Patent Docs

Interpreting 35 U.S.C. § 102 under the America Invents Act

By Kevin E. Noonan --

The Leahy-Smith America Invents Act ("AIA") changes U.S. patent law in many ways, notably by converting our patent system to a "first inventor to file" system.  However, the language of the new statute is not always "pelucidly clear" in achieving this change; one of the areas of murkiness involves the meaning of "public use" and "on sale" under  § 102(a)(1):

§ 102. Conditions for Patentability; Novelty

(a)  A person shall be entitled to a patent unless --

(1)  the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention;

(2)  the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

One issue with this statutory language is whether "public use" or "on sale" encompasses uses that are in fact secret but are involved in producing a commercial product.  Such a "secret" use has precluded patent eligibility since Metallizing Engineering Co. v. Kenyon Bearing and Auto Parts Co., 153 F.2d 516 (2d Cir. 1946) (Hand, J.), where the Court's opinion set forth the rationale for precluding patenting under these circumstances:

[I]t is a condition upon an inventor's right to a patent that he shall not exploit his discovery competitively after it is ready for patenting; he must content himself with either secrecy, or legal monopoly.

This reasoning has proven persuasive to the Federal Circuit, which has held that secret commercial exploitation of an invention begins the one-year deadline for filing an application under current § 102(b).  Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1382 (Fed. Cir. 2005).

There are ways of parsing the statute that can construe the language of new § 102(a)(1) to eliminate this effect of secret commercial practice of products or processes:

§ 102. Conditions for Patentability; Novelty

(a) A person shall be entitled to a patent unless --

(1) the claimed invention was

(i) patented,

(ii) described in a printed publication, or

(iii) in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; . . .

Under this reading, the "public use" must be public, and the sale must also be something that is not kept as a trade secret (which would permit processes and intermediates that are not sold to be patented even after extensive commercial exploitation).  Alternatively, there are canons of statutory construction that support the countervailing position, that the statute does not eliminate forfeiture of patent-eligibility by secret commercial use, including the concept that when Congress intends such a dramatic shift in the law it does so explicitly (one of the grounds used by the Supreme Court in interpreting the metes and bounds of university's patent rights under the Bayh-Dole Act in Stanford v. Roche).

The problem is that there is precious little in the record to support either view.  For example, Senator Leahy addressed the question in the Congressional Record as follows:

One of the implications of the point we are making is that subsection 102(a) was drafted in part to do away with precedent under current law that private offers for sale or private uses or secret processes practiced in the United States that result in a product or service that is then made public may be deemed patent-defeating prior art.  That will no longer be the case.  In effect, the new paragraph 102(a)(1) imposes an overarching requirement for availability to the public, that is a public disclosure, which will limit paragraph 102(a)(1) prior art to subject matter meeting the public accessibility standard that is well-settled in current law, especially case law of the Federal Circuit.

Unfortunately, these remarks were made one day after the enactment of S. 23, making it difficult to argue that the Senate intended the outcome advanced by Senator Leahy.  Senator Kyl is on record (on the date of enactment of the AIA) in supporting this position (albeit less clearly than Senator Leahy):

When the committee included the words "or otherwise available to the public" in section 102(a), the word "otherwise" made clear that the preceding items are things that are of the same quality or nature.  As a result, the preceding events and things are limited to those that make the invention "available to the public."  The public use or sale of an invention remains prior art, thus making clear that an invention embodied in a product that has been sold to the public more than a year before an application was filed, for example, can no longer be patented . . . .  But public uses and sales are prior art only if they make the invention available to the public.

How this portion of the statute is interpreted will be particularly important to the biotechnology and pharmaceutical industries because the processes involved in making their products may not be patented (or at least not comprehensively so) and there are advantages in keeping some of these processes as trade secrets.  However, there is also the risk that another will file for patent protection for a method that will be infringed by such a process kept as a trade secret; indeed, fear of this outcome (in industries in addition to pharma and biotech) was a driving force behind the prior user rights provisions (Section 5 of the Act, codified as 35 U.S.C. § 273).  Recognition of the relationship between these two sections of the AIA, however, provides a clue for whether new § 102(a)(1) maintains or eliminates the traditional forfeiture of patent eligibility by secret use of a commercial process or product.

The prior user rights provisions of the AIA reads (in relevant part) as follows:

35 U.S.C. 273 Defense to infringement based on earlier inventor.

(a)  IN GENERAL.–A person shall be entitled to a defense under section 282(b) with respect to subject matter consisting of a process, or consisting of a machine, manufacture, or composition of matter used in a manufacturing or other commercial process, that would otherwise infringe a claimed invention being asserted against the person if—

(1)  such person, acting in good faith, commercially used the subject matter in the United States, either in connection with an internal commercial use or an actual arm's length sale or other arm's length commercial transfer of a useful end result of such commercial use; and

(2)  such commercial use occurred at least 1 year before the earlier of either—

(A)  the effective filing date of the claimed invention; or

(B)  the date on which the claimed invention was disclosed to the public in a manner that qualified for the exception from prior art under section 102(b). . . .

Thus, the prior user right cannot be asserted if the commercial use was less than one year prior to the effective filing date of the claimed invention.  This provision makes sense if "secret" use of a product or process has the same consequences under new § 102(a)(1) as it did under old § 102(b):  to create a bar against patenting such a process or use against the inventor who decides to keep the process or product as a trade secret rather than seeking patent protection.  Under this interpretation, the one-year limit is needed to prevent such an inventor from attempting to patent and thus defeat the rights of the second inventor who files, since after one year that right (as to the prior user) has been forfeited.  This implies that if the prior user files within one year the "secret" use may be deemed a public disclosure that would defeat a later filer (just as disclosure of an invention on a public website would be deemed a prior public disclosure that would bar a later filer provided that the first to disclose filed for patent protection within one year of the disclosure).  This construction comports with another canon of statutory construction, that the several provisions of the Act are intended to be consistent and to be read to produce consistent results.  This reading is also in line with statements in the recently published Report from the Patent and Trademark Office on the prior user rights defense that the changes in the AIA regarding the "first inventor to file" regime created an unfairness to prior users (see "USPTO Issues Report on Prior User Rights").  While the record is unclear and the expectation is that these questions must be decided in litigation (unless Congress passes technical amendments to expressly set forth their intent), the interpretation set forth here is at least a starting point for considering the consequences of deciding to keep commercially valuable processes or products as trade secrets rather than protecting them by patenting under the AIA.

Hat tip to Steven Lendaris of Baker Botts.  Adapted from his talk, "The America Invents Act: Are Secret Uses/Sales Still Prior Art" given at ACI's Comprehensive Guide to Patent Reform for Life Sciences Companies, New York, January 31, 2012.

USPTO Proposes Rules Changes for Implementing AIA Provisions -- Oath or Declaration Provisions

By Donald Zuhn --

Last November, officials from the U.S. Patent and Trademark Office indicated that ten notices of proposed rulemaking to implement various provisions of the Leahy-Smith America Invents Act were being drafted and vetted by the Office, and that the notices would be published in January 2012.  With January drawing to a close, the Office has thus far published five of these notices.  In previous posts, we have discussed three of the notices (concerning implementation of the AIA's miscellaneous post patent provisions, preissuance submissions provision, and provisions on disciplinary proceedings -- see links below).  A subsequent post will address a recently published notice concerning the implementation of the AIA's supplemental examination provisions (77 Fed. Reg. 3666).  Today, we address the Office's notice on "Changes To Implement the Inventor’s Oath or Declaration Provisions of the Leahy-Smith America Invents Act " (77 Fed. Reg. 982).

The 22-page notice proposes changes that are intended to revise and clarify the rules of practice relating to the inventor's oath or declaration, assignments containing oath or declaration statements from inventors, and oaths or declarations signed by parties other than the inventors, as well as revise and clarify the rules of practice for powers of attorney and prosecution of an application by an assignee.  In particular, the notice proposes changes to the rules to implement AIA § 4, which amends 35 U.S.C. §§ 115 and 118 to change the practice regarding an inventor's oath or declaration, and AIA § 20, which amends, inter alia, 35 U.S.C. §§ 116, 184, 251, and 256 to remove the "without any deceptive intention" language.  A list of the specific changes to each of these sections can be found on pages 982-84 of the notice.

Following the list of specific changes to Title 35, the notice provides a general discussion regarding the implementation of AIA §§ 4 and 20.  With regard to these changes, the notice indicates that amended § 115 permits the required inventor statements (i.e., that the application was made or was authorized to be made by the affiant or declarant, and that the individual believes himself or herself to be the original inventor or an original joint inventor of a claimed invention in the application) to be made in an oath or declaration under 35 U.S.C. § 115(a), a substitute statement under 35 U.S.C. § 115(d), or an assignment under 35 U.S.C. § 115(e).  Because amended § 115 no longer requires an inventor to identify his or her country of citizenship, the Office will no longer require this information to be included in the oath or declaration.

The Office also proposes changes to the rules that will allow an assignee, a party to whom the inventor is legally obligated to assign the invention, or a party who otherwise has a sufficient proprietary interest to provide a substitute statement with respect to an inventor who is deceased, is legally incapacitated, cannot be found or reached after diligent effort, or refuses to sign the oath or declaration.  The Office further proposes changes to the rules to allow inventors to make the required statements in an assignment executed by the inventor and recorded in the Office (including a proposal to require that the assignment cover sheet identify the assignment as also being an oath or declaration).

While the AIA permits the Office to delay requiring an oath or declaration until allowance, the Office determined that it would be "better for the examination process and patent pendency to continue to require the oath or declaration during preexamination."  For example, the Office noted that it "must know the identity of the inventors to determine what prior art may be applied against the claimed invention or whether to issue a double patenting rejection."  The notice indicates that the Office considered discontinuing the practice of charging a surcharge for late filing of an oath or declaration, but states that "the cost of the special processing required for such applications should be borne by those applicants who require special processing and not by applicants whose applications are complete on filing."

With regard to powers of attorney, the Office proposes changes to the rules that will:

• Provide for the carryover of a power of attorney in continuation and divisional applications, and in continuation-in-part applications where inventorship is the same as in the immediate prior application;
• Permit practitioners who have acted only in a representative capacity in an application to change the correspondence address after a patent has issued;
• Accept the signature of a practitioner of record on a statement under 37 C.F.R. § 3.73(b) on behalf of an assignee without requiring further evidence of the practitioner's authority to act on behalf of the assignee;
• Provide a procedure for handling conflicts between different purported assignees attempting to control prosecution; and
• Harmonize the practice regarding foreign and domestic priority claims by requiring both types of claims to be set forth in an application data sheet.

A lengthy discussion of the specific changes to the rules to implement the above changes can be found on pages 985-96 of the notice.  Additional discussion of the rules changes, as well as revised versions of the affected rules (see pages 998-1003) can be found in the Office's Federal Register notice (77 Fed. Reg. 982).

Comments regarding this notice can be submitted by e-mail to [email protected]; by regular 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; or via the Federal eRulemaking Portal.  The deadline for submitting comments is March 6, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 982).

For information regarding the Office's implementation of other AIA provisions, please see:

• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Statute of Limitations Provisions for Office Disciplinary Proceedings," January 16, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Preissuance Submissions Provision," January 12, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Miscellaneous Post Patent Provisions," January 11, 2012

Court Report

By Sherri Oslick --

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

Cephalon Inc. v. Mylan Pharmaceuticals Inc. et al.
1:12-cv-00073; filed January 24, 2012 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

Cephalon Inc. v. Sandoz Inc.
1:12-cv-00074; filed January 24, 2012 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,092,832 ("Generally Linear Effervescent Oral Fentanyl Dosage Form and Methods of Administering," issued January 10, 2012) in conjunction with Mylan's prior filing of an ANDA to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer).  View the Mylan complaint here.

Abbott Laboratories et al. v. Cadila Healthcare Ltd. et al.
1:12-cv-00065; filed January 20, 2012 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendants:  Cadila Healthcare Ltd. d/b/a Zydus Cadila; Zydus Pharmaceuticals (USA) Inc.

Infringement of U.S. Patent No. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia).  View the complaint here.

Eli Lilly and Company v. Accord Healthcare, Inc., USA
1:12-cv-00086; filed January 20, 2012 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 Accord'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.

Spectrum Pharmaceuticals, Inc. et al v. Sandoz Inc.
2:12-cv-00111; filed January 20, 2012 in the District Court of Nevada

• Plaintiffs:  Spectrum Pharmaceuticals, Inc.; University of Strathclyde
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent No. 6,500,829 ("Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives," issued December 31, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Spectrum's Fusilev® (levoleucovorin, used to treat advanced metastatic colorectal cancer).  View the complaint here.

Meda Pharmaceuticals Inc. v. Apotex Inc. et al.
3:12-cv-00361; filed January 19, 2012 in the District Court of New Jersey

• Plaintiff:  Meda Pharmaceuticals Inc.
• Defendants:  Apotex Inc.; Apotex Corp.; Perrigo Co.; L. Perrigo Co.; Perrigo Israel Pharmaceutical Ltd.

Infringement of U.S. Patent No. 8,071,073 ("Compositions Comprising Azelastine and Methods of Use Thereof," issued December 6, 2011) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Meda's Astepro® (azelastine hydrochloride nasal spray, used to treat hay fever and allergy symptoms).  View the complaint here.

Conference & CLE Calendar

January 31, 2012 - Obviousness Standard for Patents: Approaches to Withstand USPTO Obviousness Rejections and Attacks on Patent Validity (Strafford) - 1:00 - 2:30 pm (EST)

January 31 - February 1, 2012 - Patent Reform for Life Sciences Companies*** (American Conference Institute) - New York, NY

January 31 - February 1, 2012 - Pharma & Biotech Patent Litigation (C5) - Amsterdam, The Netherlands

February 8, 2012 - Corporate Intellectual Property Law Conference (Law Bulletin Publishing Co.) - Chicago, IL

February 13-14, 2012 - China IP Counsel Forum (C5) - Shanghai, China

February 21-22, 2012 - Biotech & Pharmaceutical Patenting*** (IBC Legal) - Munich, Germany

February 22-23, 2012 - EU Pharma Law & Regulation*** (C5) - London, England

February 22-24, 2012 - Intensive Patent Law Training Seminar (Chisum Patent Academy) - New York, NY

February 27-29, 2012 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

February 28-29, 2012 - Medical Device Patents*** (American Conference Institute) - Boston, MA

March 14-15, 2012 - Biotech Patenting (C5) - Munich, Germany

March 20-21, 2012 - FDA Boot Camp*** (American Conference Institute) - New York, NY

March 26-27, 2012 - PTO Procedures under the America Invents Act*** (American Conference Institute) - New York, NY

March 28-30, 2012 - 27th Annual Intellectual Property Law Conference (American Bar Association (ABA) Section of Intellectual Property Law) - Arlington, VA

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

USPTO News Briefs

By Donald Zuhn --

USPTO Schedules Hearings and Seeks Comments on Genetic Diagnostic Testing

In a press release and corresponding notice in Wednesday's Federal Register (77 Fed. Reg. 3748), the U.S. Patent and Trademark Office announced that it would begin gathering information on independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests.  The Office is collecting such information in order to prepare a report to the Committee of the Judiciary for both the Senate and House pursuant to § 27 of the Leahy-Smith America Invents Act.  As part of the information gathering process, the Office noted that it would be holding two public hearings on the matter, with the first hearing to be held from 9:00 am to 4:00 pm (EST) on February 16, 2012 in the USPTO's Madison Auditorium located at 600 Dulany Street in Alexandria, Virginia, and the second hearing to be held from 9:00 am to 4:00 pm (PST) on March 9, 2012 at the Joan B. Kroc Institute for Peace & Justice at the University of San Diego.  The Office is also seeking written comments on genetic diagnostic testing.

Pursuant to AIA § 27, the Office's report to Congress must include an examination of the following topics:

(1)  The impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses;

(2)  The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test;

(3)  The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures; and

(4)  The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

The Office's notice also includes a number of additional issues (see pages 3748-49) on which the public is invited to comment.

Those wishing to present oral testimony at either hearing must do so in writing by February 8, 2012 by e-mailing the following information to Saurabh Vishnubhakat at [email protected]:  (1) The name of the person wishing to testify; (2) the person's contact information (telephone number and email address); (3) the organization(s) the person represents, if any; (4) an indication of the amount of time needed for the testimony; and (5) a preliminary written copy of the testimony.  The Office noted that the public hearings would be made available via a webcast (with details to be provided at a later date).

Those wishing to submit comments must do so by March 26, 2012 by sending such comments by e-mail to [email protected] or by regular mail addressed to Saurabh Vishnubhakat, Attorney Advisor, Office of Chief Economist, United States Patent and Trademark Office, Mail Stop External Affairs, P.O. Box 1450, Alexandria, VA 22313–1450.  Comments sent by e-mail should include "Genetic Testing Study" in the subject line.

USPTO Issues Reminder Regarding Deadline for Commenting on Locations of Satellite Offices

The U.S. Patent and Trademark Office issued a press release today reminding the patent community that the deadline for submitting written comments on potential locations for additional USPTO satellite offices is 11:59 pm (ET) on January 30, 2012.  The Office noted that this deadline would not be extended.  Last November, the Office issued a notice in the Federal Register outlining the specifics of its request for comments (see "USPTO News Briefs," December 15, 2011).  In that notice, the Office noted that:

    Comments should provide information that supports the USPTO's purposes of establishing satellite offices, including that the location will:
    (1) Increase outreach activities to better connect patent filers and innovators with the USPTO, including the number of patent filings and grants by the city/region as well as other information that provides insight into the region’s innovation activity;
    (2) Enhance patent examiner retention, including quality of life indicators such as average household income, cost of living factors, and other factors related to employee retention;
    (3) Improve recruitment of patent examiners, including data on employment rates and other economic factors in the area, science and technology professionals, as well as legal professionals in the workforce and other related information;
    (4) Decrease the number of patent applications awaiting examination; and
    (5) Improve the quality of patent examination.

In today's release, USPTO Director David Kappos stated that the Office was "looking forward to reviewing community feedback on locations for Satellite Offices to recruit and retain top talent, and to better serve our applicant community," adding that the Office was "committed to conducting an open and transparent selection process that will ultimately yield the best locations for the USPTO and its user community."

USPTO Establishes Retention Period for Patent-Related Papers

In a notice published in Wednesday's Federal Register (77 Fed. Reg. 3745), the U.S. Patent and Trademark Office announced that it is establishing a one-year retention period for patent-related papers that:  (1) began on September 1, 2011, for papers scanned into IFW or SCORE prior to September 1, 2011; or (2) began or begins on a paper's submission date, for papers scanned into IFW or SCORE on or after September 1, 2011.  The Office originally proposed the retention plan in a Federal Register notice in August (see "USPTO News Briefs," September 1, 2011).

Under the new retention plan, the USPTO will dispose of papers after the expiration of the one-year retention period unless, within sufficient time prior to disposal of the paper, an applicant, patent owner, or reexamination party files a bona fide request to correct the electronic record of the paper in IFW or SCORE, and the request remains outstanding at the time disposal of the paper would have otherwise occurred.  Previously, the Office retained papers indefinitely.  Additional information regarding the retention plan, as well as the Office's response to the lone comment it received in response to its earlier notice, can be found in the latest notice.

According to the notice, the Office will continue to accept comments regarding the new retention plan, which can be sent by e-mail to [email protected] or by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450.

Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2012)

By Andrew Williams --

In a sequel of sorts to the hugely popular Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2011), the Federal Circuit released Streck II (Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2012)) earlier this month.  Not to be upstaged by the original, this ambitious follow-up leaves the priority determination behind, and instead focuses on the infringement proceeding appeal.  Notably, Streck II clocks in at over twice the length of its predecessor.  However, if you have ever asked yourself whether a counterclaimant could maintain the full scope of a declaratory judgment challenge if a plaintiff narrows the scope of asserted claims early on in litigation, then Streck II could keep you on the edge of your seat.  Spoiler alert -- the answer is "no."

The background and cast of characters was basically the same for both opinions.  For those unfamiliar with the original Streck, the technology at issue in both cases was integrated controls for hematology analyzers.  Prior to 1996, such instruments measured reticulocytes and white blood cells separately, because the various blood components would interfere with each other, causing error in counting or classifying.  Such stand-alone controls using either true reticulocytes (also referred to as natural reticulocytes) or reticulocytes analogs were known before the filing dates of the patents-at-issue.  As the instrument makers began attempting to develop an integrated analyzer that could measure the different blood components in the same sample, both Streck and Research & Diagnostic Systems (R&D) sought to create an integrated control.  As we learned in Streck, one of the difficulties to overcome was the stability of the controls over extended periods of time.  Streck obtained a patent to such controls, U.S. Patent No. 6,221,668, and sued R&D in the U.S. District Court for the District of Nebraska for infringement of three patents.  Claim 1 of the '668 patent is representative:

1.  A hematology control composition comprising:
    a)  a stabilized reticulocyte component; and
    b)  a fixed and stabilized white blood cell component capable of exhibiting a five-part differential.

The District Court construed the claims to encompass both true reticulocytes and reticulocyte analogs.  Streck's inventor, however, only actually reduced his invention to practice with his previous developed reticulocyte analogs, while R&D's commercial product used true reticulocytes.

At this point, the plot of Streck II gets a bit convoluted.  As previously mentioned, Streck filed its lawsuit in Nebraska.  However, both parties agreed to be bound by the local patent rules of the United States District Court for the Northern District of California.  As a result, Streck served a Disclosure of Asserted Claims and Preliminary Infringement Contentions shortly after the initial case management conference.  In this disclosure, Streck narrowed the scope of asserted claims.  R&D followed up with preliminary invalidity contentions narrowly drawn to the asserted claims, but later expanded the contentions to include all but one of the claims in the patents-at-issue.  Streck further narrowed its asserted claims to ten, and then to nine, prior to the Court's Summary Judgment decision.  On September 9, 2009, the Court held that Streck's patents satisfied the Written Description requirement with respect to integrated controls with true reticulocytes, and denied R&D's motion for summary judgment on enablement.  The Court also dismissed the counterclaims with respect to Claim 3 of two of the patents, because there was "no reasonable apprehension of suit," and found that, as a matter of law, R&D infringed the asserted claims (and that there was evidence from which a jury could find willfulness).  Subsequently, just before trial, the Court sided with Streck and excluded the evidence related to the validity of all unasserted claims, stating that the validity of these claims would not go to the jury.  After an eight-day jury trial, the Court granted JMOL for Streck on enablement.  The only issues submitted to the jury were priority, damages, and willfulness.  The jury did not find R&D's infringement to be willful and awarded damages of 12.5%.  As the priority issue was covered in Streck, it will not be addressed here.  The procedural background concluded with the District Court entering an injunction against R&D.

Declaratory Judgment Jurisdiction over Counterclaims

The first issue on appeal was whether R&D could maintain invalidity counterclaims against claims that Streck was no longer asserting.  Steck originally filed suit in June 2006 alleging infringement of all claims in the patents-in-suit, but within six months, it had narrowed the asserted claims to fifteen specific claims.  R&D, in turn, responded with preliminary invalidity contentions against those fifteen claims, but expanded the scope of its invalidity contentions in the next two years to all but one claim of the patents-in-suit.  Streck subsequently narrowed the asserted claims to ten, and then to nine.  As a result, the District Court dismissed R&D's invalidity counterclaims against two claims because it had "no reasonable apprehension" it would face an infringement suit on any claim other than the claims asserted by Streck.  Moreover, prior to trial, the Court excluded R&D's evidence with regard to the unasserted claims, because of these same jurisdictional concerns.

The Federal Circuit agreed with the District Court that there was no jurisdiction, even though it used the outdated "reasonable apprehension" test.  As the Federal Circuit pointed out, even though MedImmune rejected strict reliance on the "reasonable apprehension of suit" test, it did not do away with the relevance of this test.  The Federal Circuit looked favorably on a New Jersey District Court case as persuasive authority, Hoffman-La Roche Inc. v. Mylan Inc., No. 2:09cv1692, 2009 U.S. Dist. LEXIS 114784, at *17-18 (D.N.J. Dec. 9, 2009).  In that case, like here, the patentee narrowed the scope of the asserted claims when it served infringement contentions.  That court noted that jurisdiction exists on a claim-by-claim basis at every stage of the litigation, and that even though the plaintiff's decision to change the scope of the suit did not automatically divest the court of jurisdiction, the counterclaimant must show why jurisdiction continues to exist.  Applying the same reasoning, the Federal Circuit found that "there was no evidence that R&D met its burden of showing a continuing case or controversy with respect to the unasserted claims."  In fact, the Court noted that R&D relied too heavily on the District Court's use of the "reasonable apprehension" test, and pointed out that MedImmune doesn't stand for the proposition that jurisdiction automatically exists whenever a competitor wants to mount a validity challenge.

Interestingly, the Federal Circuit cited favorably to Streck's narrowing of the scope of the claims at the outset of the litigation, prior to any dispositive rulings.  In fact, it appears that neither party cited to the preliminary infringement and invalidity contentions, but instead the Court itself identified the early nature of the narrowing of scope of the litigation.  This begs the question, therefore, of when is it advisable to narrow the scope of the claims in an infringement suit?  Should it be done as soon as possible, thereby possibly foreclosing the ability to assert relevant claims before fact discovery is completed (or perhaps has even begun)?  Or can a patentee wait until the eve of filing of Summary Judgment motions?  Of course, after MedImmune, courts must look to "all the circumstances," and therefore the answer will be fact specific.  Nevertheless, it would be advisable to monitor the claims one is asserting in an infringement suit during all stages of the litigation, especially if it is desirable to move some of those claims out of harm's way, or if the validity of those claims is in such question that taking them to the jury could have prejudicial affect.

Written Description

The second issue on appeal was whether Streck's patents satisfied the written description requirement of 35 U.S.C. § 112, ¶ 1.  Specifically, R&D alleged that the patents failed to provide sufficient details to establish that Streck was in possession of a true reticulocyte integrated control.  The test, according to Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), is whether the disclosure "conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date."  Id. at 1351.  The Federal Circuit implicitly noted that there are generally two situations where written description can be found lacking:  (1) when newly added claim language is not supported by the specification as filed, and (2) when patentees attempt to claim a broad genus without providing adequate support for enough species within that genus.  The Court found that neither of these situations applied, because the patents-in-suit specifically referred to several types of true reticulocytes, i.e., several species, as possible embodiments of the claimed invention.  And, even though it was more relevant to the enablement requirement, the Court did note that because analogs are designed to mimic true reticulocytes, and because stand-alone true reticulocytes were known in the art, it was not difficult to conclude that one skilled in the art would have recognized that the claimed integrated controls could be made with either true reticulocytes or analogs.

R&D did not appear to take its written description challenge very seriously.  Indeed, the District Court noted that the R&D focused primarily on enablement, and the Federal Circuit argument centered almost exclusively on the enablement issue.  Instead, R&D appeared to rely mainly on the testimony of a Streck inventor to establish a lack of written description.  However, R&D apparently mischaracterized the testimony.  The inventor did testified to the commercial practicalities of the use of true reticulocytes, but such evidence does not speak to the feasibility or viability of the use of true reticulocytes in a control.  Instead, it merely reflects the inventor's personal preference.  Also, R&D pointed to the inventor's difficulty in identifying support in the specification for true reticulocytes.  However, he later clarified that the patent covers both kinds of reticulocytes, and cited to the language referenced above.  Finally, R&D cited the lack of any reduction to practice by Streck of true reticulocytes.  However, actual reduction to practice is not necessary because the filed specification constitutes a constructive reduction to practice.  Therefore, such an allegation is without merit.

Enablement

R&D's lack of enablement assertions appeared to have more credibility, but they also ultimately fell short.  In fact, the Federal Circuit held that the evidence clearly supported a finding of enablement, and therefore met the exacting standard of taking this fact-laden inquiry away from the jury.  The District Court had granted JMOL after the close of evidence but before the case went to the jury, and the Federal Circuit affirmed that decision.

Much like with the written description challenge, R&D alleged that the patents-in-suit do not enable true reticulocyte integrated controls.  Of course, to satisfy the enablement requirement, the specification must enable one skilled in the art how to make and use the claimed invention without undue experimentation.  And, even though the specification need not disclose what is well known in the art, this rule is not a substitute for a basic enabling disclosure.

The question in this case appeared to center around what the novel aspects of the invention were.  R&D relied on Automotive Technologies Int'l, Inc. v. BMW of North America, Inc., 501 F.3d 1274 (Fed. Cir. 2007), which held that a patent that disclosed mechanical side-impact crash sensors for automobile airbags did not, without more, enable the use of electronic side-impact crash sensors.  In that case, the Court determined that the electronic sensors were novel, and distinctly different than mechanical sensors.  Moreover, the knowledge of one of skill in the art could not supply the missing information, especially when that missing information constituted the novel aspect of the invention.  In contrast, in the present case, the novel aspect of the invention was the integrated reticulocyte control, and the use of true reticulocyte in the invention is virtually indistinguishable from analogs.  Moreover, even though the burden was on R&D to establish lack of enablement by clear and convincing evidence, R&D failed to submit sufficient evidence to submit the case to a jury.  R&D relied heavily on its expert, but the expert provided conclusory assertions which do not give rise to a genuine issue of fact.  In fact, R&D's expert admitted on cross-examination that he had never been involved in developing controls.  Finally, R&D pointed to the testimony of the Streck inventors that the quantity of experimentation to make and use a true reticulocyte integrated control would be high.  However, this testimony was referring to the difficulties of using such a control prior to the patent disclosure.

Overbreadth of Injunction

After a quick flashback to Streck, in which the Court dismissed R&D's appeal of priority and evidentiary ruling as controlled by the outcome of the first case, Streck II concluded rather anticlimactically.  R&D argued that the permanent injunction entered by the District Court was over broad because it prohibited R&D "from otherwise infringing the asserted claims of [the Patents-in-Suit] until the expiration of the last to expire of the Patents-in-Suit."  Specifically, R&D wanted the injunction limited to the adjudicated products, and products not more than colorably different therefrom.  However, the Federal Circuit noted that the injunction as a whole did specifically refer to the products at issue in the case.  Therefore, because the injunction already contained the limitation sought, the Federal Circuit affirmed the permanent injunction entered by the District Court.

In conclusion, even though it had its slow points, we would give Streck II two thumbs up, and would recommend it to most patent practitioners, especially those embroiled in litigation, trying to determine whether it is advantageous to narrow the scope of asserted claims.

Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2012)
Panel: Circuit Judges Newman, O'Malley, and Reyna
Opinion by Circuit Judge O'Malley

The Medicines Company to Get Patent Term Extension

By Kevin E. Noonan --

One of the longest patent law sagas has apparently reached an end.  As announced by The Medicines Company (MDCO) today, the drug developer has reached a settlement of litigation with APP Pharmaceuticals over Angiomax® (bivalirudin).  Most important for MDCO, the settlement dismisses APP's appeal of the denial of its motion to intervene in MDCO’s mandamus action against the PTO's decision denying patent term extension for its patent relating to Angiomax®, the last obstacle to MDCO obtaining patent term extention for its U.S. Patent No. 5,196,404.

The tale has been often told on the circumstances surrounding MDCO's patent term extension (PTE) Request for the ‘404 patent.  Pursuant to 35 U.S.C. § 156, MDCO had 60 days from the date that Angiomax® received regulatory (FDA) marketing approval to file its PTE Request (35 U.S.C. § 156(d)(1)).  The approval letter was sent by the FDA to MDCO by facsimile transmission at 6:17 pm on Friday, December 15, 2000.  The FDA subsequently published the approval date for Angiomax® on its website as being December 19, 2000.  MDCO filed its PTE Request on February 14, 2001, a date that is 61 days after December 15, 2000, 58 days after December 18, 2000 (the Monday following the date of the Friday night fax) and 57 days after the approval date the FDA posted on its website for Angiomax®.  These calculations were complicated by a later-issued directive by the PTO that, for purposes of calculating the time period for filing a PTE Request, the Office would consider the day the FDA mailed its approval letter in the calculation (i.e., the times above are each increased by one day) (In re Patent Term Extension Application for U.S. Patent No. 5,817,338, 2008 WL 5477276 (Comm'r. Pat. Dec. December 16, 2008)).  In any case, the PTO, relying on a certification from the FDA that the approval date was Friday, December 15, 2000, refused MDCO's Request, costing the company to lose 4.5 years (about 1773 days) of extension for the ‘404 patent (which nominally expired on March 23, 2010).

MDCO filed a request for reconsideration of this decision, on the grounds that the FDA faxed its letter "after hours" on a Friday, "and that under FDA's practices, facsimiles submitted to FDA after close of business are considered received by the Agency on the next business day" (emphasis added).  Applying this standard, the approval notification date would have been Monday, December 18th, and MDCO's Request would have been timely filed even under an interpretation including the approval date in the 60-day period.  The PTO transmitted the request for reconsideration to the FDA (since the dispute involved FDA procedures), which the FDA rejected without comment or support, maintaining that the approval date was Friday, December 15th.

The PTO did not issue a formal denial of MDCO's request, but instead permitted the company to file an amended request for reconsideration and an amended extension application, which were filed on March 13, 2007.  Less than six weeks later, on April 26, 2007, the PTO denied the request, again with no explanation of the inconsistency in the FDA's position on submissions to and notices from the agency.  It was at this time that the Office applied the revised calculation for determining when a PTE Request must be filed, determining in this case that MDCO had filed its Request 2 days late.

MDCO filed a petition for leave to file a second request for reconsideration on the grounds that it had not had an opportunity to address this new interpretation of the deadline date for filing its PTE Request.  MDCO argued that there was no requirement in the statute that would preclude the Office from adopting its proposed "next business day" rule, and that such an interpretation would "comport with the statute's text and purpose."  While the Office granted leave for filing the second request for reconsideration (based on the "extraordinary situation" occasioned by its change in how days were counted for calculating the filing deadline), it denied the request substantively.  The PTO's position was that the Office did not have the authority under § 156 to adopt the proposed "next business day" rule, at least because there was no basis to distinguish "during business hours" from "after business hours" in the statute, which recites the date (per the PTO, "span[ning] the course of 24 hours").

MDCO brought suit in the Eastern District of Virginia (Claude M. Hilton, District Court Judge), and on March 16, 2010 the Court ordered on remand that the Office reconsider its position on the grounds that "§156(d)(1) was a remedial statute and that it should be liberally construed," and that "the PTO was not bound by statute or case law to reject the business day interpretation of the work date in §156(d)(1)."  Three days later, the Office "without any additional hearings" issued another decision again rejecting the "next business day" interpretation of the statute advanced by MDCO.  The Office went further, holding that the timing provisions of the statute were not remedial in nature, and that the Office was bound by Federal Circuit authority to interpret the word "date" in the statute as the calendar day on the FDA approval letter.  In response, MDCO returned to the District Court under the Administrative Procedures Act, 5 U.S.C. §§ 551-706, arguing that the agency's action was arbitrary and capricious.

On August 3, 2010, Judge Hilton ordered the PTO to consider MDCO's patent term extension application timely filed (see "The Medicines Company Prevails in Patent Term Extension Dispute").  The period for the government to appeal the Court's August 3, 2010 decision expired without government appeal.  However, on August 19, 2010, APP filed a motion to intervene for the purpose of appeal in MDCO's case against the PTO, FDA, and HHS.  On September 13, 2010, the District Court denied APP's motion (see "The Medicines Company Clearing Last Hurdles to Patent Term Extension for Angiomax®").  APP appealed the denial of its motion, as well as the District Court's August 3, 2010 order (and all related and underlying orders), to the U.S. Court of Appeals for the Federal Circuit.  The settlement announced today ends this appeal.

In addition, the settlement also contains an admission by APP that the patents involved in its ANDA filing, U.S. Patent No. 7,582,727 and 7,598,343, are not invalid or unenforceable against APP and would be infringed by APP's sale of its generic bivalirudin.  This portion of the settlement raises other issues, however.  The two later patents (i.e., the '727 and '343 patents) expire in 2028, but the settlement grants APP a license that permits APP to sell its generic bivalirudin on (or under some circumstances prior to) May 1, 2019.  In addition, APP has agreed to supply MDCO with finished drug product, an advantage in view of expected increases in demand and recent loss of manufacturing capacity by cancellation of agreements between MDCO and other contract manufacturer(s).  The settlement also includes an agreement whereby APP will supply under license additional generic products relating to "acute cardiovascular, neurological and infectious diseases."

These agreements must be submitted to the U.S. Department of Justice and the Federal Trade Commission under the Medicare Prescription Drug, Improvement and Modernization Act of 2003.  Given the FTC’s skepticism of the motivations and legality of patent settlement agreements, it is likely that this agreement (which provides final disposition of MDCO’s PTE dispute) will be critically scrutinized, particularly in view of the notoriety surrounding the circumstances and the FDA's and PTO's recalcitrance over the proper standards for awarding PTE under the statute (see "FTC Disapproves of 'Pay-for-Delay' Drug Deals" and "FTC Continues Attempts to Block Reverse Payments").

For additional information regarding this topic, please see:

• "The Medicines Company Clearing Last Hurdles to Patent Term Extension for Angiomax®," September 16, 2010
• "USPTO Acts Quickly to Comply with Court Order," August 6, 2010
• "The Medicines Company Prevails in Patent Term Extension Dispute," August 4, 2010
• "House Passes Patent Term Extension Bill," June 27, 2008

USPTO Issues Memo on Use of Non-Patent Literature During Examination

By Donald Zuhn --

Last week, the Office of the General Counsel for the U.S. Patent and Trademark Office issued a memorandum in response to several inquiries the Office has received concerning copyright infringement and the use of non-patent literature (NPL) in the examination process.  The memo, which was sent by USPTO General Counsel Bernard Knight, Jr., discusses the application of the fair use doctrine to the use of NPL during examination.

The memo begins by stating three issues involving the use of NPL:

1.  Whether it is fair use for the USPTO to make copies of copyrighted non-patent literature (NPL) and provide such copies to an applicant in the course of patent examination?

2. Whether it is fair use for the USPTO to provide certified copies of entire file histories, including copyrighted NPL, to members of the public, for a fee?

3. Whether it is fair use for an applicant to make a copy of a piece of copyrighted NPL and submit it to the USPTO?

With respect to the first issue, the memo notes that the Office "currently obtains much of its NPL through licenses, and has ensured that its licenses permit it to make copies of copyrighted NPL that is used in examination."  For unlicensed NPL, the memo states that the Office considers the copying and providing of such references to applicants to be protected by the doctrine of fair use.  In order to prevent copyrighted NPL from being copied "for reasons unrelated to patent matters," such references are not provided on PAIR.  As for the second issue, the Office considers that providing certified copies of entire file histories, including copyrighted NPL, to members of the public for a fee to also be protected by the doctrine of fair use.  Finally, with regard to the third issue, the Office considers the copying of copyrighted NPL by patent applicants and their attorneys and the submission of those copies to the USPTO "pursuant to the USPTO's disclosure requirements," to be protected by the doctrine of fair use.  The memo adds, however, that "[t]he USPTO takes no position on whether additional copies of such NPL made by an attorney or applicant during the course of patent prosecution (e.g. for the client, for other attorneys, for the inventor, or for the law firm's future reference) qualifies as fair use."  The memo also warns that "[t]o the extent applicants have obtained copyrighted NPL pursuant to a license, applicants are responsible for ensuring that the license is not inconsistent with fair use."

The memo explains that the Copyright Act provides four factors for assessing whether a particular use is a fair use, and thus considered not to be an infringement of a copyright.  Citing § 107 of the Copyright Act, the memo states that these factors are:

(1) the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes; (2) the nature of the copyrighted work; (3) the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and (4) the effect of the use upon the potential market for or value of the copyrighted work.

Applying the four factors to the first issue, the Office notes that "[i]n the 1960s, as part of an initiative to expedite the examination process, the USPTO began providing copies of cited prior art to applicants."  With respect to copying and providing unlicensed NPL to applicants, the Office notes that the first factor "weighs in favor of fair use because the USPTO is not using the work for a commercial purpose."  The Office also cites "several cases dealing with use of copyrighted works in connection with non-commercial, government functions [that] favor[] fair use."  As to the second factor, the memo states that "the USPTO and the applicants are interested in the NPL only for its factual, rather than its expressive, content," and notes that NPL typically consists of published works, which "receive less protection than unpublished works."  The Office acknowledges that the third factor "tends to be neutral in this case," because "[i]n many cases . . . an entire publication (e.g., an entire journal article) is considered relevant."  With regard to the fourth factor, the memo states that:

There is no basis for concluding that the USPTO' s provision of copyrighted NPL to patent applicants in the course of patent examination impairs the marketability of the copyrighted NPL.  The NPL at issue has typically been published several years before the USPTO's use and by the time of the USPTO's use usually has only limited commercial value.  In addition, by not providing copies of copyrighted NPL in its Public PAIR system -- and thereby preventing any possibility of systematic infringement through access to USPTO's databases -- the USPTO has taken steps to ensure that copies of NPL used in examination do not become freely available on the internet.

The memo therefore concludes that the Office's copying and providing of copyrighted NPL to applicants constitutes fair use.

On the second issue, the memo contends that "[t]he fair use analysis for providing file wrappers to the public for a fee (pursuant to 35 U.S.C. 9 and 37 C.F.R. 1.19( a)) is similar to the analysis for providing copies of the NPL during examination."  The Office states that "[t]he fact that the USPTO charges a fee for the certified file wrapper does not alter the conclusion that the use of the work is not for profit," noting that "[t]he fee is calibrated to reflect cost recovery, and the USPTO does not profit from making copies of any particular copyrighted work."  The memo therefore concludes that "the incidental inclusion of copies of copyrighted NPL in a copy of a certified file wrapper offered to the public for a fee" also constitutes fair use.

The memo next applyies the four factors to applicants' copying and submission of copyrighted NPL.  The memo contends that "[t]he fair use analysis for an applicant's IDS submission is very similar to, and reaches the same result as, the fair use analyses for the USPTO uses [specified in the first two issues]."  With respect to the first factor, the memo states that "[t]he case for fair use . . . might be even stronger for the applicant, because the applicant is required by law to submit the prior art to the patent office."  In particular, the memo explains that "[g]iven that the applicants here are not 'exploiting' the copyrighted work, and are instead merely submitting it, pursuant to a legal requirement, based on its factual, rather than its expressive, content, the first factor weighs heavily in favor of fair use."  As to the fourth factor, the memo states that "it is also worth noting that the copies of NPL that law firms typically submit to the USPTO have been obtained through legitimate, licensed databases, and thus have already been paid for once," adding that "[t]he copyright holder has already been compensated for that use (which would not typically have occurred but for the legal requirement imposed by the patent system)."  The memo therefore concludes that "it is fair use for an applicant to make copies of NPL and submit those copies to the USPTO during examination in an IDS."  The memo provides a bit of a disclaimer, however, reminding applicants that "to the extent they have obtained copies of NPL through licenses, they should consult those licenses to ensure that any proposed use of the NPL is within the scope of the license."

Hat tip to Greg Aharonian for alerting the readers of his e-mail newsletter to the Office's memo on the use of NPL during examination.

Court Report

By Sherri Oslick --

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

Alnylam Pharmaceuticals, Inc. et al. V. Tekmira Pharmaceuticals Corp.
1:12-cv-10087; filed January 17, 2012 in the District Court of Massachusetts

• Plaintiffs:  Alnylam Pharmaceuticals, Inc.; Isis Pharmaceuticals Inc.
• Defendant:  Tekmira Pharmaceuticals Corp.

Infringement of U.S. Patent Nos. 7,695,902 ("Oligoribonucleotides and Ribonucleases for Cleaving RNA," issued April 13, 2010), 6,858,225 ("Lipid-Encapsulated Polyanionic Nucleic Acid," issued February 22, 2005), 6,815,432 ("Methods for Encapsulating Plasmids in Lipid Bilayers," issued November 9, 2004), 6,534,484 (same title, issued March 18, 2003), 6,586,410 ("Lipid-Nucleic Acid Particles Prepared Via Hydrophobic Lipid-Nucleic Acid Complex Intermediate and Use for Gene Transfer," issued July 1, 2003), and 6,858,224 ("Method of Preventing Aggregation of a Lipid: Nucleic Acid Complex," issued February 22, 2005) based on Tekmira's sale and offer to sell in, and importation into, the United States dsRNA formulations comprising SNALP (stable nucleic acid-lipid particles) for use by Bristol-Myers Squibb to use for target validation purposes.  View the complaint here.

Pamlab, L.L.C. et al. v. Viva Pharmaceutical, Inc.
2:12-cv-00098; filed January 17, 2012 in the Western District of Washington

• Plaintiffs:  Pamlab, L.L.C.; Metabolite Laboratories, Inc.; Breckenridge Pharmaceutical, Inc.
• Defendant:  Viva Pharmaceutical, Inc.

Infringement of U.S. Patent No. 6,528,496 ("Compositions Treating, Preventing, or Reducing Elevated Metabolic Levels," issued March 4, 2003) based on Viva's manufacture for sale in the U.S. by Macoven Pharmaceuticals, L.L.C. folic acid products allegedly represented to be substitutable for plaintiffs' Foltx® and/or Folbic® products (vitamin B12, vitamin B6, and folic acid, used to treat hyperhomocysteinemia).  View the complaint here.

Fresenius Medical Care Holdings, Inc. v. Nostrum Laboratories, Inc.
1:12-cv-10083; filed January 13, 2012 in the District Court of Massachusetts

Infringement of U.S. Patent No. 6,576,665 ("Encapsulated Calcium Acetate Caplet and a Method for Inhibiting Gastrointestinal Phosphorous Absorption," issued June 10, 2003) following a Paragraph IV certification as part of Nostrum's filing of an ANDA to manufacture a generic version of Fresenius' PhosLo® GelCaps (calcium acetate, used to treat renal failure).  View the complaint here.

Merck Frosst Canada & Co. et al. v. Teva Pharmaceuticals USA, Inc.
3:12-cv-00210; filed January 11, 2012 in the District Court of New Jersey

• Plaintiffs:  Merck Frosst Canada & Co.; Merck Canada Inc.; Merck Sharp & Dohme Pharmaceuticals
• Defendant:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 8,007,830 ("Granule Formation," issued August 30, 2011) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Merck's Singulair® (montelukast sodium, used to treat asthma and allergic rhinitis).  View the complaint here.

Conference & CLE Calendar

January 25-26, 2012 - Biosimilars Forum 2012 (C5) - London, UK

January 26, 2012 - Life Under AIA: Anticipating and Surviving Post Grant Challenges (Technology Transfer Tactics) - 1:00 - 2:00 pm (Eastern)

January 31, 2012 - Obviousness Standard for Patents: Approaches to Withstand USPTO Obviousness Rejections and Attacks on Patent Validity (Strafford) - 1:00 - 2:30 pm (EST)

January 31 - February 1, 2012 - Patent Reform for Life Sciences Companies*** (American Conference Institute) - New York, NY

January 31 - February 1, 2012 - Pharma & Biotech Patent Litigation (C5) - Amsterdam, The Netherlands

February 8, 2012 - Corporate Intellectual Property Law Conference (Law Bulletin Publishing Co.) - Chicago, IL

February 13-14, 2012 - China IP Counsel Forum (C5) - Shanghai, China

February 21-22, 2012 - Biotech & Pharmaceutical Patenting*** (IBC Legal) - Munich, Germany

February 22-23, 2012 - EU Pharma Law & Regulation*** (C5) - London, England

February 22-24, 2012 - Intensive Patent Law Training Seminar (Chisum Patent Academy) - New York, NY

February 27-29, 2012 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

February 28-29, 2012 - Medical Device Patents*** (American Conference Institute) - Boston, MA

March 14-15, 2012 - Biotech Patenting (C5) - Munich, Germany

March 20-21, 2012 - FDA Boot Camp*** (American Conference Institute) - New York, NY

March 26-27, 2012 - PTO Procedures under the America Invents Act*** (American Conference Institute) - New York, NY

March 28-30, 2012 - 27th Annual Intellectual Property Law Conference (American Bar Association (ABA) Section of Intellectual Property Law) - Arlington, VA

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

27th Annual Intellectual Property Law Conference

The American Bar Association (ABA) Section of Intellectual Property Law will be holding the 27th Annual Intellectual Property Law Conference on March 28-30, 2012 in Arlington, VA.  Among the topics that will be covered at the conference are:

• Recent developments in patent term adjustments and extensions;
• Abstract reasoning -- Recent developments in the law of patentable subject matter under 35 U.S.C. § 101;
• E-discovery in patent litigation -- A model order to quiet the tail that wags the dog;
• Understanding the America Invents Act -- A sweeping change of U.S. patent practice before the United States Patent and Trademark Office;
• The America Invents Act -- Dissection of the new rules for post-grant review and inter partes review;
• What's going on?  A summary of hot IP topics;
• Diagnostics and gene patents: What is the future for personalized medicine patents? -- panel includes Patent Docs author Kevin Noonan; and
• Developments in the implementation of the biosimilars act:  Where are we now and where are we headed?

On March 29, the luncheon speaker will be David J. Kappos, Undersecretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office.  In addition, an evening reception will be held at the U.S. Court of Appeals for the Federal Circuit.

The program schedule for the conference can be found here.

The registration fee is $295 (law students), $345 (corporate counsel and government, public interest, and academic rate), $695 (ABA-IPL section members and members of co-sponsoring section), $770 (ABA members), or $845 (non-ABA members).  Those registering before March 14, 2012 will receive a $50 discount (or a $100 discount off the non-ABA member rate).  Detailed registration information (and a registration form) can be found here.

Corporate Intellectual Property Law Conference

The Law Bulletin Publishing Company will be holding its 7th annual Corporate Intellectual Property Law Conference on February 8, 2012 in Chicago, IL.  Among the topics to be addressed at the conference will be:

• Views from the USPTO
• Venue issues under AIA
• Update from the federal courts
• Revised MPEP's effect on budget and employees
• OED & ARDC on IP lawyer misconduct
• Post-grant review and supplemental examination
• Life after Therasense

Speakers will include:

• Hon. James Holderman, Chief Judge, U.S. District Court for the North District of Illinois
• Bruce Kisliuk, Assistant Deputy Commissioner for Patent Operations, U.S. Patent and Trademark Office
• Brian Weber, Office of Quality Review & Training, U.S. Patent and Trademark Office

The registration fee for the conference is $119.  Those registering before January 25, 2012 will receive a $30 discount.  Those interested in registering for the conference can do so here.  Additional information about the conference can be found here.

Worldwide Patent Filings and Grants on the Rise

By Donald Zuhn --

On Tuesday, the European Patent Office announced that it received 243,000 applications in 2011, which constituted a 3% increase from the 237,500 applications the EPO received in 2010.  The EPO granted 62,115 patents, which was 7% more than the number of patent grants in 2010.  With regard to the geographic origin of filings, the EPO noted that EP filings from China rose from 5% of all filings to 7%, filings from Japan rose from 18% of all filings to 19%, and filings from the U.S. fell from 26% of all filings to 24%.  The Top 10 countries of origin for European filings were:

A more complete list of filings by country of origin can be found here.

EPO President Benoît Battistelli stated that "[c]ontinued patent filings growth and the high percentage of non-European applicants are clear evidence of great confidence in Europe as a place for business," adding that "[t]he EPO will continue to play a leading role in the global patent system."

Earlier this month, IFI Claims Patent Services, a company that produces global patent databases, announced that 224,505 utility patents were issued in the U.S. last year, an increase of 2% over the 219,614 patents that were issued in 2010.  IFI also released a list of the Top 50 companies receiving U.S. patents last year.  IFI's Top 10 were:

The only life sciences company making the list was Du Pont de Nemours, E I & Co.  IFI noted that Asian companies accounted for 25 of the top 50 U.S. patent recipients, with U.S. firms capturing 17 slots.

Last month, Reuters reported that China surpassed the U.S. in terms of application filings in 2010 (figures for 2011 were not yet available).  Citing a Thomson Reuters research report, the article noted that published applications in China had risen by an average of 16.7% annually from 171,000 in 2006 to 314,000 in 2010.  According to the report, published applications are expected to top 500,000 in 2015, with filings in the U.S. and Japan amounting to 400,000 and 300,000, respectively.

In December, the World Intellectual Property Organization announced the release of its 2011 World Intellectual Property Indicators report.  The WIPO report noted that after a considerable decline in worldwide patent application filings in 2009 (a 3.6% decline), filings rose 7.2% in 2010, with China and the U.S. accounting for the greatest share of all filings.  The 7.2% increase constituted the highest growth rate in five years, and the 1.98 million worldwide applications that were filed in 2010 was an all-time high.  The report noted that some 5.17 million worldwide applications were "potentially pending" in 2010.

The WIPO report showed that the U.S. maintained the top spot for patent application filings, with 490,226, and that China slipped past Japan to capture second place with 391,177 filings.  Japan had 344,598 filings.  With regard to technology field, biotechnology filings rose 0.4% between 2005 and 2009 (the latest years for which data was available), pharmaceutical filings were down 0.1%, organic fine chemistry was down 1.3%.

USPTO News Briefs

By Donald Zuhn --

USPTO Selects Site of Detroit Satellite Office

In a press release issued earlier this month, the U.S. Patent and Trademark Office announced that it had entered into a five-year lease agreement on a 31,000 square foot space at 300 River Place Drive in Detroit, where the Elijah J. McCoy USPTO will be located.  The Detroit satellite office was so designated pursuant to § 24 of the Leahy-Smith America Invents Act (see "USPTO News Briefs," December 15, 2011).  According to the announcement, the Office intends to open the Detroit satellite office no later than July 2012, and the satellite office is expected to create more than 100 new jobs during its first year.  The Office asks prospective employees to send e-mail inquiries to [email protected] for more information.  The Office also reminded applicants and practitioners that it is currently in the process of collecting information on potential locations for future satellite offices.  Written comments regarding possible locations must be submitted by January 30, 2012 (see "USPTO News Briefs," December 15, 2011, for information regarding the Office's Federal Register notice requesting comments).

 
USPTO to Hold Seven AIA Roadshows

In a press release issued on January 9, the U.S. Patent and Trademark Office announced that it would be hosting a public series of educational "roadshows" regarding the Leahy-Smith America Invents Act.  The roadshows will allow the public to speak with USPTO officials about the new patent law and its implementation.  Seven roadshows have been scheduled, to be held at the following locations:

Friday, February 17
USPTO Campus
Alexandria, VA

Friday, February 24
Sunnyvale Public Library
Sunnyvale, CA

Monday, February 27
Marriott Library, University of Utah
Salt Lake City, UT

Wednesday, February 29
Dallas Public Library
Dallas, TX

Friday, March 2
Broward County Main Library
Ft. Lauderdale, FL

Monday, March 5
Boston Public Library
Boston, MA

Wednesday, March 7
Chicago Public Library
Chicago, IL

USPTO Patent Reform Coordinator Janet Gongola commented that "[t]he USPTO hopes that the public will find the roadshows to be an ideal forum to engage with the Office about our various proposed rules implementing provisions of the America Invents Act," adding that "[t]he roadshows also give the agency the opportunity to visit members of the patent community in different parts of the country as part of our ongoing effort to create a 21st century patent and trademark office."

According to the USPTO's Leahy-Smith America Invents Act Implementation webpage, the agenda of the roadshows will be as follows:

Welcoming Remarks -- 10:00 – 10:30 am
Patent Related Provisions -- 10:30 – 11:15 am
Break -- 11:15 – 11:30 am
Patent Related Provisions -- 11:30 am – 12:30 pm
Lunch -- 12:30 – 1:30 pm
Contested Case Provisions -- 1:30 – 3:00 pm
Break -- 3:00 – 3:15 pm
Contested Case Provisions -- 3:15 – 4:30 pm 

Patent Docs intends to attend and report on the Chicago roadshow.

USPTO Issues AIA-Mandated Reports

In a press release issued yesterday, the U.S. Patent and Trademark Office announced that it had submitted to Congress two reports mandated by the Leahy-Smith America Invents Act.  The first report concerns the scope of prior user rights defense in industrialized countries (see "USPTO Issues Report on Prior User Rights"), and the second report (prepared pursuant to AIA § 31) concerns international patent protections for small businesses.

According to the Office's announcement, the International Patent Protections for Small Businesses Report "considers how to best help small businesses with patent protection overseas, including whether a loan or grant program should be established to help small businesses cover the costs of application, maintenance, and enforcement fees or related technical assistance."

The Office noted that the AIA mandates that the USPTO conduct five more studies in the coming months.  Next on the Office's agenda is the report on secondary genetic testing; the Office will be hosting public hearings and seeking written public comments as it did for the first two reports.