Patent Docs

FDA Drug Approvals for 2011 on Pace to Surpass 2010 Despite New Safety Standards

July 13, 2011

By James DeGiulio —

The Food and Drug Administration has been the subject of recent criticism from drugmaker advocates who allege that the FDA's tougher safety standards have slowed down the pace of drug approvals and have hurt the drug industry. However, despite these allegedly repressive safety standards, the head of the FDA's drug division, Dr. Janet Woodcock, speculated in May that the FDA would approve more drugs in 2011 than the number of new drugs approved in 2010 ("FDA official sees drug approvals rising"). Barring some unforeseen event, it appears likely that this year, the FDA will easily surpass the number drug approvals for 2010. The FDA has already approved 20 new drugs so far, excluding approvals granted for vaccines or new formulations or uses of existing drugs, almost matching the 21 drugs approved in 2010, according to a recent article in the Wall Street Journal ("FDA's Drug-Approval Rate for 2011 on Pace to Exceed 2010"; subscription required for full access).

These numbers should quiet critics of the safety standards for the time being. Industry advocates and some lawmakers have criticized the FDA for instituting higher burdens on drugmakers to win approval. The FDA has tightened safety regulations since the 2004 market withdrawal of the painkiller Vioxx. After the Vioxx withdrawal, the FDA was criticized by the public for lack of vigilance, and the agency responded by re-evaluating its practices.

Last week, The House Energy and Commerce's health subcommittee held a panel hearing to discuss the reauthorization of legislation that allows the FDA to charge drug companies user fees (which is expected to be renewed, as it is supported by both parties). However, during the panel, Jonathan Leff, a managing director at Warburg Pincus LLC, a private-equity and venture-capital firm, provided written testimony asserting that the FDA's tougher focus on drug safety has hurt the drug industry and is a major contributor to the rising cost and length of drug development. Mr. Leff stated that despite potential for producing a marketable and beneficial therapeutic, many promising scientific discoveries are not being developed into new treatments for disease due to lack of investment capital. He cited figures showing venture investment in the U.S. life sciences industry declined by $2 billion from 2008 to 2010.

In response, Dr. Woodcock (at left) defended the FDA, insisting that the FDA has changed its requirements only because the new science required it. She pointed instead to the high failure rates of drugs in the development stage, rather than the FDA approval stage, as presenting the main contributor to the rising cost and length of drug development. Dr. Woodcock explained the agency meets more than 90 percent of deadlines that are part of the drug-review process. She also said first cycle approvals are at a 20-year high, and more than two-thirds of new drugs are approved within the 6-to-10-month time frame given to new drug applications. Dr. Woodcock admitted that there are certain cases where companies are asked to submit more information, which prompts additional reviews, and in other cases drugs are rejected. She did note that expert advisory panels, which generally make determinations on new drugs, have been more difficult to assemble. In 2007, the FDA tightened guidelines to minimize drugmaker industry ties that could sway a panelist's view. Since many of the individuals with the most expertise are affiliated with drugmakers, they are ineligible to sit on these advisory panels due to conflicts. Rather than relying on advisory panels for specific experimental drugs, Dr. Woodcock said she would prefer to see more panel discussions of general policy issues, such as approval standards for a specific area.
Docs at BIO: Biomarker-Based Diagnostics

July 13, 2011

By Kwame Mensah —

Last month's BIO International Conference kicked off on June 27th with a presentation entitled "IP Issues Affecting Biomarker-Based Diagnostics." The four panelists for the session were David Gass of Marshall, Gerstein & Borun, LLP; Dr. Thorlakur Jonsson, the Director of Intellectual Property at deCODE genetics ehf; Dr. Simon O'Brien of D. Young & Co. in the United Kingdom; and Dr. Jan Skouv, Director IPR at Exiqon A/S.

The session began with two talks related to recent developments in technology related to biomarkers. The first speaker was Dr. Jonsson, who focused on the use of the information provided by genome sequencing in personalized medicine. Dr. Jonsson began with a discussion of genetic variation in the human genome. He stated that the mere 1% genetic variation among humans can determine whether an individual may be at risk for a certain disease, may have certain drug metabolism, or may respond in a certain way to specific therapies. He referred to these as high risk Mendelian phenotypes, and touted the use of high throughput and microarray assays as providing faster analysis of genomic sequences. Dr. Jonsson concluded his presentation with a short summary of the work done by deCODE to investigate biomarkers for many diseases through correlation analyses of genealogy, genotype, phenotype, and genome databases.

The second speaker of the session was Dr. Skouv who discussed detection of microRNAs (miRNAs; RNA molecules of 22 nucleotides or less in length) in blood samples as biomarkers. These molecules have been found to be highly involved in the pathology of several types of cancer. Dr. Skouv stated that although the miRNA molecules were generally found to be stable when associated with blood serum and its components after EDTA treatment, introduction of locked nucleic acids (LNAs) to the miRNAs via PCR further increased stability of the miRNAs. LNAs are a class of nucleic acid analogues in which the ribose ring is "locked" by a methylene bridge connecting the 2'-O atom and the 4'-C atom of the ribose ring, which increases the molecule's affinity for other molecules. Dr. Skouv concluded his presentation by noting that Exiqon had successfully used LNA-associated miRNAs as biomarkers for the early detection of colorectal cancer, and that preliminary work had been done on the early detection of melanoma.

The next two speakers focused on patent-related issues. Generally speaking, two types of intellectual property protection exist for detection and use of biomarkers: (1) protection for the markers themselves (nucleic acid molecules, proteins, etc.) and (2) protection for use of the markers for diagnostics and therapeutics, including compositions, methods, systems, and kits. The first of the two speakers, David Gass provided a general discussion of the legal requirements for receiving a patent, and then discussed recent decisions in the federal courts within the last year relating to the patent eligibility of nucleic acid molecules and processes of analysis. He then moved to a discussion of two cases of particular relevance to biomarkers; Bilski v. Kappos and AMP v. USPTO (the "Myriad" case). Mr. Gass highlighted the fact that the Supreme Court in Bilski held that the "machine or transformation" test is not the exclusive test for determining whether a process or method of analysis is patent eligible. This is of particular relevance to the use of biomarkers because this holding indicates that determinative processes involved in the use of biomarkers do not necessarily have to be associated with a machine or be "transformative" to be patentable subject-matter.

Mr. Gass then moved to a discussion of the Myriad case, highlighting that the claims to isolated DNA molecules (gene products) were found invalid under 35 U.S.C. § 101, but that the claims related to vectors, host cells, probes. i.e., man-engineered DNA-type molecules were left intact. He specifically highlighted the amicus brief submitted during the appellate proceedings by the Department of Justice. The DOJ brief focused on the difference in the character of the nucleic acid molecules themselves, specifically asserting that "naturally occurring" nucleic acid molecules were not patentable subject-matter, whereas engineered nucleic acid molecules (e.g, vectors, host cells, cDNA) were patentable subject-matter. Mr. Gass then touched on the jurisdiction issues that were discussed during oral argument before the Federal Circuit. The panel also inquired about what it means to isolate a gene, i.e., that the breaking of covalent bonds, under traditional chemistry, creates a new molecule. Mr. Gass indicated that this line of inquiry suggests that the Federal Circuit could determine that isolated DNA is different from naturally-occurring DNA, therefore making it patentable subject-matter. This no doubt would be a big victory for the biotech industry. Mr. Gass concluded his discussion by focusing on diagnostic claims such as those in the Myriad patents. As discussed in this space previously, Myriad has argued that its diagnostic claims are not abstract and that each laboratory step is transformative.

The second patent law-related speaker of the afternoon was Dr. Simon O'Brien. He began his talk by stating that there has been a drastic decrease in the number of patent applications for gene patents since 2000. In contrast, applications for diagnostic methods have increased almost as dramatically, and the majority of these applications have been related to cancer diagnostics. Dr. O'Brien then gave a brief summary of the requirements for receiving a diagnostic method patent in Europe. The necessary steps in a claim are: examination, comparison, finding of a derivation, and attribution to a disease. Only one of these steps need be in vitro. He then pointed out that Myriad's BRCA-1 patents were found to be valid in opposition proceedings in Europe due to the fact that because isolated DNA molecules are patentable subject-matter, use of these molecules in diagnostic steps was also patentable.

Mr. Gass then returned to the microphone to discuss multi-party and multi-jurisdictional issues involved in enforcement. These are related to actions by multiple parties, in different jurisdictions or countries in performing a claimed diagnostic method. He focused on several cases that may provide some guidance as to what issues may arise regarding the enforcement of claims for biomarker-based diagnostic tests. One case discussed was BMC Resources, Inc. v. Paymentech, L.P. 478 F.3d 1373 (Fed. Cir. 2007), in which the Court stated that all steps of a method must be performed by one party in order for the claimed method to be infringed, unless a single mastermind is orchestrating performance of the method. Mr. Gass surmised that for a diagnostic method claim to be reasonably enforceable, one needs to draft a diagnostic method claim such that the method can only be performed by one party. Another case Mr. Gass discussed was Centillion Data Systems, LLC v. Qwest Communications International, Inc. (Fed. Cir. 2011), where the claim at issue was to a system with various components. The Court in Centillion stated that a party must put the system into service, control the system as a whole, and obtain a benefit from the system to infringe. Regarding territoriality issues, Mr. Gass again provided some insight into how this could affect biomarker/diagnostic claims stating that one or more steps of a method performed offshore would probably not be infringing, whereas one or more steps of a system performed offshore would be. Mr. Gass recommended using various types of diagnostic method claims within the same claim set to increase the likelihood of securing reasonably enforceable claims.

Dr. O'Brien concluded the session with a discussion of issues related to performing certain steps of a diagnostic method in another country as a means to circumvent infringement. He echoed Mr. Gass' suggestion that claims be drafted such that it is necessary for a method to be performed by the same person, such as by limiting the number of steps in the method. He stated that in Europe, one court determined that a patent holder may only receive protection for a method related to the DNA when the DNA is performing its native function. For example, using a cancer probe to diagnose a different disease would likely not be infringing.

Overall the session's discussion of use of biomarkers in diagnostic methods provided guidance for patent prosecutors in drafting good claims, and provided an excellent summary of the state of the industry related to biomarkers.
Patent Reform News Briefs

July 12, 2011

By Donald Zuhn —

Reports Suggest Senate Action on Patent Reform Bill Could Be Weeks Away

In Monday's IPO Daily News, the Intellectual Property Owners Association (IPO) suggested that H.R. 1249, which the House passed on June 23 (see "House Passes H.R. 1249"), might not be brought up by the Senate until after Congress' August recess, which is scheduled to begin on August 6. The IPO report also noted that while Sen. Patrick Leahy (D-VT) is seeking Senate passage of the bill passed by the House, other Senators are objecting to a few provisions in the bill, including § 37 (the so-called MedCo amendment; see "The Medicines Company Clearing Last Hurdles to Patent Term Extension for Angiomax®"), which would amend 35 U.S.C. § 156(d)(1) by adding the following text:

For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive such permission on the next business day. For purposes of the preceding sentence, the term 'business day' means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5.

On Saturday, Hal Wegner (at left) stated in his e-mail newsletter that "[a]n early Senate vote is now considered unlikely on the Leahy-Smith America Invents Act, with the strong likelihood that any full Senate consideration will take place at the earliest after Labor Day" (emphasis in original).

A copy of the House bill as it was received in the Senate and placed on the Senate legislative calendar on June 27 can be found here.

Economist Asks Congress to "Let the Patent Office Keep Its Money"

In an Op-Ed published last week by Bloomberg Businessweek, Economist Dr. Scott Shane contends that "[f]ee diversion is wreaking havoc on the patent system and undermining our national competitiveness" ("Let the Patent Office Keep Its Money"). Dr. Shane (at right), a Professor of Economics at Case Western Reserve University, should be familiar to Patent Docs readers for his contributions to the patent reform debate (particularly with respect to patent damages) in 2009 (see "Manufacturing Alliance on Patent Policy: Apportionment of Damages Provision Will Have Adverse Effects"; "MAPP Economist Advises Congress on Damages Provision"; and "Patent Reform Efforts Opposed by Small Business Group").

Noting that between 2000 and 2010 the annual number of applications filed rose 65%, Dr. Shane argues in his article that "[t]o meet this demand, the USPTO needs more patent examiners to handle the greater volume of applications," and that "[b]y taking away a portion of the patent office's fees, Congress has prevented the USPTO from hiring enough examiners to evaluate patent applications in a timely manner." He concludes that "[i]f the House adopts the Senate's version [of the USPTO funding provisions], fee diversion will end, but if the Senate adopts the House's version, then I'm much less optimistic that the USPTO will get the money it needs to operate successfully."

American Action Forum Urges Senate to Retain USPTO Funding Provisions of S. 23

The American Action Forum, an organization that describes itself as "a forward-looking policy institute dedicated to keeping America strong, free and prosperous," which "seeks to promote common-sense, innovative, and solutions-based policies that will reform government, challenge out-dated assumptions, and create a smaller, smarter government that will serve its citizens better," issued a statement today calling on Senate leadership to prevent fee diversion in the U.S. Patent and Trademark Office. American Action Forum President Doug Holtz-Eakin, a former Director of the Congressional Budget Office, pointed out that "[e]ach year over $800 million in user fees are diverted away from the USPTO through the Congressional appropriations process." He urged Senate Majority Leader Harry Reid (D-NV) and Minority Leader Mitch McConnell (R-KY) "to adopt the language in S.23, a bill that will effectively end this process."

In a letter to Sen. Reid and Sen. McConnell, Mr. Holtz-Eakin stated that "[t]he establishment of the Patent and Trademark Fee Reserve Fund in H.R. 1249 would be ineffective in stopping the diversion of fees from USPTO." In contrast, he explained that "the Senate bill [S. 23] creates a USPTO Public Enterprise Fund at the Treasury Department, which would receive all fees paid to USPTO and which would be available to USPTO when needed," stating that "[t]he funds would not be funneled through the Congressional appropriations process and would, therefore, not be exposed to the threat of being diverted to general government spending." "If it is, in fact, the goal of Congress to end fee diversion and ensure that the USPTO is authorized to spend the fees it collects from its users," Mr. Holtz-Eakin contended that "the language contained in S.23 is clearly superior to the language of H.R.1249."
Reckitt Benckiser Inc. v. Watson Laboratories, Inc. – Florida (Fed. Cir. 2011)

July 11, 2011

By Donald Zuhn —

Last week, in Reckitt Benckiser Inc. v. Watson Laboratories, Inc. – Florida, the Federal Circuit affirmed a decision by the District Court for the Southern District of Florida holding that Defendant-Appellee Watson Laboratories, Inc. – Florida did not infringe the asserted claims of U.S. Patent No. 6,372,252. The Federal Circuit also determined that the District Court correctly construed the asserted claims of the '252 patent.

Plaintiff-Appellant Reckitt Benckiser Inc. markets bilayer tablets comprising guaifensin, an expectorant used to relieve congestion, as Mucinex®. Reckitt's bilayer tablets contain guaifensin in both immediate release (IR) and sustained release (SR) formulations. In obtaining FDA approval for its Mucinex® products, Reckitt listed the '252 patent in the Orange Book as covering the guaifensin tablets.

Seeking approval to market guaifensin tablet formulations, Watson filed an Abbreviated New Drug Application (ANDA) with the FDA. In response to Watson's ANDA filing, Reckitt brought suit against Watson for infringement of claims 24, 26-28, 31-34, 39, 57, and 58 of the '252 patent. Representative claim 24 reads (emphasis added by panel):

24. A modified release product having two portions, wherein a first portion comprises a first quantity of guaifenesin in an immediate release form which becomes fully bioavailable in the subject's stomach and a second portion comprises a second quantity of guaifenesin in a sustained release form wherein the ratio of said first quantity to said second quantity provides a Cmax in a human subject equivalent to the Cmax obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed every four hours over a 12 hour period and wherein said product also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject according to serum analysis.

In construing the term "portion," which appears in each of the asserted independent claims, the District Court determined that the term means "a discrete part of the product." Following a bench trial, the District Court found that Watson's products, which are non-layered polymer matrix tablets made from a single guaifenesin formulation, do not have separate IR and SR portions, and therefore do not literally infringe the asserted claims of the '252 patent. The District Court also found no infringement under the doctrine of equivalents because Reckitt disclaimed products lacking two discrete structural portions during prosecution, and Watson's products lack two discrete structural portions.

In its opinion, the Federal Circuit noted that the prosecution history of the '252 patent was relevant to the parties' arguments on appeal. The Court pointed out that as originally filed, claims 1-11 were directed to a SR composition, claims 12-24 were limited to products with two portions, and claims 25-32 were directed to modified release tablets. In response to a rejection of claims 1-32 for obviousness, applicants cancelled the claims and added new claims 33-55, stating that the new claims were directed to "[a] modified release tablet having two portions," and adding that "the sustained release claims have been cancelled to facilitate prosecution." Applicants also distinguished the new claims over the cited prior art, stating that one reference "does not disclose a composition having both an immediate release portion . . . and a sustained release portion," and that the other reference, despite disclosing tablets with two separate portions, "specifically teaches away from employing any immediate realease portion."

On appeal, Reckitt argued that the District Court erred in construing "portion" and in finding no infringement either literally or under the doctrine of equivalents. In determining that the District Court did not err in construing the term "portion" to mean "a discrete part of the product," the Federal Circuit noted that:

The applicants disavowed claim coverage of sustained release tablets by cancelling original claims 1-11 and remarking to the examiner that "[o]riginal claims 1-11 were directed to a sustained release formulation . . . . [T]he sustained release claims have been cancelled to facilitate prosecution." The unmistakable effect of that disavowal, evident from the applicants' remarks distinguishing the prior art, was to limit the remaining claims to two-portion guaifenesin products [citations omitted].

The panel determined that "[t]he file history thus demonstrates a 'clear and unambiguous' prosecution disclaimer."

As for the District Court's finding of no infringement, the Federal Circuit stated that:

As the court correctly found, Watson's products do not infringe because they are non-layered, single-formulation polymer matrix tablets that do not contain the claimed "first portion" or "second portion." . . . The district court correctly concluded that Watson's products do not have two structural portions and that guaifenesin granules on the surface of Watson’s tablets do not constitute the claimed first portion of guaifenesin in an IR form.

With respect to infringement under the doctrine of equivalents, the panel concluded that:

[O]n the facts of this case, prosecution history estoppel bars Reckitt from recapturing single-formulation SR guaifenesin tablets like those it disclaimed in obtaining the '252 patent. As the district court correctly noted, Reckitt's narrowing claim amendments were made for reasons of patentability [citations omitted].

The Federal Circuit therefore affirmed the District Court's finding of no infringement, either literally or under the doctrine of equivalents.

Reckitt Benckiser Inc. v. Watson Laboratories, Inc. – Florida (Fed. Cir. 2011)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Linn, and Dyk
Opinion by Circuit Judge Lourie
Court Report

July 10, 2011

By Sherri Oslick —

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

Ferring B.V. v. Watson Pharmaceuticals, Inc. et al.
3:11-cv-00481; filed July 7, 2011 in the District Court of Nevada

• Plaintiff: Ferring B.V.
• Defendants: Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Watson Laboratories, Inc. – Florida; Watson Pharma, Inc.

Infringement of U.S. Patent No. 7,947,739 ("Tranexamic Acid Formulations," issued May 24, 2011) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Ferring's Lysteda® (tranexamic acid, used to treat heavy menstrual bleeding). View the complaint here.

Intervet Inc. et al. v. Boehringer Ingelheim Vetmedica Inc.
1:11-cv-00595; filed July 6, 2911 in the District Court of Delaware

• Plaintiffs: Intervet Inc. d/b/a Merck Animal Health; Arizona Board of Regents
• Defendant: Boehringer Ingelheim Vetmedica Inc.

Infringement of U.S. Patent No. 5,610,059 ("Etiological Agent for Porcine Enteritis," issued March 11, 1997) based on Boehringer's manufacture and sale of its Enterisol® Ileitis product. View the complaint here.

Shire LLC et al. v. Roxane Laboratiores, Inc.
2:11-cv-03886; filed July 6, 2011 in the District Court of New Jersey

• Plaintiffs: Shire LLC; Shire Development Inc.
• Defendant: Roxane Laboratiores, Inc.

Shire LLC et al. v. Sandoz Inc.
3:11-cv-03787; filed June 30, 2011 in the District Court of New Jersey

• Plaintiffs: Shire LLC; Shire Development Inc.
• Defendant: Sandoz Inc.

Shire LLC et al. v. Amneal Pharmaceuticals, LLC
3:11-cv-03781; filed June 30, 2011 in the District Court of New Jersey

• Plaintiffs: Shire LLC; Shire Development Inc.
• Defendant: Amneal Pharmaceuticals, LLC

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 7,105,486 ("Abuse-resistant amphetamine compounds," issued September 12, 2006), 7,223,735 ("Abuse resistant lysine amphetamine compounds," issued May 29, 2007), 7,655,630 ("Abuse-resistant amphetamine prodrugs," issued February 2, 2010), 7,659,253 ("Abuse-resistant amphetamine prodrugs," issued February 9, 2010), 7,659,254 ("Abuse-resistant amphetamine prodrugs," issued February 9, 2010), 7,662,787 ("Abuse resistant lysine amphetamine compounds," issued February 16, 2010), 7,671,030 ("Abuse-resistant amphetamine prodrugs," issued March 2, 2010), 7,671,031 ("Abuse-resistant amphetamine prodrugs," issued March 2, 2010), 7,674,774 ("Abuse-resistant amphetamine prodrugs," issued March 9, 2010), 7,678,770 ("Abuse-resistant amphetamine prodrugs," issued March 16, 2010), 7,678,771 ("Abuse-resistant amphetamine prodrugs," issued March 16, 2010), 7,687,466 ("Abuse-resistant amphetamine prodrugs," issued March 30, 2010), 7,687,467 ("Abuse-resistant amphetamine prodrugs," issued March 30, 2010), 7,700,561 ("Abuse-resistant amphetamine prodrugs," issued April 20, 2010), 7,718,619 ("Abuse-resistant amphetamine prodrugs," issued May 18, 2010), 7,723,305 ("Abuse-resistant amphetamine prodrugs," issued May 25, 2010) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Shire's Vyvanse® (lisdexamfetamine dimesylate, used to treat Attention Deficit Hyperactivty Disorder). View the Sandoz complaint here. [NB: The complaint against Amneal does not assert U.S. Patent No. 7,659,254.]

Alcon Pharmaceuticals Ltd. et al. v. Lupin Ltd. et al.
1:11-cv-00587; filed July 1, 2011 in the District Court of Delaware

• Plaintiffs: Alcon Pharmaceuticals Ltd.; Alcon Research Ltd.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Alcon's Vigamox® (moxifloxacin, used to treat bacterial conjunctivitis). View the complaint here.

Orexo AB v. Mylan Pharmaceuticals Inc. et al.
3:11-cv-03788; filed June 30, 2011 in the District Court of New Jersey

• Plaintiff: Orexo AB
• Defendants: Mylan Pharmaceuticals Inc.; Mylan, Inc.

Infringement of U.S. Patent No. 6,761,910 ("Pharmaceutical Composition for the Treatment of Acute Disorders," issued July 13, 2004), licensed to Meda Pharmaceuticals, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Meda's Edluar (zolpidem sublingual tablets, used to treat short-term insomnia). View the complaint here.
Conference & CLE Calendar

July 10, 2011

July 16-19, 2011 – 2011 Annual Meeting; The Nuts & Bolts of Patent Prosecution Practice; and 2011 Patent Practice Update (National Association of Patent Practitioners) – Las Vegas, NV

July 18-19, 2011 – Hatch-Waxman Boot Camp*** (American Conference Institute) – San Diego, CA

July 20-21, 2011 – Advanced Forum on Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – San Francisco, CA

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

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

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

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

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

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

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

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

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

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

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

***Patent Docs is a media partner of this conference or CLE
Biosimilars and Biobetters Conference

July 8, 2011

The SMi Group will be holding its 2nd conference on Biosimilars and Biobetters from September 26-27, 2011 in London, UK. The conference will offer presentations on the following topics:

• The market for biosimilars: Unraveling the mystery;
• The EMA scientific advice compared with EMA guidelines;
• Industry interpretation the new guideline on biosimilar mAbs;
• Next generation monoclonal antibody development and clinical challenges with biosimilar drug development;
• EU litigation considerations and update;
• The ins and outs of the biosimilar regulatory pathway;
• The developing biosimilars regulatory framework in the U.S.;
• U.S. patent issues in biosimilars;
• Biosimilars: Patent protection issues;
• Maintaining a consistent quality standard of biosimilars;
• From imitation to innovation — Biosimilars are not generics;
• Making things last longer for less;
• Pharmacovigilance & biosimilar monoclonal antibodies: Practical considerations;
• Factors to be considered for biosimilar CMC development;
• GCSF biosimilar case study;
• Biosimilar sales forecast in seven unregulated markets in 2016: How large is the opportunity?
• Opportunities to drive your longer term biosimilars strategy — India and emerging market perspective.

Two post-conference workshops will be offered on September 28, 2011. The first workshop, entitled "How similar is similar?" will cover a variety of factors that dictate and determine exactly how similar is similar. The second workshop, entitled " A Global View of Biosimilars: Regulatory Analysis and Pricing Structure Case Studies," will examine the potential of companies with a strong biosimilars portfolio in emerging markets to expand into highly-regulated markets via alliances, M&A deals and utilization of post-marketing data.

The programme for the Biosimilars and Biobetters conference can be found here (Day 1), here (Day 2), and here (workshops). A complete brochure for this conference can be obtained here.

The registration fee for the conference is £1,399 and for each workshop is £599. Those registering for the conference by July 15, 2011 will receive a £200 discount. Those interested in registering for the conference and workshops can do so here.

Patent Docs is a supporting publication of the Biosimilars and Biobetters conference.
IPIC 85th Annual Meeting

July 8, 2011

The Intellectual Property Institute of Canada (IPIC) will be holding its 85th Annual Meeting on September 14-16, 2011 in Chicago, IL. Among the presentations being offered at the annual meeting are:

• Canada's Global Perspective on SR&ED (Scientific Research & Experimental Development) — pre-conference workshop;
• Building a 21st Century Patent System in the Digital Age — USPTO Director David Kappos;
• Contrasting Ethics in the Canadian and U.S. Courts — Chief Judge James F. Holderman of the U.S. District Court for the Northern District of Illinois and Honourable Roger T. Hughes of the Federal Court of Canada;
• Fraud on the Patent Office;
• Predictions on the Law of Sound Prediction;
• Growing Your International Business;
• Managing Multi-Jurisdictional Litigation;
• High Tech Subject Matter — What Can You Patent?
• United States Patent Office Roundtable; and
• The Post-Sanofi World.

A program for the meeting, including an agenda, descriptions of the scheduled sessions, and list of speakers, can be obtained here, and a brochure for the meeting can be obtained here.

The registration fee for the meeting is $1,890 (IPIC members), $2,090 (non-members), or $550 (IPLAC members) (attendees registering by August 12, 2011 will receive a discount of between $55 and $200). Additional registration fees are required for the meeting events. Those interested in registering for the meeting can do so here.
Pharmaceutical Law Academy 2011

July 8, 2011

IBC Legal Conferences will be holding its 8th Annual Pharmaceutical Law Academy on September 6-7, 2011 in London, UK. IBC Legal faculty will offer presentations on the following topics:

• Clinical trials;
• Legal aspects of paediatric medicines regulation;
• EU vertical and horizontal block exemption regulations — Implications for the pharmaceutical industry;
• Generics and biosimilars — Regulatory data protection and other related issues;
• Regulatory perspective — Pharmacovigilance & risk management plans;
• Regulatory case study & debate on case study;
• Research and development — The issues;
• SPCs — European case law update;
• Patent update;
• Dealing effectively with parallel trading issues;
• Follow-on Products;
• Pharma sector competition law developments; and
• Competition law and IP rights case study & debate on case study.

A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is £1798.80. Those registering by August 5, 2011 will receive a £100 discount. Those interested in registering for the conference can do so here, by calling +44 (0)20 7017 5503, or by faxing a registration form to +44 (0)20 7017 4746.
Docs at BIO: Session on IP Challenges for Personalized Medicine

July 7, 2011

By Andrew Williams —

On June 29, a panel at the 2011 BIO International Conference discussed the topic of "IP Challenges for Personalized Medicine: Navigating Bilski, Myriad, and Prometheus." This session addressed one of the most prevalent issues at this year's conference — are the courts going to alter the intellectual property landscape for biomarkers and personalized medicine? As moderator, Jennifer Gordon of Baker Botts L.L.P. began the session by providing a definition for personalized medicine — a definition that included at its core the ability to "classify individuals into sub-populations." And how is this accomplished? By identifying biomarkers (compositions of matter), and building diagnostics around them (methods). As a result, Dr. Gordon identified three IP challenges: (1) potential limitations on meaningful claim coverage for composition of matter claims; (2) potential limitations on meaningful claim coverage for companion diagnostic claims; (3) and the proliferation of patent thickets that results when many patents cover a particular diagnostic.

Hans Sauer, Associate General Counsel of BIO, addressed the first of these challenges by introducing and discussing the Myriad case (Association for Molecular Pathology v. USPTO). Dr. Sauer pointed out the differences of this case as compared to other patent cases, specifically noting that the plaintiffs brought this suit on behalf of breast cancer survivors by attempting to reach the patent holder of a diagnostic test related to the risk of developing breast and ovarian cancer. This is distinct from the typical patent case in which both of the parties are commercial actors. In his general observations of the case, Dr. Sauer noted that there are two types of claims at issue, broad method claims and composition-of-matter claims, otherwise referred to here as "gene patents." And gene patents, because they are claimed as isolated DNA, are legally indistinguishable from other biological chemicals such as proteins and antibodies. Dr. Sauer opined that what the courts are being asked to decide is what does it take to go from a discovery to an invention? In other words, how much human intervention is enough? Of course, merely isolating and purifying a composition of matter has never been enough to obtain a patent, because a patentee still needs to meet the requirements that the invention be new, useful, and non-obvious, for example. The Patent Office does not simply give away gene patents. Therefore, as Dr. Sauer concluded, patent eligibility might not be the best tool to address these issues.

Mark Seka, Global Head of IP for Novartis Molecular Diagnostics, addressed the second identified challenge, the limitation on meaningful claim coverage for companion diagnostic claims, by specifically discussing the Prometheus case (Prometheus Laboratories, Inc. v. Mayo Collaborative Services). At the outset, Mr. Seka noted that personalized medicine is basically a spin-off technology from the human genome project, and that the original mapping was just the beginning. Because it is very costly to bring such a diagnostic invention to market, the cases currently making their way through the court system are threatening the ability of commercial enterprises to recoup their investments through the protection of their intellectual property. Mr. Seka noted that the Prometheus case involved two types of claims, those that test a patient's blood to determine the presence of an analyte with a therapeutic administrative step, and those that just contain the testing step. The Federal Circuit reversed a summary judgment ruling that the claims are patent ineligible because they recite a natural phenomenon. The Federal Circuit used the machine or transformation test, and found that because both types of claims involved a transformation, they were both patent eligible. However, in the wake of the Supreme Court's Bilski ruling, in which it held that the machine or transformation test was not the only test to determine patent eligibility, the Court remanded the case to the Federal Circuit to render a decision consistent with the Bilski ruling. Mr. Seka noted that the Supreme Court did not dispense with the machine or transformation test, and so the Federal Circuit was able to reach the same result. Of course, just recently, four Justices voted to take up the Prometheus in the next term, so the uncertainty continues.

Dr. Sauer played devil's advocate by asking Mr. Seka whether the patentees in Prometheus were just using old knowledge, and therefore asked if they were really entitled to patent protection. After all, weren't the drugs old, and didn't the patentees just discover that the drug was metabolized — is that enough for patent protection? Mr. Seka responded two-fold. First, the issue being decided is not whether the methods are novel, but rather whether you can even get in the door of the Patent Office with such claims. Second, it is the correlation that is the silver bullet — the invention converted an ineffective treatment to an effective one. Dr. Sauer followed up by questioning Mayo's motivation in bringing such a suit, and asking why Mayo finds such claims so objectionable. A possible answer was supplied by the final panelist — because access to treatment is being blocked.

Kristin Neuman, on behalf of MPEG LA, LLC, addressed the final challenge — that of patent thickets, or multiple patents covering a diagnostic method owned by multiple parties (Ms. Neuman's presentation can be found here). She started out noting that there is something different about diagnostic claims, because the market would like these tests to be freely available. In fact, she believes that the Myriad case is actually about the business model of exclusivity. As an alternative, she suggested that the proper model might be that of the non-exclusive license. MPEG LA was involved in pioneering modern patent pool licensing with the MPEG-2 standard, allowing multiple users to acquire patent rights from multiple patent holder. Such licensees account for most MPEG-2 products in the market, including TVs, DVD players, set-top boxes, etc. Ms. Neuman noted that a similar issue exists in for personalized medicine, citing a study looking at Lynch Syndrome, which is a predisposition to various cancers. They found that ten institutions, including both universities and companies, owned patents related to this syndrome. The problem is that one patent holder can hold back access to the technology. Ms. Neuman explained that the goal of MPEG LA was to help clear patent rights to make the technology widely available to the public. As a result, they are developing Librassay^TM, which is a web-based store of molecular diagnostic patent rights. The vision of Librassay is larger than any single disease or test, and is not limited to gene patents. With this system, the patents are grouped in meaningful categories to help customize a particular license while maintaining reasonable fees. Dr. Sauer asked if there were any other services included, such as enforcement. Ms. Neuman explained that the pool wouldn't enforce the patent rights, but it could help the owners coordinate their resources. However, MPEG LA's experience has been that there are very few enforcement actions because it is easier to join the pool than hold out.

Overall, the panel thoughtfully addressed the challenges that were identified at the outset, and provided interesting and thought-provoking perspectives from individuals that deal with these issues, sometimes on a daily basis. In addition, the panel provided plenty of interaction for the speakers, both from within the panel, and from the audience. Clearly, those in attendance, as well as just about every other member of the patent bar, will be paying close attention to how these issues play out in the upcoming year.

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