Patent Watch: In re Rosuvastatin Calcium Patent Litig.

by BakerHostetler
Contact

"The law does not require that no competent attorney or alert inventor could have avoided the error sought to be corrected by reissue."

On December 14, 2012, in In re Rosuvastatin Calcium Patent Litig., the U.S. Court of Appeals for the Federal Circuit (Newman,* Mayer, Plager) affirmed the district court's judgment that U.S. Reissue Patent No. 37,314 (a reissue of U.S. Patent No. 5,260,440), which related to rosuvastatin marketed by AstraZeneca as Crestor® for the control of cholesterol and the treatment of atherosclerosis, was not invalid, enforceable and infringed by Aurobindo Pharma Ltd., Mylan Pharmaceuticals Inc., Apotex Corp., Cobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc., Sun Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc., Par Pharmaceuticals, Inc., and Sandoz, Inc. The Federal Circuit stated:

The Defendants challenge patent validity on the ground of obviousness. Obviousness is decided as a matter of law based on four basic factual inquiries . . . (1) the scope and content of the prior art, (2) the level of ordinary skill in the field of the invention, (3) the differences between the claimed subject matter and the prior art, and (4) any objective indicia of unobviousness, such as commercial success or long-felt need, or failure of others.

The Defendants identified as the closest prior art European Patent Office Publication No. 0 367 895 of the Sandoz company ("Sandoz"), published May 16, 1990, which describes numerous pyrimidine-based statin compounds, including a compound designated as Compound 1b [that the Defendants argued] would be a good "lead compound" for further research [and] the change of the -CH3 group to a -SO2CH3 group would have been obvious because it would make Compound 1b more hydrophilic. The Defendants stated that numerous publications taught that liver-selective statins may have fewer undesirable side effects, and that hydrophilic statins are more liver-selective. The Defendants argued that persons of ordinary skill in this field would have been motivated to make Sandoz Compound 1b more hydrophilic, and that the C2 position was the logical place to modify Compound 1b because the other parts of the structure were known to be essential to statin activity. The Defendants argued that a person of ordinary skill would have considered a limited number of common substitutions, including a sulfonyl "spacer" -SO2- at the C2 position to increase hydrophilicity. The Defendants argued that a person of ordinary skill would have predicted that this change would produce a statin with fewer adverse side effects, thereby rendering the compound obvious.

In response, the Plaintiffs pointed out that Sandoz Compound 1b demonstrated unexpected increased toxicity, and therefore was not an encouraging lead compound. The Plaintiffs stated that other compounds in the Sandoz European application, such as Compound 11, demonstrated better in vitro potency. The Plaintiffs responded to the argument that in 1991 a scientist would have known that Compound 1b should be made more hydrophilic, by pointing to publications that state that lipophilic substituents at the C2 position, the converse of hydrophilic, can increase statin potency. The Plaintiffs argued that the prior art provided no suggestion of rosuvastatin's unexpectedly superior properties as compared with Compound 1b or any other known compound, thus creating no "reasonable expectation of success."

The Plaintiffs highlighted the unpredictability that was associated with statin development. For example, the pyrrole-based statin corresponding in all other structural aspects to the pyrimidine-based rosuvastatin displayed toxic side effects. The Plaintiffs pointed out that at least five pharmaceutical companies had abandoned their research on statins with pyrimidine cores, on the prevailing belief that pyrimidine-based statins were not promising leads to improved products. The Plaintiffs pointed out that no reference, or combination of references, suggested that the previously unknown molecule rosuvastatin would have its advantageous properties. The Plaintiffs pointed to objective indicia of non-obviousness, including commercial success, long felt but unfilled need, failure of others, and unexpected results as support for the district court's judgment of unobviousness. . . .

The district court concluded that the Defendants did not demonstrate the required motivation for selecting Sandoz Compound 1b as a lead compound, or for making this specific sulfonyl change in the Compound 1b molecule. We agree that "obvious to try" was negated by the general skepticism concerning pyrimidine-based statins, the fact that other pharmaceutical companies had abandoned this general structure, and the evidence that the prior art taught a preference not for hydrophilic substituents but for lipophilic substituents at the C2 position. The district court correctly held that patent invalidity on the ground of obviousness had not been shown for the compound rosuvastatin. That ruling is affirmed. . . .

The Defendants also argued that the '314 patent was improperly reissued, arguing that the statutory reissue requirement of error without deceptive intent had not been met. . . . The Defendants argued that Shionogi deliberately presented a claim in the '440 patent that overlapped the products in the Sandoz reference in an attempt to get greater protection. The Defendants also argued that Shionogi acted deliberately in obtaining only generic claims in the '440 patent in order to conceal the rosuvastatin species. The Plaintiffs pointed out that rosuvastatin was specifically described in the specification as the most effective of the four compounds that are described with test data.

[F]or reissue purposes "error is established where there is no evidence that the appellant intentionally omitted or abandoned the claimed subject matter." Here, the district court found as fact that Shionogi erred by failing to file an IDS citing the Sandoz and Bayer references, and by omitting a specific claim to the preferred species. However, the court found no evidence of a deliberate choice to omit or abandon the rosuvastatin species, which was described in the specification as the most effective product. . . .

The district court received live testimony from the purported culprits, and found that "the evidence adduced in this case shows no such deliberate choices . . . and no violations of rules or statutes that would render the reissue of the '440 patent improper." In discussing the scope of the claims, the district court found that Ms. Kitamura credibly testified that she was unaware that there was overlap between the claims of the '440 application and the prior art because "the internal Shionogi search report of which she was aware, did not raise a patentability problem with respect to Sandoz, and a full copy of the Sandoz reference was not sent to her." These internal search reports do not show the chemical structures of the Sandoz reference. The district court found that the evidence showed that after Ms. Kitamura's departure, Shionogi was not alerted to the need for further attention to the Sandoz reference because of "chaos, confusion, and inexperience," "lack of legal training within the Shionogi Patent Department, the changing and limited personnel within that department, . . . the ongoing confusion level," and "unintentional miscommunications" between Shionogi's patent personnel. These findings have not been shown to be clearly erroneous. And the Defendants' charge that Shionogi deliberately obtained claims in the '440 patent that it knew to be invalid is not plausible. The district court found that "the Court is ultimately not convinced that the claims of the '440 patent that overlapped the Sandoz reference were the result of some planned strategy or sinister motivation as opposed to mere mistake or oversight by overworked individuals with limited training and expertise." . . .

"The law does not require that no competent attorney or alert inventor could have avoided the error sought to be corrected by reissue." The Shionogi error in failing to file an IDS was agreed to be an error, and was rectified promptly upon its discovery. Our colleague in dissent does not complain about the speed of the moves to correct the error, but would hold that the error should have been detected sooner, and that this failure of detection is fatal to the reissue patent. However, all of the cited cases relate to the absence of diligence in correcting the error after it was detected. In contrast, the reissue application here was filed promptly upon discovery of the error. . . . In sum, the district court correctly found that reissue was available, and that the scope of the reissue was in accordance with law.

If you have questions about the material presented above, please contact Dr. Lawrence M. Sung ( lsung@bakerlaw.com or 202.861.1537) or any member of our Intellectual Property Team.

See information regarding BakerHostetler's Patent Litigation and IP Prosecution and Portfolio Management practices.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© BakerHostetler | Attorney Advertising

Written by:

BakerHostetler
Contact
more
less

BakerHostetler on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
Feedback? Tell us what you think of the new jdsupra.com!