Lundbeck and Forest Labs responded by filing a counterclaim against Infosint for infringement of Lundbeck's U.S. Patent No. 6,403,813.  At trial, a jury found that Lundbeck's process for preparing the starting material for citalopram infringed the '973 patent, but that other processes used by Lundbeck did not infringe that patent.  Infosint then sought judgment as a matter of law that Lundbeck and Forest Labs infringed claim 24 of the '973 patent by selling citalopram manufactured through the infringing process.

In its most recent filing, Infosint seeks an increase in the award that would reflect interest and additional infringement.  However, both Lundbeck and Forest Labs also filed post trial motions in which the defendants argue that claim 24 of the '973 patent is invalid on grounds of obviousness.

Court Upholds Record $1.7 Billion Infringement Judgment

The U.S. District Court for the Eastern District of Texas has upheld a record $1.7 billion award against Abbott Laboratories for Abbott's infringement of patents belonging to Centocor Ortho Biotech Inc. and New York University.  In June 2009, the District Court found Abbott liable for infringement of U.S. Patent Nos. 7,070,775 and 7,276,239 with respect to Abbott's blockbuster arthritis drug Humira® (see "Biotech/Pharma Docket," June 30, 2009).  In the wake of that decision, Abbott asked the Court to rule that the '775 was invalid on grounds of inequitable conduct and prosecution laches.  Abbott also alleged that the asserted claims of the '775 patent were indefinite because those having ordinary skill in the art would not understand the claim limitations as disclosed in the patent.

The District Court disagreed with Abbott's allegations, holding that Abbott had failed to prove by clear and convincing evidence that the '775 patent was either unenforceable or invalid.  The Court left undisturbed its award, which includes $1.17 billion in lost profits and $504 million in royalties.

Settlement Announced in Carbatrol® Suit

The U.S. District Court for the District of New Jersey has approved a settlement agreement between Shire and Apotex Inc. over their patent dispute regarding Shire's epilepsy drug, Carbatrol®.  Shire originally filed suit in 2008 following receipt of a letter from Apotex that alerted Shire to Apotex's filing of an Abbreviated New Drug Application with the FDA seeking permission to market and manufacture generic extended-release capsules containing carbamazepine, the active ingredient in Carbatrol® (see "Court Report," July 27, 2008).  Shire's complaint alleged that Apotex's proposed generic would infringe upon two Shire patents, U.S. Patent Nos. 5,326,570 and 5,912,013, and sought to have Apotex enjoined from making its generic product before the expiration of Shire's patents.  Apotex responded by filing a motion seeking a declaratory judgment that the patents were either invalid or would not be infringed.

Under the terms of the settlement agreement, Shire has agreed to grant Apotex a license to both patents-in-suit and a covenant not to sue.  Apotex has agreed to acknowledge that all claims of one of the patents are valid and that Apotex's proposed product would have infringed the claims of that patent.  Other terms and conditions of the agreement remain confidential.

Next Up: Ariad v. Lilly Rehearing En Banc

    By Donald Zuhn --

With oral argument before the Supreme Court in In re Bilski now concluded, patent practitioners can begin to turn their attention toward the next big patent case awaiting oral argument:  the Federal Circuit's en banc rehearing of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., which is scheduled for December 7th.  Last month, Plaintiffs-Appellees Ariad Pharmaceuticals, Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research, and the Presidents and Fellows of Harvard College ("Ariad") filed their principal brief for rehearing en banc.  In response to the two questions presented by the Federal Circuit's en banc order, Ariad answered that "§ 112, ¶ 1, does not contain a written description requirement separate from an enablement requirement [and that] it necessarily follows that the statute provides no scope or purpose for a separate written description requirement."

Ariad contends that "[u]nder a plain reading of [§ 112, ¶ 1], a patent specification must be in writing and must contain a description (i) of the invention, and (ii) of the manner and process of making and using it."  According to Ariad, the first paragraph of § 112 can thus be represented as follows:

The specification shall contain

[A] a written description

[i] of the invention, and

[ii] of the manner and process of making and using it,

[B] in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . . .

Under the above construction:

[C]lauses [i] and [ii] are components of [A]; they are both parts of the "written description."  The final prepositional phrase [B] ("in such full . . . terms as to enable") modifies the noun [A], "a written description," and thereby provides the standard to assess the legal adequacy of the whole of the written description.  This construction has the important benefit of following ordinary rules of English grammar.

Instead of construing § 112 in this manner, Ariad argues that the Federal Circuit's written description cases "tend to truncate the statutory language after the phrase 'written description of the invention,' and solely focus on only this one phrase, ignoring the remaining language in the paragraph."  Ariad notes that the Federal Circuit's approach yields an alternate construction, which can be represented as follows:

The specification shall contain

[A] a written description

[i] of the invention, and

[ii] of the manner and process of making and using it,
[B] in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . . .

Ariad asserts that there are three significant problems with the above construction:  (1) "the statute provides no standard for testing the legal adequacy of the 'written description of the invention,'" (2) "this alternate construction of the statute does not make sense as a matter of grammar because, in the context of the sentence, the prepositional phrase [B] ('in such . . . terms') can only modify the word 'description,'" and (3) "under the alternative reading of the statute, the addition of a comma between the phrases 'the manner and process of making and using it' and 'in such . . . terms' is inexplicable."

In its brief, Ariad also argues that none of the four earlier major revisions of the patent laws (i.e., the Patent Acts of 1790, 1793, 1836, and 1870) support a separate written description requirement.  It contends that the Patent Acts of 1790 and 1793 "required a written description that served two purposes: (i) to distinguish the invention from the prior art, and (ii) to enable those of ordinary skill in the art to make and use the invention."  Ariad asserts that beginning with the Patent Act of 1836, the first purpose was eliminated from the written description requirement and transferred to the claims and "the 'written description' henceforth served a single purpose: enablement."

According to Ariad, neither Supreme Court nor CCPA precedent supports the existence of a separate written description requirement.  Noting that Federal Circuit opinions focusing on the written description requirement primarily rely on the Supreme Court's decision in Evans v. Eaton, Ariad states that "Evans interpreted the 1793 Patent Act which . . . differs from the 1836 and subsequent Patent Acts in that the 1793 Act required the written description of the invention to serve two purposes."

As for the CCPA, Ariad argues that "[f]or at least the first fifteen years after adoption of the 1952 Patent Act, cases interpreting § 112, ¶ 1 'did not differentiate written description from enablement.'"  Ariad cites two examples of CCPA cases in which it contends the CCPA so interpreted the statute:  In re Gay and In re Wilke.  In both cases, Ariad asserts that "the CCPA explained that § 112, ¶ 1 had just two aspects – (i) to describe the invention so a person of ordinary skill can make and use it, and (ii) to describe the best mode contemplated by the inventor for carrying out the invention."  Ariad also argues that a "careful reading" of the CCPA's decision in In re Ruschig, "frequently cited as the leading case construing § 112, ¶ 1 as containing separate written description requirement separate from enablement," demonstrates that this case has been misread.  Finally, noting that Judge Markey once observed (in In re Barker) that he could not see how one may, in "full, clear, concise and exact terms," enable the skilled artisan to practice an invention and still have failed to describe it, Ariad states that it is "in complete agreement with Judge Markey's opinion in Barker and believe[s] it should be adopted by this Court en banc."

As for the Federal Circuit's creation of a separate written description requirement (and a standard for assessing compliance with this separate requirement), Ariad argues that:

Enablement is clearly provided for in the statute, whereas a separate written description doctrine requiring evidence of "possession" is not.  Yet many patents challenged under § 112, first paragraph are resolved under the non-statutory written description doctrine rather than under statutory requirement of enablement.  The present case is simply one such example.

The reason for this is simple.  Once written description was de-linked from enablement, it was necessary to frame some other test for determining whether the judicially-construed "separate written description requirement" was satisfied.  For this purpose, the Court created a new standard: "the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention."

Ariad also contends that the Federal Circuit's separate "written description-possession" requirement has severe adverse consequences for research universities.  Noting that university patentees were involved in Ariad, Regents of the University of California v. Eli Lilly & Co., and University of Rochester v. G.D. Searle & Co., the Ariad brief states that the university's patents "were held invalid under the 'separate written description' doctrine at the behest of pharmaceutical companies whose commercial activities are downstream of, and benefit from, the type of discoveries that universities make."

In the last portion of its brief, Ariad explains how the specification of the patent-in-suit would satisfy a properly construed written description requirement.  In particular, Ariad argues that:

[T]he inventors of the patent-in-suit discovered a previously unknown protein in cells, NF-κB, that plays a crucial role in regulating the immune response to inflammatory stimuli.  They realized the important benefits that would flow from reducing NF-κB activity in cells and promptly published their discoveries both in the scientific literature and in patent applications that described how to achieve such reduction.  Other scientists promptly practiced these teachings and expressly cited and referred to the publications of the present inventors as the basis for their own results.

Contending that the proper test for assessing the adequacy of a description is not possession, but rather whether the description enables any person skilled in the art to make and use the claimed invention, and further that this test "is well illustrated in the Supreme Court cases, which focus on whether the claimed scope matches the inventor's contribution," Ariad asserts that "[t]he claimed methods [of the patent-in-suit] encompass no more than the important contribution that these inventor[s] described in the 1989 priority application."

For additional information regarding this and other related topics, please see:
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Amgen, Inc. v. Ariad Pharmaceuticals, Inc. (Fed. Cir. 2009)," June 1, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

Supreme Court Bilski Argument

    By Kevin E. Noonan --

The highest form of tea leaf-reading is guessing how the Supreme Court will rule based on oral argument.  Yet occasionally the Court's questioning suggests general trends and tendencies, and today's argument in Bilski v. Kappos may be one of those times.

The claims at issue are directed to a method for hedging risk in a commodities trade, and are broadly directed to such methods (i.e., there is no requirement that the method be performed using a computer or other particular machine).  The claims were rejected by the Patent Office and appealed to a Federal Circuit panel, but before the panel decision was issued, the CAFC sua sponte ordered rehearing en banc.  In its en banc decision, the Federal Circuit promulgated a new, exclusive test for patent eligibility of method claims, requiring that a method either be tied to a machine or transform a particular article into a different state or thing (the "machine or transformation" test).  The Supreme Court granted certiorari to consider whether this test was contrary to the Court's "precedent declining to limit the broad statutory grant of patent eligibility for 'any' new and useful process beyond excluding patents for 'laws of nature, physical phenomena, and abstract ideas'."

In today's argument, it became clear that the Justices thought little of the argument that Bilski's claim should be patent-eligible.  Bilski's advocate, J. Michael Jakes, staunchly kept to his position that what should be considered a patent-eligible process be broadly construed, refusing to concede that any method posed as a hypothetical by the Court should be per se ineligible.  These far-fetched hypothetical methods included methods for teaching antitrust law without putting students to sleep (Justice Breyer), speed-dating (Justice Sotomayor), horse-whispering (Justice Scalia), as well as more concrete examples ("an estate plan, tax avoidance, how to resist a corporate takeover [or] how to choose a jury," by Justice Ginsberg).  The Court was clearly concerned about conferring the broadest scope to method claims, such as "anything that helps any businessman succeed is patentable because we reduce it to a number of steps," according to Justice Breyer.  To each of these instances, Mr. Jakes argued that such a claim was "potentially patentable," subject to the other requirements of the statute.  To Justice Sotomayor's question about how to limit patent eligibility to "something reasonable" if it is not limited to technology or the sciences, Mr. Jakes argued that the useful arts excludes "[s]peaking, literature, poems" and that "a corporation [or] a human being" were not included in the statutory categories of the useful arts.  However, Mr. Jakes did not specifically assert that Bilski's claim should be patent-eligible, merely that the Federal Circuit's test was without support in the plain language of the statute or any of the Court's earlier precedent.

The Chief Justice asked how the claim was not disqualified as being a mere abstract idea, in the process conflating what may not be patentable ("classic commodity hedging that has been going on for centuries") with what should be patent-eligible.  Justice Kennedy, citing the development of actuarial tables and methods for calculating risk by the nascent insurance industry in the 17th Century, asked whether Congress would have intended that "only one person [would have] the capacity to issue insurance."  Mr. Jakes did not directly answer this question, but maintained that such methods could be patent-eligible, falling within the ambit of the statutory definitions of patent-eligible inventions.

Justice Ginsburg was concerned about the practices in other countries, which do not include methods like the Bilski method within the scope of patent-eligible subject matter.  Mr. Jakes responded by reminding the Court that other countries have defined "technology" differently than the U.S. has, and it was these definitions that provide the basis for excluding types of inventions patent-eligible under 35 U.S.C. § 101.  Mr. Jakes also challenged the assertion by Justice Sotomayor that "a patent limits the free flow of information," asserting (correctly) that patents promote disclosure of inventions, so that "information gets to the public generally," while conceding Justice Scalia's point that the public cannot use an invention until the patent expires.

Justice Stevens asked two interesting jurisprudential questions.  The first was for Mr. Jakes to identify the "strongest case" from the Court's jurisprudence that supported his position, and without apparent irony (in view of the Federal Circuit majority's reliance upon it) he answer Diamond v. Diehr.  (Justice Stevens did not appear to think the Diehr case provided much support for Mr. Jakes's position.)  Second, the Justice asked whether Judge Rich had ever written on the scope of patent-eligibility for process claims, to which Mr. Jakes answered that he had written the Alappat decision as well as the State Street decision.

Turning to the Diehr decision, the Court seemed to grapple with the similarities and distinctions between methods for curing rubber ("an industrial process of the conventional type," as characterized by Mr. Jakes) and methods for manipulating information or electronic signals (although Justice Sotomayor drew a distinction between manipulation of electronic signals and manipulation of information as being "different in kind").  Justice Breyer made the distinction explicit, saying that there are "four things in patent law that everyone accepts."  These include "two that are a plus" (increased innovation and disclosure) and "two that are a minus" (higher prices and "having to get permission [that] can really slow things down and destroy advance").  (Despite the negative tone, he characterized this situation as "a balance.")  In the 19th Century, he said, methods were directed towards machines, whereas Mr. Jakes's position is that today patent-eligible methods should include those performed on information.  To that proposition and how the appropriate balance should be drawn the Justice candidly admitted "I don't know.  And I don't know whether across the board or in this area or that area patent protection would do no harm or more harm than good."

The Court also considered the Morse and Bell patents, with Justice Scalia arguing that the Bell claims would pass the "transformation" prong of the Federal Circuit's test, since sound was transformed into electrical signals and vice versa in the practice of the claimed method for transmitting sound over a distance.

The Court closely questioned the government's position as articulated by Deputy Solicitor General Malcolm Stewart.  Speaking for the first time, Justice Alito asked whether the Court should render a decision on the "very broad issue" raised by Bilski, to which Mr. Stewart answered that the government would prefer to prevail more narrowly.  In doing so, Mr. Stewart asserted that the Federal Circuit's "machine or transformation" test was not "rigid or inflexible" based in large part in the questions left unanswered in the opinion (such as the extent to which a process is "tied to a particular machine").  Justice Sotomayor asked the fundamental question of whether the Court should simply declare that business methods are unpatentable and avoid the issues of destroying the computer or biomedical industries as had been argued by various amici.  This wouldn't solve the problem, according to Mr. Stewart, because the basis for business method patents (the State Street case) involved a machine rather than a process (Justice Sotomayor impliedly agreeing by saying "[n]o ruling in this case is going to change State Street").  Justice Breyer characterized the Federal Circuit's decision as a "pull back" on the scope of patent-eligible methods, but with little guidance from the Federal Circuit on the scope of how far they CAFC has "pulled back," in view of the failure to define the extent of transformation or ties to a particular machine that would satisfy the standard.

The Chief Justice took Mr. Stewart to task for "the last footnote" of the government's brief, which he understood to assert that the use of a computer in Bilski's method might make the process patentable -- he characterized this as the equivalent of saying that using a typewriter to type out a method would make a process patentable.  Mr. Stewart attempted to distinguish this interpretation using a hypothetical involving an interactive website for practicing the method but with little success; the Chief Justice said that the government's hypothetical "involves the most tangential and insignificant use of a machine."  Importantly, Mr. Stewart then indicated that the government did not want the Court to opine broadly in its decision:

I guess the point I'm trying to make is simply that we don't want the Court, for instance, in the area of software innovations or medical diagnostic techniques to be trying to use this case as the vehicle for identifying the circumstances in which innovations of that sort would and would not be patent eligible, because the case really doesn't present any -- any question regarding those technologies.

Justice Sotomayor agreed with this sentiment, saying in response that "by saying that we exclusively rely on the machine-or-transformation test, that we're precluding applications of the patent law in those fields, the things we can't imagine.  Once you announce an exclusive test, you're shoe-horning technologies that might be different."  She also asked the Deputy's help in fashioning a test "that doesn't go to the extreme the Federal Circuit did" with regard to having to reverse earlier precedent that did not preclude methods that would fail the "machine or transformation" test.  Justice Ginsburg asked whether Judge Mayer's calculus in his concurrence -- "if it's technology, then it's within the realm of patent, and if it's not technology, it isn't" -- wasn't the simplest test to be used, and Mr. Stewart answered that "our test . . . has a shorthand version of that," suggesting at least an acquiescence to a "technology arts" standard.  He went on to say however that this was not the simple solution it appeared to be, based on the definition of "technology" and what should be "properly regarded as technological advances," as well as whether the "technology" component was "sufficiently substantial" to render a process claim patent-eligible.  Several of the Justices also voiced the view that merely programming a computer to perform a new process did not convert the computer into a "new" machine, again seeming to conflate patent eligibility with patentability.

Returning to the government's view of the appropriate scope of the Court's decision in this case, the Deputy argued:

We thought that this case would provide an unsuitable vehicle for resolving the hard questions because the case doesn't involve computer software or medical diagnostic techniques, and therefore, we thought the Court would arrive at the position that I think, at least some members are feeling that you have arrived at, that you will decide this case, and most of the hard questions remain unresolved.  And, frankly, we think that's true.

To Justice Steven's remark following this statement that "[w]e know that things that we haven't yet contemplated may be around the corner, and when they happen, we will deal with them," Mr. Stewart responded that the government "would be entirely content with a ruling like that."

In his brief rebuttal, Mr. Jakes appeared to agree with this sentiment:

The Federal Circuit did announce this test as the sole test for all processes.  It said it applied no matter what the process was, so we do have to face these difficult questions.  I think the question can be avoided, because we don't need a rigid test of this type based on machine-or-transformation.  The question we are looking at and should be looking at is:  Are we trying to patent an abstract idea?

It appears evident that the Court does not believe that Bilski's claims are patentable, but that this case is not the case to make any broad pronouncements on subject matter eligibility for computer software or diagnostic methods claims.  While it is reassuring to believe that the Court is thus disinclined to "shoehorn" the patent-eligibility of these types of method claims into its decision on Bilski's claims (and the Federal Circuit's "machine or transformation" test), it also suggests that the Court (or at least Justices Breyer and Stevens, whose views are on record in the Metabolite dissent) may recognize that a more appropriate occasion to consider diagnostic method claims is available with the certiorari petition in Prometheus Laboratories, Inc. v. Mayo Collaborative Services case.  Until the Court decides whether it will hear that case, the status of diagnostic method claims will remain in doubt no matter how the Court rules in Bilski.

A transcript of today's oral argument is available here.

Reminder: RCE Docketing Change Effective November 15, 2009

    By Christopher P. Singer --

As reported a few weeks ago, the U.S. Patent and Trademark Office issued a pre-OG Notice regarding the way it will docket requests for continued examination (RCE) beginning on November 15, 2009.  For any RCE that is filed on or after that date, the Office will place that RCE on an examiner's "Special New" application docket, which also includes divisional and continuation applications as well as applications that have been granted petitions to make special under 37 C.F.R. § 102(c).  So if you are planning to file an RCE in the near future, it may be a good idea to file the RCE this week so that it gets placed on the examiner's current "amended docket."

This change, along with changes to the way in which examiners receive counts for RCEs (see "USPTO Proposes Changes to Count System"), may significantly impact the rate at which examiners review and respond to RCEs.  Since applicants do not seem to have any recourse regarding this docketing change, it will likely have little to no effect on prosecution strategy.  And because the claims in an RCE have been prosecuted and examined, it may be that the examiners will be more inclined to review and respond to an RCE than a divisional or continuation application that contains claims that have not yet been examined.  Practitioners may also be more inclined to review Final Office actions more closely to ensure the finality has been properly asserted (see M.P.E.P. § 706.07(a)) as well as more frequently request Examiner interviews in order to discuss potential amendments to place the claims in condition for allowance.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Novartis AG et al. v. Apotex Inc. et al.
1:09-cv-06950; filed November 4, 2009 in the Northern District of Illinois

• Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 6,025,391 ("Enteric-coated Pharmaceutical Compositions of Mycophenolate," issued February 15, 2000), 6,172,107 ("Entric-coated Pharmaceutical Compositions," issued on January 9, 2001), and 6,306,900 (same title, issued on October 23, 2001) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Novartis' Myfortic7 delayed-release tablets (mycophenolate sodium, used for the prevention of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids).  View the complaint here.

Teva Pharmaceuticals USA, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.
1:09-cv-00152; filed November 4, 2009 in the Northern District of West Virginia

• Plaintiffs:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
• Defendants:  Mylan Pharmaceuticals, Inc.; Mylan Inc.; Natco Pharma Ltd.

Infringement of U.S. Patent Nos. 7,199,098 ("Copolymer-1 Improvements in Compositions of Copolymers," issued April 3, 2007), 6,939,539 (same title, issued September 6, 2005), 6,054,430 (same title, issued April 25, 2000), 6,620,847 (same title, issued September 16, 2003), 5,981,589 (same title, issued November 9, 1999), 6,342,476 (same title, issued January 29, 2002), and 6,362,161 (same title, issued March 26, 2002) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction of frequency of relapses in patients with relapsing-remitting multiple sclerosis).  View the complaint here.

Illumina, Inc. v. Affymetrix, Inc.
3:09-cv-00665; filed November 3, 2009 in the Western District of Wisconsin

Infringement of U.S. Patent No. 7,612,020 ("Composite Arrays Utilizing Microspheres with a Hybridization Chamber," issued November 3, 2009) based on Affymetix's manufacture and sale of certain products, including its GeneChip® HT RG-230 PM Array Plate, the GeneChip® HT Rat Focus Array Plate, the GeneChip® HT HG-U133+ PM Array Plate, the GeneChip® HT Human Genome U133A/U133B Array Plate Set, the GeneChip® HT MG-430 PM Array Plate, and GeneChip® HT Mouse Genome 430A/430B Array Plate Set.  View the complaint here.

Medicis Pharmaceutical Corp. v. Glenmark Generics Inc., USA et al.
2:09-cv-05556; filed October 30, 2009 in the District Court of New Jersey

• Plaintiff:  Medicis Pharmaceutical Corp.
• Defendants:  Glenmark Generics Inc., USA; Glenmark Generics Ltd.

Infringement of U.S. Patent No. 7,018,656 ("Antimycotic Gel with High Active Substance Release," issued March 28, 2006) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of Medicis' Loprox® Gel (ciclopirox gel, used as an antifungal agent).  View the complaint here.

Purdue Pharma Products L.P. et al. v. Cipher Pharmaceuticals Inc.
2:09-cv-00544; filed October 30, 2009 in the Eastern District of Virginia

• Plaintiffs:  Purdue Pharma Products L.P.; Napp Pharmaceutical Group LTD.
• Defendant:  Cipher Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,254,887 ("Controlled Release Tramadol," issued July 3, 2001) and 7,074,430 ("Controlled Release Tramadol Tramadol [sic] Formulation," issued July 11, 2006) following a Paragraph IV certification as part of Cipher's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of plaintiffs' Ultram® ER (tramadol hydrochloride, used to treat moderate to moderately severe chronic pain).  View the complaint here.

Aventis Pharma S.A. et al. v. Sandoz Inc.
1:09-cv-00810; filed October 29, 2009 in the District Court of Delaware

• Plaintiffs:  Aventis Pharma S.A.; Sanofi-Aventis US LLC
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 5,714,512 ("Compositions Containing Taxane Derivatives," issued February 3, 1998) 5,750,561 (same title, issued May 12, 1998), and 5,438,072 ('Taxoid-Based Compositions," issued August 1, 1995) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Aventis' Taxotere® (docetaxel, used to treat breast, lung, prostate, gastric, and head and neck cancers).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Teva Pharmaceuticals USA, Inc. et al.
3:09-cv-05531; filed October 29, 2009 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent Nos. 5,006,528 ("Carbostyril Derivatives," issued April 9, 1991) and 6,977,257 ("Aripiprazole Oral Solution," issued December 20, 2005) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Elan Pharma International Ltd. et al. v. Impax Laboratories, Inc.
2:09-cv-05541; filed October 29, 2009 in the District Court of New Jersey

• Plaintiffs:  Elan Pharma International Ltd.; Fournier Laboratories Ireland Ltd.
• Defendant:  Impax Laboratories, Inc.

Infringement of U.S. Patent Nos. 5,145,684 ("Surface Modified Drug Nanoparticles," issued September 8, 1992), 7,276,249 ("Nanoparticulate Fibrate Formulations," issued October 2, 2007), and 7,320,802 ("Methods of Treatment Using Nanoparticulate Fenofibrate Compositions," issued January 22, 2008), all licensed to Abbott, following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels).  View the complaint here.

Abbott Laboratories et al. v. Impax Laboratories, Inc.
2:09-cv-05517; filed October 29, 2009 in the District Court of New Jersey

• Plaintiffs:  Abbott Laboratories; Laboratoires Fournier S.A.
• Defendant:  Impax Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,277,405 ("Fenofibrate Pharmaceutical Composition Having High Bioavailability and Method for Preparing It," issued August 21, 2001), 7,037,529 (same title, issued May 2, 2006), and 7,041,319 ("Fenofibrate Pharmaceutical Composition Having High Bioavailabilty," issued May 9, 2006) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels).  View the complaint here.

Deston Therapeutics LLC et al. v. TriGen Laboratories Inc. et al.
1:09-cv-00809; filed October 28, 2009 in the District Court of Delaware

• Plaintiffs:  Deston Therapeutics LLC; Unigen Pharmaceuticals Inc.
• Defendants:  TriGen Laboratories Inc.; Irisys Inc.

Infringement of U.S. Patent Nos. 6,683,116 ("Polycosanols from Ericerus Pela Wax," issued January 27, 2004) and 7,034,060 (same title, issued April 25, 2006) based on defendants' manufacture and sale of its Treagan® Otic Solution (acetic acid / antipyrine / benzocaine / u-polycosanol 410, used to treat pain associated with otitis media and otitis externa).  View the complaint here.

Mathilda and Terence Kennedy Institute of Rheumatology Trust v. Amgen Inc. et al.
1:09-cv-00805; filed October 27, 2009 in the District Court of Delaware

• Plaintiff:  Mathilda and Terence Kennedy Institute of Rheumatology Trust
• Defendants:  Amgen Inc.; Wyeth

Infringement of U.S. Patent No. 6,270,766 ("Anti-TNF Antibodies and Methotrexate in the Treatment of Arthritis and Crohn's Disease," issued August 7, 2001) based on defendants' manufacture and sale of its Enbrel® product (etanercept, used to treat arthritis).  View the complaint here.

Alcon Research Ltd. v. Apotex Corp. et al.
1:09-cv-00798; filed October 23, 2009 in the District Court of Delaware

• Plaintiff:  Alcon Research Ltd.
• Defendants:  Apotex Corp.; Apotex Inc.

Infringement of U.S. Patent Nos. 5,510,383 ("Use of Cloprostenol, Fluprostenol and Their Salts and Esters to Treat Glaucoma and Ocular Hypertension," issued April 23, 1996), 5,631,287 ("Storage-Stable Prostaglandin Compositions," issued May 20, 1997), 5,849,792 (same title, issued December 15, 1998), 5,889,052 ("Use of Cloprostenol and Fluprostenol Analogues to Treat Glaucoma and Ocular Hypertension," issued March 30, 1999) and 6,011,062 ("Storage-Stable Prostaglandin Compositions," issued January 4, 2000) following a Paragraph IV certification as part of Aptoex's filing of an ANDA to manufacture a generic version of Alcon's Travatan® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention).  View the complaint here.

Novo Nordisk Inc. et al. v. Actavis Pharma Manufacturing Pvt. Ltd. LLC et al.
1:09-cv-08939; filed October 23, 2009 in the Southern District of New York

• Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk A/S
• Defendants:  Actavis Pharma Manufacturing Pvt. Ltd. LLC; Actavis Inc.

Infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novo Nordisk's PrandiMet® (repaglinide and metformin, used to treat type 2 diabetes).  View the complaint here.

Cephalon Inc. v. Barr Pharmaceuticals Inc. et al.
1:09-cv-00794; filed October 22, 2009 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Barr Pharmaceuticals Inc,; Barr Pharmaceuticals, LLC; Barr Laboratories Inc.

Infringement of U.S. Patent No. 6,264,981 ("Oral Transmucosal Drug Dosage Using Solid Solution," issued July 24, 2001) following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer).  View the complaint here.

Astrazeneca AB et al. v. Lupin Ltd. et al.
3:09-cv-05404; filed October 21, 2009 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI Inc.; KBI-E Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988), 5,877,192 ("Method for the Treatment of Gastric Acid-Related Diseases and Production of Medication Using (-)Enantiomer of Omeprazole," issued March 2, 1999), 6,875,872 ("Compounds," issued April 5, 2005), 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

Conference & CLE Calendar

November 9-10, 2009 - Patent Litigation 2009 (Practising Law Institute) - Atlanta, GA

November 9-11, 2009 - Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) - London, England

November 10, 2009 - The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) - Baltimore, MD

November 10, 2009 - The 'Day After' Show: Analyzing the Bilski Oral Arguments at the U.S. Supreme Court (Intellectual Property Owners Association) - 2:00 PM (EST)

November 11, 2009 - Bilski Spreme Court Arguments: Eyewitness Report and Expert Analysis (Practising Law Institute) - 1:00-2:00 PM (EST)

November 12, 2009 - Avoid Patent Unenforceability Claims Due to Inequitable Conduct (Managing IP & Lexis Nexis) - 12:00-1:30 PM (EST)

November 12-13, 2009 - Paragraph IV on Trial*** (American Conference Institute) - New York, NY

November 13, 2009 - The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) - Las Vegas, NV

November 16-17, 2009 - Patent Litigation 2009 (Practising Law Institute) - New York, NY

November 17-18, 2009 - Structuring, Negotiating, and Managing Pharma/Biotech Collaborative Agreements (American Conference Institute) - New York, NY

December 7, 2009 - 20th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) (Intellectual Property Owners Association (IPO) and U.S. Patent and Trademark Office) - Washington, DC

December 7-8, 2009 - Foreign Patent Law & Regulation*** (American Conference Institute) - New York, NY

***Patent Docs is a media partner of this conference or CLE

Bilski CLE Options

On Monday, November 9, 2009, the Supreme Court will hear oral argument in In re Bilski, and two CLE providers plan to offer same day or next day coverage of the proceedings.

Practising Law Institute (PLI) will be offering same day coverage on its Patent Practice Center blog.  Gene Quinn, the editor of the Patent Practice Center blog and founder of IPWatchdog, Inc., and John White, the Director of PLI Patent Professional Development and a patent attorney with Berenato, White & Stavish, LLC, will be filing reports throughout the day.

PLI will also offer an audio briefing entitled: "Bilski Supreme Court Arguments: Eyewitness Report and Expert Analysis " on Wednesday, November 11, 2009, from 1:00-2:00 PM (EST).  For the audio briefing, Gene Quinn and John White will be joined by Scott Alter of Faegre & Benson LLP and Douglas Nemec of Skadden, Arps, Slate, Meagher & Flom LLP.  The registration fee for the audio webcast is $299.  Those interested in registering for the webcast can do so here.

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled: "The 'Day After' Show: Analyzing the Bilski Oral Arguments at the U.S. Supreme Court" on Tuesday, November 10, 2009 beginning at 2:00 PM (EST).  The IPO webinar will provide the views of three eyewitnesses to the proceedings:  David Ball, Jr., a partner at Weil, Gotshal & Manges LLP; Mark Perry, a litigation partner at Gibson, Dunn & Crutcher LLP who co-authored an amicus brief on behalf of Microsoft Corporation, Koninklijke Philips Electronics N.V., and Symantec Corporation in support of Kappos; and Wayne Sobon, Associate General Counsel and Director of Intellectual Property for Accenture, which filed multiple amicus briefs in support of Bilski.  The speakers will discuss what to do about existing patents, pending applications, and claims drafting for inventions likely to be affected by the Bilski ruling.  The registration fee for the webinar is $100.  Those interested in registering for the webinar can do so here.

For additional information regarding the Bilski decision and its impact on biotech subject matter, please see:
• "BIO Files Amicus Brief in Bilski," August 13, 2009
• "The Supreme Court, In re Bilski and the Lingering Question of LabCorp v. Metabolite," June 1, 2009
• "Applying In re Bilski to Diagnostic Method Claims," February 5, 2009
• "The Relevance of In re Bilski to the Patentability of the Metabolite Claim," November 17, 2008

CLE on Avoiding Inequitable Conduct Claims

Managing IP and Lexis Nexis will be offering a free web seminar entitled: "Avoid Patent Unenforceability Claims Due to Inequitable Conduct" on November 12, 2009 from 12:00-1:30 PM (EST).  J. Timothy Meigs of BD Technologies, Lawrence Sung of Dewey & LeBoeuf LLP, and Jeffrey Lindeman of Nixon Peabody LLP will provide tips for conducting the business and legal affairs associated with research and development to minimize the risks that an inequitable conduct defense will be lodged in litigation.  The panelists will also address the following topics:

• The present standards for the findings of materiality and intent to deceive;
• The required specificity in pleading; and
• Judicial and proposed legislative and administrative agency responses.

Those interested in registering for the web seminar, can do so here.

Follow-on Biologics News Briefs - No. 9

    By Donald Zuhn --

Patient Groups Back Senate and House Committee FOB Legislation

In September, twenty-seven patients' groups sent a letter to Sen. Harry Reid (D-NV), Sen. Mitch McConnell (R-KY), Speaker of the House Nancy Pelosi (D-CA), and Rep. John Boehner (R-OH), expressing their "strong support for the inclusion of a regulatory pathway for biosimilars in the America's Affordable Health Choices Act of 2009."  The groups urged Congress "to identify the appropriate balance between access, patient safety, and the need for continued innovation," and noted that they "were heartened to see complementary amendments passed by both Committees of jurisdiction in the Senate and House with strong bi-partisan support" (see "Senators Champion 12-Year Data Exclusivity in Senate" and "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period").  In particular, the groups expressed support for "the important, compromise Hagan/Enzi/Hatch and Eshoo/Inslee/Barton amendments which establish a regulatory pathway for biosimilars."

The signatories to the letter include:  AA CSA Foundation, Alliance for Aging Research, American Association of Orthopaedic Surgeons, American Autoimmune Related Diseases Association, American Institute for Medical and Biological Engineering, Californians for Cures, CANN - Community Access National Network, Celiac Disease Center at Columbia University, Children's Tumor Foundation, Colon Cancer Alliance, Community Health Charities, Dystonia Medical, Research Foundation, Easter Seals, Hereditary Disease Foundation, Immune Deficiency Foundation, In Need Of Diagnosis, Inc., International Cancer Advocacy Network, Lung Cancer, Circle of Hope, Men's Health Network, MLD Foundation, National Alliance on Mental Illness, Parkinson's Action Network, Research for Cure, RetireSafe, The AIDS Institute, Vietnam Veterans of America, and Vital Options International.

DelawareBio and BIO Seek Support of Delaware Delegation

On Monday, Bob Dayton, the President of the Delaware BioScience Association, and Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO), co-authored a letter on delawareonline, encouraging Delaware Sen. Thomas Carper (D), Sen. Edward Kaufman (D), and Rep. Mike Castle (R) to join them "in supporting a biosimilars pathway that protects patient safety and encourages continued innovation."  Noting that Senate and House committees had passed health care reform amendments that would establish a follow-on biologic regulatory pathway -- as well as provide a 12-year data exclusivity period for biologic drug makers (see "Senators Champion 12-Year Data Exclusivity in Senate" and "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period"), Mr. Dayton and Mr. Greenwood contend that "[t]he pathway to regulatory approval of biosimilars included in the House and Senate health care reform bills will ensure that these medicines are tested for safety while expanding access, lowering costs through expanded competition and providing incentives for biotech companies to continue innovating."  The biotech industry leaders also noted that "[p]atient advocates, doctors, labor unions, universities and governors, including Gov. Jack Markell, agree that the provisions must be included in the final health care bill" (see "Governors Send Letter to Congressional Leaders in Support of 12-Year Data Exclusivity Period").

Coalition for a Competitive Pharmaceutical Market Asks Congress to Fix FOB Provisions of Health Care Reform Legislation

Last week, the Coalition for a Competitive Pharmaceutical Market (CCPM) released a statement "appealing to Congress to fix the excessive 12-year market exclusivity and ever-greening provisions for biologics or drop it altogether."  CCPM Chair Annette Guarisco stated that coalition members "would rather have the status quo than legislation that guarantees profits for a few at the expenses of the American public."  In its release, the CCPM noted that a letter had been sent to Sen. Harry Reid (D-NV) and Speaker of the House Nancy Pelosi (D-CA), "urg[ing] lawmakers to resolve the current provision that will create an ineffective pathway to bringing biogenerics or biosimilars to patients and consumers," and "implor[ing] Congress not to overlook the immediate opportunity to bend the long-term cost curve of health care through a workable pathway for biogenerics."

The CCPM pointed to a recent Time magazine article (see "Time Magazine on Data Exclusivity Debate") as evidence of the "skepticism among the American public, pharmaceutical researchers, medical students, and industry economic experts about the results of BIO and PhRMA's influence on the health care reform deal."  The group also pointed to a paper in the New England Journal of Medicine (see "NEJM Authors Say Five Years of Data Exclusivity Would Be Sufficient"), which the CCPM contends "highlights the shortcomings of biologics provisions [in current health care reform legislation]."  In particular, the group says the article indicates that biosimilar legislation "would have no value because it would create a pathway that would scarcely be used," and further, "would allow for 'ever-greening,' or for manufacturers to obtain an additional 12-year exclusivity period by making minor changes to the structure of an approved product."  The group concludes that "[f]inding the right balance between incentives for innovation and timely access to care means that Congress needs to fix or drop the current biogenerics provision [in health care reform legislation]."

According to the CCPM website, the group has 33 participating members, which include Apotex, Hospira, Momenta Pharmaceuticals, Mylan Labs, Ranbaxy Pharmaceuticals, Teva Pharmaceuticals USA, Watson Pharmaceuticals, and the Generic Pharmaceutical Association (GPhA).

TJU Dean Asks Congress to Focus on Patient Safety

In a letter to the congressional daily The Hill, Dr. David Nash (at right), Dean of the Jefferson School of Population Health at Thomas Jefferson University in Philadelphia, PA, urges Congress not to ignore "the broader need of ensuring patient safety" when crafting a follow-on biologics (FOB) regulatory pathway in current health care reform legislation.  Dr. Nash, who last spring moderated a policy forum entitled:  "Regulation of Follow-on Biologics: Ensuring Quality and Patient Safety" at the National Press Club in Washington, DC (see "Follow-on Biologics News Briefs - No. 3"), noted that much of the FOB discussion has focused on the issue of data exclusivity.  He contends that "[t]his focus is extremely shortsighted, and ignores the broader need of ensuring patient safety for both current and future drugs."  Stating that "it is not possible to create an identical biologic copy of the original drug because of the living proteins and carbohydrates used to make them," Dr. Nash warns that "the complexity of the genetic engineering demanded for producing [follow-on biologics] creates serious safety concerns."  As a result, "[q]uestions of patient safety that hinge on the interchangeability and immunogenicity of FOBs can be answered only through rigorous and comprehensive human testing."  Dr. Nash also contends that FOBs should be subject to post-marketing study and surveillance.  He concludes that "[o]nly these actions can ensure that we're placing a higher premium on patient safety than other considerations."

Biotech/Pharma Docket

    By Suresh Pillai --

Mayo Seeks Supreme Court Review in Prometheus Labs Case

Following the U.S. Court of Appeals for the Federal Circuit's ruling that Prometheus Laboratories' method patents were valid under In re Bilski, the Mayo Clinic has petitioned the U.S. Supreme Court to review the ruling.  The patents-in-suit, U.S. Patent Nos. 6,355,623 and 6,680,302, claim methods for calibrating dosages of drugs used in the treatment of autoimmune diseases.  The Mayo Clinic had originally used tests obtained from Prometheus, but Mayo, having designed its own test internally and intending to sell this test to other hospitals, stopped using the Prometheus test.  Prometheus sued for patent infringement.

The U.S. District Court for the Southern District of California held that Mayo had not infringed the patents, as the patents claim the correlations between drug metabolite levels and therapeutic efficacy.  The District Court concluded that because the steps involving drug administration and the determination of metabolic levels were unpatentable data-gathering steps for use in correlations, such non-transformative steps were invalid and, therefore, claims containing these steps were not infringed by Mayo.

The Federal Circuit, however, disagreed and reversed the holding of the District Court.  The Federal Circuit concluded that the claims were transformative in nature and not mere data-gathering steps.  The CAFC reasoned that, as the steps were transformative, the steps were patentable subject matter under In re Bilski.

Mayo's petition, which argues that the claims of the patents-in-suit "attempt to turn a physician's thought processes into infringement," represents the second time such an issue has been appealed to the Supreme Court.  In Laboratory Corp. v. Metabolite Labs., Inc. (LabCorp), the same issue went up on appeal and was granted certiorari, yet the Supreme Court did not resolve the case on the merits because the petitioner had failed to preserve the issue on appeal.

For a more detailed analysis of the Federal Circuit's decision, please see "Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2009)."

Warner Chilcott Suit Dismissed in Maryland; To Be Heard in Delaware

The U.S. District Court for the District of Maryland has granted Warner Chilcott's request for voluntary dismissal of its patent infringement suit against Lupin Ltd. over Warner-Chilcott's patents covering the birth control medications Loestrin® 24 Fe and Femcon® Fe.  The case, however, will proceed in the District Court for the District of Maryland.  Warner Chilcott claimed to drop the suit in Maryland because of the parallel litigation pending in Delaware (see "Court Report," September 13, 2009).  The Maryland suit, filed on September 11, 2009 (two days after the filing of the Delaware suit) was filed as a protective action in the event that Lupin challenged jurisdiction in Delaware (see "Court Report," September 27, 2009).  As Lupin failed to file such a challenge, Warner Chilcott dropped the parallel suit.

The original suits were filed on the heels of Lupin's submissions of Abbreviated New Drug Applications with the FDA seeking permission to market and manufacture generic versions of Loestrin® and Femcon®.  Both applications included Paragraph IV certifications stating that the patent for each drug was invalid, unenforceable, or would not be infringed by the proposed generic versions of the drugs.  The patents-in-suit are U.S. Patent Nos. 5,552,394 and 6,667,050, with Loestrin® covered by the '394 patent and Femcon® covered by the '050 patent.  Earlier this year, Warner Chilcott settled litigation with Watson Pharmaceuticals over the same patents by entering into a licensing agreement with Watson that granted Watson a non-exclusive license to market generic equivalents of the disputed products (see "Biotech/Pharma Docket," February 2, 2009).

Settlement Announced in Oxytrol® Litigation

Watson Laboratories has announced a settlement in its patent infringement suit against Barr Pharmaceuticals.  The patents-in-suit, U.S. Patent Nos. 5,601,839, 5,834,010, 6,743,441, 7,081,249, 7,081,250, 7,081,251, 7,081,252, and 7,179,483, cover Oxytrol®, Watson's drug for overactive bladder control.  The original suit was filed in October 2008 after Barr's filing of an Abbreviated New Drug Application with the FDA seeking permission to market and manufacture a generic version of Watson's drug (see "Court Report," November 2, 2008).

Under the terms of the settlement, Watson has agreed to provide Barr with a royalty-bearing license to all of the patents-in-suit.  This allows Barr to bring their generic version of the drug to market in 2015, or earlier if certain conditions are met.

Apotex and Purdue Settle Suit over Oxycontin®

The U.S. District Court for the Southern District of New York has signed off on a consent order between Purdue Pharma and Apotex Inc., ending the litigation between the two companies over Purdue's painkiller drug, Oxycontin®.  Purdue filed the original complaint in September 2007 following Apotex's filing of an Abbreviated New Drug Application with the FDA seeking permission to manufacture and market a generic version of Oxycontin® (see "Court Report," September 24, 2007).  The ANDA included a Paragraph IV certification stating that Purdue's patent, U.S. Patent No. 5,508,042, was invalid, unenforceable, or would not be infringed by the proposed generic product.  Apotex filed a counterclaim stating that the patent was invalid on grounds of being procured through inequitable conduct in the form of failing to disclose relevant prior art during prosecution.  Apotex also claimed that Purdue engaged in antitrust activity by engaging in an anti-competitive scheme designed to delay Apotex from marketing a generic version of the drug.

Under the terms of the settlement agreement, Apotex has acknowledged that its ANDA, if approved, would infringe the '042 patent and that the '042 patent is valid and enforceable.  This acknowledgement of patent validity also extends to related patents from Purdue:  U.S. Patent Nos. 5,549,912, 5,266,331, and 5,656,295.  The settlement agreement also enjoins Apotex from selling its generic product until after expiry of the '042 patent in April 2013.  Finally, the settlement agreement dismisses all counterclaims made by Apotex challenging patent validity and alleging antitrust activity on the part of Purdue.  A copy of the consent order can be found here. 

House Health Care Bill Includes Biosimilar Licensure Pathway

    By Donald Zuhn --

Last Thursday, Rep. John Dingell (D-MI) introduced the Affordable Health Care for America Act (H.R. 3962) in the House of Representatives.  The 1,990-page bill, which was co-sponsored by Rep. Robert Andrews (D-NJ), George Miller (D-CA), Frank Pallone, Jr. (D-NJ), Charles Rangel (D-NY), Pete Stark (D-CA), and Henry Waxman (D-CA), includes a section (§ 2575) providing for the establishment of a licensure pathway for biosimilar biological products.

With regard to the issue of interchangeability, the bill states that a biological product (i.e., follow-on biologic or biosimilar) shall be determined to be interchangeable with a reference product (i.e., innovator biologic) if information is provided showing that "the biological product . . . is biosimilar to the reference product" and "can be expected to produce the same clinical result as the reference product in any given patient."  Biosimilarity is defined as meaning "that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components," and that "there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product."  For biological products that are administered to an individual more than once, information must also be provided showing that "the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch."

With regard to the issue of data exclusivity, the bill states that a biosimilar application cannot be approved "until the date that is 12 years after the date on which the reference product was first licensed," and further, that a biosimilar application may not be submitted "until the date that is 4 years after the date on which the reference product was first licensed."  The bill also provides an additional 6 months of exclusivity for the use of reference products "in the pediatric population."

Following introduction, H.R. 3962 was referred to the Committees on Energy and Commerce, Education and Labor, Ways and Means, Oversight and Government Reform, Budget, Rules, Natural Resources, and Judiciary, for consideration of the provisions of the bill falling within the jurisdiction of each of the Committees.

12 Senators Write in Support of 12-Year Data Exclusivity Period

    By Donald Zuhn --

On October 23, twelve Senators sent a letter to Sen. Harry Reid (D-NV), asking the Senate majority leader to "support the establishment of a responsible pathway for the approval of follow-on biologic treatments, or 'biosimilars,' that ensures patient safety and includes 12 years of data exclusivity."  The letter, which was signed by Mark Udall (D-CO), Christopher Bond (R-MO), Ben Nelson (D-NE), Kay Bailey Hutchinson (R-TX), John Kerry (D-MA), Robert Bennett (R-UT), Thomas Carper (D-DE), Thad Cochran (R-MS), Barbara Boxer (D-CA), Dianne Feinstein (D-CA), Paul Kirk, Jr. (D-MA), and Mary Landrieu (D-LA), states that "[t]he bipartisan vote this past summer by the Health, Education, Labor, and Pension (HELP) Committee to provide 12 years of data exclusivity for innovator biotechnology companies will help ensure the twin goals of making life-changing and life-saving biologic treatments more accessible and affordable, while continuing to foster the ongoing search for new cures and treatments."

The Senators contend that "lengthy and costly research and development must be coupled with an adequate period of data exclusivity for the innovator to ensure the future of new life-saving biotech discoveries."  Nothing that "more than 150 patient organizations, research universities, venture capital groups, and innovators have stated strongly that 12 years of data exclusivity is crucial for ensuring continued growth and discovery in the biotech industry," the Senators "urge [the majority leader], this year, to support the enactment of 12 years of data exclusivity for innovator biotechnology companies."

BRCA Patent Suit to Continue in Southern District of New York

    By Kevin E. Noonan --

Judge Robert W. Sweet of the Southern District of New York ruled against the defendants' motions to dismiss in Association for Molecular Pathology v. U.S. Patent and Trademark Office (see Opinion).

The defendants brought these motions under Federal Rules of Civil Procedure 12(b)(1) (for lack of subject matter jurisdiction), (b)(2) (for lack of personal jurisdiction), and (b)(6) (for failure to state a claim).  The judge denied the U.S. Patent and Trademark's motion under Fed. R. Civ. Pro. 12(b)(1) that the plaintiff's claims lacked subject matter jurisdiction, distinguishing the legal precedent asserted by the Office as being limited to instances where there was alleged "a statutory violation for which the Patent Act provided a remedy."  Here, the District Court found that the "novel circumstances presented by this action against the USPTO, the absence of any remedy provided in the Patent Act, and the important constitutional rights the Plaintiffs seek to vindicate establish subject matter jurisdiction over the Plaintiff's claims against the USPTO."  The Court further ruled that the plaintiffs have standing to sue the Patent Office for "constitutional violations" for similar reasons of a lack of statutory remedy.

As for Myriad and the Directors of the Utah University Research Foundation ("UURF," a not-for-profit corporation alleged by Plaintiffs to be "operated, supervised and/or controlled" by patent assignee University of Utah), the District Court found that the plaintiffs had standing to sue arising from the Supreme Court's broad interpretations of the contours of the Declaratory Judgments Act in MedImmune Inc. v. Genentech, Inc.  Like the non-breaching licensee in MedImmune, the District Court found that the Plaintiffs were not required to infringe Myriad's claims in order to challenge their constitutional validity.  The existence of the patent, and Myriad's actions in threatening enforcement, were sufficient to establish standing to sue.  (Although it seems likely that the Court would have found standing even under the Federal Circuit's pre-MedImmune "reasonable apprehension of suit" test, the MedImmune decision enabled the District Court to distinguish precedent asserted by Myriad and its Directors challenging standing.)  Using the Supreme Court's "all the circumstances" test, said the lower court, there was an actual "case or controversy" alleged by Plaintiffs that conferred standing; in particular the District Court found that the "cease and desist" letters and other actions by Myriad and its Directors satisfied the "affirmative acts" prong of the test with regard to two of the named Plaintiffs (Drs. Kazazian and Ganguly) and noted prior litigation against alleged infringers in support of its analysis.  The Plaintiff researchers asserted readiness, willingness, and ability to undertake infringing activity was sufficient for the Court to find that the "meaningful preparations for infringing action" prong was also satisfied.

The personal jurisdictional challenge denied by the District Court relates to the UURF Directors, and the Court's analysis was performed under Federal Circuit law and New York State's "long-arm" statute with regard to both general and specific jurisdiction.  The standard is merely that Plaintiffs have made a prima facie showing, and all uncontroverted facts alleged in the complaint are accepted as true, with factual conflicts being resolved in the plaintiff's favor.  The claims asserted by Plaintiffs were not directed towards the Directors personally, but in their capacity as Utah state officials.  The Court found that the UURF Directors had entered into an exclusive licensing agreement authorizing Myriad to market products in New York protected by UURF patents.  "Because the claims in this case are directly related to that license agreement, the Directors have purposefully availed themselves of the privilege of conducting business in New York," satisfying the specific jurisdiction requirement of New York jurisdictional law.  This conclusion was supported, according to the Court, by continued obligations imposed by the license on the Directors, including agreeing (as patent owner) to join any infringement lawsuit brought by Myriad coupled with Myriad's actions seeking to enforce the patents in New York.

Finally, turning to the failure to state a claim basis for Defendants' motion to dismiss, the District Court found that the Plaintiffs allegations of Constitutional violations were sufficient, specifically holding that the complaint satisfied the higher pleadings requirements imposed by the Supreme Court in Ashcroft v. Iqbal.  These allegations go to the heart of the complaint, that the BRCA mutations are not "inventions" but "exist in nature," and that the correlation between the presence of these mutations and an increased risk of cancer are "nothing more than a naturally-occurring phenomenon."  While noting that the standard is a liberal one, and that a complaint should be dismissed on these grounds only if "it appears beyond doubt that the plaintiff can prove no set of facts in support of its claims that would entitle it to the relief it seeks," the Court found that the allegations regarding the First Amendment violations were enough for the Plaintiffs to withstand Defendants' motion to dismiss on these grounds.

This case will not go to trial; summary judgment motions are next on the agenda, with eventual appeal (ultimately to the Supreme Court) no matter what decision the District Court reached in the merits.  While no longer named in the suit, the American Civil Liberties Union (as well as the Public Patent Foundation) is representing the Plaintiffs.  The ACLU has taken up this cause and is unlikely to not see it through.  While the Court's decision today may dash the hopes that the case would just disappear quietly, the decision provides no evidence that either party will prevail, just that the Court believes that the case has the jurisdictional and substantive competence to go forward.  And a possible silver lining in the District Court's decision is that, in keeping the USPTO in the case, the judge left the government with sufficient skin in the game to motivate a spirited defense of gene patenting as appropriate public policy in fulfillment of the Constitutional mandate to "promote the Progress . . . of the Useful Arts."

For additional information regarding this and other related topics, please see:

• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
• "Science Article Should Help Allay Gene Patenting Fears," December 17, 2008

Follow-on Biologics Data Exclusivity Debate Scorecard - Part III

    By Donald Zuhn --

Over the past twelve months, Patent Docs has reported on a number of papers, letters, and statements that outline positions taken by various players in the follow-on biologics (FOB) data exclusivity debate.  In view of the recent Time magazine article "How Drug-Industry Lobbyists Got Their Way on Health Care," which mentions that Duke University Prof. Henry Grabowski's oft-cited data exclusivity study was funded by the Pharmaceutical Research and Manufacturers of America (PhRMA) and two partisan patient groups (see "Time Magazine on Data Exclusivity Debate"), a review of these players and their positions on the issue seems appropriate.  Last week, we summarized the positions of seventeen individuals or groups that have participated in the debate (see "Follow-on Biologics Data Exclusivity Debate Scorecard" - Part I and Part II).  Today, we examine the positions of another eleven participants in the debate.  Among those who have advocated for shorter data exclusivity periods (i.e., less than 8 years) are:

• Alfred Engelberg, a New York patent attorney who represented the Generic Pharmaceutical Industry Association and played a role in the passage of the Hatch-Waxman Act in 1984; Dr. Aaron Kesselheim, a patent attorney and Instructor in Medicine at the Harvard Medical School; and Dr. Jerry Avorn, a Professor of Medicine at the Harvard Medical School, who published an article in the New England Journal of Medicine contending that FOB legislation being proposed in the House and Senate, which provides 12 years of data exclusivity, would "upset[] the delicate balance between the interests of consumers and those of innovators" (see "NEJM Authors Say Five Years of Data Exclusivity Would Be Sufficient").  The authors also argue that "[e]ven if the new legislation is adopted, manufacturers of potential follow-on products would probably prefer to ignore the new pathway and opt to file a standard BLA, which would not be subject to the 12-year delay," and therefore contend that "as currently fashioned, the biosimilar legislation would have no value, because it would create a pathway that would scarcely be used."  The authors therefore suggest that the legislation currently being proposed in the House and Senate be amended to "give the FDA the mandate to evaluate and approve biosimilar drugs in a reasonable period, starting, as with small-molecule products, 5 years after the approval of the original drug."

• James Love, the director of the public interest advocacy group Knowledge Ecology International; and James Glassman, the former under secretary of State for public diplomacy and public affairs in the George W. Bush administration, who authored an article in the Congressional newspaper Roll Call expressing "alarm" regarding Congressional action to establish a follow-in biologics (FOB) regulatory pathway, and contending that passage of FOB provisions by the House Energy and Commerce and Senate HELP Committees would "make it difficult, if not impossible, for generic drugs to compete with biologics, even after patents have expired" (see "Roll Call Authors Unite against Current Follow Biologics Legislation").  The authors state that "[t]he original proposal for biogenerics would have retained most of the features of the 1984 Hatch-Waxman Act, including the five-year exclusion [i.e., exclusivity period]," and assert that "after an intense lobbying campaign by the manufacturers of biologics, new amendments to the Senate and House versions of the bill made it much more difficult for makers of generics to enter the market."

• Momenta Pharmaceuticals Inc., which issued a statement supporting a shorter data exclusivity period (see "Follow-on Biologics News Briefs - No. 6").  The Cambridge-based company, which is developing a technology platform that provides a series of analytic tools to help determine and reproduce exactly how a biologic drug was made, did not specify the particular data exclusivity period that it was seeking.

Among those who have advocated for longer data exclusivity periods (i.e., 10 or more years) are:

• The AIDS Institute, Community Access National Network, CAEAR Foundation, and National Minority AIDS Council, which sent a letter to Sen. Ted Kennedy in July noting that approximately 32 HIV/AIDS drugs had been developed since 1987, and opining that "[a]ll of these life-saving drugs were developed with private investment [that] was only possible because pharmaceutical and biotechnology companies were able to recoup their investment in the extensive clinical research and clinical trials required to make these drugs available to the people that need them" (see "Follow-on Biologics News Briefs - No. 6").  The signatories to this letter therefore "strongly urge [Congress] to include a period of data exclusivity relative to biologics of 12 years."

• The Alliance for Aging Research, which sent a letter to Rep. Anna Eshoo (D-CA) announcing its support for Rep. Eshoo's FOB bill -- which would have provided up to 14.5 years of data exclusivity (see "Follow-on Biologics News Briefs - No. 6").

• The ALS Association, which also sent a letter to Rep. Eshoo arguing that "any biosimilars legislation . . . must foster innovation," and therefore supporting a regulatory pathway providing a 12 year period of data exclusivity (see "Follow-on Biologics News Briefs - No. 6").

• The California Healthcare Institute (CHI), an independent organization comprising more than 250 biomedical companies and academic and research institutions involved in researching and advocating policy to forward the interests of California's biomedical community, which issued a statement "support[ing] the development of a science-based biosimilars approval pathway that employs the best science to make sure that products are safe for patients, that encourages price competition among manufacturers, and provides ample incentives to encourage continued private-sector investment in the next generation of breakthroughs," and stating that it was "pleased" that Congressional legislation would "provide[] for 12 years of data exclusivity" (see "Follow-on Biologics News Briefs - No. 7").

• Governors Deval Patrick of Massachusetts, M. Jodi Rell of Connecticut, Bill Ritter, Jr. of Colorado, John Markell of Delaware, Martin O'Malley of Maryland, Beverly Perdue of North Carolina, Theodore Kulongoski of Oregon, Donald Carcieri of Rhode Island, Luis Fortuño of Puerto Rico, and Christine Gregoire of Washington, who sent a letter to Speaker of the House Nancy Pelosi (D-CA), House minority leader John Boehner (R-OH), Senate majority leader Harry Reid (D-NV), and Senate minority leader Mitch McConnell (R-KY) stating that "the balance struck in the Senate Health, Education, Labor and Pensions Committee on 12 years of data exclusivity for biologics represents a critical element needed to ensure appropriate incentives for continued biomedical innovation" (see "Governors Send Letter to Congressional Leaders in Support of 12-Year Data Exclusivity Period").  In their letter, the Governors assert that "[i]nnovator companies must be provided with at least 12 years of non-patent data exclusivity to allow for recovery of their original investment and to ensure licensing payments to our research institutions."  Governors Patrick, Ritter, Markell, O'Malley, Perdue, Kulongoski, and Gregoire are Democrats, and Governors Rell, Carcieri, and Fortuño are Republicans -- Gov. Fortuño is also a member of the New Progressive Party of Puerto Rico.

• Dr. Henry Grabowski (at right), a Professor of Economics at The Fuqua School of Business at Duke University, who published a paper in Nature Reviews Drug Discovery, in which he determined that the "break even" point for biologic drugs requires a data exclusivity period from between 12.9 and 16.2 years (see "Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs").  In his paper, Dr. Grabowski cautions that the discount rates used to calculate the break even periods are conservative and that "smaller publicly listed biotechnology companies and non-listed private biotechnology firms would generally have a much higher cost of capital," suggesting that the actual "break even" point may require even longer data exclusivity periods.  As noted above, Dr. Grabowski's study was funded in part by the Pharmaceutical Research and Manufacturers of America (PhRMA).

• The Rhode Island BioGroup and the New England Biotech Association, which ran radio spots and full-page newspaper ads supporting an FOB regulatory pathway providing 12 years of data exclusivity (see "Follow-on Biologics News Briefs - No. 6").

In addition to the above advocates, at least one other group has addressed the data exclusivity issue without taking a position on an appropriate exclusivity period:

• Deloitte Consulting LLP, which published a paper assessing the differences between the small molecule pharma industry, which was a stable and mature in 1984 when Hatch-Waxman was implemented, and the biotech industry, which is nascent and complex (both scientifically and financially), and concluding that "[i]n establishing a path to market for follow-on biologics, Congress may need to employ a different set of levers to achieve the same results" (see "Deloitte White Paper Addresses Unintended Consequences of Follow-on Biologic Regulatory Pathway").  The Deloitte paper, which was authored by Jim Hollingshead and Rob Jacoby, suggests that an FOB regulatory pathway patterned too closely on the Hatch-Waxman regime would likely have unintended, and potentially adverse, consequences for the biotech industry.

In summary, the following advocates support "shorter" data exclusivity periods:

• Federal Trade Commission -- 0 years
• Alfred Engelberg, Dr. Aaron Kesselheim, and Dr. Jerry Avorn (NEJM authors) -- 5 years
• Dr. Laurence J. Kotlikoff -- 5 years
• James Love and James Glassman (Roll Call authors) -- 5 years
• National Coalition on Health Care -- 5 years
• AARP -- 5.5 years
• Alex Brill -- 7 years
• Office of Management and Budget -- 7 years
• Momenta Pharmaceuticals Inc. -- undefined

And the following advocates support "longer" data exclusivity periods:

• AIDS Institute, Community Access National Network, CAEAR Foundation, and National Minority AIDS Council -- 12 years
• ALS Association -- 12 years
• California Healthcare Institute -- 12 years
• Governors Deval Patrick, M. Jodi Rell, Bill Ritter, Jr., John Markell, Martin O'Malley, Beverly Perdue, Theodore Kulongoski, Donald Carcieri, Luis Fortuño, and Christine Gregoire -- 12 years
• National Venture Capital Association -- 12 years
• Pharmaceutical Research and Manufacturers of America -- 12 years
• Rhode Island BioGroup and New England Biotech Association -- 12 years
• Senators Orrin Hatch (R-UT), Barbara Mikulski (D-MD), Michael Enzi (R-WY), and Kay Hagan (D-NC) -- 12 years
• Stuart Watt (Amgen Inc.) -- 12 years
• Dr. John Calfee (American Enterprise Institute) -- 12 to 14 years (period mentioned but not specifically endorsed)
• Dr. Henry Grabowski -- 12.9 and 16.2 years
• Biotechnology Industry Organization -- 14 years
• Andrew Grossman (Heritage Foundation) -- 14 years (period mentioned but not specifically endorsed)
• Intellectual Property Owners Association -- 14 years
• Audrey Philips (Johnson & Johnson) -- 14 years
• Alliance for Aging Research -- 14.5 years
• Dr. Howard Dean (Democratic National Committee) -- 14.5 years
• Robert Armitage (Eli Lilly) - 15-20 years

Readers are encouraged to review our prior coverage of the papers and letters described in this series.  Patent Docs will continue to update the list of data exclusivity debate participants -- on both sides of the issue -- as additional players make their positions known.