By Sherri Oslick --
About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.
Adams Respiratory Therapeutics, Inc. et al v. Perrigo Company et al.
2:07-cv-04619; filed September 27, 2007 in the District Court of New Jersey
Infringement of U.S. Patent No. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002) following a paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Adams' Mucinex® (guaifenesin, used to treat chest congestion). View the complaint here.
Hoffmann-La Roche Inc. v. Orchid Chemicals & Pharmaceuticals Ltd. et al.
2:07-cv-04582; filed September 25, 2007 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007) and 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic Acid or Salt Thereof," issued September 25, 2001) following a paragraph IV certification as part of Orchid's filing of an ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis). View the complaint here.
Sanofi-Aventis et al. v. Actavis South Atlantic LLC et al.
1:07-cv-00572; filed September 21, 2007 in the District Court of Delaware
Sanofi-Aventis et al. v. Barr Laboratories Inc.
1:07-cv-00574; filed September 21, 2007 in the District Court of Delaware
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 4,661,491 ("Alfuzosine Compositions and Use," issued April 28, 1987) and 6,149,940 ("Tablet with Controlled Release of Alfuzosine Chlorhydrate," issued November 21, 2000) following a paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of plaintiffs' Uroxatral® (alfuzosin hydrochloride, used to treat benign prostatic hyperplasia). View the Actavis complaint here.
Sanofi-Aventis U.S. LLC et al. v. Mayne Pharma Limited et al.
3:07-cv-04550; filed September 21, 2007 in the District Court of New Jersey
Infringement of U.S. Patent No. 5,338,874 ("Cis oxalato (trans 1-1,2- cyclohexanediamine) PT(II) Having Optically High Purity," issued August 16, 1994) following a paragraph IV certification as part of Mayne's filing of an ANDA to manufacture a generic version of plaintiffs' Eloxatin® (oxaliplatin for injection, used to treat colorectal cancer). View the complaint here.
Hoffman-La Roche Inc. v. Cobalt Pharmaceuticals Inc. et al.
2:07-cv-04540; filed September 21, 2007 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007), 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic Acid or Salt Thereof," issued September 25, 2001), and 4,927,814 ("Diphosphonate Derivatives, Pharmaceutical Compositions and Methods of Use," issued May 22, 1990) following a paragraph IV certification as part of Cobalt's filing of an ANDA to manufacture a generic version of Roche's Boniva® (150 mg once-monthly tablets) (ibandronate sodium, used to treat post-menopausal osteoporosis). View the complaint here.
Hoffman-La Roche Inc. v. Cobalt Pharmaceuticals Inc. et al.
2:07-cv-04539; filed September 21, 2007 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 6,143,326 ("Oral Pharmaceutical Preparation Containing Ibandronat," issued November 7, 2000), 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic Acid or Salt Thereof," issued September 25, 2001), and 4,927,814 ("Diphosphonate Derivatives, Pharmaceutical Compositions and Methods of Use," issued May 22, 1990) following a paragraph IV certification as part of Cobalt's filing of an ANDA to manufacture a generic version of Roche's Boniva® (2.5mg tablets) (ibandronate sodium, used to treat post-menopausal osteoporosis). View the complaint here.
Hoffmann-La Roche Inc. v. Dr. Reddy's Laboratories, Ltd. et al.
2:07-cv-04516; filed September 20, 2007 in the District Court of New Jersey
Infringement of U.S. Patent No. 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic Acid or Salt Thereof," issued September 25, 2001) following a paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis). View the complaint here.
Eli Lilly and Company v. Sun Pharmaceutical Industries, Limited
2:07-cv-13989; filed September 20, 2007 in the Eastern District of Michigan
Infringement of U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/ Hyperactivity Disorder," issued August 19, 1997) following a paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Lilly's Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder). View the complaint here.
Warner Chilcott Company, Inc. v. Barr Laboratories, Inc.
2:07-cv-04560; filed September 24, 2007 in the District Court of New Jersey
Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive," issued December 23, 2003) following a paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Warner Chilcott's Femcon Fe® (formerly Ovcon® 35 Fe, norethindrone and ethinyl estradiol tablets, and ferrous fumarate tablets, used for oral contraception). View the complaint here.
October 10-12, 2007 - 
As Patent Docs
claims. The Patent Office
official had told the questioner that the Office would consider a divisional to
be precluded for any claims examined during the International phase, since the
new rules limited divisional application claims to claims that had not been
previously examined. According to the
official, the International Preliminary Examination would qualify as a
"previous examination," and the divisional filing would be improper.
Commissioner
Doll stated at lunch that it was not the Office's intention that an International
Preliminary Examination would preclude an applicant from filing divisional
applications in response to a U.S. Examiner-imposed restriction requirement in
a national phase application. He also
promised to "get back to us" on the proper interpretation of the
rule.
This week Eli Lilly agreed to pay $18 million to settle
its contract and patent dispute with biotech start-up Emisphere. In the late 90s, the two companies had agreed
to work together to develop an oral delivery of parathyroid hormone (PTH) for
treatment of osteoporosis. Lilly already
sells Forteo
In a 2005 bench trial, a District Court in Indianapolis
found that Lilly had breached its agreement with Emisphere by (1) using the carrier technology for projects that lay outside of the
agreed scope of the collaboration, and (2) disseminating proprietary knowledge
of Emisphere's technology to unapproved researchers at Lilly. Therefore, the District Court permitted
Emisphere to terminate its relationship with Lilly, and issued an injunction
ordering Lilly to assign all of its interest in the inventions of WO 03/072195
to Emisphere. Lilly indicated that it
would appeal Judge Hamilton's injunction, but PACER records for the Seventh
Circuit show no indication of an appeal having been filed.
Seeking approval to market generic gabapentin, Defendants-Appellees Purepac Pharmaceutical Co., Faulding Inc., Teva Pharmaceutical Industries, Inc., Teva Pharmaceuticals USA, Inc., Zenith Laboratories, Inc. (now IVAX Pharmaceuticals NV, Inc.), Zenith Goldline Pharmaceuticals, Inc. (now IVAX Pharmaceuticals, Inc), IVAX Corp., and Eon Labs Manufacturing, Inc. (Appellees) filed Abbreviated New 
Drug Applications (ANDAs) with the FDA. In response, Warner Lambert brought number of infringement actions against the Appellees; the suits were consolidated in the District Court of New Jersey.
As noted in the stipulation, the amendment to a Paragraph III certification means that Ranbaxy agrees not to make, use, sell, offer to sell, or import into the United States any product until after the expiration of Novartis' exclusivity, or until the claims of the patent-in-suit are declared invalid or unenforceable following a final decision in a U.S. district court. The patent in suit is U.S. Patent No. 
The American Conference Institute is holding its Biotech Patents conference this week in Boston, and the lunchtime speaker was John Doll, Commissioner for Patents. Commissioner Doll (at right) is the happy face of the U.S. Patent and Trademark Office: smiling, self-deprecating, and charming while he espouses the Patent Office mantra that the Office is willing to do everything possible to improve the patenting process in the United States. And if his audience was skeptical, it was due in part to opposition to the recently-issued final rules for patent continuations and limitations on the number of claims. Another factor is that Commissioner Doll's numbers in support of his message don't add up (like they didn't in the infamous Town Hall meetings that accompanied the new rules when first proposed).
The Commissioner provided historical and recent evidence on patent "quality," which he explained was determined by reviewing applications allowed by the Examining Corps, and rejecting any application having at least one claim that "should not have been allowed." The data show that this "allowance error rate" has ranged between 7.5% and 2.75% over the past thirty-two years, and is at about 3.5% for 2006 (the last year for which the statistics are available). The Commissioner did not explain whether the "errors" calculated in this way were based on art, sufficiency of disclosure (i.e., under 35 U.S.C. § 112) or other sections of the rules or statutes (such as obviousness-type double patenting). Also not addressed was the converse error rate: the number of pending applications having at least one patentable claim the Office refuses to allow; he did indicate that this kind of review was done and had a conclusory slide claiming a 90% "in process compliance rate" for this metric (i.e., about 3-fold higher than the allowance error rate; the Office is obviously content when claims that should be allowed are not). In view of the complexity of the issues that can be presented during patent prosecution, and the amount of time it takes for an examiner to properly understand the invention and its relationship to the art, it is likely that the "error rate" with which the Patent Office "allowance error rate" is determined is both high and the result of cursory and subjective determinations.
The Commissioner is appropriately proud of the electronic filing system, which is now used to file more than 60% of the applications filed each week. He also extolled the virtues of the Accelerated Examination (AE) program (which replaced the Petition to Make Special practice) and the pilot peer review program. The AE program has been used by only a small number of applicants, in part because the Office set a significant number of hurdles for an application to qualify. However, the Commissioner reported that one application in Technology Center 2800 issued within 97 days (and was allowed in 18 days). Examiners in the program are reviewing unpublished applications (since these will qualify as prior art unavailable during the truncated prosecution of the AE program), and in instances where relevant unpublished patents are found, the application is withdrawn from the program and prosecution suspended until the application becomes available.
As 
About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.
On August 21, 2007, the U.S. Patent and Trademark Office published new
rules concerning continuation and claims practice that will undoubtedly
have a profound effect on the way patent attorneys and agents prosecute
applications before the Patent Office. In view of the 128-page 
This is an important question, since many biotech and pharma patent practitioners have probably begun considering the benefits of filing an international application instead of a U.S. nonprovisional application under the new rules. One significant benefit of such a strategy is the up to 18 months of additional time for plotting a prosecution strategy that an applicant can obtain by filing an international application and then waiting until the last possible moment to enter national stage in the U.S.
September 24-25, 2007 - 
On Thursday, 
Earlier this month, CODA Genomics, Inc. 
According to the statement released by 
An 
The case involved ofloxacin (at left), a topical antibiotic used for treating ear infections. Although many antibiotics can cause damage to the ear when applied topically, specialists in the field knew that ciprofloxacin (below) showed no such damage. Since ofloxacin and ciprofloxacin are antibiotics having similar molecular structures, those aware of ciprofloxacin's success would have possessed the requisite motivation to use ofloxacin in similar ways.
But the District Court had included pediatricians and general practice physicians within the class of those having ordinary skill in the art. Since these non-specialist medical practitioners rarely, if ever, use ciprofloxacin to treat ear infections, the court ruled that ofloxacin's success would not be obvious to PHOSITA. The Federal Circuit reversed, holding that the District Court should have limited PHOSITA to otologists and persons who develop pharmaceutical formulations. Since this narrower class of experts would have been aware of ciprofloxacin's success, the use of ofloxacin to treat the same ailment is obvious.
In the Federal Register published Monday, September 10, 2007 (available 
September 10, 2007 is the effective date for the changes to 37 C.F.R. §§ 1.57 (incorporation by reference), 1.437 (drawings), and 1.465 (application processing based on corrected/added/withdrawn priority date), while November 9, 2007 is the effective date for the changes to 37 C.F.R. §§ 1.17 (fee for unintentionally delayed priority claim, $1,370) and 1.445 (search fee, $1,800; and supplemental search fee, per additional invention, $1,800), as well as the addition of 37 C.F.R. § 1.452 (restoration of right of priority).
Earlier today, Patent Docs participated in a conference call with 
On the issue of patent reform, Mr. Greenwood (at left) stated that the House bill was "largely inspired" by the information technology industry, which relies on a business model that is quite different from that of the biotech/pharma sector. Mr. Greenwood predicted that if the House bill were passed into law, it would be "easier and less costly to infringe patents." While noting that the bill which the House approved by a 220-175 margin was better than the legislation the House had started out with, Mr. Greenwood believed the House bill was "still bad." As a result, Mr. Greenwood said that BIO would continue to oppose the House bill and work with the Senate to pass a bill more favorable to the 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations comprising BIO.
As reported 
Strattera®, or atomoxetine hydrochloride, a norepinephrine reuptake inhibitor, is a non-stimulant medication used in the treatment of Attention-Deficit/ Hyperactivity Disorder (ADHD) in children, adolescents, and adults. The method of treatment is covered by U.S. Patent No. 
