Patent Docs

Johnson & Johnson Petitions Federal Circuit for Rehearing En Banc

July 28, 2011

By Kevin E. Noonan —

As discussed yesterday, a panel of the Federal Circuit seemingly expanded the scope of the written description requirement in its Boston Scientific Corp. v. Johnson & Johnson decision. At issue was the extent of disclosure required for combination claims, i.e., inventions combining components known in the art to produce a new, useful, and non-obvious article. Rapamycin-coated stents for coronary angioplasty were the subject matter of the lawsuit between the parties, and the basis of the Federal Circuit's decision affirming invalidation on summary judgment by the District Court was that while the claims encompassed various rapamycin analogs, the specifications of the patents-in-suit disclosed only rapamycin itself.

Johnson & Johnson argued that this was a departure from black letter patent law, citing In re Herschler, 591 F.2d 693, 702 (C.C.P.A. 1979), and In re Fuetterer, 319 F.2d 259 (C.C.P.A. 1963), for the principle that "when claiming a combination of known elements, as opposed to a novel compound, the specification 'need not list examples' nor is any 'comprehensive description' required." Johnson & Johnson also argued that the prior art contained "a known correlation between the structure of rapamycin and its analogs and their function," and hence that patentees were entitled to their claims without having a specification that "contains examples of specific macrocyclic lactone analogs of rapamycin." In rejecting these arguments, the opinion expressed agreement with Boston Scientific's position that a patentee is required to show possession of the claimed invention at the time a patent application is filed, and that "[a] written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials," citing Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). The 1997 patents fail this test, according to the Court, due to the complete absence of any examples of a macrocyclic lactone analog in the specification. Citing the en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the opinion states that a "sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." While disclaiming any "bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim," the opinion reiterated the "factors" to be considered from Ariad: "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue."

Now Johnson & Johnson has petitioned the Federal Circuit for rehearing, by the panel or the en banc court. In its petition, the company poses two questions "of exceptional importance" for the Court's consideration:

(1) Where an inventor claims a novel combination of known elements, does the written description requirement of section 112 require a detailed recitation of information already known in the prior art concerning those known elements, if the specification otherwise teaches one of skill in the art how to make and use the invention?

(2) Where an inventor claims a novel combination of known elements, must the inventor provide examples of possible combinations of those known elements, even if otherwise unnecessary to understand how to make and use the claimed invention?

The panel decision is contrary not only to In re Hershcler, but also to Hybritech Inc. v. Monoclonal Antibodies and Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., according to the petition. Moreover, "the written description defense has been rapidly replacing inequitable conduct as the defense of last resort" because "[n]o matter how much an inventor has disclosed, accused infringers are contending that it was not enough," the petition states. This results in courts "exercising their discretion broadly to invalidate meritorious patents based on perceived insufficiencies that are at best ancillary to a patent's teaching of what is new" and this case, the petitions asserts, is an example. Granting the petition will give the Court the "an opportunity . . . to assure patentees that where a novel combination of known elements is claimed, superfluous information about the prior art need not be disclosed in the text or examples of a patent as long as the patent otherwise teaches how to make and use the invention." Failure to do so "will lead to massive over-disclosure of prior art information to the PTO, senseless invalidations of otherwise meritorious patents, and a general loss of confidence in the reliability of U.S. patent protection."

Taking this asserted precedent in turn, the petition cites Herschler (as it did to the panel) for the principle that "claims to combinations of known compounds require a written description 'only so specific as to lead one having ordinary skill in the art to that class of compounds,' Hershcler, 591 F.2d at 702, and distinguished that level of disclosure from the more extensive disclosure required to support claims to a novel compound, Id. at 701." The contrary holding in Hybritech was the oft-repeated maxim that "a patent need not, and indeed should not, repeat what is already known in the art. 802 F.2d at 1384." Finally, the petition asserts that the panel invalidated the patents-in-suit for failing to provide any examples of a rapamycin analog, which is contrary to the principle that "[a] patent specification . . . need not disclose any examples" (italics in original), citing both Ariad, 598 F.3d at 1352, and Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006). Making an analogy to the tendency for "excessive and counter-productive disclosures that impeded patent prosecution" caused by an (until recently) expansive inequitable conduct doctrine, citing Therasense, Inc. v. Becton, Dickinson & Co., the petition states that refusing to correct the panel's decision will "likewise increase the burden on applicants, the PTO, and the public by forcing disclosures that go far beyond those needed to describe and enable the patentee's actual contribution to the art."

The question posed by the petition is a fundamental one: "[w]hen an invention is made in an area having an established body of knowledge, how much of that knowledge must the patent recite in order to satisfy the written description requirement?" The petition characterizes as "settled law" that a patentee is not required to repeat (and include within the specification) "what was already known in the art," and that the extent of the adequacy of the written description must be determined in light of what was known to the person of ordinary skill in the art. The panel's error, according to the petition, was in ignoring what was known in the art and focusing too closely on what was expressly disclosed in the specifications of the patents-in-suit. The closest analogy was with Herschler, where the invention was the combination of dimethyl sulfoxide (DMSO) and "physiologically active steroidal agent[s]" and the assertion was whether the disclosure of one example — dexamethzsone-21-phosphate — provided an adequate written description. In Herschler, the CCPA held that since the applicant was not "claiming chemical compounds per se," the disclosure of one species of a sub-genus (glucocorticosteroids) of a larger sub-genus (corticosteroids) of an even larger genus ("physiologically active agents") was an adequate written description. One distinction is that the alternate components of the combination claimed in Hershcler's application were "awesome in their diversity. The scope of exemplified 'physiologically active substances' includes iodine (Example 1), pressed pellet feed for rats (Example 4), penicillin (Example 10), procaine (Example 16), various chemotherapeutic agents (Examples 17 & 18), barbiturates (Example 19), oral insulin (Example 21), antihistamines (Example 29), various local anesthetics (Examples 34 & 35), etc." Another distinction is the statement in Herschler that "[w]ere this application drawn to novel 'steroidal agents,' a different question would be posed." Nonetheless, there is no question that the CCPA applied the preclusive effect of the written description requirement more parsimoniously in Herschler than the panel did in this case.

The petition also distinguishes the instant case from the circumstances surrounding the Federal Circuit's decision in Carnegie Mellon University v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008), which the petition fairly characterizes as a basis for the panel decision. In that case, the claimed subject matter was novel DNA molecules encoding novel DNA polymerases, where only three species of "potentially millions" were disclosed. The petition contends that the difference is that the claims in Carnegie Mellon encompassed new molecules, not ones known in the art, and that where the written description may have been properly applied by the Court there it was not consistent with established law to apply in this case, where the art disclosed species of rapamycin analogs. And the petition also challenged another basis for the panel's decision, that the mechanism of rapamycin action was the subject of continued research when the applications were filed, citing Parker v. Frilette, 462 F.2d 544, 547 (CCPA 1972), for the proposition that "[a]n inventor need not understand precisely why his invention works in order to achieve an actual reduction to practice." (Indeed, the petition notes that "[t]he precise manner" by which many drugs act in the human body, including aspirin, are not fully understood but does not preclude patentability.)

Finally, the petition cites as erroneous the panel's reasoning that multiple examples of rapamycin analogs must be recited in the specification to satisfy the written description requirement, in light of that information being available in the art.

This case represents the consequences of the Federal Circuit's expansive view of the written description requirement, which necessitates a determination of where to draw the line in every case to answer the question of "how much" disclosure is enough. Since this is a fact-specific question, there can be no easy, bright-line answers generally; here, Johnson & Johnson suggests that the line should be drawn so that "combination" inventions require a lesser degree of disclosure than "composition" inventions. Perhaps it is more fruitful to make the distinction between factual situations like that in Herschler where the art discloses a multiplicity of alternative embodiments, in contrast with this case where the universe of rapamycin analogs was more limited (on the order of about 40 or so). Particularly in view of the complexity of the rapamycin structure and the large number of structural analogs with unpredictable effects on function, it might be more productive to perform the analysis (at least for the 1997 patents) on enablement rather than written description grounds (as suggested by concurring Judge Gajarsa). If the Federal Circuit refuses to rehear this case en banc, Johnson & Johnson could petition the Supreme Court for certiorari, giving the Court the opportunity to opine of an area of patent law that has so far escaped its notice.
Myriad Writes to Federal Circuit on Standing Issue

July 28, 2011

By Kevin E. Noonan —

As anyone following the AMP v. USPTO (Myriad) case will appreciate, one of the the grounds for appeal by Defendant Myriad is that the plaintiffs do not have standing to bring the suit. Since the District Court declined to rule on the Constitutional issues (1st Amendment/freedom of speech and 14th Amendment denial of due process claims with regard to the genetic information of the individual women plaintiffs), the standing issue comes down to whether any of the doctors and researchers named as plaintiffs are "ready, willing and able" to provide BRCA gene testing should Myriad's patents be invalidated. This question arose during oral argument on April 4th at the Federal Circuit, with Judge Moore joined by Judge Bryson particularly questioning Chris Hansen, the ACLU lawyer representing the plaintiffs, about the identity of at least one such named plaintiff (see "AMP v. USPTO: Oral Argument at the Federal Circuit"). Mr. Hansen provided one: Dr. Harry Ostrer from New York University, who alone among all the plaintiffs had evinced the "capability and desire" required for standing (at least according to Mr. Hansen), and that his institution, Langone Medical Center, had the "personnel, expertise and facilities" required for such testing.

That situation has changed. It seems that Dr. Ostrer is moving from his position at NYU and will be affiliated with the Department of Genetics at the Albert Einstein Medical Center in the Bronx, effective in August 2011. While academic scientists change institutions with some regularity, this change in location has prompted Defendants, through their counsel Greg Castanias, to write to the Federal Circuit to inform the Court of a change of circumstance that accompanies Dr. Ostrer's move. In their letter, Mr. Castanias informs the Court that the Genetics Department at Albert Einstein "does not offer, and is not qualified to offer, clinical genetic testing," including inter alia BRCA testing.

The significance of this change in circumstance is that the standing issue is not one that is decided once and then becomes the law of the case; as stated in Mr. Castanias' letter, plaintiffs had the burden to establish declaratory judgment jurisdiction, and this requirement continues from the time the complaint is filed through the appeals process. At least one plaintiff must have a "personal stake in the outcome" in order for jurisdiction to be maintained he writes, citing Lewis v. Continental Bank Corp., 494 U.S. 472, 477-78 (1990).

The result is that even if Dr. Ostrer could provide the plaintiffs with standing to sue heretofore, he cannot do so now, according to Defendant's letter. Without specifically petitioning for the outcome, the letter should certainly raise even more questions for the panel (Judges Lourie, Bryson, and Moore) as they continue considering their opinion in this case.

Hat tip to Hal Wegner who alerted Patent Docs to Myriad's letter.
Boston Scientific Corp. v. Johnson & Johnson (Fed. Cir. 2011)

July 27, 2011

Federal Circuit's Expanding Application of the Written Description Requirement

By Kevin E. Noonan —

Last month, the Federal Circuit affirmed a District Court finding on summary judgment that claims relating to coronary artery stents coated with rapamycin analogs were invalid for failure to satisfy the written description requirement.

The technology relates to drug-eluting coronary artery stents, used to reduce restenosis after angioplasty. Rapamycin coating inhibits proliferation of arterial smooth muscle cells that caused the restenosis by a process called neointimal proliferation. Plaintiffs Johnson & Johnson, Cordis Corp., and Wyeth ("Johnson & Johnson) sold stents protected by U.S. Patent Nos. 7,217,286, 7,223,286, and 7,229,473 (collectively, "the 1997 patents") and U.S. Patent No. 7,300,662 (the '662 patent); the following claims are representative:

U.S. Patent No. 7,217,286

1. A device comprising a metallic stent, a biocompatible, nonabsorbable polymeric carrier, and a therapeutic agent, wherein: said polymeric carrier comprises an acrylate-based polymer or copolymer, a fluorinated polymer, or a mixture thereof, and said therapeutic agent is rapamycin, or a macrocyclic lactone analog thereof, and is present in an amount effective to inhibit neointimal proliferation.

2. The device according to claim 1 wherein said therapeutic agent is a macrocyclic lactone analog of rapamycin.

U.S. Patent No. 7,223,286

10. [A stent having a coating applied thereto, wherein said coating comprises a biocompatible polymer/drug mixture and said drug is rapamycin or a macrocyclic lactone analog thereof], wherein the coating comprises a lactone-based polyester; a lactone-based copolyester; a polyanhydride; a polyaminoacid; a polysaccharide; a polyphosphazene; a poly(ether-ester) copolymer; a polydimethylsiloxane; a poly(ethylene)vinylacetate; a poly(hydroxy)ethylmethylmethacrylate; an acrylate based polymer; an acrylate based copolymer; a polyvinyl pyrrolidone; a cellulose ester; a fluorinated polymer; or a blend thereof.

27. A stent according to any one of claims 1 to 26 wherein said drug is a macrocyclic lactone analog of rapamycin.

32. A stent according to any one of claims 1 to 26 wherein said rapamycin or macrocyclic lactone analog thereof is present in a therapeutically beneficial amount to inhibit neointimal proliferation.

33. A stent according to claim 32 wherein said drug is a macrocyclic lactone analog of rapamycin.

U.S. Patent No. 7,229,473

1. A metallic stent having a coating applied thereto, wherein: said coating comprises a mixture of a biocompatible polymeric carrier and a therapeutic agent; said polymeric carrier comprises at least one nonabsorbable polymer; said therapeutic agent is rapamycin, or a macrocyclic lactone analog thereof, present in an amount effective to inhibit neointimal proliferation; and said stent provides a controlled release of said therapeutic agent over a period of several weeks.

2. The metallic stent according to claim 1 wherein said therapeutic agent is a macrocyclic lactone analog of rapamycin.

U.S. Patent No. 7,300,662

1. A drug delivery device comprising: an intraluminal stent; a biocompatible, nonerodible polymeric coating affixed to the intraluminal stent; and from about 64 .mu.g to about 197 .mu.g of rapamycin or a macrocyclic triene analog thereof that binds FKBP12 incorporated into the polymeric coating, wherein said device provides an in-stent late loss in diameter at 12 months following implantation in a human of less than about 0.5 mm, as measured by quantitative coronary angiography.

13. A method of inhibiting neointimal proliferation in a coronary artery resulting from percutaneous transluminal coronary angioplasty comprising implanting in the lumen of said coronary artery a drug delivery device comprising: an intraluminal stent; a biocompatible, nonerodible polymeric coating affixed to the intraluminal stent; and from about 64 .mu.g to about 197 .mu.g of rapamycin or a macrocyclic triene analog thereof that binds FKBP12 incorporated into the polymeric coating, wherein said method provides a mean in-stent late loss in diameter in a human population at 12 months following implantation of less than about 0.5 mm, as measured by quantitative coronary angiography.

The District Court found the claims of each of the patents in suit to be invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112, 1st paragraph. In addition, the Court found the claims of the 1997 patents to be invalid for lacking an enabling disclosure. The patents claimed "rapamycin or a macrocyclic lactone analog of rapamycin" (the 1997 patents) or "a macrocyclic triene analog of rapamycin (the '662 patent). These portions of the molecule that can be derivatized are illustrated below. The District Court construed "macrocyclic lactone analog" and "macrocyclic triene analog" broadly to mean "any molecule with structural similarity to rapamycin."

The District Court relied on testimony and statements in the specification of the patents in suit that indicated there was no "clear path or direction towards a particular drug therapy for restenosis" at the time the invention was made. In addition, the specifications of the 1997 patents contained statements relevant to both the District Court's and the Federal Circuit's opinion regarding the state of (and knowledge in) the art at the time the applications were filed, including:

• "[n]umerous agents [that] are being actively studied as antiproliferative agents for use in restenosis and [that] have shown some activity in experimental animal models."

• rapamycin "is capable of inhibiting both the inflammatory response known to occur after arterial injury and stent implanta-tion, as well as the [smooth muscle cell] hyperproliferative response."

• "the precise mechanism of rapamycin is still under active investigation,"

• "the ideal agent for restenosis has not yet been identified."

The prior art disclosed some limited number (approximately 40) of rapamycin analogs known in the art, including the analog used by Boston Scientific's accused infringing product.

Regarding the '662 patent, rapamycin was defined to include "rapamycin, rapamycin analogs, derivatives and congeners that bind FKBP12 and possess the same pharmacologic properties as rapamycin." However, the '662 patent specification did not identify any specific rapamycin analogs, and did not define a "macrocyclic triene analog" or provide any examples. For both the 1997 patents and the '662 patent there were no teachings, disclosure or data of any species other than rapamycin.

The District Court granted summary judgment to Boston Scientific that the claims of the patents-in-suit were all invalid for failure to satisfy the written description requirement, and the claims of the 1997 patents were also invalid for lack of enablement. With regard to the 1997 patents, the Court found that the term "macrocyclic lactone analogs of rapamycin" "in no way restricts the universe of potential analogs fitting the limitations as construed by the court." The District Court also found that the specifications of the 1997 patents did not disclose any "definitions, examples, or experimental models . . . for determining whether a compound is a structurally similar analog as contemplated by the patentees." With regard to the ~40 rapamycin analogs known in the prior art, the Court noted that there were "numerous potential analogs of rapamycin," a number much greater than the ~40 known analogs. The District Court also found that merely specifying the required function of the rapamycin analog was insufficient to fulfill the written description requirement, because "describing certain functions of the genus of claimed analogs does not equate to a description of the claimed analogs themselves." The Court also relied on deposition testimony from the inventors that the had not experimented with any rapamycin analogs, saying that "[l]ogically, the inventors could not have described a knowledge that they did not possess."

The District Court distinguished the content of the '662 specification, recognizing that the scope of the rapamycin analogs was lower (limited to macrocyclic triene analogs) and the '662 patent specification provides more detail on the analogs and their properties, including mechanism of action. However, the Court found that this disclosure was also insufficient, because "[n]o macrocyclic triene analogs are named, structurally depicted, exemplified, or otherwise described in the '662 patent specification. No assays or other experimental models are provided with respect to testing an analog candidate's ability to function as rapamycin." Even though the claimed genus is limited by function, there is no description of any species falling within the scope of the genus. As a consequence, the District Court found that the disclosure did not specify the "sufficient species" required by Federal Circuit precedent to fulfill the written description requirement. The Court thus "concluded that '[t]he inventors were required to describe at least one representative macrocyclic triene analog; having failed to do so, the '662 patent is [therefore] invalid for lack of written description.'"

The Federal Circuit affirmed in an opinion by Judge Moore, joined by Judge Bryson and by Judge Gajarsa with regard to the '662 patent. The opinion specifically rejected Johnson & Johnson's argument that the disclosure was sufficient based on the facts:

1) that the structure and the mechanism of action of rapamycin were known;

2) that the correlation between the structural elements of rapamycin and its mechanism of action and biological activity was known;

3) that dozens of rapamycin analogs having the same macrocyclic ring structure as rapamycin and comparable biological activity were known; and

4) that persons of ordinary skill knew of assays to determine if analogs had the same mechanism of action as rapamycin and thus would also inhibit cell proliferation.

Johnson & Johnson's argument was that the amount of the disclosure the patent specification was required to provide was reduced based on what was known in the art, citing In re Herschler, 591 F.2d 693, 702 (C.C.P.A. 1979), and In re Fuetterer, 319 F.2d 259 (C.C.P.A. 1963), for the principle that "when claiming a combination of known elements, as opposed to a novel compound, the specification 'need not list examples' nor is any 'comprehensive description' required." Johnson & Johnson also argued that the prior art contained "a known correlation between the structure of rapamycin and its analogs and their function," and hence Johnson & Johnson was entitled to its claims without having a specification that "contains examples of specific macrocyclic lactone analogs of rapamycin." In rejecting these arguments, the opinion expressed agreement with Boston Scientific's position that a patentee is required to show possession of the claimed invention at the time a patent application is filed, and that "[a] written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials," citing Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). The 1997 patents fail this test, according to the Court, due to the complete absence of any examples of a macrocyclic lactone analog in the specification. Citing the en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the opinion states that a "sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." While disclaiming any "bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim," the opinion reiterated the "factors" to be considered from Ariad: "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue."

The specifications of the 1997 patents fail this test, containing "virtually no information regarding macrocyclic lactone analogs of rapamycin." Significantly, citing the absence of the term "macrocyclic lactone analog" until the claims were amended "nine years after the effective filing date," the opinion cites in detail the lack of disclosure relating to analogs. While not relying exclusively on the absence of any examples of macrocyclic lactone analogs in the specification, the opinion notes that such a lack of disclosure is a factor that "may be considered" when making a determination of whether the written description requirement is satisfied. In language reminiscent of how courts perform an enablement analysis, the opinion states that the 1997 patent specifications contain "no examples of macrocyclic lactone analogs of rapamycin, and give no guidance on how to properly determine whether a compound is a macrocyclic lactone analog of rapamycin besides vaguely indicating they must be 'structural[ly] similar' to rapamycin." The Court also recites the "structural complexity" of rapamycin (even going so far as enumerating the "fifty-one carbon atoms, seventy-nine hydrogen atoms, thirteen oxygen atoms and a nitrogen atom" comprising rapamycin). The opinion states that "the universe of potential compounds that are structurally similar to rapamycin and classifiable as macrocyclic lactones is potentially limitless" (and mentions the District Court's determination that "tens of thousands of potential macrocyclic lactone analogs [of rapamycin] exist"). Finally, the opinion states that "even the minor structural changes to the molecular structure of rapamycin that are necessary to create analogs may have significant and unpredictable effects on functionality," none of which were disclosed in the patent specifications.

The opinion discounts the existence of rapamycin analogs in the prior art, saying that "[a]ny suggestion that these references represented existing knowledge in the art so well known as to excuse including a more detailed disclosure of the macrocyclic lactone analogs genus in the specification is belied by the state of the art at the time of the invention." The patentees' own arguments (relating to non-obviousness) were turned against them in this regard, as the Court used the unpredictability associated with assertions of non-obviousness to establish that what was known in the art was insufficient to provide the knowledge of macrocyclic lactone analogs absent in the specifications. These arguments were also supported by statements in the 1997 patent specifications, including:

• "The exact hormonal and cellular processes promoting restenosis are still being determined."

• "The exact mechanism for restenosis is still under active investigation."

• "The mechanisms for most agents employed [to prevent smooth muscle cell proliferation] are still unclear."

• "The ideal agent for restenosis has not yet been identified."

• "The precise mechanism of rapa-mycin is still under active investigation."

The Federal Circuit expressly addressed the argument that there is (or should be) a distinction between claims directed to chemical compounds per se and claims (like the ones in suit) directed to a combination comprising chemical compounds. Citing Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d. 1115, 1126 (Fed. Cir. 2008), the Court said that "our case law regarding generic claims is applicable to both inventions claiming novel genera of chemical and biological compounds as well as inventions claiming combinations of prior art compounds with other elements." "The test for written description is the same whether the claim is to a novel compound or a novel combination of known elements. The test is the same whether the claim element is essential or auxiliary to the invention," citing in support the statement in Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 345 (1961), that "there is no legally recognizable or protected 'essential' element, 'gist' or 'heart' of the invention in a combination patent."

Ultimately, the Court based its opinion on the knowledge in the prior art of a small subset of macrocyclic lactone analogs of rapamycin out of the "tens of thousands" of possible species, coupled with the failure to establish a correlation between the structure of such analogs and their function as restenosis inhibitors; in this regard the Court rebutted Johnson & Johnson's proffered expert evidence and a prior art article on rapamycin function with express statements in the 1997 patent specifications (such as "the precise mechanism of rapamycin is still under active investigation"; italics in opinion). Again echoing a traditional enablement analysis, the Court affirmed the District Court based on "the absence of information regarding structural characteristics of macrocyclic lactone analogs or examples of macrocyclic lactone analogs in the specification, the unpredictability of the art and the nascent state of using drug-eluting stents to inhibit restenosis."

With regard to the '662 patent, while coming to the same ultimate conclusion, the Court acknowledged that this specification contained more information regarding the mechanism of rapamycin action than the specifications of the 1997 patents. Regardless, the Court notes that Johnson & Johnson's own experts admitted that "researchers continued to struggle to find compounds that would work in a drug-eluting stent to prevent restenosis," and thus "the technology was still in its infancy" at the effective filing date of the '662 patent. And the '662 patent "fails to disclose even a single member of either the genus of 'analogs' of rapamycin or the more specific genus of "macrocyclic triene analogs" of rapamycin" recited in the '662 patent claims. Citing Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996), the opinion holds that the '662 specification lacked sufficient "blaze marks . . . 'as to what compounds other than those disclosed as preferred, might be of special interest . . . simply describing a large genus of compounds is not sufficient to satisfy the written description requirement as to particular species or sub-genuses.'" In view of the "nascent state of using drug-eluting stents to treat restenosis" at the effective filing date of the '662 patent, the opinion states that the "lack of such blaze marks . . . prevents any conclusion that the patent contains sufficient written description of the claimed triene analogs of rapamycin." This conclusion was supported, according to the opinion, by the fact that the mechanism of action of rapamycin was not well known, and thus the knowledge in the art "did not excuse[] the patentee's failure to explicitly disclose the claimed sub-genus or any species within the sub-genus." As with the 1997 patents, the express disclosure of the '662 patent specification rebutted Johnson & Johnson's arguments regarding the sufficiency of its disclosure based on the knowledge of one of ordinary skill in the art, insofar as that disclosure indicated that "the mechanism of action corresponding to the function of rapamycin and its analogs [was] still under investigation." The '662 patent claims also suffered, according to the opinion, by the specific activity required by the expressly recited range of macrocyclic triene analogs, in view of the absence of any information (in the specification or the art) about how such analogs having such activity could be selected (other than "trial and error," again utilizing an enablement ("undue experimentation") analysis). Returning to written description, the opinion states that "[t]here is . . . no indication of which structural features of analogs of rapamycin are necessary to achieve these results."

Judge Gajarsa, perhaps reacting to the portions of the Court's analysis sounding in enablement, concurred in part because he would expressly affirm (regarding the 1997 patents) on enablement rather than written description grounds, saying that this portion of 112, 1st paragraph is "the appropriate tool for invalidating claims that are broader than their disclosure."

One explanation for the result in this case is that the 1997 patents, and even the '662 patent, were drafted at a time before the Federal Circuit's current emphasis on the written description requirement became fully evident. However, the opinion illustrates once again that the Federal Circuit is not cabining its written description jurisprudence to chemical, pharmaceutical, or biotechnological patents. In this case, the "invention" was the combination of the stent, which was known in the art, with compounds (rapamycin and analogs) that inhibited restenosis. Traditionally, the extent of the disclosure in the 1997 patents and the '662 patent regarding the restenosis-inhibiting compound might have been enough to satisfy the written description requirement; certainly disclosure of chemical genera has not been conventionally limited by the ratio of the species disclosed and the species in the genus, or no chemical specification could ever satisfy the requirement. After Ariad (and Carnegie Mellon), it is clear that the Court will apply its written description rubrics developed (sensibly) for biotechnology inventions (where the doctrine prevents applicants from claiming complex molecules that they have not yet isolated or identified) to more traditional chemical genera. The consequence, as here, is that claim scope will be limited, particularly for those claims drafted and granted prior to the sea change started by Regents v. Eli Lilly. Whether this stimulates or inhibits innovation in these technologies appears to be the legal and technological experiment that the Court will now have performed.

Boston Scientific Corp. v. Johnson & Johnson (Fed. Cir. 2011)
Panel: Circuit Judges Bryson, Gajarsa, and Moore
Opinion by Circuit Judge Moore; opinion concurring-in-part by Circuit Judge Gajarsa
Unforeseeability a Slender Reed for Rebutting Presumption of Prosecution History Estoppel

July 26, 2011

By Kevin E. Noonan —

The doctrine of equivalents, and the extent to which prosecution history estoppel limits application of the doctrine, was perhaps the issue that prompted the Supreme Court to start its decade-long review (and, generally, reversal) of Federal Circuit precedent (in cases like eBay Inc. v. MercExchange, L.L.C., KSR Int'l Co. v. Teleflex Inc., MedImmune, Inc. v. Genentech, Inc., Microsoft Corp. v. AT&T Corp., and Quanta Computer, Inc. v. LG Electronics, Inc.). The Supreme Court and the Federal Circuit used the Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. case to set rough contours of how these two legal doctrines interact. The Supreme Court's last word, in Festo VIII, established three grounds for rebutting a presumption of estoppel for amendments submitted during patent prosecution for reasons "substantially related to patentability." These are: 1) that the equivalent was unforeseeable, 2) that the amendment had only a tangential relation to the equivalent, or 3) that there was "some other reason" that suggested the patentee would not have reasonably been expected to describe the equivalent. The Federal Circuit, tasked with establishing the extent to which these exceptions apply, last spoke in Festo X, where the Court held that "an alternative is foreseeable if it is disclosed in the pertinent prior art in the field of the invention. In other words, an alternative is foreseeable if it is known in the field of the invention as reflected in the claim scope before amendment." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 493 F.3d 1368, 1379 (Fed. Cir. 2007).

However, as in other areas of patent law where the Federal Circuit must labor to flesh out rather broad, general directives from the Supreme Court (such as obviousness under KSR), development in the lower courts occurs on a case-by-case basis. The latest case in which the Court assessed the scope of foreseeability for rebutting prosecution history estoppel, Duramed Pharmaceuticals, Inc. v. Paddock Laboratories, Inc., followed a trend started in Festo X and applied in several other doctrine of equivalents decisions by the Federal Circuit in the nine years since the Supreme Court established foreseeability as a basis for rebutting the presumption of prosecution history estoppel. The Court affirmed a District Court finding that the presumption of prosecution history estoppel applied to the claim limitation at issue (relating to ethyl cellulose used as a moisture barrier coating element in a pharmaceutical formulation of conjugated estrogens) because the patentee, Duramed, narrowed the scope of that claim element to response to a rejection over prior art. The Federal Circuit rejected Duramed's assertion that the alleged equivalent used by accused infringer Paddock Labs (polyvinyl alcohol) was not foreseeable, because polyvinyl alcohol was known in the pharmaceutical arts as a moisture barrier coating for pharmaceuticals, and that the failure of the art to teach this use specifically in combination with conjugated estrogens did not make its use unforeseeable.

This decision is consistent with how the Federal Circuit has consistently applied unforeseeability as a basis for rebutting the presumption of prosecution history estoppel. In Festo X, the Court held that "foreseeability does not require that the accused infringing product or process be foreseeable, nor that any equivalent exist at the time; rather foreseeability only requires that one of ordinary skill in the art would have reasonably foreseen the proposed equivalent at the pertinent time." Festo X, 493 F.3d at 1382. Further:

This criterion presents an objective inquiry, asking whether the alleged equivalent would have been unforeseeable to one of ordinary skill in the art at the time of the amendment. Usually, if the alleged equivalent represents later-developed technology (e.g., transistors in relation to vacuum tubes, or Velcro® in relation to fasteners) or technology that was not known in the relevant art, then it would not have been foreseeable. In contrast, old technology, while not always foreseeable, would more likely have been foreseeable. Indeed, if the alleged equivalent were known in the prior art in the field of the invention, it certainly should have been foreseeable at the time of the amendment. By its very nature, objective unforeseeability depends on underlying factual issues relating to, for example, the state of the art and the understanding of a hypothetical person of ordinary skill in the art at the time of the amendment. Therefore, in determining whether an alleged equivalent would have been unforeseeable, a district court may hear expert testimony and consider other extrinsic evidence relating to the relevant factual inquiries.

Festo IX, 344 F.3d at 1369. The theoretical underpinnings of this standard were enunciated by the Federal Circuit in Honeywell Int'l, Inc. v. Hamilton Sundstrand Corp., 523 F.3d 1304, 1312-13 (Fed. Cir. 2008):

The principle of foreseeability ties patent enforcement appropriately to patent acquisition. In making this connection, foreseeability reconciles the preeminent notice function of patent claims with the protective function of the doctrine of equivalents. Thus, foreseeability in this context ensures that the doctrine does not capture subject matter that the patent drafter could have foreseen during prosecution and included in the claims. The goal of the principle is to ensure that the claims continue to define patent scope in all foreseeable circumstances, while protecting patent owners against insubstantial variations from a claimed element in unforeseeable circumstances. The foreseeability principle thus relegates the doctrine of equivalents to its appropriate exceptional place in patent enforcement.

The Court specifically rejected the argument (raised again by Duramed) that the equivalent must be foreseeable for the specific use for which it is applied in the allegedly infringing article in Schwarz Pharma, Inc. v. Paddock Labs., Inc., 504 F.3d 1371 (Fed. Cir. 2007). There, the accused infringing article contained MgO as an equivalent to an alkali or alkaline earth metal carbonate in a pharmaceutical formulation of moexipil hydrochloride (and ACE inhibitor).

The Court came to the same conclusion in Glaxo Wellcome, Inc. v. Impax Laboratories, Inc., 356 F.3d 1348 (Fed. Cir. 2004), which involved sustained release formulations of bupropion hydrochloride sold by Glaxo as Wellbutrin®SR for treatment of depression and as Zyban® for smoking cessation. The limitation added by amendment was that the formulation comprised hydroxypropyl methylcellulose (HPMC, a partly O-methylated and O-(2-hydroxypropylated) cellulose), where the accused infringing article contained hydroxypropyl cellulose (HPC). The Federal Circuit affirmed the District Court's finding that "anyone skilled in the art [at the relevant time] would have known that HPC and HPMC were substantially equivalent," and that the Supreme Court required that a patent "must show that at the time of the amendment [that] one skilled in the art could not reasonably be expected to have drafted a claim that would have literally encompassed the alleged equivalent." Festo VIII, 535 U.S. at 741. "The Supreme Court ties foreseeability to whether the applicant would have been expected to know of, and thus properly claim, the proposed equivalent at the time of amendment." The "quintessential example of an unforeseeable equivalent" according to the Court, is after-arising technology, and unforeseeability as a basis for rebutting the presumption of prosecution history estoppel "compensates for the patentee's inability to claim" the unforeseeable.

In Glaxo, the Federal Circuit expressly uncoupled the existence (and hence foreseeability) of an equivalent from whether it was known to be an equivalent, citing this language from the Supreme Court's Festo VIII opinion:

The Supreme Court's passage addresses the time of amendment only and does not address the instance where the applicant could not properly claim a known equivalent because it had purposely left that known substitute out of its disclosure at the time of filing. In such an instance, the applicant should have foreseen and included the proposed equivalent in its claims at the time of filing. The Supreme Court states clearly in Festo: "The patentee, as the author of the claim language, may be expected to draft claims encompassing readily known equivalents." 535 U.S. at 740.

Viewed in this light, the result in Duramed is unremarkable, but points out once again that the Federal Circuit will seek (under the appropriate evidentiary circumstances) to use prosecution history estoppel to limit the scope of equivalents available to patentees. This is particularly important in technologies, such as the biotech and especially the pharmaceutical industries, where salts, excipients, and other components of commercially valuable formulations and dosage forms can be substituted to provide substantially the same active pharmaceutical agent in alternative forms. These alternative excipients will thus always exist in the pharmaceutical arts and thus presumptively be foreseeable at the time an estoppel-raising amendment is made. Moreover, the argument regarding unforeseeability supporting the rebuttal of prosecution history estoppel is in conflict with the assertion that the accused infringing article comprises an equivalent: the same factors (interchangeability, insubstantial differences) that support infringement under the doctrine of equivalents also support the argument that the equivalent was foreseeable. See Ranbaxy Pharms. Inc. v. Apotex, Inc., 350 F.3d 1235 (Fed. Cir. 2003). The availability of these choices suggests that claims useful and sufficient to protect pharmaceutical and biotech drugs should be pursued with the minimum of amendment, either by crafting several claims of narrow scope or including in claims only the minimum required ingredients to provide operable embodiments of the invention. The commercial and pharmaceutical "equivalence" of PVA and ethyl cellulose-containing excipients as moisture barrier agents was established by Paddock's successful incorporation of PVAs into it commercial embodiments. The legal equivalence as evidenced by the cited art suggests that the patentees could profitably have either included PVAs (and any other promising, or not so promising, moisture barrier coatings) in their specification, or avoided reciting these excipients in the claims of the '638 patent. In either case, because only hindsight is 20-20, it will remain a challenge to appropriately protect pharmaceutical and biologic drugs in view of the Federal Circuit's parsimonious application of the doctrine of equivalents.
EMA Continues to Defer Approval of First Gene Therapy Application in Europe

July 26, 2011

By James DeGiulio —

Last year we reported that gene therapy was experiencing a revival of sorts, now that many of the safety concerns raised from early clinical trials have been resolved (see "Gene Therapy Experiencing a Revival"). However, this revival has not yet produced marketable therapeutics, as the FDA has yet to approve a gene therapy therapeutic in the U.S., and in March 2010, the European Medicines Agency (EMA) rejected Europe's first filed gene therapy application. Expectations in the field were that Amsterdam Molecular Therapeutics' (AMT) new Glybera therapy could very well be the first for approval — but on June 24, AMT announced that the EMA had rejected its application for a gene therapy therapeutic for lipoprotein lipase deficiency (LPLD). AMT moved quickly and has already filed an application for re-examination. However, the reward for the first approved gene therapy therapeutic in a registered market remains unclaimed.

Glybera (alipogene tiparvovec) was developed as a treatment for the rare genetic disorder LPLD. Because of a defective gene, LPLD patients do not produce an enzyme that normally breaks down a certain type of fat carrying particles in the blood. Glybera uses an adeno-associated virus (AAV) vector that carries a gene for lipoprotein lipase, which restores the enzyme's activity required to process the fat carrying particles. LPLD patients have extremely high fat levels in their blood, resulting in recurrent and potentially lethal pancreatitis as well as an increased risk of cardiovascular complications and diabetes. Currently, there exists no effective treatment or cure for the serious disease.

The EMA told AMT that it has not provided enough evidence of the long-term efficacy of the product. LPLD is an extremely rare condition, and the clinical trial data submitted to EMA for approval included only 27 patients. The EMA said at present there are too few patients for whom sufficiently long-term data were available, and as a result, there was insufficient evidence of a reduction in the rate of pancreatitis. Importantly, the EMA did not have any concerns about the safety of Glybera, which supports an emerging inclination that the safety of gene therapy is no longer the roadblock to regulatory approval as it has been in the past. Indeed, the first gene therapy product ever to be filed for approval with EMA was Cerepro, a gene therapy for treating brain cancer, which also presented no concerns about the safety of the product. The EMA refused approval of Cerepro because there was not enough evidence that Cerepro was effective.

AMT believes it can avoid the pitfalls of Cerepro, and has already filed for re-examination of its application. AMT must now collect more data to show that there is a long-term reduction in the incidence of pancreatitis in treated patients. AMT said it will be possible to generate the additional data required from the existing treated patients, and the data will come from a trial which the company had already planned to do as a postmarketing study. AMT hopes to garner the additional data and resubmit the Glybera file by the end of 2011. In addition to its pursuit of Glybera, AMT will also continue development of other gene therapy products in the company's pipeline, such as therapeutics for Parkinson's disease and Huntington's disease. AMT is also preparing to apply for market approval of Glybera in Canada and the U.S.
Bill Prohibiting Reverse Payments Voted out of Committee

July 25, 2011

By Donald Zuhn —

On Thursday, the Senate Judiciary Committee reported the Preserve Access to Affordable Generics Act (S. 27) out of committee without amendment by a 10-8 vote. The bill, which was introduced by Senator Herb Kohl (D-WI) (at right) in February (see "Sen. Kohl Introduces Bill to Prohibit Reverse Payments"), is designed to prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs into the market. Senator Kohl was joined by Judiciary Committee Chairman Patrick Leahy (D-VT) and Senators Chuck Grassley (R-IA), Dianne Feinstein (D-CA), Chuck Schumer (D-NY), Richard Durbin (D-IL), Sheldon Whitehouse (D-RI), Amy Klobuchar (D-MN), Al Franken (D-MN), and Richard Blumenthal (D-CT) in voting in favor of the bill. Voting against the bill were Senators Orrin Hatch (R-UT), Jon Kyl (R-AZ), Jeff Sessions (R-AL), Lindsey Graham (R-SC), John Cornyn (R-TX), Michael Lee (R-UT), Christopher Coons (D-DE), and Tom Coburn (R-OK).

The bill passed out of committee would allow the Federal Trade Commission to initiate an enforcement proceeding "against the parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product." In such proceedings, "an agreement shall be presumed to have anticompetitive effects and be unlawful if — (i) an ANDA filer receives anything of value; and (ii) the ANDA filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the ANDA product for any period of time," unless "the parties to such agreement demonstrate by clear and convincing evidence that the procompetitive benefits of the agreement outweigh the anti-competitive effects of the agreement." The bill lists a number of factors to be considered in determining whether the parties to the agreement have met the above burden. The bill also provides a number of penalties for violating the Act, including a civil penalty in the amount of three times the value received by an NDA holder or given to an ANDA filer that is in violation of the Act.

On Friday, S. 27 was placed on the Senate Legislative Calendar and is now eligible for Senate floor consideration.

Following last week's committee vote, Sen. Hatch (at right) issued a statement in which he noted that he could not support legislation that "would give unprecedented authority to unelected Washington bureaucrats" to settle patent-infringement cases out of court. Sen. Hatch's complete statement, which is not available on his website (due to a incorrect link), states:

HATCH OPPOSES MISGUIDED PATENT SETTLEMENT LEGISLATION

WASHINGTON – Sen. Orrin Hatch (R-Utah), a former chairman of the Senate Judiciary Committee, issued the following statement today after the Judiciary Committee reported the deceptively-named Preserve Access to Affordable Generics Act (S. 27), which effectively bans patent settlements between brand and generic pharmaceutical manufacturers:

"As someone who has been a longtime proponent of allowing businesses to settle patent-infringement cases out of court, I cannot support legislation that would give unprecedented authority to unelected Washington bureaucrats to perform this role, as this bill seeks to do. This legislation stifles innovation and would make both name brand and generic drugs much more expensive. Patent holders, generic drug manufacturers, and the American people, deserve better. The bill passed the committee by a near party-line vote and in its current form will not become law."

In a letter sent to Chairman Leahy and Ranking Member Grassley last Tuesday, the Intellectual Property Owners Association (IPO) expressed its opposition to S. 27 and urged the two Senators to vote against the bill. The group said it did not believe that consumers are harmed by reverse payment settlements, and "[i]n many instances, consumers benefit by such settlements, which provide for certain generic products to launch before the expiration of the litigated patent." The letter suggested that "[s]ettlement agreements may promote competition because they may provide market entry of a generic before the generic company would otherwise have been able to enter, that is, at the expiration of a valid and enforceable patent." With respect to the bill, the IPO stated that "[b]y imposing a presumption of anti-competition and illegality, S. 27 undermines and devalues pharmaceutical patents by imposing a presumption that any settlement involving a payment to the generic applicant is to protect an undeserved pharmaceutical patent." Contending that "current antitrust laws are adequate to challenge settlement agreements that are truly anticompetitive," the IPO noted that "[t]he FTC already has broad powers to monitor Hatch-Waxman settlement agreements and enforce its powers when warranted," and "[t]he courts also have the power under existing antitrust law to hold the settlement unlawful when warranted."

The Generic Pharmaceutical Association (GPhA) issued a press release following the Judiciary Committee's vote, expressing its disappointment with the Judiciary Committee's decision to "once again controversially report[] out this misguided legislation," which the GPhA said constituted "a legislative ban on pro-consumer patent settlements." The group predicted that the legislation, if enacted, "would cost consumers and the government billions of dollars and potentially force the removal of lifesaving generic medications from the market." The GPhA also noted that "the Courts have consistently held that these settlements are pro-consumer and pro-competitive" (see "Reverse Payments in Generic Drug Settlements," – Part I, Part II, Part III, and Part IV). Stating that "[p]atent settlements have never prevented competition beyond a patent's expiration, and in many cases have resulted in making lower-cost generics available months and even years before patents have expired," the group pointed out that "of the 23 new generic drug launches expected in 2011, settlements made 17 of these possible where the generic will launch prior to a patent's expiration."

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

• "Sen. Kohl Introduces Bill to Prohibit Reverse Payments," February 2, 2011
• "Pay-For-Delay Provision Added to Senate Appropriations Bill," August 5, 2010
• "Senate Removes Pay-For-Delay Provision from Appropriations Bill," July 29, 2010
• "House Slips Pay-For-Delay Provision into Appropriations Bill," July 7, 2010
• "Consumer Groups Ask Congress to Add Pay-for-Delay Provision to Health Care Bill," January 13, 2010
• "Senate Judiciary Committee Acts on Reverse Payments," October 20, 2009
• "Bill to Prohibit Reverse Payments Introduced in the Senate," February 4, 2009
Court Report

July 24, 2011

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Medicis Pharmaceutical Corp. v. Nycomed U.S., Inc.
1:11-cv-04962; filed July 19, 2011 in the Southern District of New York

Medicis Pharmaceutical Corp. v. Perrigo Co., Inc.
1:11-cv-04963; filed July 19, 2011 in the Southern District of New York

Medicis Pharmaceutical Corp. v. Taro Pharmaceuticals U.S.A., Inc. et al.
1:11-cv-04965; filed July 19, 2011 in the Southern District of New York

• Plaintiff: Medicis Pharmaceutical Corp.
• Defendants: Taro Pharmaceuticals U.S.A., Inc.; Taro Pharmaceutical Industries, Ltd.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 7,981,909 ("Use of 1-Hydroxy-2-Pyridones for the Treatment of Seborrheic Dermatitis," issued July 19, 2011) based on Nycomed's manufacture and sale of a generic version of Medicis' Loprox® Shampoo (ciclopirox, used for the topical treatment of seborrheic dermatitis of the scalp). View the Nycomed complaint here.

Galderma Laboratories, L.P. et al. v. Tolmar Inc.
3:11-cv-01714; filed July 18, 2011 in the Northern District of Texas

• Plaintiffs: Galderma Laboratories LP; Galderma SA
• Defendant: Tolmar Inc.

Infringement of U.S. Patent No. 7,981,916 ("Solubilizing of Metronidazole," issued July 19, 2011) based on Tolmar's filing of an ANDA to manufacture a generic version of Galderman's MetroGel® (metronidazole gel, used to treat rosacea). View the complaint here.

Eli Lilly and Company et al. v. APP Pharmaceuticals LLC
1:11-cv-00628; filed July 15, 2011 in the District Court of Delaware

• Plaintiffs: Eli Lilly and Company; Trustees of Princeton University
• Defendant: APP Pharmaceuticals LLC

Infringement of U.S. Patent No. 5,344,932 ("N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-Glutamic Acid Derivatives," issued September 6, 1994), licensed to Eli Lilly, following a Paragraph IV certification as part of APP's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer). View the complaint here.

Eli Lilly and Company v. APP Pharmaceuticals, LLC
1:11-cv-00942; filed July 15, 2011 in the Southern District of Indiana

Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of APP's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer). View the complaint here.

Shire LLC et al. v. Actavis Elizabeth LLC et al.
2:11-cv-04053; filed July 14, 2011 in the District Court of New Jersey

• Plaintiffs: Shire LLC; Shire Development Inc.
• Defendants: Actavis Elizabeth LLC; Actavis Inc.

Infringement of U.S. Patent Nos. 7,105,486 ("Abuse-resistant amphetamine compounds," issued September 12, 2006), 7,223,735 ("Abuse resistant lysine amphetamine compounds," issued May 29, 2007), 7,655,630 ("Abuse-resistant amphetamine prodrugs," issued February 2, 2010), 7,659,253 (same title, issued February 9, 2010), 7,659,254 (same title, issued February 9, 2010), 7,662,787 ("Abuse resistant lysine amphetamine compounds," issued February 16, 2010), 7,671,030 ("Abuse-resistant amphetamine prodrugs," issued March 2, 2010), 7,671,031 (same title, issued March 2, 2010), 7,674,774 (same title, issued March 9, 2010), 7,678,770 (same title, issued March 16, 2010), 7,678,771 (same title, issued March 16, 2010), 7,687,466 (same title, issued March 30, 2010), 7,687,467 (same title, issued March 30, 2010), 7,700,561 (same title, issued April 20, 2010), 7,718,619 (same title, issued May 18, 2010), 7,723,305 (same title, issued May 25, 2010) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Shire's Vyvanse® (lisdexamfetamine dimesylate, used to treat Attention Deficit Hyperactivty Disorder). View the complaint here.

Shire LLC et al. v. Mylan Pharmaceuticals, Inc. et al.
1:11-cv-03414; filed July 14, 2011 in the Eastern District of New York

• Plaintiffs: Shire LLC; Shire Development Inc.
• Defendants: Mylan Pharmaceuticals, Inc.; Mylan Inc.

Infringement of U.S. Patent No. 7,700,561 ("Abuse-resistant amphetamine prodrugs," issued April 20, 2010) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Shire's Vyvanse® (lisdexamfetamine dimesylate, used to treat Attention Deficit Hyperactivty Disorder). View the complaint here.

Tibotec Inc. et al. v. Lupin Ltd. et al.
2:11-cv-04027; filed July 13, 2011 in the District Court of New Jersey

• Plaintiffs: Tibotec Inc.; Tibotec Pharmaceuticals
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent No. 7,700,645 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued April 20, 2010) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Tibotec's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.
Conference & CLE Calendar

July 24, 2011

July 25-27, 2011 – Intensive Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

July 26, 2011 – The New Inequitable Conduct Standard in Patent Litigation: Asserting and Defending Inequitable Conduct Challenges After the Landmark Therasense Decision (Strafford) – 1:00 – 2:30 PM (EDT)

August 4-7, 2011 – 2011 Annual Meeting (American Bar Association) – Toronto, Ontario

August 15-19, 2011 – Intellectual Property Law Summer School 2011 (IBC Legal) – Cambridge, UK

August 16-18, 2011 – The Bilski Impact: Procuring & Enforcing Software, Business Methods & Bioinformatics Patents (Patent Resources Group) – Alexandria, VA and Southfield, MI

September 6-7, 2011 – Pharmaceutical Law Academy (IBC Legal Conferences) – London, UK

September 11-13, 2011 – 2011 Annual Meeting (Intellectual Property Owners Association) – Los Angeles, CA

September 14-16, 2011 – 85th Annual Meeting (Intellectual Property Institute of Canada) – Chicago, IL

September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa*** (South African Department of Science and Technology) – Cape Town, South Africa

September 19-21, 2011 – Business of Biosimilars & Biobetters*** (Institute for International Research) – Boston, MA

September 22-23, 2011 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

September 26-27, 2011 – Biosimilars and Biobetters*** (SMi Group) – London, UK

September 26-27, 2011 – Life Sciences Business Development & Acquisitions in Emerging Markets (American Conference Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
Duramed Pharmaceuticals, Inc. v. Paddock Laboratories, Inc. (Fed. Cir. 2011)

July 21, 2011

By Donald Zuhn —

In Duramed Pharmaceuticals, Inc. v. Paddock Laboratories, Inc., the Federal Circuit today affirmed a decision by the District Court for the Southern District of New York granting summary judgment of noninfringement to Paddock Laboratories, Inc. with respect to U.S. Patent No. 5,908,638. The '638 patent, which is assigned to Duramed, relates to a conjugated estrogen forumulation that includes a moisture barrier coating (MBC) (the claimed conjugated estrogens are extremely water sensitive and therefore highly susceptible to moisture degradation during storage).

During prosecution of the '638 patent, Duramed overcame an obviousness rejection by amending claim 1, which originally recited a conjugated estrogen pharmaceutical composition "coated with a moisture barrier coating," to incorporate the limitations of dependent claim 7, which frecited a moisture barrier coating comprising ethylcellulose. Claim 1 as issued recites (emphasis added):

1. A pharmaceutical composition in a solid, unit dosage form capable of oral administration for the hormonal treatment of peri-menopausal, menopausal and post-menopausal disorders in a woman comprising:
conjugated estrogens coated onto one or more organic excipients forming a powdered conjugated estrogen composition where said composition is substantially free of inorganic excipients and further comprises about 30-70% gel-forming organic excipient and about 30-70% non-gel forming organic excipient by weight and having less than about 2.5% free water by weight and greater than 2.5% total water wherein said solid unit dosage form is coated with a moisture barrier coating comprising ethylcellulose.

Seeking approval to market a generic version of Duramed's conjugated estrogen hormone replacement therapy Cenestin®, Paddock filed an Abbreviated New Drug Application (ANDA) with the FDA. In response to that ANDA filing, Duramed brought suit against Paddock for infringement of claims 1, 4, and 6-8 of the '638 patent under the doctrine of equivalents (Paddock's proposed generic uses a polyvinyl alcohol (PVA) MBC, marketed as Opadry AMB, instead of ethylcellulose). Paddock then moved for summary judgment of noninfringement, asserting that Duramed was barred by prosecution estoppel from alleging that PVA met the "moisture barrier coating comprising ethylcellulose" limitation of the asserted claims. In its motion for summary judgment, Paddock relied, in part, on an International publication (the Colorcon PCT) disclosing formulations of PVA-based MBCs, including Opadry AMB. The District Court granted Paddock's motion, holding that the amendment adding the ethylcellulose limitation was substantially related to patentability, this amendment narrowed the scope of the asserted claims, and that Duramed had surrendered all subject matter between the original and amended claim scope. The District Court also held that PVA MBCs were foreseeable at the time of the narrowing amendment based on, inter alia, the prior art disclosure of both PVA as "a moisture barrier coating for pharmaceutical tablets" and the Opadry AMB formulation used by Paddock.

In an opinion authored by Judge Lourie and joined by Judges Gajarsa and Dyk, the Federal Circuit noted that because Duramed narrowed the scope of claim 1 in response to a prior art rejection, a presumption of prosecution history estoppel applied. The Court also noted that Duramed could attempt to rebut this presumption by showing that the alleged equivalent would have been unforeseeable at the time of the amendment. Duramed argued on appeal that PVA MBCs were not foreseeable because the relevant art did not disclose either PVA or Opadry AMB as suitable MBCs for moisture-sensitive pharmaceutical compounds, such as conjugated estrogens. The Court noted, however, that "to the extent that Duramed argues that foreseeability requires that PVA must have been known as an MBC for use with conjugated estrogens, we have previously rejected such a restrictive definition of the field of invention." The Court then determined that "the Colorcon PCT discloses PVA MBCs, including Opadry AMB, in the field of pharmaceutical compositions, rendering such PVA MBCs 'known in the field of the invention,' and thus foreseeable."

In response to Duramed's argument that the Colorcon PCT fails to establish that PVA-based Opadry AMB was suitable as an MBC because it provides only conclusory statements that the inventors had solved the technical drawbacks of PVA MBCs, the Federal Circuit noted that "foreseeability does not require such precise evidence of suitability," adding that:

[E]ven if the PCT disclosure indicates that PVA is less than ideal in some pharmaceutical uses as an MBC, it is still disclosed to be useful as such, and that renders it foreseeable for purposes of prosecution history estoppel. Foreseeability does not require flawless perfection to create an estoppel.

Finding that Duramed had failed to show that PVA MBCs would have been unforeseeable at the time of its narrowing amendment, the Federal Circuit affirmed the District Court's grant of summary judgment of noninfringement.

Duramed Pharmaceuticals, Inc. v. Paddock Laboratories, Inc. (Fed. Cir. 2011)
Panel: Circuit Judges Lourie, Gajarsa, and Dyk
Opinion by Circuit Judge Lourie
USPTO Proposes Change in Duty of Disclosure

July 21, 2011

By Kevin E. Noonan —

The U.S. Patent and Trademark Office issued a notice in the Federal Register today (76 Fed. Reg. 43631) proposing to change the Office's definition of materiality in Rule 56 and Rule 555(b) to be consistent with the materiality standard enunciated by the Federal Circuit in Therasense, Inc. v. Becton, Dickinson & Co. on May 25. While stating that the Office does not believe the change is mandatory, the notice cites the following reasons for the proposed change:

The materiality standard set forth in Therasense should reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, consequently reducing the incentive to submit information disclosure statements containing marginally relevant information and enabling applicants to be more forthcoming and helpful to the Office. At the same time, it should also continue to prevent fraud on the Office and other egregious forms of misconduct. Additionally, harmonization of the materiality standards is simpler for the patent system as a whole.

The proposed change will amend 37 C.F.R. §§ 1.56 and 1.555(b) to require "but for" materiality as defined by Therasense. The notice explains that:

"[w]hen an applicant fails to disclose prior art to the PTO, that prior art is but-for material if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.'' Therasense, 2011 WL 2028255, at *11. Said differently, the Court explained: ''[I]n assessing the materiality of a withheld reference, the court must determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference[,] * * * apply[ing] the preponderance of the evidence standard and giv[ing] claims their broadest reasonable construction.'' Id. The Court also recognized that ''affirmative acts of egregious misconduct,'' Id. at *12, before the PTO are unacceptable: ''Although but-for materiality generally must be proved to satisfy the materiality prong of inequitable conduct, this court recognizes an exception in cases of affirmative egregious misconduct.'' Id. The Court reasoned that ''a patentee is unlikely to go to great lengths to deceive the PTO with a falsehood unless it believes that the falsehood will affect issuance of the patent.'' Id. The Court clarified that ''neither mere nondisclosure of prior art references to the PTO nor failure to mention prior art references in an affidavit constitutes affirmative egregious misconduct.'' Id. Lastly, the Court identified the submission of an unmistakably false affidavit as an example of affirmative egregious misconduct. Id.

The Office acknowledges that this test is not as inclusive as the current Rule 56, but the notice states that "[w]hile not as inclusive as current  § 1.56(b), the Office expects that the 'but-for-plus' standard from Therasense will result in patent applicants providing the most relevant information and reduce the incentive for applicants to submit information disclosure statements containing only marginally relevant information out of an abundance of caution," and further that:

The Court stated that its "but-for-plus" standard, "[b]y creating an exception to punish affirmative egregious acts without penalizing the failure to disclose information that would not have changed the issuance decision, * * * strikes a necessary balance between encouraging honesty before the PTO and preventing unfounded accusations of inequitable conduct." Therasense, 2011 WL 2028255, at *12.

Thus, according to the Office, it expects that the "'but-for-plus' standard will reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, thereby reducing the incentive for applicants to submit marginally relevant information to the Office," and "[a]t the same time, it will continue to prevent applicants from deceiving the Office and breaching their duty of candor and good faith."

The notice also expresses the Office's opinion that a "unitary materiality standard" will be simpler for the patent bar to implement, because "patent applicants will not be put in the position of having to meet one standard for materiality as defined in Therasense in defending against inequitable conduct allegations and a second, different materiality standard to fulfill the duty to disclose before the Office."

Under the proposed rule, "information is material to patentability under Therasense if: (1) The Office would not allow a claim if  it were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction; or (2) the applicant engages in affirmative egregious misconduct before the Office as to the information." Further, "[a]s stated in Therasense, neither mere nondisclosure of information to the Office nor failure to mention information in an affidavit, declaration, or other statement to the Office constitutes affirmative egregious misconduct." The notice also states that the Office "appreciates and expects that patent applicants are inclined to be forthcoming and submit information beyond that required by proposed Rule 56, in an effort to assist examiners in performing their duties."

Although the Office is proposing to revise §§ 1.56(b) and 1.555(b) to match the ''but-for-plus'' materiality standard announced in Therasense, the Office recognizes that Therasense could be reviewed by the U.S. Supreme Court. Because the rulemaking process is lengthy and because the Office prefers to receive and consider public comments before issuing a final rule, the Office is proceeding in parallel with the possibility of a Therasense certiorari petition. Should a petition for certiorari be filed and the Supreme Court grant review of the case, the Office will consider delaying issuance of a final rule until the Supreme Court has issued its decision.

Finally, the notice contains suggestions that the Office is considering other "ways to encourage applicants to submit information beyond that required under the Therasense materiality standard."

The following is the text of the proposed revised rules:

§ 1.56 Duty to disclose information material to patentability.

* * *

(b) Information is material to patentability if it is material under the standard set forth in Therasense, Inc. v. Becton, Dickinson & Co., ____F.3d ____(Fed. Cir. 2011). Information is material to patentability under Therasense if:

(1) The Office would not allow a claim if it were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction; or

(2) The applicant engages in affirmative egregious misconduct before the Office as to the information.

§ 1.555 Information material to patentability in ex parte reexamination and inter partes reexamination proceedings.

* * *

(b) Information is material to patentability if it is material under the standard set forth in Therasense, Inc. v. Becton, Dickinson & Co., ____F.3d ___(Fed. Cir. 2011). Information is material to patentability under Therasense if:

(1) The Office would not find a claim patentable if it were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction; or

(2) The patent owner engages in affirmative egregious misconduct before the Office as to the information.

Comments must be submitted by September 19, 2011 to AC58.comments@uspto.gov or by mail addressed to: Mail Stop Comments- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Hiram H. Bernstein, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy.

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