Ortho-McNeil kept it’s exclusivity on topiramate after a district court blocked Mylan Labs from infringing Ortho-McNeil’s U.S. Patent No. 4,513,006 covering Topomax® (topiramate), an anticonvulsive drug used to treat epilepsy. The trial court also reset the effective approval date for Mylan’s Abbreviated New Drug Application (ANDA).

The United States Court of Appeals for the Federal Circuit affirmed the district court rulings on claim construction, inequitable conduct, obviousness, and enablement. Ortho-Mcneil Pharmaceutical v. Mylan Laboratories (07-1223).

Mylan filed an ANDA with the FDA with a paragraph IV certification asserting that Ortho-McNeil’s ‘006 patent is invalid or not infringed. Ortho-McNeil sent the usual congratulatory note (a lawsuit), triggering a 30-month stay on approval of Mylan’s ANDA.

After a Markman proceeding to decide what words mean what in the patent, the district court rejected Mylan’s position that the ‘006 patent doesn’t cover topiramate. The court then ruled against Mylan’s affirmative defenses of unenforceability due to inequitable conduct and invalidity based on obviousness and non-enablement.

Mylan argued that the district court improperly construed the word and to mean or in independent claim 1, and under the proper (Mylan’s) construction, the claim does not cover topiramate.

Claim 1 of the ‘006 patent is for a sulfamate of the following formula (I):

wherein X is oxygen; R1 is hydrogen or alkyl; and R2, R3, R4 and R5 are independently hydrogen or lower alkyl and R2 and R3 and/or R4 and R5 tgether may be a group of the following formula (II):

wherein R6 and R7 are the same or different and are hydrogen, lower alkyl or are alkyl and are joined to form a cyclopentyl or cyclohexyl ring.

In the molecule topiramate, R2 and R3 and R4 and R5 together are a group of formula (II), wherein R6 and R7 are methyl. Mylan argued that the use of the term and precludes the claim from encompassing topiramate. In context, the term and falls between several R group recitations: R2, R3, R4, and R5 are independently hydrogen or lower alkyl and R2 and R3 and/or R4 and R5 together may be a group of formula (II) (emphasis added).

Mylan argued that the phrase contains two independent claim limitations: (1) that “R2, R3, R4, and R5 are independently hydrogen or lower alkyl” and (2) that “R2 and R3 and/or R4 and R5 together may be a group of formula (II).” Under Mylan’s construction, both of these limitations must be met in order for a compound to infringe. Both of these limitations are not met in topiramate. None of the R2, R3, R4, and R5 subunits are hydrogen or lower alkyl because both R2 and R3 and R4 and R5 together are a group of formula (II).

Au contraire, mon amie. The court said that the claim language depicts two subsets of compounds, but does not require their simultaneous existence:

In one subset of compounds covered by claim 1, the groups R2, R3, R4, and R5 are independent of one another, in which case, according to the claim, they are either hydrogen or lower alkyl. In a second subset of compounds covered by claim 1, the R2 through R5 groups are not independent, but rather R2 and R3 are together, and/or R4 and R5 are together, to form either one or two groups of formula (II). Topiramate is an example of this type of compound. In it, R2 and R3 are arranged together in a group, as are R4 and R5. Thus, as used in this claim, and conjoins mutually exclusive possibilities.

The claim also does not use and in isolation but in a larger context that clarifies its meaning. Specifically, and appears in conjunction with the adverbs independently and together. As the district court explained, these terms signal that and links alternatives that occur under the different conditions of independence or togetherness. In context, it is clear that one of the subunits (R2, R3, R4, or R5) does not always have to be either a hydrogen or lower alkyl.

The court said that it did not need to look at extrinsic evidence but did anyway:

Nonetheless, this court notes that dictionary definitions of and, while most often listing the additive sense as the most common usage of the term, also show usage of the term to connote alternatives. Webster’s Third New International Dictionary (2002). In the circumstances of this case, the use of and to express alternatives was chosen and adequately expressed by the applicant. Thus, extrinsic evidence too offers support for the district court’s reading of the disputed term.

In light of the plain language of independent  claims, the specification, and the extrinsic evidence, the court decide that claim 1’s use of the term and means or.

Good news for Ortho-McNeil. Sales of topiramate exceed $1 billion annually.

Posted April 11th, 2008 by Stephen Albainy-Jenei in IP Litigation
| | 2 Comments »

Forest Labs had a bit of a reversal of fortune in its patent dispute with Caraco Pharmaceutical Labs over its drug Lexapro®, which is used to treat depression and generalized anxiety disorder.

The U.S. Court of Appeals for the Federal Circuit reversed and remanded the case back to the U.S. District Court, which had dismissed Caraco’s request for a declaratory judgment of noninfringement. Caraco Pharmaceutical Labs v. Forest Labs (07-1404).

Caraco’s action was dismissed for lack of Article III jurisdiction on the grounds that it had been rendered moot when Forest unilaterally granted Caraco a covenant not to sue for infringement of the patent-in-suit, U.S. Patent No. 6,916,941.

What’s interesting is that Forest’s covenant not to sue did not eliminate the controversy between the parties. So, the court held that Caraco’s declaratory judgment action presents a continuing Article III controversy.

In filing its Lexapro® NDA, Forest listed two patents in the FDA’s Orange Book, namely: U.S. Patent Nos. Re. 34,712 and 6,916,941. The ’712 patent includes claims covering substantially pure forms of escitalopram, the active ingredient of Lexapro®. The ’941 patent generally covers crystalline particles of escitalopram oxate of a particular size range, as well as dosage forms containing particles of this size range, and methods of manufacturing particles in this size range. The ’712 patent expires in 2012; the ’941 patent expires in 2023.

The first ANDA applicant to file a Paragraph IV certification for Forest’s ’712 and ’941 patents was Ivax Pharmaceuticals. Therefore, Ivax is entitled to 180 days of generic market exclusivity, which will begin either on the day it begins marketing its generic drug, or on the date a court determines that the ’712 and ’941 patents are invalid or not infringed—whichever comes first.

Forest thanked Ivax by suing them for infringement of the ’712 patent, the earlier of the two patents to expire. Ivax counterclaimed that the ’712 patent was invalid. Despite suing Ivax on the ’712 patent, Forest did not sue Ivax for infringement of the ’941 patent.

By holding the ’941 patent card, Forest kept it from an invalidity or noninfringement challenge by Ivax. Forest won and obtained a judgment that the drug described in Ivax’s ANDA infringed the ’712 patent. Because Ivax didn’t obtain a judgment that both of Forest’s Orange-Book-listed patents are invalid or not infringed it didn’t get its 180-day exclusivity period.

The court said that only two pathways remain open to subsequent Paragraph IV ANDA filers who seek to trigger Ivax’s exclusivity period before the ’712 patent expires in 2012.

First, a subsequent Paragraph IV ANDA filer could obtain a court judgment invalidating the ’712 patent, which would allow the FDA to approve Ivax’s drug. With FDA approval, Ivax would be legally free to sell its generic drug, and its exclusivity period would be triggered on the day of its first commercial marketing.

Second, a subsequent Paragraph IV ANDA filer could trigger Ivax’s exclusivity period immediately—regardless of when Ivax begins marketing its drug—via the court-judgment trigger. However, because Ivax was the first Paragraph IV ANDA filer with respect to both the ’712 and ’941 patents, a subsequent Paragraph IV ANDA filer can only activate Ivax’s exclusivity period via the court-judgment trigger by obtaining a judgment that both the ’712 and ’941 patents are invalid or not infringed.

If a subsequent Paragraph IV ANDA filer is not able to pursue either of these two pathways to triggering Ivax’s exclusivity period, then Ivax’s exclusivity period cannot begin until the ’712 patent expires in 2012. Ivax’s exclusivity period will not be triggered on the date the ’712 patent expires unless Ivax actually begins marketing its generic drug on that date. Even if Ivax does so, the FDA will still be restricted from approving any subsequent Paragraph IV ANDA until 181 days after the date the ’712 patent expires.

In short, absent an event triggering Ivax’s exclusivity, all subsequent Paragraph IV ANDA filers, including Caraco, will be denied entry to the drug market for a significant time. These subsequent Paragraph IV ANDA filers will be precluded from the market regardless of whether the generic drugs described in their ANDAs infringe Forest’s Orange-Book-listed patents and regardless of whether Forest’s patents are valid.

Got that?

So, when Caraco filed an ANDA for generic escitalopram that included a Paragraph IV certification for Forest’s ’712 and ’941 patents, Forest sued Caraco for infringement of the ’712 patent — Forest did not sue Caraco on the ’941 patent.

Since Caraco has an economic interest in determining whether the ’941 patent is invalid or not infringed by the drug described in its ANDA — because only a judgment of invalidity or noninfringement with respect to both the ’712 and ’941 patents can trigger Ivax’s exclusivity period.

Forest filed a motion to dismiss Caraco’s action on the grounds that the action did not present a “case” or “controversy” as required by Article III of the Constitution. In its motion, Forest argued that there was no controversy because Caraco did not have a reasonable apprehension of suit on the ’941 patent. Forest hinged its entire argument for dismissal on the covenant not to sue, stating: “There is no controversy because we gave a covenant not to sue.” The district court agreed, stating from the bench that “[t]here’s a covenant not to sue on the ’941 so there’s not going to be any loss, there’s no threat of lawsuit.”

In overturning the decision, the court found that the district court failed to take into account the more recent cases:

(1) In, MedImmune v Genentech, the Supreme Court said that whether a declaratory judgment action presents an Article III controversy must be determined based on “all the circumstances,” not merely on whether the declaratory judgment plaintiff is under a reasonable apprehension of suit.

(2) In Novartis v. Teva, the CAFC held that where an NDA holder brings an infringement suit against a Paragraph IV ANDA filer on only one of several Orange-Book-listed patents covering its NDA, the ANDA filer has standing to seek a declaratory judgment on any of the NDA holder’s remaining Orange-Book-listed patents for that NDA. However, Novartis had not been decided at the time so Ivax never sought a declaratory judgment that Forest’s ’941 patent was invalid or not infringed by its generic drug. Even though Novartis only sued Teva on one of its Orange-Book-listed patents, this was sufficient to trigger a 30-month stay barring Teva’s ANDA from approval under 21 U.S.C. § 355(j)(5)(B)(iii).

In reversing and remanding, the CAFC pointed out that:

First, the dissent states that there is “no basis to conclude that the first-filing generic manufacturer will, or is likely to, delay bringing its product to market after the ’712 patent expires.” We agree. What the dissent fails to recognize, however, is that the injury upon which Caraco’s suit is premised is the delay (in triggering Ivax’s exclusivity period) between now and when the ’712 patent expires in 2012, not any delay (in triggering Ivax’s exclusivity period) after the ’712 patent expires. Thus, the dissent is in error when it notes that our analysis requires speculating as to when Ivax decides to market its drug after the ’712 patent expires.

Second, the dissent states that we assume that a first Paragraph IV ANDA filer who unreasonably delays in marketing its drug cannot lose its right to exclusivity. The dissent is incorrect. Our conclusion that the first filer in this case, i.e. Ivax, cannot forfeit its exclusivity period is not based on an assumption, but rather the texts of the Hatch-Waxman Act and the MMA. A s discussed, the MMA amendments to the Hatch-Waxman Act include a grandfather provision that specifically exempts a certain class of Paragraph IV ANDA filers, including Ivax, from being subject to the MMA’s 180-day exclusivity forfeiture provisions. Accordingly, it cannot plausibly be argued that Ivax may nevertheless forfeit its exclusivity period.

Third, the dissent states that our analysis “assumes that [Caraco] will prevail in its non-infringement claim—an uncertain assumption at best.” We make no such assumption, nor need we. A plaintiff need not prove it will prevail on the merits of its case in order to prove that it has standing to bring the case. Steel Co., 523 U.S. at 89 (”It is firmly established in our cases that the absence of a valid (as opposed to arguable) cause of action does not implicate subject-matter jurisdiction, i.e., the courts’ statutory or constitutional power to adjudicate the case.”).

Expect to see more on this issue. Forest had Lexapro sales of about $2.5 billion last year.

More at the Orange Book blog and IPBiz.

Posted April 9th, 2008 by Stephen Albainy-Jenei in Generic drugs, IP Litigation
| | 1 Comment »

Eighteen states and the District of Columbia have filed suit against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier for allegedly entering into a scheme to block the generic version of the cholesterol lowering drug TriCor®  (fenofibrate), indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.

According to the AGs in the states, the companies made trivial changes to the formulations of TriCor, and marketed those while withdrawing the original drug from the market. The companies deleted references to the original forms of the drug from national drug databases, according to prosecutors, making it more difficult for a generic version of TriCor to obtain generic status

The states filed their lawsuit in federal court in Wilmington, Delaware, accusing Abbott and of undermining efforts to bring generic drugs to market by patenting new formulations of TriCor with only minor changes to the drug.

TriCor, which costs more than $3 a pill, generated sales of $1.2 billion for Abbott in 2007, but the company, according to the lawsuit, has tried to maintain a monopoly on the market by obtaining term-extending patents. Abbott denies the allegations saying it has not prevented other fenofibrate drugs from being marketed.

The prosecutors say Fournier obtained patents covering the variations of TriCor and then filed patent infringement lawsuits against generic companies that tried to compete. The litigation meant that the Food and Drug Administration could not approve generic versions of TriCor.

In a long-running battle with Teva Pharmaceutical, Abbott has tried to stay one step ahead of the generic entry. Originally, Teva filed an ANDA for ANDA for a TriCor capsule formulation and made a Paragraph IV certification that U.S. Pat. No. 4,895,726 was invalid so not infringed. A bbott sued and initiated a 30-month stay of FDA approval.

While the capsule battle was continuing, Abbott filed a new NDA for 54 mg and 160 mg TriCor in a tablet formulation arguing that the tablet was bioequivalent to the capsule. After this was approved, Abbott stop selling the capsules and bought back all the capsules from the market.

The Abbott, in a move that was probably too smart for their own good, changed the code for TriCor capsules in the National Drug Data File (NDDF) to “obsolete.” The NDDF is a private database that provides information about FDA-approved drugs. Changing the code to obsolete then removed the TriCor capsule drug formulation from the NDDF, which prevented pharmacies from filling TriCor prescriptions with a generic capsule formulation.

Needless to say, Teva took it kind of hard and added antitrust counterclaims to its suit against Abbott. Abbott is no longer marketing the 54 mg and 160 mg strength tablets because it has now changed its Tricor product to 48 mg and 145 mg strength tablets. Abbott even filed a new NDA for 48 mg and 145 mg TriCor tablets looking to change the label to state that the new tablets do not need to be taken with food (the dissolvable version).

Teva claims that Abbott’s actions have frustrated generic competition in Fenofibrate products through a combination of two market conversions and the gaming of the Hatch-Waxman Act, denying consumers access to a generic alternative to Abbott’s products.

The dissolvable version of TriCor retains patent protection until 2018.

In the current suit by various AGs, the states involved are Arizona, Arkansas, California, Connecticut, the District of Columbia, Florida, Iowa, Kansas, Maine, Maryland, Minnesota, Missouri, Nevada, New York, Oregon, Pennsylvania, South Carolina, Washington, and West Virginia.

No word yet on when Abbott’s new magic orange-colored TriCor comes out.

See a timeline at the Orange Book blog.

Posted March 21st, 2008 by Stephen Albainy-Jenei in Generic drugs, FDA, IP Litigation
| | 4 Comments »

The University of California and Abbott appealed after the district court turned down their attempt to stop Dako from making and selling its HER2 FISH pharmDXTM kit, allegedly infringing U.S. Patents 5,447,841 and 6,596,479.   The Regents of the University Of California, Abbott Labs v. Dakocytomation California (06-1334, -1452; 07-1202)

The inventions claimed in the patents are improved methods for identifying and classifying chromosomes to detect chromosomal abnormalities associated with genetic disorders, degenerative diseases, and exposure to agents known to cause degenerative diseases, such as cancer.

There are three general types of chromosomal abnormalities: extra or missing individual chromosomes, extra or missing portions of a chromosome, or chromosomal rearrangements. Procedures in the prior art required that chromosomes be in the metaphase phase of the cell cycle because it was not possible to visualize nonmetaphase, or interphase chromosomes due to their dispersed condition in the cell nucleus, which is extremely difficult and time consuming, and almost impossible for tumor cells.

Other prior art techniques used probes comprised of DNA and RNA fragments for gene mapping and were limited by the nonspecificity of that technique — due to repetitive nucleotide sequences that were present throughout the chromosomes. Labeled probes would not only hybridize with the target chromosomal DNA, but with repetitive sequences as well, thereby producing false-positive results.

Abbott’s new technique allowed detection of chromosomal abnormalities in both metaphase and interphase cells using standard clinical and laboratory equipment.

In denying a preliminary injunction, the court concluded that appellants failed to show a likelihood of success on the merits of their infringement claim under the ’479 patent based on its claim construction of two claim limitations, of “morphologically identifiable chromosome or cell nucleus” and “heterogeneous mixture of labeled unique sequence nucleic acid fragments.” The court also based its conclusion on appellants’ failure to show a likelihood of success that the accused product met the “blocking nucleic acid” limitation of the ’841 patent under the doctrine of equivalents.

While an appeal was pending, the district court amended its basis for rejecting appellants’ proposed construction of the term “heterogeneous mixture of labeled unique sequence nucleic acid fragments.” The court amended “its previous order to the extent it improperly cite[d] 35 U.S.C. § 102 as the basis for questioning the validity of the claims of the ’479 patent” in light of the ’841 patent, and instead stated that the ’479 patent would likely be rendered invalid under the doctrine of nonstatutory (obviousness) double patenting.

After the district court held a Markman hearing, the court granted summary judgment of noninfringement of the ’479 patent as to all of the accused products based on its construction of the “heterogeneous mixture” limitation. The court further granted summary judgment of noninfringement on the ’841 patent, concluding that Abbott was barred from asserting infringement of the “blocking nucleic acid” limitation under the doctrine of equivalents. The court also denied summary judgment on the ’841 patent as to the remaining twenty accused products. The court did not address whether Dako’s products met the “morphologically identifiable” limitation — a claim limitation that was at issue in the preliminary injunction motion.

Abbott argued that the district court erred in its construction of the claim limitation “heterogeneous mixture of labeled unique sequence nucleic acid fragments” to mean “heterogeneous mixture of labeled nucleic acid fragments that includes only unique sequence fragments,” whereas Dako’s kits contain repetitive sequences. Abbott said that the court erred by interpreting that language to mean that the heterogeneous mixture excludes repetitive sequences.

According to Dako, the claim language supports a construction that excludes repetitive sequences because the specification supports that construction in statements and embodiments and in light of the prosecution history of the ’479 patent. In addition, Dako argues that the doctrine of claim differentiation is not an absolute rule. Where construction of an independent claim leads to a clear conclusion inconsistent with a dependent claim, the doctrine of claim differentiation must yield.

The CAFC held:

Although the district court erred in its reasoning as set forth above, we nonetheless will affirm the court’s construction of the heterogeneous mixture limitation. The court correctly evaluated the prosecution history and determined the proper claim construction. We also agree with the court’s conclusion set forth in its summary judgment decision that the patentees disclaimed embodiments that include repetitive sequences during the prosecution of the ’479 patent. Thus, the district court was correct in concluding that the accused products, which employ a mixture that includes repetitive sequences, do not infringe the ’479 patent.

Posted March 20th, 2008 by Stephen Albainy-Jenei in IP Litigation
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The Court of Appeals for the Federal Circuit upheld a lower court ruling that Teva Pharmaceutical Industries Ltd. infringed two patents held by Pfizer Inc. for Celebrex, a non-steroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis and rheumatoid arthritis. Pfizer v. Teva (07-1271).

Pfizer has three patents listed in the FDA’s Orange Book protecting its arthritis drug Celebrex (celecoxib), selective non-steroidal anti-inflammatory drug used to treat pain and inflammation. Pfizer sued Teva in 2004 after the company filed an Abbreviated New Drug Application (ANDA) filing for generic approval with the U.S. Food and Drug Administration. Because the patents covering celecoxib were listed in the Orange Book, Teva was required to certify that those patents were invalid or will not be infringed by the manufacture, use or sale of the new drug. Teva’s ANDA challenged the validity of the patents covering celecoxib.

Last year, the U.S. District Court for the Northern District of New Jersey ruled that all three of Pfizer’s Celebrex patents, U.S. Patent Nos. 5,466,823, 5,563,165, and 5,760,068, were valid and infringed by Teva’s ANDA filing. The district court also held that the asserted claims of the three patents were not invalid for a best mode violation and that the asserted claims of the ’068 patent were not invalid for obviousness-type double patenting. The court stopped Teva from selling its generic drug until until December 2015, when the ‘068 patent expires.

In a split decision, the Court of Appeals for the Federal Circuit held that one of the patents, the ‘068 patent, is invalid for double patenting in view of the earlier filed ‘165 patent.

Pfizer originally filed one patent application covering multiple inventions encompass a broad genus of non-steroidal anti-inflammatory compounds, compositions using those compounds, and methods of using those compositions. The claims of the patents include celecoxib—the active ingredient in Celebrex. During review of the application, the patent the patent examiner issued a restriction requirement, which required an election of the following inventions under 35 U.S.C. §121: <

1. Claims 1-20, compounds.
2. Claims 21-26, compositions.
3. Claims 27-37, methods of use.

In response, Pfizer chose to prosecute the generic compound claims and, within that genus, the single compound species celecoxib. The resulting compound claims ultimately issued as the ’823 patent. Subsequent to the restriction requirement but before the ’594 application issued, Pfizer filed a series of continuation applications claiming priority to the ’594 application and covering the non-elected subject matter which it had elected not to prosecute in the original ’594 application.

In particular, Pfizer filed a divisional application, which ultimately issued as the ’165 patent, that included the restricted-out composition claims, and a continuation-in-part application (”CIP”), which ultimately issued as the ’068 patent, that included the restricted-out method claims.

The issue in this case is that patent law prohibits getting more than one patent on the same invention — that is, you cannot get a second patent if it claims an invention that was disclosed or would have been obvious in light of the first patent. However, there is also a rule that says the first patent can’t be used against the second one if the second one is filed in response to the restriction requirement made in the earlier parent application.

35 U.S.C. § 121 provides a safe harbor to patents that issue on applications filed as a result of a restriction requirement:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.

In addition to the express requirements of section 121, the statute requires consonance: the applicant must maintain the line of demarcation between the independent and distinct inventions that prompted the restriction requirement. The court held that this safe harbor applies exclusively to divisional applications since a divisional application contains an identical disclosure to its parent application. This consonance requirement prevents an applicant from amending the claims in the divisional application in a way that would violate the originally imposed restriction requirement and thereby impermissibly extend the patent term as to that subject matter.

In the present case, Pfizer had filed a continuation-in-part application, which includes some portion of the original application but also introduces new matter. Teva argued that section 121 applies exclusively to divisional applications, and that because the ’068 patent issued on a CIP rather than on a divisional application, it does not fall within the terms of the statute.

Pfizer tried arguing that the terminology of the application did not matter but the appeals court pooh-poohed it:

There is no suggestion, however, in the legislative history of section 121 that the safe-harbor provision was, or needed to be, directed at anything but divisional applications. The commentary and materials published since section 121’s enactment similarly contain no suggestion that section 121 was meant to cover any applications other than divisionals. Although the legislative history reveals no reason why Congress drafted section 121 only to benefit divisional applications, there are certainly plausible reasons why Congress would have concluded that section 121 should be limited to divisional applications, and not include CIPs. The need for the protection only existed when a divisional application was filed as a result of the restriction.

Because the second application then was without the safe harbor, the court held that it was invalid for obviousness-type double patenting, a judicially created doctrine that prohibits someone from obtaining an extension of their patent rights by filing a later patent that are not patentably distinct from the first. The Appeals Court ruled in Teva’s favor that the patent covering the use in the treatment of inflammation was invalid.

The court ruled that two other patents covering the active ingredient in Celebrex are valid, enforceable and infringed by the Teva’s product. The decision will keep Teva from selling a generic counterpart in the U.S. until May 2014.

It is obviously good news for Pfizer tht they did not lose all of the patents, given that it is one of its biggest sellers with global sales of Celebrex totalling $2.3 billion a year, including $1.7 billion in the U.S. alone. However, the decision will cut Pfizer’s patent term by one and a half years.

Posted March 20th, 2008 by Stephen Albainy-Jenei in IP Litigation
| | 1 Comment »

What happens when a brand name drug company asserts that a patent covers its drug and then pulls it out from the Orange Book? You fight to get it back in, that’s what.

In August, Teva Pharmaceuticals USA submitted a Citizen Petition pursuant to section 505 of the Food, Drug, and Cosmetic Act (FDCA) asking the FDA to do just that.

The FDA’s official Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book“) listed two patents as claiming Risperdal® tablets: U.S. Patent No. 4,804,663, which was set to expire on December 29, 2007, and U.S. Patent No. 5,158,952 (”the ‘952 patent”), which will expire on October 27, 2009.  Risperidone is an antipsychotic medication sold by Janssen Pharmaceutica (a subsidiary of Johnson & Johnson) under the trade-name Risperdal®.

Teva submitted an original Abbreviated New Drug Application (ANDA) seeking approval to market generic risperidone tablets. Because the Orange Book listed both the ‘663 and ‘952 patents for Risperdal® tablets, Teva was required to certify as to both patents.

Teva filed a certification under § 355(j)(2)(A)(vii)(III) (”Paragraph III certification”) as to the ‘663 patent, which is set to expire on December 29, 2007, and a certification under § 355(j)(2)(A)(vii)(IV) (”Paragraph IV certification”) as to the ‘952 patent, asserting that the patent was invalid or would not be infringed by Teva’s generic risperidone tablets.

Ordinarily, Teva would be entitled to 180 days of marketing exclusivity for its generic risperidone tablets as a result of its paragraph IV certification to the ‘952 patent. That’s because the ‘952 patent appeared in the official Orange Book when it originally filed – that meant that Teva was required to submit a certification to that patent at the time it submitted its ANDA for generic risperidone drug products. Teva then became the first company to submit a paragraph IV certification to any of the listed patents claiming Risperdal®.

On October 12, 2001, FDA notified Teva that it had “delisted” the ‘952 patent from the Orange Book (even though it continued to appear in the official Orange Book at that time) It also informed Teva that it would not accept Teva’s ANDA for filing unless Teva modified its patent certification to reflect that the ‘952 patent was no longer listed as claiming the reference drug product.

In November 2006, the D.C. Circuit ruled that the plain text of the FDCA prevented the FDA from effectuating the delisting of a patent following the submission of a paragraph IV certification as to that patent. Ranbaxy Laboratories Ltd. v. Leavitt, 469 F.3d 120, 125-26 (D.C. Cir. 2006). The court struck down the FDA’s practice because it “changed the incentive structure adopted by Congress,” by “depriving the generic applicant of a period of marketing exclusivity” after the generic manufacturer had expended significant resources in developing a non-infringing generic substitute and undertaken the risk of infringing the patent by filing a paragraph IV certification.

Teva then filed a Citizen’s Petition with the FDA arguing that the FDCA entitles Teva to a 180-day period of first-filer exclusivity for generic Risperdal® tablets since it was the first generic manufacturer to file an ANDA for generic risperidone tablets containing a paragraph IV certification as to the ‘952 patent.

Under 21 U.S.C. § 355(j)(5)(B)(iv) (2002), the earliest any subsequently-filed paragraph IV ANDA can be approved is “one hundred and eighty days after” Teva first commercially markets its generic risperidone tablets or the date of a court decision holding the ‘952 patent to be invalid or not infringed.

Teva argued that both FDA regulations and case law make clear that the agency does not adjudicate questions of patent law; instead, it plays only a ministerial role in maintaining the Orange Book. As a result, where a patent remains listed for a particular drug in the official Orange Book, a generic applicant has no choice but to believe that the NDA holder is continuing to assert that patent as claiming the listed drug.

Thus, at the time of its ANDA submission in August 2001, Teva was required to submit a certification to the ‘952 patent. Teva now wants its 180-exclusivity for these drug products.

The question here is whether or not a brand manufacturer can game the system by delisting a patent after the submission of a paragraph IV certification and without notice, forcing generic manufacturers to invest resources and assume the risk of patent litigation without any guarantee of the 180-day exclusivity reward.

The FDA wrote back a nice note to Teva:

We have carefully reviewed your Petition and have concluded that the ‘952 patent was delisted before Teva submitted ANDA 76-228 to FDA. For the reasons described in further detail in this Response, we deny your request that FDA relist the ‘952 patent. As Teva’s ANDA did not contain a paragraph IV certification for a listed patent, and Teva did not provide the required notice of such certification to the holder of the NDA for the reference listed drug and each owner of the listed patent, Teva would not be eligible for 180-day exclusivity pursuant to section 505(j)(5)(B)(iv) of the Act for its pending ANDA 76-228.

Like a game of Calvinball*, since the FDA had itself forced Teva to remove the paragraph IV certification or it wouldn’t accept the ANDA, the FDA now claims that Teva’s out of luck because it did, in fact, take out the certification.

Nice.

It probably wouldn’t take a law degree to guess that Teva has filed a lawsuit in federal court to try to get the Petition granted. Johnson & Johnson’s sales of antipsychotics in the U.S. were more than $2.7 billion last year with Risperdal accounting for a large part of that amount. A generic can make quite a bit in just 180 days.

Stay tuned.

Teva vs. FDA Complaint

[*Note: Under the Official Rules of Calvinball, Rule 1.2. states: “Any player may declare a new rule at any point in the game (Figure 1.2). The player may do this audibly or silently depending on what zone (Refer to Rule 1.5) the player is in.”]

Posted March 7th, 2008 by Stephen Albainy-Jenei in Pharmaceutical, Generic drugs, FDA, IP Litigation
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To paraphrase Ronald Reagan, “Well, There You Go Again!” The Court of Appeals for the Federal Circuit again affirmed that, while the practice of savings seeds after a harvest to plant the next season is as old as farming itself, you can’t save patented seeds.

After the district court held that Loren David knowingly infringed Monsanto’s seed patent, it awarded Monsanto damages, attorney fees, prejudgment interest, and costs of $786,989.43. On appeal, the CAFC affirmed that the patent was infringed but that some of the damages awarded were wrong. See Monsanto v. Loren David (07-1104).

Monsanto went after the farmer for breaching a technology agreement over genetically modified crops that resist glyphosphate herbicide. After planting these crops, farmers can spray glyphosphate herbicide over their fields to kill weeds while leaving the resistant crops intact. Monsanto sells seeds of the genetically modified crops, in this case soybeans, under the trade name Roundup Ready.

Monsanto’s U.S. Patent No. 5,352,605 claims a plant seed containing a genetic promoter sequence that facilitates a plant’s production of the modified enzyme that allows plants to survive exposure to glyphosphate herbicide. Monsanto distributes the patented seeds by authorizing various companies to produce the seeds and sell them to farmers. Monsanto required those seed companies to obtain a signed “Technology Agreement” from purchasers.

The Technology Agreement stipulates that buyers may use the seeds for the planting of only a single commercial crop, but that no seeds from that crop may be saved for future harvests. The Technology Agreement assures Monsanto that farmers must purchase new Roundup Ready® seeds each harvesting season, rather than simply saving seeds from the prior year’s harvest, as they normally would with conventional soybean seeds. Monsanto also charges a Technology Fee for each unit of Roundup Ready® soybean seeds sold. The Technology Agreement also contains a clause granting Monsanto the full amount of its legal fees and other costs that may have to be expended in enforcing the agreement.

Along comes Farmer David, a commercial farmer who owns soybean fields in North and South Dakota. He signs a Monsanto Technology Agreement in 1999 and plants some of the magic soybeans again in 2003. Monsanto claims that the seeds that David planted were Roundup Ready® soybeans improperly saved from the previous year’s harvest but David claims he did not save any seed.

Earlier, David purchased 645 units of Roundup Ready® soybean seeds, an amount of seeds that could not have covered David’s soybean fields in 2003. David also bought over 1,000 gallons of glyphosate-based herbicides in 2003, herbicide. Monsanto, ever vigilant for seed savers, tested David’s crops and found that they were from patented seeds.

David cleverly tried to show he purchased 993 units of Roundup Ready® soybean seed on May 31, 2003, but that was nearly a month after he claimed to have planted the majority of his soybean crop for the year. The court said “Nice try but no dice!”

Furthermore, the court found David’s testimony regarding his claimed purchase of conventional herbicides “not believable” and that David was unreliable as a witness. Hence, it ordered David to pay up.

It is important to note that the ‘605 patent claims a gene sequence, not a plant variety or a seed. David tried pleading that the ’605 patent cannot be infringed merely by saving seeds from plants containing the patented gene sequence. He argued that the written description of the ’605 patent lacks the specificity that would be required of a patented plant variety under the utility patent statute; thus, the ’605 patent is limited to the gene sequence and does not cover the plant containing such a gene.

David tried to fly under the premise that under J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, plants can only receive patent protection under the Plant Patent Act of 1930, the Plant Variety Protection Act of 1970, or under a utility patent on a plant variety. Thus, a utility patent on a gene sequence does not entitle the holder of that patent to enforce its grant of exclusivity against growers of plant varieties that contain the gene sequence.

Monsanto responded by showing that the holding of J.E.M. is just the opposite of what David claims it to be; patentable subject matter remains unmodified by the existence of the P.V.P.A. and the P.P.A. Moreover, Monsanto points to various decisions of this court that have read the ’605 patent onto plants and seeds containing the patented gene and holding those who save seeds liable for infringement.

The Supreme Court’s decision in J.E.M. stated that the existence of statutes specifically authorizing the patenting of plants (the P.P.A. and the P.V.P.A.) did not eliminate the availability of utility patent protection covering plants.

In smacking David down, the CAFC scolded him saying:

David’s real complaint seems to be that he should be able to save seed from his harvest, regardless of Monsanto’s patent. We have dealt with this complaint before. See e.g. Monsanto Co. v. McFarling, 302 F.3d 1291 (Fed. Cir. 2002). In McFarling, we held that a farmer who saved seed containing a patented gene was liable for patent infringement. Id. at 1299 (citing J.E.M., 534 U.S. at 604). McFarling further established that “the right to save seed of plants registered under the PVPA does not impart the right to save seed of plants patented under the Patent Act.” Id. We note that McFarling dealt with the very patent at issue in this case—the ’605 patent. We may not disregard a prior decision of this court regarding the same matter.

…

Due to his continually changing testimony, the court disregarded much of David’s testimony. See id. Given David’s unreliability as a witness, and a complete lack of other evidence supporting his claims, we conclude that the district court did not clearly err in determining that David planted saved seed.

David also tried to get the seed report tests conducted by Monsanto and the testimony of Monsanto’s expert Koppatschek, which relied on those seed report tests, thrown out.

Rule 702 of the Federal Rules of Evidence allows expert testimony if “(1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.”

This didn’t work since the Federal Rules of Evidence establish that an expert need not have obtained the basis for his opinion from personal perception. Reliance on scientific test results prepared by others may constitute the type of evidence that is reasonably relied upon by experts for purposes of Rule of Evidence 703.

See also:

Monsanto Planted By Patent Office Re-Exam
Re-Planting Biotech Crops A No-No

Posted February 13th, 2008 by Stephen Albainy-Jenei in BioAg, IP Litigation
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Earlier, in Wisconsin Alumni Research Foundation (WARF) v. Xenon Pharmaceuticals, the U.S. Court of Appeals for the Federal Circuit held that just because a case involves patents doesn’t mean that you automatically get federal jurisdiction. 

The court ruled that it has no jurisdiction over the case because it does not present a claim arising under the patent laws. Xenon Pharmaceutical looked to the mention of the Bayh-Dole Act  (35 U.S.C. 200 et seq.) in WARF’s complaint to get jurisdiction. 

In the end, the case was transferred to the United States Court of Appeals for the Seventh Circuit to resolve the issue — a case where WARF won a $1 million jury award against Xenon Pharmaceuticals in a dispute over licensing of WARF’s stem cell patent.

Xenon then filed a combined petition for panel rehearing and rehearing en banc that was rejected by the circuit judges in an order without any opinion.

Not happy with how the process went, Judge Rader (joined by Newman and Moore) issued a dissent saying:

While the panel dismissed the notion that the Bayh-Dole Act’s “mere inclusion” in Title 35 does not make it a “patent law,” it seems to me that this is actually a pretty good indicator. After all, Title 35 is itself entitled “Patents,” and Chapter 18, which encompasses only §§ 200-212, is called “Patent Rights in Inventions Made with Federal Assistance.”  Also, the language within some of the sections of the Bayh-Dole Act suggests its provenance as a patent law. 

For example, 35 U.S.C. § 201(d) defines “invention” as “any invention or discovery which is or may be patentable . . . .”  Section 201(e) explains that a “subject invention” is an invention conceived of or first reduced to practice by a contractor.  “Conception” and “reduction to practice” are familiar patent law terms of art.  Also, § 200 states that the Act intends “to use the patent system to promote the utilization of inventions arising from federally supported research or development . . . .” The Bayh-Dole Act is, “at its heart,” a patent law, albeit a patent law that employs some government contract rules to facilitate its patent-related policy objectives.

To resolve this dispute, some court will have to compare the claims of the pending patent applications of the WARF/Xenon agreement with the alleged “improvements,” and the contract’s use of patent infringement parlance to define this term will necessitate some sort of patent analysis, starting with construction of the pending claims. Thus, this is a patent dispute for still another reason.

Ultimately, the Patent Office may decide.  After PUBPAT filed formal reexamination requests, the U.S. Patent and Trademark Office (PTO) rejected the claims of three WARF patents (US 5,843,780, US 6,200,806 and US 7,029,913) that cover research using human embryonic stem cells.

The proceedings are currently ongoing.

See also: A Patent License Does Not Create A Suit Under Patent Laws

Posted February 6th, 2008 by Stephen Albainy-Jenei in Biotech, IP Litigation
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